Balloon Angioplasty Versus Self-expanding Stent for Recanalization of Chronic Total Occlusions of the Femoral Artery
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Chronic Total Occlusion of Artery of the Extremities
- Sponsor
- University of Patras
- Enrollment
- 150
- Locations
- 5
- Primary Endpoint
- Primary patency
- Last Updated
- 14 years ago
Overview
Brief Summary
This is a multicenter double-arm randomized trial investigating plain balloon angioplasty versus primary placement of self-expanding nitinol stents after endovascular recanalization of femoral CTOs. Study will recruit up to 200 patients to be adequately powered for detection of a significant difference in vessel patency after 1 year.
Detailed Description
Primary placement of new-generation nitinol stents compared to plain old balloon angioplasty has shown encouraging long-term results in the femoropopliteal artery. However, there is complete lack of data about performance of new-generation nitinol stents in the treatment of chronic total occlusions (CTO) of the Femoral artery. This is a multicenter double-arm randomized trial investigating plain balloon angioplasty versus primary placement of self-expanding nitinol stents after endovascular recanalization of femoral CTOs. Study will recruit up to 200 patients to be adequately powered for detection of a significant difference in vessel patency after 1 year.
Investigators
SIABLIS DIMITRIOS
Professor of Radiology
University of Patras
Eligibility Criteria
Inclusion Criteria
- •Age \>/= 30 years, both genders, no healthy volunteers
- •Negative pregnancy test for women of childbearing age
- •Symptomatic leg ischemia by Rutherford/Becker Classification (category 3, 4 or 5), i.e. lifestyle-limiting claudication or critical limb ischemia Single completely occluded de-novo superficial femoral artery lesion (femoral artery CTO target lesion)
- •Combined overall length of treatable occluded SFA lesion \>/= 4.0 cm to \</= 15.0 cm, by visual estimate. The occlusion must be treatable with no more than two stents, minimizing the stent overlap.
- •Randomization process before successful subintimal or intraluminal recanalization of the lesion in order to evaluate technical success
- •Use of re-entry devices at the discretion of the operator
- •All lesions are to be located at least three centimeters (3 cm) proximal to the superior edge of the patella
- •Reference vessel diameter (RVD) \>/= 4.0 mm and \</ 6.0 mm by visual assessment
- •At least 1 patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (\< 50% stenosis) to the ankle or foot
- •Poor aortoiliac or common femoral "inflow" (i.e. angiographically defined \> 50% stenosis of the iliac or common femoral artery) lesions must be successfully treated prior to treatment of the target lesion
Exclusion Criteria
- •In-stent restenotic lesions (ISR occlusions)
- •Distal popliteal of 3-vessel tibial occlusion
- •Patients on hemodialysis because of heavily calcified vessels
- •Recent thrombophlebitis, uremia, or deep venous thrombus (within past 30 days)
- •Patients receiving dialysis or immunosuppressant therapy
- •Thrombolysis of the target vessel within 72 hours prior to the index procedure with residual intraluminal thrombi
- •Recent major stroke within the past 6 months
- •Aneurysmal disease of the aorta, iliac, femoral or popliteal arteries
- •Required stent placement across or within 0.5 cm of the femoral bifurcation
- •Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of a stent device if necessary
Outcomes
Primary Outcomes
Primary patency
Time Frame: Immediate and at 6 months follow-up
Primary patency after 6 months follow-up defined as no significant reduction of flow detectable by vascular imaging through the index lesion and without any further clinically driven target vessel revascularization performed in the interim
Primary Patency
Time Frame: 12 months
Primary patency after 12 months follow-up defined as no significant reduction of flow detectable by vascular imaging through the index lesion and without any further clinically driven target vessel revascularization performed in the interim
Secondary Outcomes
- Freedom from major adverse event(30-days to 1year)
- Binary vessel restenosis(6 months to 1 year)
- Secondary vessel patency(Immediate to 1 year)
- AHA Clinical Improvement Score(At 3 months, 6 months and 1 year)
- QALY estimation(At 6 months and 1 year)