NCT00566436

Remote Endarterectomy Versus Suprageniculate Femoropopliteal Bypass

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: St. Antonius Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Arterial Occlusive Disease
• Atherosclerosis

Interventions

Type	Name	Description
PROCEDURE	Remote endarterectomy of the superficial femoral artery	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.
PROCEDURE	Suprageniculate femoropopliteal bypass	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)

Timeline

• Start date: 2004-10-01
• Completion: 2012-03-01
• First posted: 2007-12-03
• Last updated: 2007-12-03

Locations

4 sites across 1 country: Netherlands