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| ID | Type | Description | Link |
|---|---|---|---|
| P.04.1298L |
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| Name | Class |
|---|---|
| UMC Utrecht | OTHER |
| Albert Schweitzer Hospital, Netherlands | UNKNOWN |
| Amphia Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REA | Active Comparator | 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 |
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| Bypass | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote endarterectomy of the superficial femoral artery | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| (re-)occlusion of the endarterectomized superficial femoral artery or suprageniculate femoropopliteal bypass | 5 year |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne S Gisbertz, MD | St. Antonius Hospital | Principal Investigator |
| Jean Paul PM de Vries, MD, PhD | St. Antonius Hospital | Principal Investigator |
| Frans L Moll, MD, PhD | UMC Utrecht | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amphia Hospital | Breda | North Brabant | 4818CK | Netherlands | ||
| Albert Schweitzer Ziekenhuis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12787704 | Background | Smeets L, Ho GH, Hagenaars T, van den Berg JC, Teijink JA, Moll FL. Remote endarterectomy: first choice in surgical treatment of long segmental SFA occlusive disease? Eur J Vasc Endovasc Surg. 2003 Jun;25(6):583-9. doi: 10.1053/ejvs.2002.1921. | |
| 18990592 | Derived | Gisbertz SS, Ramzan M, Tutein Nolthenius RP, van der Laan L, Overtoom TT, Moll FL, de Vries JP. Short-term results of a randomized trial comparing remote endarterectomy and supragenicular bypass surgery for long occlusions of the superficial femoral artery [the REVAS trial]. Eur J Vasc Endovasc Surg. 2009 Jan;37(1):68-76. doi: 10.1016/j.ejvs.2008.09.014. Epub 2008 Nov 5. |
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| ID | Term |
|---|---|
| C564658 | Peripheral Arterial Occlusive Disease 1 |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Suprageniculate femoropopliteal bypass | Procedure | 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) |
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| Dordrecht |
| South Holland |
| 3318AT |
| Netherlands |
| St Antonius Hospital | Nieuwegein | Utrecht | 3435CM | Netherlands |
| UMC Utrecht | Utrecht | Utrecht | 3584CX | Netherlands |