Remote Endarterectomy Versus Suprageniculate Femoropopliteal Bypass

Atherosclerosis Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00566436
• Other study ID #: C-04.04
• Secondary ID: P.04.1298L
• Status: Active, not recruiting
• Phase: N/A
• First received: November 29, 2007
• Last updated: November 29, 2007
• Start date: October 2004
• Est. completion date: March 2012

Study information

• Verified date: November 2007
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 126
• Est. completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Atherosclerosis
• Peripheral Arterial Disease
• Peripheral Arterial Occlusive Disease

Intervention

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.
• 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)

Locations

Country	Name	City	State
Netherlands	Amphia Hospital	Breda	Noord-Brabant
Netherlands	Albert Schweitzer Ziekenhuis	Dordrecht	Zuid-Holland
Netherlands	St Antonius Hospital	Nieuwegein	Utrecht
Netherlands	UMC Utrecht	Utrecht

Sponsors (4)

Lead Sponsor	Collaborator
St. Antonius Hospital	Albert Schweitzer Hospital, Amphia Hospital, UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(re-)occlusion of the endarterectomized superficial femoral artery or suprageniculate femoropopliteal bypass		5 year	No
Secondary	(a)symptomatic (re)stenosis of the superficial femoral artery or bypass for which a re-intervention was carried out		5 year	No
Secondary	major amputation of the ipsilateral leg		5 year	No