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

Not Applicable

Withdrawn

• Conditions: Femoropopliteal Stenosis
• Interventions: Device: Life Stent; Device: Supera Stent

• Registration Number: NCT01643746
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-16
• Study First Submitted QC: 2012-07-17
• Study First Posted: 2012-07-18
• Study Start: 2017-12-01
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-01
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-19
• Last Update Posted: 2018-07-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LifeStent	Life Stent	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.
Supera stent	Supera Stent	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.

Primary Outcome Measures

Name	Time	Method
Stent expansion	At the completion of the intervention	Difference in minimal lumen diameter (MLD), minimal lumen area (MLA) and incomplete stent expansion as defined by C-arm CT between both groups

Secondary Outcome Measures

Name	Time	Method
Stent patency	1 year	Correlate stent opening with stent patency as documented by Doppler ultrasound at one year post implantation

Trial Locations

Locations (2)

Centre hospitalier de l'université de Montréal; 🇨🇦 Montreal, Quebec, Canada

Queen Elizabeth II Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada