IN.PACT Global Clinical Study

Peripheral Arterial Disease Clinical Trial

Official title:

The IN.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the IN.PACT Admiral™ Drug-Eluting Balloon.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01609296
• Other study ID #: 10048613
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: January 17, 2020

Study information

• Verified date: February 2021
• Source: Medtronic Endovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to collect safety and efficacy data on the IN.PACT Admiral™ Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease in the superficial femoral and/or popliteal arteries in a "real world" patient population.

Description:

Peripheral artery disease (PAD) commonly results from progressive narrowing of the arteries in the lower extremities, usually due to atherosclerosis. Progression of PAD can result in critical limb ischemia (CLI), manifested by ischemic pain at rest or in the breakdown of the skin, resulting in ulcers or gangrene which ultimately may lead to amputation and death. The IN.PACT Global Clinical Study aims to expand and understand the safety and efficacy data on the IN.PACT Admiral™ DEB in a real world population of subjects with intermittent claudication and/or rest pain (Rutherford class 2-3-4) due to obstructive disease of the superficial femoral and/or popliteal arteries.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1535
• Est. completion date: January 17, 2020
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

General inclusion Criteria:

• Age = 18 years or minimum age as required by local regulations.
• Subject with documented diagnosis of peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and/or popliteal artery (PA) (including P1, P2, P3) classified as Rutherford class 2-3-4.
• Angiographically documented single or multiple lesions/occlusions (de novo or re-stenotic lesion(s) or in-stent restenosis) within the target vessels with a minimum lesion length of 2 cm including bilateral disease if both limbs are treated within 35 days.

General exclusion Criteria:

• High probability of non-adherence to Clinical Investigation Protocol follow-up requirements.
• Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations).
• Lesion within or adjacent to an aneurysm or presence of a popliteal aneurysm.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• IN.PACT Admiral™ Drug Eluting Balloon
IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon.

Locations

Country	Name	City	State
Argentina	Fundación Favaloro	Buenos Aires
Argentina	Clinica La Sagrada Familia	Bueos Aires
Australia	Royal Prince Alfred Hospital	Sydney
Austria	Medizinische Universität Graz	Graz
Austria	Landesklinikum Thermenregion Mödling	Mödling
Belgium	Onze-Lieve-Vrouwziekenuis	Aalst
Belgium	Imelda Ziekenhuis	Bonheiden
Belgium	AZ St. Blasius	Dendermonde
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	Ziekenhuis Oost Limburg - Campus St.-Jan	Genk
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	Regionaal Ziekenhuis Heilig Hart	Tienen
Canada	Centre hospitalier universitaire Sherbrooke (CHUS)	Sherbrooke
Canada	Toronto General Hospital	Toronto
Colombia	Clinica Santa Maria	Medellin
Colombia	Clinica Medilaser Neiva	Neiva
Czechia	Faculty Hospital Hradec Kralove	Hradec Kralove
Egypt	As-Salam International Hospital	Cairo
Egypt	Egypt Air Hospital	Cairo
Finland	Helsingin Seudun Yliopistollinen Keskussairaala	Helsinki
France	Group Hospitalier Pellegrin - CHU	Bordeaux Cedex
France	Les Hospitaux Universitaires de Strasbourg	Strasbourg
Germany	Herzzentrum Bad Krozingen	Bad Krozingen
Germany	Augusta-Krankenhaus	Duesseldorf
Germany	Augusta Krankenhaus	Düsseldorf
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Park-Krankenhaus Leipzig	Leipzig
Germany	Universitatsklinikum Leipzig AoR	Leipzig
Germany	St. Franziskus Hospital GmbH	Münster
Germany	RoMed Klinikum Rosenheim	Rosenheim
Germany	Universitätsklinikum Tübingen	Tübingen
Greece	University Hospital of Patras	Patra
Hungary	Semmelweis University	Budapest
Hungary	Bacs Kiskun Megyei Korhaz	Kecskemét
Israel	Carmel Medical Centre	Haifa
Israel	Rabin Medical Center - Beilison Hospital	Petach Tikva
Italy	Policlinico Vittorio Emanuele	Catania
Italy	Maria Eleonora Hospital	Palermo
Italy	Policlinico Gemelli	Rome
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Severence Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Lithuania	Kaunas Mecial University Clinic	Kaunas
Netherlands	Jeroen Bosch Ziekenhuis	's Hertogenbosch
Netherlands	Rijnstate Ziekenhuis	Arnhem
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Sint Antonius Hospital	Nieuwegein
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht
Poland	Euromedic Medical Center	Katowice
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 2	Szczecin
Portugal	Hospital Santa Marta	Lisbon
Russian Federation	City Clinical Hospital named after M.E. Zhadkevich	Moscow
Singapore	Changi General Hospital	Singapore
Slovakia	Stredoslovensky ustav srdcovych a cievnych chorob (SUSCCH)	Banská Bystrica
Slovakia	Národný ústav srdcových a cievnych chorôb a.s. (NUSCH)	Bratislava
Slovakia	Východoslovenský ústav srdcových a cievnych chorôb, a.s.(VUSH)	Kosice
Slovenia	University Medical Centre Maribor	Maribor
Sweden	Karolinska Universitetssjukhuset	Solna
Switzerland	Inselspital - Universitätsspial Bern	Bern
Switzerland	Hopital Cantonal HFR	Fribourg
Switzerland	Kantonspital Luzern	Luzern
United Kingdom	Manchester Royal Infirmary	Manchester
United Kingdom	Northern General Hospital	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Endovascular

