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Remote Endarterectomy Versus Suprageniculate Femoropopliteal Bypass (REVAS)

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ClinicalTrials.gov Identifier: NCT00566436
Recruitment Status : Unknown
Verified November 2007 by St. Antonius Hospital.
Recruitment status was:  Active, not recruiting
First Posted : December 3, 2007
Last Update Posted : December 3, 2007
Sponsor:
Collaborators:
UMC Utrecht
Albert Schweitzer Hospital
Amphia Hospital
Information provided by:
St. Antonius Hospital

November 29, 2007
December 3, 2007
December 3, 2007
October 2004
Not Provided
(re-)occlusion of the endarterectomized superficial femoral artery or suprageniculate femoropopliteal bypass [ Time Frame: 5 year ]
Same as current
No Changes Posted
  • (a)symptomatic (re)stenosis of the superficial femoral artery or bypass for which a re-intervention was carried out [ Time Frame: 5 year ]
  • major amputation of the ipsilateral leg [ Time Frame: 5 year ]
Same as current
Not Provided
Not Provided
 
Remote Endarterectomy Versus Suprageniculate Femoropopliteal Bypass
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Peripheral Arterial Occlusive Disease
  • Atherosclerosis
  • Procedure: 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.
    Other Names:
    • Remote superficial artery endarterectomy
    • Distal cutting endarterectomy
  • 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)
    Other Names:
    • Above knee bypass
    • Femoropopliteal bypass
  • 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
    Intervention: Procedure: Remote endarterectomy of the superficial femoral artery
  • 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
    Intervention: Procedure: Suprageniculate femoropopliteal bypass

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
126
Same as current
March 2012
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT00566436
C-04.04
P.04.1298L
No
Not Provided
Not Provided
Drs SS Gisbertz, St. Antonius Hospital
St. Antonius Hospital
  • UMC Utrecht
  • Albert Schweitzer Hospital
  • Amphia Hospital
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
St. Antonius Hospital
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP