The Surgical Treatment of Long Occlusions of the Superficial Femoral Artery: Initial Success and Long Term Results of Remote Endarterectomy Versus Suprageniculate Bypass Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Occlusive Disease
- Sponsor
- St. Antonius Hospital
- Enrollment
- 126
- Locations
- 4
- Primary Endpoint
- (re-)occlusion of the endarterectomized superficial femoral artery or suprageniculate femoropopliteal bypass
- Last Updated
- 18 years ago
Overview
Brief Summary
The objective of this study is to compare remote superficial femoral artery endarterectomy with suprageniculate bypass surgery in the treatment of long occlusions of the superficial femoral artery. The study hypothesis is that patency rates are comparable and therefore the minimal invasive remote superficial femoral artery endarterectomy can be considered in patients presenting with a long occlusion of the superficial femoral artery.
Detailed Description
Different strategies exist in the treatment of chronic long occlusions of the superficial femoral artery and yet we still suffer a significant percentage of restenosis, re-occlusions and even major amputations, reason for continuous development of new techniques. One such technique is the recently developed minimal invasive remote endarterectomy, which shows promising patency rates and possibly less complications with earlier recovery. A more experienced and the most implemented technique is the suprageniculate femoropopliteal bypass graft, which, when using the saphenous vein, has proved durable. A randomized trial comparing both modalities was lacking so far, what makes the objective of this study a comparison of patency rates between those 2 techniques in a randomized fashion.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients presenting with Fontaine IIB, III, IV ischemia
- •Long (\>10 cm) occlusion of the superficial femoral artery, with patent popliteal artery and at least 1 patent crural vessel
- •Atherosclerotic disease
Exclusion Criteria
- •Previous operations on the superficial femoral artery
- •Radiation therapy groin/leg region
- •Diameter superficial femoral artery \< 4 mm
- •Contrast allergy
Outcomes
Primary Outcomes
(re-)occlusion of the endarterectomized superficial femoral artery or suprageniculate femoropopliteal bypass
Time Frame: 5 year
Secondary Outcomes
- (a)symptomatic (re)stenosis of the superficial femoral artery or bypass for which a re-intervention was carried out(5 year)
- major amputation of the ipsilateral leg(5 year)