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Remote Endarterectomy Versus Suprageniculate Femoropopliteal Bypass (REVAS)

Primary Purpose

Peripheral Arterial Occlusive Disease, Atherosclerosis

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Remote endarterectomy of the superficial femoral artery
Suprageniculate femoropopliteal bypass
Sponsored by
St. Antonius Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Occlusive Disease focused on measuring Peripheral Arterial Occlusive Disease, Superficial Femoral Artery, Remote Endarterectomy, Suprageniculate Bypass Surgery, Blood Vessel Prosthesis Implantation, Vascular Patency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Amphia Hospital
  • St Antonius Hospital
  • Albert Schweitzer Ziekenhuis
  • UMC Utrecht

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

REA

Bypass

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

(a)symptomatic (re)stenosis of the superficial femoral artery or bypass for which a re-intervention was carried out
major amputation of the ipsilateral leg

Full Information

First Posted
November 29, 2007
Last Updated
November 29, 2007
Sponsor
St. Antonius Hospital
Collaborators
UMC Utrecht, Albert Schweitzer Hospital, Amphia Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00566436
Brief Title
Remote Endarterectomy Versus Suprageniculate Femoropopliteal Bypass
Acronym
REVAS
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Unknown status
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
St. Antonius Hospital
Collaborators
UMC Utrecht, Albert Schweitzer Hospital, Amphia Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Occlusive Disease, Atherosclerosis
Keywords
Peripheral Arterial Occlusive Disease, Superficial Femoral Artery, Remote Endarterectomy, Suprageniculate Bypass Surgery, Blood Vessel Prosthesis Implantation, Vascular Patency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
REA
Arm Type
Active Comparator
Arm Description
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
Arm Title
Bypass
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Remote endarterectomy of the superficial femoral artery
Other Intervention Name(s)
Remote superficial artery endarterectomy, Distal cutting endarterectomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Suprageniculate femoropopliteal bypass
Other Intervention Name(s)
Above knee bypass, Femoropopliteal bypass
Intervention Description
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)
Primary Outcome Measure Information:
Title
(re-)occlusion of the endarterectomized superficial femoral artery or suprageniculate femoropopliteal bypass
Time Frame
5 year
Secondary Outcome Measure Information:
Title
(a)symptomatic (re)stenosis of the superficial femoral artery or bypass for which a re-intervention was carried out
Time Frame
5 year
Title
major amputation of the ipsilateral leg
Time Frame
5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne S Gisbertz, MD
Organizational Affiliation
St. Antonius Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean Paul PM de Vries, MD, PhD
Organizational Affiliation
St. Antonius Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frans L Moll, MD, PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amphia Hospital
City
Breda
State/Province
Noord-Brabant
ZIP/Postal Code
4818CK
Country
Netherlands
Facility Name
St Antonius Hospital
City
Nieuwegein
State/Province
Utrecht
ZIP/Postal Code
3435CM
Country
Netherlands
Facility Name
Albert Schweitzer Ziekenhuis
City
Dordrecht
State/Province
Zuid-Holland
ZIP/Postal Code
3318AT
Country
Netherlands
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3584CX
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
12787704
Citation
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.
Results Reference
background
PubMed Identifier
18990592
Citation
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.
Results Reference
derived

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Remote Endarterectomy Versus Suprageniculate Femoropopliteal Bypass

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