Atherosclerosis, Peripheral Arterial Occlusive Disease
Conditions
Keywords
Peripheral Arterial Occlusive Disease, Superficial Femoral Artery, Remote Endarterectomy, Suprageniculate Bypass Surgery, Blood Vessel Prosthesis Implantation, Vascular Patency
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.
Interventions
PROCEDURERemote 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.
PROCEDURESuprageniculate 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)
Sponsors
UMC Utrecht
Albert Schweitzer Hospital, Netherlands
Amphia Hospital
St. Antonius Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (re-)occlusion of the endarterectomized superficial femoral artery or suprageniculate femoropopliteal bypass | 5 year |
Secondary
| Measure | 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 |
Countries
Netherlands
Outcome results
None listed