Countries where clinical trial is conducted

Argentina,  Australia,  Austria,  Belgium,  Canada,  Colombia,  Czechia,  Egypt,  Finland,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Korea, Republic of,  Lithuania,  Netherlands,  Poland,  Portugal,  Russian Federation,  Singapore,  Slovakia,  Slovenia,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Cohort ITT - Primary Effectiveness Endpoint	Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI = 20% or > 0.15 when compared to post-index procedure baseline ABI.	12 months
Primary	Clinical Cohort ITT - Primary Safety Endpoint	A composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 12 months post-index procedure.	12 months
Primary	Imaging Cohort ITT - Primary Effectiveness Endpoint	Primary Patency within 12 months post-index procedure, which is defined as: Freedom from clinically-driven TLR and; Freedom from restenosis as determined by DUS Peak Systolic Velocity Ratio (PSVR) = 2.4.; Restenosis determined by either PSVR >2.4 as assessed by an independent DUS core lab or >50% stenosis as assessed by an independent angiographic core lab.	12 months
Primary	150mm DEB ITT Cohort - Primary Effectiveness Endpoint	Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI = 20% or > 0.15 when compared to post-index procedure baseline ABI.	12 months
Secondary	Clinical Cohort ITT - MAEs	MAE (Major Adverse Events) is defined as all-cause mortality, clinically-driven TVR (Target Vessel Revascularization), major target limb amputation, thrombosis at the target lesion site.	12 months
Secondary	Clinical Cohort ITT - TLR	Any Target lesion revascularisation	12 months
Secondary	Clinical Cohort ITT - TVR	Any Target vessel revascularisation	12 months.
Secondary	Clinical Cohort ITT - Device Success	Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)	Index-procedure
Secondary	Clinical Cohort ITT - Clinical Success	Clinical success is defined as procedural success without procedural complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge	prior to discharge
Secondary	Clinical Cohort ITT - MAEs	MAE (Major Adverse Events) is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.	60 months
Secondary	Clinical Cohort ITT - Clinically-driven TLR	Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of = 20% or > 0.15 when compared to post-index procedure baseline ABI.	60 months
Secondary	Clinical Cohort ITT - TVR		60 months
Secondary	Clinical Cohort ITT - TLR		60 months
Secondary	Clinical Cohort ITT - Time to First Clinically-driven TLR (Days)		60 months
Secondary	Clinical Cohort ITT - MAEs	Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 30 days.	30 days
Secondary	Clinical Cohort ITT - MAEs	MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site	6 Months
Secondary	Clinical Cohort ITT - MAEs	MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.	24 Months
Secondary	Clinical Cohort ITT - MAEs	MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.	36 Months
Secondary	Clinical Cohort ITT - MAEs	MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.	48 Months
Secondary	Clinical Cohort ITT - Clinically-driven TLR	Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of = 20% or > 0.15 when compared to post-index procedure baseline ABI.	30 days
Secondary	Clinical Cohort ITT - Clinically-driven TLR	Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of = 20% or > 0.15 when compared to post-index procedure baseline ABI.	6 Months
Secondary	Clinical Cohort ITT - Clinically-driven TLR	Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of = 20% or > 0.15 when compared to post-index procedure baseline ABI.	24 Months
Secondary	Clinical Cohort ITT - Clinically-driven TLR	Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of = 20% or > 0.15 when compared to post-index procedure baseline ABI.	36 Months
Secondary	Clinical Cohort ITT - Clinically-driven TLR	Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of = 20% or > 0.15 when compared to post-index procedure baseline ABI.	48 Months
Secondary	Clinical Cohort ITT - TLR	Any Target lesion revascularisation	6 Months
Secondary	Clinical Cohort ITT - TLR	Any Target lesion revascularisation	24 Months
