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
  Purpose

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.


Condition Intervention
Femoropopliteal Stenosis
Device: Supera Stent
Device: Life Stent

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: C-arm CT Evaluation of Luminal Expansion in Stenting Severe Femoro-popliteal Atherosclerotic Disease: Supera Versus LifeStent

Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: March 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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).
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.
Device: Life Stent

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01643746

Contacts
Contact: Andrée Cliche, RN, M.Sc. (514) 890-8000 ext 28212 andree.cliche.chum@ssss.gouv.qc.ca

Locations
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Principal Investigator: Christopher Lightfoot, MD         
Sub-Investigator: Robert Berry, MD         
Canada, Quebec
Centre hospitalier de l'université de Montréal Not yet recruiting
Montreal, Quebec, Canada, H2L 4M1
Principal Investigator: Gilles Soulez, MD, MSc         
Sub-Investigator: Vincent L Oliva, MD         
Sub-Investigator: Eric Thérasse, MD         
Sub-Investigator: Marie-France Giroux, MD         
Sub-Investigator: Stéphane Elkouri, MD         
Sub-Investigator: Claude Kauffmann, PhD         
Sponsors and Collaborators
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
Investigators
Study Director: Gilles Soulez, MD, MSc Centre hospitalier de l'université de Montreal
  More Information

No publications provided

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01643746     History of Changes
Other Study ID Numbers: CE 12.048
Study First Received: July 16, 2012
Last Updated: March 12, 2013
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on October 02, 2014