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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor:
Collaborators:
IDev Technologies, Inc.
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Queen Elizabeth II Health Sciences Centre
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01643746
First received: July 16, 2012
Last updated: March 12, 2013
Last verified: March 2013

July 16, 2012
March 12, 2013
March 2013
March 2014   (final data collection date for primary outcome measure)
Stent expansion [ Time Frame: At the completion of the intervention ] [ Designated as safety issue: No ]
Difference in minimal lumen diameter (MLD), minimal lumen area (MLA) and incomplete stent expansion as defined by C-arm CT between both groups
Same as current
Complete list of historical versions of study NCT01643746 on ClinicalTrials.gov Archive Site
Stent patency [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Correlate stent opening with stent patency as documented by Doppler ultrasound at one year post implantation
Same as current
Not Provided
Not Provided
 
Evaluation of Luminal Expansion Following Stenting of Femoro-popliteal Occlusive Disease
C-arm CT Evaluation of Luminal Expansion in Stenting Severe Femoro-popliteal Atherosclerotic Disease: Supera Versus LifeStent

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Femoropopliteal Stenosis
  • Device: Supera 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).
  • Device: Life Stent
  • Active Comparator: 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.
    Intervention: Device: Supera Stent
  • Active Comparator: LifeStent
    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.
    Intervention: Device: Life Stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
March 2015
March 2014   (final data collection date for primary outcome measure)

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%
Both
18 Years and older
No
Contact: Andrée Cliche, RN, M.Sc. (514) 890-8000 ext 28212 andree.cliche.chum@ssss.gouv.qc.ca
Canada
 
NCT01643746
CE 12.048
No
Centre hospitalier de l'Université de Montréal (CHUM)
Centre hospitalier de l'Université de Montréal (CHUM)
  • IDev Technologies, Inc.
  • Centre de Recherche du Centre Hospitalier de l'Université de Montréal
  • Queen Elizabeth II Health Sciences Centre
Study Director: Gilles Soulez, MD, MSc Centre hospitalier de l'université de Montreal
Centre hospitalier de l'Université de Montréal (CHUM)
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP