Remote Endarterectomy Versus Suprageniculate Femoropopliteal Bypass

Not Applicable

• Conditions: Peripheral Arterial Occlusive Disease; Atherosclerosis
• Interventions: Procedure: Remote endarterectomy of the superficial femoral artery; Procedure: Suprageniculate femoropopliteal bypass

• Registration Number: NCT00566436
• Lead Sponsor: St. Antonius Hospital

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.

Study Timeline

• Study Start: 2004-10
• Status Verified: 2007-11
• Study First Submitted: 2007-11-29
• Study First Submitted QC: 2007-11-29
• Last Update Submitted: 2007-11-29
• Study First Posted: 2007-12-03
• Last Update Posted: 2007-12-03
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REA	Remote endarterectomy of the superficial femoral artery	Patients presenting with a long occlusion of the superficial femoral artery enrolled in REA arm will undergo remote endarterectomy of the occluded superficial femoral artery
Bypass	Suprageniculate femoropopliteal bypass	Patients presenting with a long occlusion of the superficial femoral artery enrolled in Bypass arm will undergo suprageniculate femoropopliteal bypass surgery to bypass the occluded superficial femoral artery

Primary Outcome Measures

Name	Time	Method
(re-)occlusion of the endarterectomized superficial femoral artery or suprageniculate femoropopliteal bypass	5 year

Secondary Outcome Measures

Name	Time	Method
(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

Trial Locations

Locations (4)

Amphia Hospital; 🇳🇱 Breda, Noord-Brabant, Netherlands

St Antonius Hospital; 🇳🇱 Nieuwegein, Utrecht, Netherlands

Albert Schweitzer Ziekenhuis; 🇳🇱 Dordrecht, Zuid-Holland, Netherlands

UMC Utrecht; 🇳🇱 Utrecht, Netherlands