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

Femoropopliteal Stenosis Clinical Trial

Official title:

C-arm CT Evaluation of Luminal Expansion in Stenting Severe Femoro-popliteal Atherosclerotic Disease: Supera Versus LifeStent

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01643746
• Other study ID #: CE 12.048
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: July 2018
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Femoropopliteal Stenosis

Intervention

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).
• 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).

Locations

Country	Name	City	State
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	Centre hospitalier de l'université de Montréal	Montreal	Quebec

Sponsors (4)

Lead Sponsor	Collaborator
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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Stent patency	Correlate stent opening with stent patency as documented by Doppler ultrasound at one year post implantation	1 year