MedTrace Logo

Remote Endarterectomy Versus Suprageniculate Femoropopliteal Bypass

NCT00566436 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2007-12-03

No results posted yet for this study

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.

Conditions

Interventions

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.

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)

Sponsors & Collaborators

  • UMC Utrecht

    collaborator OTHER

  • Albert Schweitzer Hospital, Netherlands

    collaborator UNKNOWN

  • Amphia Hospital

    collaborator OTHER

  • St. Antonius Hospital

    lead OTHER

Principal Investigators

  • Suzanne S Gisbertz, MD · St. Antonius Hospital

  • Jean Paul PM de Vries, MD, PhD · St. Antonius Hospital

  • Frans L Moll, MD, PhD · UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Completion
2012-03-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00566436 on ClinicalTrials.gov