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

NCT01643746 | Withdrawn FDA Device

• 1 other identifier: CE 12.048
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Femoropopliteal Stenosis

Outcome Measures

Primary Outcomes (1)

• Stent expansion

  Difference in minimal lumen diameter (MLD), minimal lumen area (MLA) and incomplete stent expansion as defined by C-arm CT between both groups

  At the completion of the intervention

Secondary Outcomes (1)

• Stent patency

  1 year

Study Arms (2)

Supera stent

ACTIVE COMPARATOR

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

LifeStent

ACTIVE COMPARATOR

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

Interventions

Supera Stent DEVICE

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).

Supera stent

Life Stent DEVICE

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).

LifeStent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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%

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Abbott Medical Devices: collaborator
• Centre de Recherche du Centre Hospitalier de l'Université de Montréal: collaborator
• Queen Elizabeth II Health Sciences Centre: collaborator

Study Sites (2)

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Centre hospitalier de l'université de Montréal

Montreal, Quebec, H2L 4M1, Canada

Location

Study Officials

• Gilles Soulez, MD, MSc

  Centre hospitalier de l'université de Montreal

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2012
• First Posted: July 18, 2012
• Study Start: December 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 20, 2018

Record last verified: 2018-07

Locations

CA (2)