Evaluation of Luminal Expansion Following Stenting of Femoro-popliteal Occlusive Disease

Centre hospitalier de l'Université de Montréal (CHUM)

Status: Withdrawn

Conditions: Femoropopliteal Stenosis

Treatments: Device: Supera Stent; Device: Life Stent

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01643746

CE 12.048

Details and patient eligibility

About

The primary goal of this trial is to compare prospectively stent opening of Supera (IDEV Technologies) versus a reference stent (LifeStent, Bard Medical) using C-arm CT. A secondary goal is to correlate stent opening with stent patency as documented by Doppler ultrasound at one year post implantation.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Patient (or legally authorized representative) must give a written informed consent.
• Symptomatic peripheral-artery disease with moderate or severe intermittent claudication and failure of medical treatment (Rutherford stage 2,3) or chronic critical limb ischemia with pain while the patient is at rest (Rutherford stage 4) or chronic critical limb ischemia with ischemic ulcers (Rutherford stage 5, 6) and stenosis of more than 70 percent or occlusion of the ipsilateral superficial femoral artery and/or proximal popliteal artery with a target-lesion length of ≥ 8 and ≤ 20 cm and at least one patent (less than 50 percent stenosed) tibioperoneal runoff vessel (TASC A,B,C lesions)25. Proximal popliteal artery is defined as the popliteal artery above the joint line. The distal portion of the lesion should be located at least 4 cm above the joint line and the distal end of the stent 2 cm above the joint line.
• ABI ≤ 0.9 at rest. Toe-Brachial Index (TBI) may be used if ABI is inadequate.
• Lesion with a calcification percentage of at least 25% based on CTA evaluation (within 6 months of patient enrolment)

Exclusion criteria

• Acute critical limb ischemia
• Untreated inflow disease of the ipsilateral pelvic arteries (more than 50 percent stenosis or occlusion).
• Renal failure, creatinine clearance < 50 µmol /l
• Severe allergy to iodine contrast
• Patients with uncorrected bleeding disorders or patients who cannot receive anticoagulation or antiplatelet aggregation therapy
• Lesions < 8 and > 20 cm in length
• Calcification volume of less than 25%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Supera stent

Active Comparator group

Description:

The Supera stent is a novel interwoven nitinol stent design with high flexibility and radial strength. The radial force of the Supera stent is 4 times higher than comparable nitinol stent.

Treatment:

Device: Supera Stent

LifeStent

Active Comparator group

Description:

LifeStent is likely the best reference nitinol stent for comparison because a low restenosis rate has been reported at 1 year with low target revascularization.

Treatment:

Device: Life Stent