Femoropopliteal Stenosis
Conditions
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.
Interventions
DEVICESupera Stent
Angioplasty and stenting will performed according to the guidelines of the Society of Interventional Radiology and the instruction for use for each stent. Patients will be allocated to Supera stent versus LifeStent based on block randomization (block size 4 patients).
DEVICELife Stent
Angioplasty and stenting will performed according to the guidelines of the Society of Interventional Radiology and the instruction for use for each stent. Patients will be allocated to Supera stent versus LifeStent based on block randomization (block size 4 patients).
Sponsors
Abbott Medical Devices
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Queen Elizabeth II Health Sciences Centre
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Stent patency | 1 year | Correlate stent opening with stent patency as documented by Doppler ultrasound at one year post implantation |
Countries
Canada
Outcome results
None listed