The IN.PACT SFA Clinical Study for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery Using the IN.PACT Admiral™ Drug-Eluting Balloon in a Chinese Patient Population

Atherosclerosis Clinical Trial

Official title:

The IN.PACT SFA Clinical Study for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery Using the IN.PACT Admiral™ Drug-Eluting Balloon in a Chinese Patient Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02118532
• Other study ID #: IN.PACT SFA China
• Status: Completed
• Phase: N/A
• First received: April 11, 2014
• Last updated: December 29, 2016
• Start date: March 2014
• Est. completion date: September 2016

Study information

• Verified date: December 2016
• Source: Medtronic Endovascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to confirm that the IN.PACT Admiral is safe and effective for the interventional treatment of new and non-stented restenotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA) in Chinese patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age = 18 years and = 85 years.

• Subject with documented diagnosis of peripheral arterial disease (PAD) classified as Rutherford class 2-3-4 in the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) above the knee, located in the arterial segment starting at least 1 cm beyond the Common femoral artery (CFA) bifurcation between the superficial and profunda femoris arteries (proximal anatomical landmark to the distal P1 segment of the popliteal artery at the level of the proximal edge of the patella (distal anatomical landmark).

• Target lesion consists of a single de novo or non-stented restenotic lesion (or a tandem lesion) or is a combination lesion

• Reference vessel diameter = 4 mm and = 7 mm by visual estimate.

• Subject able to walk without assistive devices (e.g. walker, cane).

• If subject has ipsilateral/contralateral iliac disease that requires treatment during the index procedure

• Angiographic evidence of adequate distal run-off to the foot (at least one native calf vessel [posterior tibial, anterior tibial, or peroneal arteries] is patent, defined as < 50% diameter stenosis).

• Female subjects of childbearing potential must have a negative pregnancy test = 7 days before index procedure and willing to use a reliable method of birth control for the duration of the study or must have documented adequate birth control.

• Signed and dated Patient Informed Consent (PIC) form.

• Understands and accepts the duration of the study and is able and willing to comply with all requirements, including follow-up visits and evaluations.

• Life expectancy, in the Investigator's opinion, of at least 12 months.

Exclusion Criteria:

• In the investigator's opinion subject is unlikely to comply with the followup schedule.

• Stroke or STEMI within the 3 months prior to index procedure.

• Either local or systemic thrombolytic therapy within 48 hours prior to the index procedure.

• Inability to tolerate oral anticoagulation therapy (blood thinners such as warfarin) while on concomitant dual antiplatelet therapy (DAPT).

• Known allergies or sensitivities to heparin, aspirin (ASA), other anticoagulant/anti-platelet therapies, and/or paclitaxel or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure.

• Breastfeeding woman.

• Chronic renal insufficiency with serum creatinine > 2.5 mg/dL within 14 days prior to index procedure.

• WBC < 3.0 (3,000 cells/mm3) within 14 days prior to index procedure.

• PLT count < 80,000 cells/mm3 or > 700,000 cells/mm3 within 14 days prior to index procedure.

• Known or suspected active systemic infection evidenced by WBC > 14.0 (14000/mm3) within 14 days prior to index procedure.

• Diagnosed with bleeding diatheses or hypercoagulable state.

• Subject is enrolled in another investigational device, drug or biologic study or subject was previously enrolled to the IN.PACT SFA China trial.

• Any major (e.g., cardiac. peripheral, abdominal) surgical procedure or intervention performed within 30 days prior to the index procedure.

• Any major (e.g., cardiac. peripheral, abdominal) elective procedure or intervention within 30 days post index procedure.

• Contralateral SFA/PPA disease requiring treatment in the same setting as index procedure.

• Presence of additional lesions in the target vessel that require treatment during index procedure but do not meet the definitions of tandem lesions.

• Target lesion is an in-stent or post-DEB restenosis or has been previously treated with bypass surgery.

• Failure to successfully cross the target lesion with a guide wire

• Lesion within or adjacent to an aneurysm.

• Acute or sub-acute thrombus in the target vessel.

• Angiographic evidence of severe calcification

• Target lesion known in advance of enrollment to require treatment with alternative therapy such as drug-eluting stent (DES), drug-eluting balloon (DEB), laser, atherectomy, cryoplasty, re-entry devices, cutting/scoring balloon, brachytherapy. Use of embolic protection devices is also prohibited.

