Remote Endarterectomy Versus Suprageniculate Femoropopliteal Bypass (REVAS)

St. Antonius Hospital

Status: Unknown

Conditions: Peripheral Arterial Occlusive Disease; Atherosclerosis

Treatments: Procedure: Remote endarterectomy of the superficial femoral artery; Procedure: Suprageniculate femoropopliteal bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT00566436

P.04.1298L

C-04.04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

REA

Active Comparator group

Description:

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

Treatment:

Procedure: Remote endarterectomy of the superficial femoral artery

Bypass

Active Comparator group

Description:

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

Treatment:

Procedure: Suprageniculate femoropopliteal bypass