Clinical trial NCT00566436: Remote Endarterectomy Versus Suprageniculate Femoropopliteal Bypass
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
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Occlusive Disease
Atherosclerosis
Keywords: Peripheral Arterial Occlusive Disease
Superficial Femoral Artery
Remote Endarterectomy
Suprageniculate Bypass Surgery
Blood Vessel Prosthesis Implantation
Vascular Patency
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
Collaborators: name: UMC Utrecht
name: Albert Schweitzer Hospital, Netherlands
name: Amphia Hospital
First posted: 2007-12-03
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: (re-)occlusion of the endarterectomized superficial femoral artery or suprageniculate femoropopliteal bypass
timeFrame: 5 year
Secondary outcomes:
measure: (a)symptomatic (re)stenosis of the superficial femoral artery or bypass for which a re-intervention was carried out
timeFrame: 5 year
measure: major amputation of the ipsilateral leg
timeFrame: 5 year
Other outcomes:
Locations:
city: Breda
country: Netherlands
facility: Amphia Hospital
state: Noord-Brabant
city: Nieuwegein
country: Netherlands
facility: St Antonius Hospital
state: Utrecht
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
state: Zuid-Holland
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: St. Antonius Hospital
name: Suzanne S Gisbertz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Antonius Hospital
name: Jean Paul PM de Vries, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC Utrecht
name: Frans L Moll, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.