PMCF Study for Peripheral Arteries Above the Knee (ATK)

Peripheral Arterial Disease Clinical Trial

Official title:

A Retrospective PMCF Study Evaluating the Safety and Clinical Performance of the S.M.A.R.T. Flex Stent Iliac, S.M.A.R.T. Flex SFA/PP, S.M.A.R.T. Control Nitinol Stent, S.M.A.R.T. Nitinol Stent, PALMAZ Blue .018 Peripheral Stent on Slalom, PALMAZ Genesis .035 Peripheral Stent on Opta Pro, SABER OTW PTA Catheter, SABERX PTA Dilatation Catheter and PowerFlex Pro PTA Catheter for the Endovascular Interventions in the Ilio-femoropopliteal Vessels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05312580
• Other study ID #: FCRE-220105_ATK
• Status: Completed
• Start date: June 1, 2022
• Est. completion date: November 7, 2022

Study information

• Verified date: July 2023
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The rationale of this study is to confirm and support the clinical safety and performance of the products in a real-word population of 350 patients who underwent an endovascular intervention within standard-of-care (SOC) of the ilio-femoropopliteal artery, using at least 1 of the products (named above) from Cordis US Corp.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 387
• Est. completion date: November 7, 2022
• Est. primary completion date: October 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient is >18 years old at conduction of the procedure.

2. Patient who underwent endovascular procedure of the ilio-femoropopliteal vessel with at least one of the following the S.M.A.R.T. Flex Stent Iliac and/or S.M.A.R.T. Flex SFA/PP and/or S.M.A.R.T. Control Nitinol Stent and/or S.M.A.R.T. Nitinol Stent and/or PALMAZ Blue .018 Peripheral Stent on Slalom and/or PALMAZ Genesis .035 Peripheral Stent on Opta Pro and/or SABER OTW PTA Catheter and/or SABERX PTA Dilatation Catheter and/or PowerFlex Pro PTA Catheter as described in the IFU of the devices.

3. Target Lesion is located in the ilio-femoropopliteal vessels.

Exclusion Criteria:

1. Anatomy or size of vessels that did not allow appropriate usage of the devices, following IFU of the devices.

2. Known contraindication and/or allergy to (a component of) the device as described in the IFU of the devices.

3. Women who were pregnant or lactating at the time of the procedure.

4. Life expectancy of less than 12 months at the time of procedure.

5. Any patient who was hemodynamically unstable at onset of procedure.

Related Conditions & MeSH terms

• Femoropopliteal Stenosis
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Locations

Country	Name	City	State
Austria	Medizinische Universität Innsbruck	Innsbruck
Austria	KABEG-Klinikum Klagenfurt am Wörthersee	Klagenfurt am Wörthersee
Austria	Universitätsklinikum St. Pölten - Lilienfeld	St.Pölten
Austria	Medizinische Universität WienMedizinische Universität Wien	Wien
France	Public health establishment, Arras Hospital	Arras
France	Hospital de la Timone	Marseille
France	Clinique River Gauche	Toulouse
France	The Public Hospital, Centre Hospitalier Universitaire de Toulouse	Toulouse
Netherlands	Leiden University Medical Center (LUMC)	Leiden

Sponsors (2)

Lead Sponsor	Collaborator
Cordis Corporation	FCRE (Foundation for Cardiovascular Research and Education)

