Remote Endarterectomy Versus Suprageniculate Femoropopliteal Bypass

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Surgical Treatment of Long Occlusions of the Superficial Femoral Artery: Initial Success and Long Term Results of Remote Endarterectomy Versus Suprageniculate Bypass Surgery

Conditions
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Peripheral Arterial Occlusive Disease, Atherosclerosis

Intervention / Treatment
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* Procedure: Remote endarterectomy of the superficial femoral artery
* Procedure: Suprageniculate femoropopliteal bypass


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: REA<br>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 | Procedure: Remote endarterectomy of the superficial femoral artery<br>* Exposure of the common femoral, superficial femoral and profunda femoral artery through a single groin incision. Arteriotomy in the proximal SFA followed by dissection of the intima core beyond the occluded segment using the Vollmar ringstripper. The ringstripper is exchanged for a Mollring cutter all under fluoroscopic guidance. With the Mollring Cutter transection of intima core is carried out, remote from the site of entry. After removal of the intima core the transection zone is secured with an aSpire stent after balloon angioplasty. A completion arteriography will verify a patent artery, and embolectomy can be performed when necessary. As indicated a common femoral artery and profundaplasty can be performed and the arteriotomy may be closed with or without patch.<br>* Other names: Distal cutting endarterectomy;|
| Active Comparator: Bypass<br>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 | Procedure: Suprageniculate femoropopliteal bypass<br>* Groin and suprageniculate incision, venous (Saphenous vein) or PTFE graft with end to side anastomoses. If the saphenous vein is truly applicable for grafting will ultimately be an intra-operative decision (despite pre-operative venous mapping)<br>* Other names: Femoropopliteal bypass;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (re-)occlusion of the endarterectomized superficial femoral artery or suprageniculate femoropopliteal bypass |  | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Arterial Occlusive Disease, Superficial Femoral Artery, Remote Endarterectomy, Suprageniculate Bypass Surgery, Blood Vessel Prosthesis Implantation, Vascular Patency