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

This study is not yet open for participant recruitment.
Verified September 2016 by Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01643746
First Posted: July 18, 2012
Last Update Posted: August 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Abbott Vascular
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)
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 ]
    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 ]
    Correlate stent opening with stent patency as documented by Doppler ultrasound at one year post implantation


Estimated Enrollment: 100
Anticipated Study Start Date: December 2017
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (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
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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01643746


Contacts
Contact: Dominique Aubin, MSc (514) 890-8000 ext 23483 dominique.aubin.chum@ssss.gouv.qc.ca
Contact: Jennifer Satterthwaite, Msc 514-890-8000 ext 23483 jennifer.satterthwaite.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)
Abbott Vascular
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

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01643746     History of Changes
Other Study ID Numbers: CE 12.048
First Submitted: July 16, 2012
First Posted: July 18, 2012
Last Update Posted: August 3, 2017
Last Verified: September 2016

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Phenobarbital
Anticonvulsants
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
GABA Agents
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers