A Superiority Trial of the SUPERA Peripheral Stent System in Patients With Femoro-popliteal Artery Disease

A Prospective Randomized, Parallel-group, Multicentre, Superiority Trial of the SUPERA Peripheral Stent System in Patients With Femoro-popliteal Artery Disease

The purpose of this study (superiority trial) is to compare the Supera® Peripheral Stent System with a standard nitinol self-expanding stent for treatment of femoro-popliteal arterial occlusive disease.

Hypothesis:

The Supera® stent is superior to a standard nitinol self-expanding stent, for treatment of femoro-popliteal artery disease in terms of (1) primary patency rate and (2) need for revascularization up to 24 months after stent insertion.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Supera® Peripheral Stent System; Device: EverFlex™ Self-Expanding Peripheral Stent System

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Málaga, Spain, 29010
    • Hospital Carlos Haya
• Switzerland
  • Sankt Gallen, Switzerland, CH-9007
    • Kantonsspital St. Gallen
  • Winterthur, Switzerland, CH-8401
    • Kantonsspital Winterthur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with femoro-popliteal artery disease, who will require a stent femoro-popliteal following failed percutaneous transluminal angioplasty (PTA)
• Target Lesion length <200mm
• Planned follow-up available for at least 24 months
• Written informed consent to participate in the study and agreement to comply with the study protocol must be obtained from the patient prior to initiation of any study-mandated procedure and randomization

Exclusion Criteria:

• Life expectancy <24 months
• Patients who cannot receive dual antiplatelet therapy (aspirin 100mg and clopidogrel 75mg) or anticoagulation therapy
• Patients with known allergies to: nitinol (nickel titanium); or contrast agent, that cannot be medically managed
• Participation in another study with investigational drug/device within the 30 days preceding and during the present study
• Previous enrolment into the current study
• Prior stenting at the location of intended stenting
• Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system
• Enrolment of study investigator, his/her family members, employees and other dependent persons
• If female and of childbearing potential: known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supera® Peripheral Stent System; Femoro-popliteal arterial stenting with Supera® Peripheral Stent System as CE-marked by the manufacturer Abbott	Device: Supera® Peripheral Stent System; The index procedure is placing a selfexpandable stent at a femoro-popliteal location. The way the stenosis or occlusion is traversed is not part of the study. It is mandatory to prepare then the vessel with PTA (at least the size of the stent) and thereafter insert the stent. Post-PTA can be performed with same balloon, but post-PTA is not mandatory to be performed.
Active Comparator: EverFlex™ Self-Expanding Peripheral Stent System; Femoro-popliteal arterial stenting with EverFlex™ Self-Expanding Peripheral Stent System with Entrust™ Delivery System or as Protégé™ EverFlex™	Device: EverFlex™ Self-Expanding Peripheral Stent System; The index procedure is placing a selfexpandable stent at a femoro-popliteal location. The way the stenosis or occlusion is traversed is not part of the study. It is mandatory to prepare then the vessel with PTA (at least the size of the stent) and thereafter insert the stent. Post-PTA can be performed with same balloon, but post-PTA is not mandatory to be performed.; Other Names: EverFlex™ with Entrust™ Delivery System or Protégé™ EverFlex™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in primary patency rate (proportion of patients classed as treatment succsess)	Peak systolic velocity ratio assessed with Duplex ultrasound (Treatment success is defined as Peak Systolic Velocity (PSV) ratio < 2.5 at the stented target lesion measured by Duplex ultrasound (DUS) indicating freedom from >50% restenosis with no clinically driven re-intervention within the stented segment.)	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in primary patency rate	Peak systolic velocity ratio assessed with Duplex ultrasound	1 month, 6 months, 12 months
Difference in target lesion/vessel revascularization	Patients with target lesion revascularization due to restenosis or target vessel revascularization.	24 months
Difference in amputation	Proportion of patients with amputation (minor or major)	24 months
Difference in time to restenosis (and time to target lesion revascularization due to restenosis)		24 months
Difference in Anklre Brachial Index	Ankle Brachial Index of the treated lesion	1 month, 6 months, 12 months, 24 months
Difference in Fontaine classification	Fontaine classification	1 month, 6 months, 12 months, 24 months

Other Outcome Measures

Outcome Measure	Time Frame
Rate of site complications [Safety Endpoint]	1 month
Rate of prolonged hospital stay [Safety Endpoint]	1 month
Rate of need for surgical revision [Safety Endpoint]	1 month

Collaborators and Investigators

• Sponsor: Kantonsspital Winterthur KSW
• Collaborators: Abbott; Cantonal Hospital of St. Gallen
• Investigators: Principal Investigator: Christoph A Binkert, MD, Kantonsspital Winterthur KSW

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2019
• Primary Completion (Actual): March 19, 2026
• Study Completion (Actual): March 19, 2026

Study Registration Dates

• First Submitted: May 2, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: BASEC 2019-00312; CTU 17/037 (Other Identifier: CTU Kantonsspital St. Gallen)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No