Clinical trial NCT01643746: Evaluation of Luminal Expansion Following Stenting of Femoro-popliteal Occlusive Disease
Official title: C-arm CT Evaluation of Luminal Expansion in Stenting Severe Femoro-popliteal Atherosclerotic Disease: Supera Versus LifeStent
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Femoropopliteal Stenosis
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
name: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
name: Queen Elizabeth II Health Sciences Centre
First posted: 2012-07-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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%

Primary outcomes:
measure: Stent expansion
timeFrame: At the completion of the intervention
Secondary outcomes:
measure: Stent patency
timeFrame: 1 year
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Montreal
country: Canada
facility: Centre hospitalier de l'université de Montréal
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'université de Montreal
name: Gilles Soulez, MD, MSc
role: STUDY_DIRECTOR
References: