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

Kantonsspital Winterthur KSW3 sites in 2 countries300 target enrollmentJune 25, 2019

ConditionsPeripheral Arterial Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Arterial Disease
Sponsor: Kantonsspital Winterthur KSW
Enrollment: 300
Locations: 3
Primary Endpoint: Difference in primary patency rate (proportion of patients classed as treatment succsess)
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 25, 2019

End Date

March 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kantonsspital Winterthur KSW

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Difference in primary patency rate (proportion of patients classed as treatment succsess)

Time Frame: 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 Outcomes

Difference in primary patency rate(1 month, 6 months, 12 months)
Difference in target lesion/vessel revascularization(24 months)
Difference in amputation(24 months)
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)
Difference in Anklre Brachial Index(1 month, 6 months, 12 months, 24 months)