Remote Endarterectomy Versus Suprageniculate Femoropopliteal Bypass

NCT ID: NCT00566436

Last Updated: 2007-12-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2012-03-31

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.

Conditions

Peripheral Arterial Occlusive Disease; Atherosclerosis

Keywords

Peripheral Arterial Occlusive Disease; Superficial Femoral Artery; Remote Endarterectomy; Suprageniculate Bypass Surgery; Blood Vessel Prosthesis Implantation; Vascular Patency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

REA

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

Group Type: ACTIVE_COMPARATOR

Remote endarterectomy of the superficial femoral artery

Intervention Type: 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.

Bypass

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

Group Type: ACTIVE_COMPARATOR

Suprageniculate femoropopliteal bypass

Intervention Type: 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)

Interventions

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.

Intervention Type: 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)

Intervention Type: PROCEDURE

Other Intervention Names

Remote superficial artery endarterectomy; Distal cutting endarterectomy; Above knee bypass; Femoropopliteal bypass

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UMC Utrecht

OTHER

Sponsor Role: collaborator

Albert Schweitzer Hospital, Netherlands

UNKNOWN

Sponsor Role: collaborator

Amphia Hospital

OTHER

Sponsor Role: collaborator

St. Antonius Hospital

OTHER

Sponsor Role: lead

Responsible Party

St. Antonius Hospital

Principal Investigators

Suzanne S Gisbertz, MD

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Hospital

Jean Paul PM de Vries, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Hospital

Frans L Moll, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

Amphia Hospital

Breda, North Brabant, Netherlands

Albert Schweitzer Ziekenhuis

Dordrecht, South Holland, Netherlands

St Antonius Hospital

Nieuwegein, Utrecht, Netherlands

UMC Utrecht

Utrecht, Utrecht, Netherlands

Countries

Netherlands

References

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.

Reference Type: BACKGROUND

PMID: 12787704 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 18990592 (View on PubMed)

Other Identifiers

P.04.1298L

Identifier Type: -

Identifier Source: secondary_id

C-04.04

Identifier Type: -

Identifier Source: org_study_id