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

Kantonsspital Winterthur KSW

Status: Active, not recruiting

Conditions: Peripheral Arterial Disease

Treatments: Device: Supera® Peripheral Stent System; Device: EverFlex™ Self-Expanding Peripheral Stent System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03941314

CTU 17/037 (Other Identifier)

BASEC 2019-00312

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Supera® Peripheral Stent System

Experimental group

Description:

Femoro-popliteal arterial stenting with Supera® Peripheral Stent System as CE-marked by the manufacturer Abbott

Treatment:

Device: Supera® Peripheral Stent System

EverFlex™ Self-Expanding Peripheral Stent System

Active Comparator group

Description:

Femoro-popliteal arterial stenting with EverFlex™ Self-Expanding Peripheral Stent System with Entrust™ Delivery System or as Protégé™ EverFlex™

Treatment:

Device: EverFlex™ Self-Expanding Peripheral Stent System