Remote Endarterectomy Versus Suprageniculate Femoropopliteal Bypass

NCT00566436 | Unknown

• 2 other identifiers: C-04.04P.04.1298L
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (1)

• (re-)occlusion of the endarterectomized superficial femoral artery or suprageniculate femoropopliteal bypass

  5 year

Secondary Outcomes (2)

• (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

Study Arms (2)

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

Procedure: Remote endarterectomy of the superficial femoral artery

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

Procedure: Suprageniculate femoropopliteal bypass

Interventions

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.

Also known as: Remote superficial artery endarterectomy, Distal cutting endarterectomy

REA

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)

Also known as: Above knee bypass, Femoropopliteal bypass

Bypass

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous operations on the superficial femoral artery
• Radiation therapy groin/leg region
• Diameter superficial femoral artery \< 4 mm
• Contrast allergy

Sponsors & Collaborators

• St. Antonius Hospital: lead
• UMC Utrecht: collaborator
• Albert Schweitzer Hospital, Netherlands: collaborator
• Amphia Hospital: collaborator

Study Sites (4)

Amphia Hospital

Breda, North Brabant, 4818CK, Netherlands

Location

Albert Schweitzer Ziekenhuis

Dordrecht, South Holland, 3318AT, Netherlands

Location

St Antonius Hospital

Nieuwegein, Utrecht, 3435CM, Netherlands

Location

UMC Utrecht

Utrecht, Utrecht, 3584CX, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 12787704 BACKGROUND

• 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.

  PMID: 18990592 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1; Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 29, 2007
• First Posted: December 3, 2007
• Study Start: October 1, 2004
• Study Completion: March 1, 2012
• Last Updated: December 3, 2007

Record last verified: 2007-11

Locations

NL (4)