Secondary	Clinical Cohort ITT - TLR	Any Target lesion revascularisation	36 Months
Secondary	Clinical Cohort ITT - TLR	Any Target lesion revascularisation	48 Months
Secondary	Clinical Cohort ITT - TVR	Any Target lesion revascularisation	24 Months
Secondary	Clinical Cohort ITT - TVR	Any Target lesion revascularisation	36 Months
Secondary	Clinical Cohort ITT - TVR	Any Target lesion revascularisation	48 Months
Secondary	Clinical Cohort ITT - TVR	Any Target lesion revascularisation	6 Months
Secondary	Clinical Cohort ITT - Time to All-cause Mortality Through 60 Months Post-index Procedure.	All-cause mortality is reported by using the survival estimate of all cause mortality through 60 months	60 months
Secondary	Clinical Cohort ITT - Primary Sustained Clinical Improvement	Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects	6 Months
Secondary	Clinical Cohort ITT - Primary Sustained Clinical Improvement	Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects	12 Months
Secondary	Clinical Cohort ITT - Primary Sustained Clinical Improvement	Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects	24 Months
Secondary	Clinical Cohort ITT - Primary Sustained Clinical Improvement	Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects	36 Months
Secondary	Clinical Cohort ITT - Secondary Sustained Clinical Improvement	Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	6 Months
Secondary	Clinical Cohort ITT - Secondary Sustained Clinical Improvement	Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	12 Months
Secondary	Clinical Cohort ITT - Secondary Sustained Clinical Improvement	Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	24 Months
Secondary	Clinical Cohort ITT - Secondary Sustained Clinical Improvement	Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	36 Months
Secondary	Clinical Cohort ITT - Immediate Hemodynamic Improvement at Post-index Procedure	Immediate hemodynamic improvement is defined as an ABI improvement of = 0.1 or to an ABI = 0.9	Post procedure
Secondary	Clinical Cohort ITT - Sustained Hemodynamic Improvement	Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with = 0.1 as compared to baseline values or to an ABI = 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	6 Months
Secondary	Clinical Cohort ITT - Sustained Hemodynamic Improvement	Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with = 0.1 as compared to baseline values or to an ABI = 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	12 Months
Secondary	Clinical Cohort ITT - Sustained Hemodynamic Improvement	Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with = 0.1 as compared to baseline values or to an ABI = 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	24 Months
Secondary	Clinical Cohort ITT - Sustained Hemodynamic Improvement	Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with = 0.1 as compared to baseline values or to an ABI = 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	36 Months
Secondary	Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)		6 Months
Secondary	Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)		12 Months
Secondary	Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)		24 Months
Secondary	Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)		36 Months
Secondary	Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)	The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.	6 Months
Secondary	Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)	The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.	12 Months
Secondary	Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)	The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.	24 Months
Secondary	Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)	The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.	36 Months
Secondary	Clinical Cohort ITT - Procedural Success	Procedural Success is defined as residual stenosis of = 50% (non-stented subjects) or = 30% (stented subjects) by visual estimate	at procedure
Secondary	Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 2.0) of the Target Lesion		at 12 months, or at the time of re-intervention
