Remote Endarterectomy Versus Suprageniculate Femoropopliteal Bypass (REVAS)
November 29, 2007 updated by: St. Antonius Hospital
The Surgical Treatment of Long Occlusions of the Superficial Femoral Artery: Initial Success and Long Term Results of Remote Endarterectomy Versus Suprageniculate Bypass Surgery
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.
Study Overview
Status
Unknown
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.
Study Type
Interventional
Enrollment (Actual)
126
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Utrecht, Netherlands, 3584CX
- UMC Utrecht
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Noord-Brabant
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Breda, Noord-Brabant, Netherlands, 4818CK
- Amphia Hospital
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Utrecht
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Nieuwegein, Utrecht, Netherlands, 3435CM
- St Antonius hospital
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Zuid-Holland
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Dordrecht, Zuid-Holland, Netherlands, 3318AT
- Albert Schweitzer Ziekenhuis
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: 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
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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.
Other Names:
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Active Comparator: 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
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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)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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(re-)occlusion of the endarterectomized superficial femoral artery or suprageniculate femoropopliteal bypass
Time Frame: 5 year
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5 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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(a)symptomatic (re)stenosis of the superficial femoral artery or bypass for which a re-intervention was carried out
Time Frame: 5 year
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5 year
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major amputation of the ipsilateral leg
Time Frame: 5 year
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5 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Suzanne S Gisbertz, MD, St. Antonius Hospital Nieuwegein
- Principal Investigator: Jean Paul PM de Vries, MD, PhD, St. Antonius Hospital Nieuwegein
- Principal Investigator: Frans L Moll, MD, PhD, UMC Utrecht
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2004
Study Completion (Anticipated)
March 1, 2012
Study Registration Dates
First Submitted
November 29, 2007
First Submitted That Met QC Criteria
November 29, 2007
First Posted (Estimate)
December 3, 2007
Study Record Updates
Last Update Posted (Estimate)
December 3, 2007
Last Update Submitted That Met QC Criteria
November 29, 2007
Last Verified
November 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-04.04
- P.04.1298L
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