REVAS
The Surgical Treatment of Long Occlusions of the Superficial Femoral Artery: Initial Success and Long Term Results of Remote Endarterectomy Versus Suprageniculate Bypass Surgery
Sponsor study identifier
Secondary identifiers
interventional
126
1 country
4
Study Start
October 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
March 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2004
Date type not reportedThis date has not been verified as actual or estimated.
November 29, 2007
Actual (reported)December 3, 2007
Actual (reported)March 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
(re-)occlusion of the endarterectomized superficial femoral artery or suprageniculate femoropopliteal bypass
5 year
(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
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
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
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.
Amphia Hospital
Breda, North Brabant, 4818CK, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, South Holland, 3318AT, Netherlands
St Antonius Hospital
Nieuwegein, Utrecht, 3435CM, Netherlands
UMC Utrecht
Utrecht, Utrecht, 3584CX, Netherlands
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.
Suzanne S Gisbertz, MD
St. Antonius Hospital
Jean Paul PM de Vries, MD, PhD
St. Antonius Hospital
Frans L Moll, MD, PhD
UMC Utrecht
126 participants (actual enrollment reported by the registry).
First Submitted
November 29, 2007
First Posted
December 3, 2007
Study Start
October 2004
Date type not reportedThis date has not been verified as actual or estimated.
Study Comparing Legflow Versus Bare Balloon Angioplasty for Treatment of Atherosclerotic Disease
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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Study Completion
March 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 3, 2007
Record last verified: 2007-11
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Source: ClinicalTrials.gov.
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