Secondary	Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 3.4) of the Target Lesion		At 12 months, or at the time of re-intervention
Secondary	150mm DEB ITT Cohort - MAEs	Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 30 days.	30 days
Secondary	150mm DEB ITT Cohort - MAEs	Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 6 months.	6 months
Secondary	150mm DEB ITT Cohort - MAEs	Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 12 months.	12 months
Secondary	150mm DEB ITT Cohort - MAEs	Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 24 months.	24 months
Secondary	150mm DEB ITT Cohort - MAEs	Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 36 months.	36 months
Secondary	150mm DEB ITT Cohort - MAEs	Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 48 months.	48 months
Secondary	150mm DEB ITT Cohort - MAEs	Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 60 months.	60 months
Secondary	150mm DEB ITT Cohort - Clinically-driven TLR	Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of = 20% or > 0.15 when compared to post-index procedure baseline ABI.	30 days
Secondary	150mm DEB ITT Cohort - Clinically-driven TLR	Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of = 20% or > 0.15 when compared to post-index procedure baseline ABI.	6 months
Secondary	150mm DEB ITT Cohort - Clinically-driven TLR	Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of = 20% or > 0.15 when compared to post-index procedure baseline ABI.	24 months
Secondary	150mm DEB ITT Cohort - Clinically-driven TLR	Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of = 20% or > 0.15 when compared to post-index procedure baseline ABI.	36 months
Secondary	150mm DEB ITT Cohort - Clinically-driven TLR	Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of = 20% or > 0.15 when compared to post-index procedure baseline ABI.	48 months
Secondary	150mm DEB ITT Cohort - Clinically-driven TLR	Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of = 20% or > 0.15 when compared to post-index procedure baseline ABI.	60 months
Secondary	150mm DEB ITT Cohort - TLR	Any Target lesion revascularisation	6 Months
Secondary	150mm DEB ITT Cohort - TLR	Any Target lesion revascularisation	12 Months
Secondary	150mm DEB ITT Cohort - TLR	Any Target lesion revascularisation	24 Months
Secondary	150mm DEB ITT Cohort - TLR	Any Target lesion revascularisation	36 Months
Secondary	150mm DEB ITT Cohort - TLR	Any Target lesion revascularisation	48 Months
Secondary	150mm DEB ITT Cohort - TLR	Any Target lesion revascularisation	60 Months
Secondary	150mm DEB ITT Cohort - TVR	Any Target lesion revascularisation	6 Months
Secondary	150mm DEB ITT Cohort - TVR	Any Target lesion revascularisation	12 Months
Secondary	150mm DEB ITT Cohort - TVR	Any Target lesion revascularisation	24 Months
Secondary	150mm DEB ITT Cohort - TVR	Any Target lesion revascularisation	36 Months
Secondary	150mm DEB ITT Cohort - TVR	Any Target lesion revascularisation	48 Months
Secondary	150mm DEB ITT Cohort - TVR	Any Target lesion revascularisation	60 Months
Secondary	150mm DEB ITT Cohort - Time to First Clinically-driven TLR (Days)		60 months
Secondary	150mm DEB ITT Cohort - Time to All-cause Mortality Through 60 Months Post-index Procedure.	All-cause mortality is reported by using the survival estimate of all-cause mortality through 60 months	60 months
Secondary	150mm DEB ITT Cohort - Primary Sustained Clinical Improvement	Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	6 months.
Secondary	150mm DEB ITT Cohort - Primary Sustained Clinical Improvement	Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	12 months.
Secondary	150mm DEB ITT Cohort - Primary Sustained Clinical Improvement	Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	24 months
Secondary	150mm DEB ITT Cohort - Primary Sustained Clinical Improvement	Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	36 months
Secondary	150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement	Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	6 Months
Secondary	150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement	Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	12 Months