• Pre-dilation resulted in a major ( = Grade D) flow-limiting dissection (observed on 2 orthogonal views) or residual stenosis > 70% and translesional peak gradient > 10mm Hg.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Device:
• IN.PACT Admiral Paclitaxel-Eluting Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
IN.PACT Admiral Paclitaxel-Eluting Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter originally developed, approved and commercialized by Invatec Technology Center GmbH is the investigational medical device used in the study. Medtronic Inc. acquired Invatec on April 21, 2010. Medtronic

Locations

Country	Name	City	State
China	301 Hospital/Chinese PLA General Hospital	Beijing
China	Anzhen Hospital, Capital Medical University	Beijing
China	Peking University First Hospital	Beijing
China	Xuanwu Hospital, Capital Medical University	Beijing
China	West China Hospital	Chengdu
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing
China	The First Affiliated Hospital, Dalian Medical University	Dalian
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou
China	The 1stAffiliated Hospital of Sun Yat-sen University	Guangzhou
China	The 2nd Affiliated Hospital of Harbin Medical University	Harbin
China	The first affiliated Hospital of Harbin Medical University	Harbin
China	Nanjing Drum Tower Hospital	Nanjing
China	Shanghai 9th People Hospital Affiliated Shanghai Jiao Tong University School of Medecine	Shanghai
China	Zhongshan Hospital, Fudan University	Shanghai
China	Shengjing Hospital of China Medical University	Shenyang

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Endovascular

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary effectiveness endpoint: Primary patency within 12 months post-index procedure	Primary patency is defined as freedom from clinically-driven target lesion revascularization (TLR)1 and freedom from restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) = 2.4	12 months	No
Primary	Primary Safety Endpoint	A composite of freedom from device- and procedure-related mortality, freedom from major target limb amputation and freedom from clinicallydriven TLR within 30-day post-index procedure	30 days post-index procedure	Yes
Secondary	Major Adverse Events	MAE is defined as all-cause mortality, clinically-driven Target Vessel Revascularization (TVR), major target limb amputation or thrombosis at the target lesion site, through 12 months	12 months	Yes
Secondary	Death of any cause	Death of any cause at 30 days, 6 and 12 months	30 days, 6 and 12 months	Yes
Secondary	Target Lesion Revascularization	Clinically-driven TLR at 30 days, 6 and 12 months TLR at 6 and 12 months	30 days, 6 and 12 months	Yes
Secondary	Target Vessel Revascularization	Clinically-driven TVR at 30 days, 6 and 12 months TVR at 6 and 12 months	30 days, 6 and 12 months	Yes
Secondary	Major target limb amputation	Major target limb amputation at 30 days, 6 and 12 months	30 days, 6 and 12 months	Yes
Secondary	Thrombosis at the target lesion site	Thrombosis at the target lesion site at 30 days, 6 and 12 months	30 days, 6 and 12 months	Yes
Secondary	Time to first clinically-driven Target Lesion Revascularization	Time to first clinically-driven TLR through 12 months post-index procedure	12 months	Yes
Secondary	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 and 12 months	No
Secondary	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 and 12 months	No
Secondary	Duplex-defined binary restenosis (PSVR > 2.4) of the target lesion	Duplex-defined binary restenosis (PSVR > 2.4) of the target lesion at 6 and 12 months post-index procedure, or at the time of reintervention prior to any pre-specified time point	6 and 12 months	Yes
Secondary	Duplex-defined binary restenosis (PSVR > 3.4) of the target lesion	Duplex-defined binary restenosis (PSVR > 3.4) of the target lesion at 6 and 12 months post-index procedure, or at the time of reintervention prior to any pre-specified time point	6 and 12 months	No
Secondary	Walking capacity assessment	Walking capacity assessment by Walking Impairment Questionnaire (WIQ) at 30 days, 6 and 12 months	30 days, 6 and 12 months	No
Secondary	Walking distance	Walking distance as assessed by 6 Minute Walk Test (6MWT) at 30 days, 6 and 12 months as change from baseline	30 days, 6 and 12 months	No
Secondary	Quality of life assessment	Quality of life assessment by EQ5D questionnaire at 30 days, 6 and 12 months as change from baseline	30 days, 6 and 12 months	No
Secondary	Device success	Device success is defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP).	Post procedure	No
Secondary	Procedural success	Procedural success is defined as residual stenosis of = 50% (non-stented subjects) or = 30% (stented subjects) by core lab assessment.	Post procedure	No
Secondary	Clinical success	Clinical success is defined as procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge.	Post procedure	No
Secondary	Days of hospitalization due to the target lesion	Days of hospitalization due to the target lesion from procedure through 6 and 12 months	6 and 12 months	No