Countries where clinical trial is conducted

Austria,  France,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from Serious Adverse Events	Acute primary Safety Endpoint: Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Effect (SADEs) during the procedure and up to 30 days after the procedure.	30 days
Primary	Freedom from Serious Adverse Events	Primary Safety Endpoint: Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Effect (SADEs) up to 12 months after the procedure.	12 months
Primary	Technical success rate	Acute Primary Efficacy Endpoint: Technical success rate defined as successful crossing, introduction, deployment (stents)/deflation (balloon catheter) and a <30% residual stenosis on visual assessment of S.M.A.R.T. Flex Stent Iliac, S.M.A.R.T. Flex SFA/PP, S.M.A.R.T. Control Nitinol Stent, S.M.A.R.T. Nitinol Stent, PALMAZ Blue .018 Peripheral Stent on Slalom, PALMAZ Genesis .035 Peripheral Stent on Opta Pro, SABER OTW PTA Catheter, SABERX PTA Dilatation Catheter and PowerFlex Pro PTA Catheter according to the respective IFU.	During the procedure
Primary	Freedom from clinically-driven target lesion revascularization	Primary Efficacy Endpoint: The primary efficacy endpoint is freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months, defined as any reintervention at the target lesion due to symptoms.	12 months
Secondary	Technical success rate	Technical success rate defined as successful crossing, introduction, deployment and successful completion of the procedure of the Cordis guidewires (Emerald, ATW, Stablizer, Storq, SV 0.018", Wizdom) and/or the Cordis guiding catheters (Adroit, Vista Brite Tip) and/or the Cordis diagnostic catheters (Super Torque, Super Torque MB, Super Torque Plus, Infiniti 4F/5F/6F, Tempo 4F, Tempo Aqua, High Flow, Pigtail Straightener) and/or the Cordis vascular access devices (Avanti+, Brite Tip, Vista Brite IG, vessel dilator) and/or the Cordis vascular closure devices (MynxGrip and Mynx Control) and/or the Cordis OUTBACK CTO catheters according to the respective IFU.	During the procedure
Secondary	Technical success rate	Technical success rate defined as successful hemostasis without conversion to manual/mechanical compression of the Cordis vascular closure devices (MynxGrip and Mynx Control) according to the respective IFU.	Day of procedure
Secondary	Freedom from CD-TLR	Freedom from clinically-driven target lesion revascularization (CD-TLR) at 36- and 60-months, defined as any reintervention at the target lesion due to symptoms.	36- and 60-months
Secondary	Stent fracture rate	Stent fracture rate assessed at up to 30 days post-procedure, 12-, 36- and 60-months.	Up to 30 days post-procedure, 12-, 36- and 60-months
Secondary	Stent migration rate	Stent migration rate assessed at up to 30 days post-procedure, 12-, 36- and 60-months.	Up to 30 days post-procedure, 12-, 36- and 60-months
Secondary	Change of Ankle Brachial Index	Change of Ankle Brachial Index (ABI) assessed at up to 30 days post-procedure, 12-, 36- and 60-months compared to baseline ABI.	Up to 30 days post-procedure, 12-, 36- and 60-months
Secondary	Time-to-hemostasis	Time-to-hemostasis assessed for the Cordis vascular closure devices (MynxGrip and Mynx Control). Categorized as Hemostatic time category (HTC) =2, HTC >2 to =4, HTC >4 to =5, HTC >5 to =7, HTC >7 to =10 min.	Day of procedure
Secondary	Time-to-ambulation	Time-to-ambulation assessed for the Cordis vascular closure devices (MynxGrip and Mynx Control) defined as time between end of the procedure and ambulation in hours.	Day of procedure
Secondary	Rate of Major Amputation free survival	Rate of Major Amputation free survival defined as any amputation above the knee assessed at up to 30 days post-procedure, 12-, 36- and 60-months.	Up to 30 days post-procedure, 12-, 36- and 60-months
Secondary	Clinical success	Clinical success at up to 30 days post procedure, 12-, 36- and 60-months, defined as an improvement of the Rutherford Classification of one class or more, as compared to the pre-procedure Rutherford Classification.	Up to 30 days post-procedure, 12-, 36- and 60-months
Secondary	Vessel perforation/dissection	Vessel perforation/dissection during the procedure.	During the procedure
Secondary	Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADEs)	Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADEs) at 36- and 60-months after the procedure.	36- and 60-months
Secondary	All cause of mortality	All cause of mortality through life of the study.	procedure through study completion (12 months)