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

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03941314
• Other study ID #: BASEC 2019-00312
• Secondary ID: CTU 17/037
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 25, 2019
• Est. completion date: March 2026

Study information

• Verified date: March 2024
• Source: Kantonsspital Winterthur KSW
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Carlos Haya	Málaga
Switzerland	Kantonsspital St. Gallen	St. Gallen
Switzerland	Kantonsspital Winterthur	Winterthur

Sponsors (3)

Lead Sponsor	Collaborator
Kantonsspital Winterthur KSW	Abbott, Cantonal Hospital of St. Gallen

Countries where clinical trial is conducted

Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of site complications [Safety Endpoint]		1 month
Other	Rate of prolonged hospital stay [Safety Endpoint]		1 month
Other	Rate of need for surgical revision [Safety Endpoint]		1 month
Primary	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	Difference in primary patency rate	Peak systolic velocity ratio assessed with Duplex ultrasound	1 month, 6 months, 12 months
Secondary	Difference in target lesion/vessel revascularization	Patients with target lesion revascularization due to restenosis or target vessel revascularization.	24 months
Secondary	Difference in amputation	Proportion of patients with amputation (minor or major)	24 months
Secondary	Difference in time to restenosis (and time to target lesion revascularization due to restenosis)		24 months
Secondary	Difference in Anklre Brachial Index	Ankle Brachial Index of the treated lesion	1 month, 6 months, 12 months, 24 months
Secondary	Difference in Fontaine classification	Fontaine classification	1 month, 6 months, 12 months, 24 months