Secondary	150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement	Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	24 Months
Secondary	150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement	Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	36 Months
Secondary	150mm DEB ITT Cohort - Immediate Hemodynamic Improvement at Post-index Procedure	Immediate hemodynamic improvement is defined as an ABI improvement of = 0.1 or to an ABI = 0.9	Post procedure
Secondary	150mm DEB ITT Cohort - Sustained Hemodynamic Improvement	Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with = 0.1 as compared to baseline values or to an ABI = 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	6 Months
Secondary	150mm DEB ITT Cohort - Sustained Hemodynamic Improvement	Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with = 0.1 as compared to baseline values or to an ABI = 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	12 Months
Secondary	150mm DEB ITT Cohort - Sustained Hemodynamic Improvement	Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with = 0.1 as compared to baseline values or to an ABI = 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	24 Months
Secondary	150mm DEB ITT Cohort - Sustained Hemodynamic Improvement	Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with = 0.1 as compared to baseline values or to an ABI = 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.	36 Months
Secondary	150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)		6 Months
Secondary	150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)		12 Months
Secondary	150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)		24 Months
Secondary	150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)		36 Months
Secondary	150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)	The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.	6 Months
Secondary	150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)	The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.	12 Months
Secondary	150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)	The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.	24 Months
Secondary	150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)	The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.	36 Months
Secondary	150mm DEB ITT Cohort - Device Success	Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)	Index-procedure
Secondary	150mm DEB ITT Cohort - Procedural Success	Procedural Success is defined as residual stenosis of = 50% (non-stented subjects) or = 30% (stented subjects) by visual estimate	at procedure
Secondary	150mm DEB ITT Cohort - Clinical Success	Clinical success is defined as procedural success without procedural complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge	prior to discharge
Secondary	Clinical Cohort ITT - All-cause Mortality		30 days
Secondary	Clinical Cohort ITT - All-cause Mortality		6 Months
Secondary	Clinical Cohort ITT - All-cause Mortality		12 Months
Secondary	Clinical Cohort ITT - All-cause Mortality		24 Months
Secondary	Clinical Cohort ITT - All-cause Mortality		36 Months
Secondary	Clinical Cohort ITT - All-cause Mortality		48 Months
Secondary	Clinical Cohort ITT - All-cause Mortality	The difference in death count calculation between the compliance table (participant flow: 253 deaths) and the event table (244 deaths) is explained as follow: Calendar days (365/year) is used for compliance table whereas 360-day annual cutoff is used for event rate calculation; Compliance table used visit window as specified by protocol (60 days for 5-year follow-up) whereas, not window is used for event rate calculation; Nine patients died between 1801 and 1885 (1825 + 60) and were therefore not included in the 5-year death rate summary but were included in the compliance summary for patients that died through the upper window of the 60 month visit.; The denominator of 1215 for 1800-day event rate includes those who had an event within 1800 days and those who did not have any event but had at least 1740 days of follow-up (1740 is the low bound of the 60-day visit window from the target day of 1800)	60 Months
Secondary	Clinical Cohort ITT - Clinically-driven TVR	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of = 20% or > 0.15 when compared to post-index procedure baseline ABI.	30 days
Secondary	Clinical Cohort ITT - Clinically-driven TVR	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of = 20% or > 0.15 when compared to post-index procedure baseline ABI.	6 Months
Secondary	Clinical Cohort ITT - Clinically-driven TVR	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of = 20% or > 0.15 when compared to post-index procedure baseline ABI.	12 Months
Secondary	Clinical Clinical Cohort ITT - Clinically-driven TVR	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of = 20% or > 0.15 when compared to post-index procedure baseline ABI.	24 Months
Secondary	Clinical Cohort ITT - Clinically-driven TVR	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of = 20% or > 0.15 when compared to post-index procedure baseline ABI.	36 Months
Secondary	Clinical Cohort ITT - Clinically-driven TVR	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of = 20% or > 0.15 when compared to post-index procedure baseline ABI.	48 Months
Secondary	Clinical Cohort ITT - Clinically-driven TVR	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of = 20% or > 0.15 when compared to post-index procedure baseline ABI.	60 Months
Secondary	Clinical Cohort ITT - Major Target Limb Amputation		30 days
Secondary	Clinical Cohort ITT - Major Target Limb Amputation		6 Months
Secondary	Clinical Cohort ITT - Major Target Limb Amputation		12 Months
Secondary	Clinical Cohort ITT - Major Target Limb Amputation		24 Months
Secondary	Clinical Cohort ITT - Major Target Limb Amputation		36 Months
Secondary	Clinical Cohort ITT - Major Target Limb Amputation		48 Months
Secondary	Clinical Cohort ITT - Major Target Limb Amputation		60 Months
Secondary	150mm DEB ITT Cohort - All-cause Mortality		30 days
Secondary	150mm DEB ITT Cohort - All-cause Mortality		6 Months
Secondary	150mm DEB ITT Cohort - All-cause Mortality		12 Months
Secondary	150mm DEB ITT Cohort - All-cause Mortality		24 Months
Secondary	150mm DEB ITT Cohort - All-cause Mortality		36 Months
Secondary	150mm DEB ITT Cohort - All-cause Mortality		48 Months
Secondary	150mm DEB ITT Cohort - All-cause Mortality		60 Months
Secondary	150mm DEB ITT Cohort - Clinically-driven TVR	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of = 20% or > 0.15 when compared to post-index procedure baseline ABI.	30 days
Secondary	150mm DEB ITT Cohort - Clinically-driven TVR	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of = 20% or > 0.15 when compared to post-index procedure baseline ABI.	6 Months
Secondary	150mm DEB ITT Cohort - Clinically-driven TVR	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of = 20% or > 0.15 when compared to post-index procedure baseline ABI.	12 Months
Secondary	150mm DEB ITT Cohort - Clinically-driven TVR	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of = 20% or > 0.15 when compared to post-index procedure baseline ABI.	24 Months
Secondary	150mm DEB ITT Cohort - Clinically-driven TVR	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of = 20% or > 0.15 when compared to post-index procedure baseline ABI.	36 Months
Secondary	150mm DEB ITT Cohort - Clinically-driven TVR	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of = 20% or > 0.15 when compared to post-index procedure baseline ABI.	48 Months
Secondary	150mm DEB ITT Cohort - Clinically-driven TVR	Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of = 20% or > 0.15 when compared to post-index procedure baseline ABI.	60 Months
Secondary	150mm DEB ITT Cohort - Major Target Limb Amputation		30 days
Secondary	150mm DEB ITT Cohort - Major Target Limb Amputation		6 Months
Secondary	150mm DEB ITT Cohort - Major Target Limb Amputation		12 Months
Secondary	150mm DEB ITT Cohort - Major Target Limb Amputation		24 Months
Secondary	150mm DEB ITT Cohort - Major Target Limb Amputation		36 Months
Secondary	150mm DEB ITT Cohort - Major Target Limb Amputation		48 Months
Secondary	150mm DEB ITT Cohort - Major Target Limb Amputation		60 Months