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

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01643746
• Collaborator: Abbott Medical Devices (Industry), Centre de Recherche du Centre Hospitalier de l'Université de Montréal (Other), Queen Elizabeth II Health Sciences Centre (Other)
• Enrollment: 0
• Locations: 2
• Arms: 2
• Patients Per Site: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Femoropopliteal Stenosis	Device: Supera Stent; Device: Life Stent	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• 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
• Actual Study Start Date: Dec 1, 2017
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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).

Outcome Measures

Primary Outcome Measures

1. Stent expansion [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

1. Stent patency [1 year]

   Correlate stent opening with stent patency as documented by Doppler ultrasound at one year post implantation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia	Canada	B3H 2Y9
2	Centre hospitalier de l'université de Montréal	Montreal	Quebec	Canada	H2L 4M1

Sponsors and Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM)
• Abbott Medical Devices
• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
• ClinicalTrials.gov Identifier: NCT01643746
• Other Study ID Numbers: CE 12.048
• First Posted: Jul 18, 2012
• Last Update Posted: Jul 20, 2018
• Last Verified: Jul 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Study Results

No Results Posted as of Jul 20, 2018