Remote Endarterectomy Versus Suprageniculate Femoropopliteal Bypass (REVAS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by St. Antonius Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
UMC Utrecht
Albert Schweitzer Hospital
Amphia Hospital
Information provided by:
St. Antonius Hospital
ClinicalTrials.gov Identifier:
NCT00566436
First received: November 29, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Peripheral Arterial Occlusive Disease
Atherosclerosis
Procedure: Remote endarterectomy of the superficial femoral artery
Procedure: Suprageniculate femoropopliteal bypass

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Surgical Treatment of Long Occlusions of the Superficial Femoral Artery: Initial Success and Long Term Results of Remote Endarterectomy Versus Suprageniculate Bypass Surgery

Resource links provided by NLM:


Further study details as provided by St. Antonius Hospital:

Primary Outcome Measures:
  • (re-)occlusion of the endarterectomized superficial femoral artery or suprageniculate femoropopliteal bypass [ Time Frame: 5 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • (a)symptomatic (re)stenosis of the superficial femoral artery or bypass for which a re-intervention was carried out [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  • major amputation of the ipsilateral leg [ Time Frame: 5 year ] [ Designated as safety issue: No ]

Enrollment: 126
Study Start Date: October 2004
Estimated Study Completion Date: March 2012
Arms Assigned Interventions
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
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
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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566436

Locations
Netherlands
Amphia Hospital
Breda, Noord-Brabant, Netherlands, 4818CK
St Antonius Hospital
Nieuwegein, Utrecht, Netherlands, 3435CM
Albert Schweitzer Ziekenhuis
Dordrecht, Zuid-Holland, Netherlands, 3318AT
UMC Utrecht
Utrecht, Netherlands, 3584CX
Sponsors and Collaborators
St. Antonius Hospital
UMC Utrecht
Albert Schweitzer Hospital
Amphia Hospital
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Drs SS Gisbertz, St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT00566436     History of Changes
Other Study ID Numbers: C-04.04, P.04.1298L
Study First Received: November 29, 2007
Last Updated: November 29, 2007
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by St. Antonius Hospital:
Peripheral Arterial Occlusive Disease
Superficial Femoral Artery
Remote Endarterectomy
Suprageniculate Bypass Surgery
Blood Vessel Prosthesis Implantation
Vascular Patency

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Atherosclerosis
Peripheral Arterial Disease
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014