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

Not Applicable

Active, not recruiting

• Conditions: Peripheral Arterial Disease
• Interventions: Device: EverFlex™ Self-Expanding Peripheral Stent System; Device: Supera® Peripheral Stent System

• Registration Number: NCT03941314
• Lead Sponsor: Kantonsspital Winterthur KSW

Brief Summary

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-05-02
• Study First Submitted QC: 2019-05-06
• Study First Posted: 2019-05-07
• Study Start: 2019-06-25
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-03-29
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EverFlex™ Self-Expanding Peripheral Stent System	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™
Supera® Peripheral Stent System	Supera® Peripheral Stent System	Femoro-popliteal arterial stenting with Supera® Peripheral Stent System as CE-marked by the manufacturer Abbott

Primary Outcome Measures

Name	Time	Method
Difference in primary patency rate (proportion of patients classed as treatment succsess)	24 months	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.)

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Hospital Carlos Haya; 🇪🇸 Málaga, Spain

Kantonsspital Winterthur; 🇨🇭 Winterthur, Switzerland

Kantonsspital St. Gallen; 🇨🇭 St. Gallen, Switzerland