Status:
TERMINATED
Bypass or Thurpass for Superficial Femoral Artery Occlusion? Scandinavian Thurpass Study
Lead Sponsor:
University of Helsinki
Collaborating Sponsors:
W.L.Gore & Associates
Conditions:
Femoral Artery Occlusion
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of the study is to compare PTFE-graft bypass surgery versus Viabahn endoprosthesis for femoropopliteal arterial occlusion in intermittent claudication and critical ischaemia in patients who wo...
Detailed Description
Femoropopliteal bypass graft surgery with PTFE-prosthesis has proven to be an acceptable treatment for stable incapacitating claudication and critical ischaemia in patients with superficial femoral ar...
Eligibility Criteria
Inclusion
- Superficial femoral artery occlusion from 5 to 25 cm in length above the knee joint.
- Patient must be equally eligible for both procedures.
- Patient must present intermittent claudication with resistance to medical therapy and exercise or critical ischaemia.
- Normal adjacent vessel diameter must be between 4.8 and 6.5 mm.
- At least one patent distal run-off vessel and at least 1 cm of healthy superficial femoral artery below and above the lesion to allow proper placement of the endoprosthesis.
- Patient must be 18 years or older.
- Women of childbearing age must have negative pregnancy test prior to inclusion.
Exclusion
- Known allergy or contraindications to aspirin, clopidogrel, dipyridamole or anticoagulants.
- Bleeding diatheses
- Presence of one or several previously placed endoprosthesis or grafts in the superficial femoral artery segment.
- Planned other endovascular therapy of the same segment.
- Other than 6-7 mm diameter endoprosthesis or 6 mm PTFE-prosthesis is needed.
- Presence of evolving malignant cancer or any other illness posing an immediate threat to life.
- Life-expectancy less than 2 years due to co-morbidity or other situation that would make the patient unlikely candidate for follow-up visits.
- Participation in another vascular clinical study less than 30 days prior to inclusion.
- Patients unable to fill out the prescribed quality of life questionnaires themselves or unable to understand the full meaning of the informed consent.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00810134
Start Date
January 1 2003
End Date
April 1 2008
Last Update
December 17 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Vascular Surgery, Helsinki University Central Hospital
Helsinki, Finland, 00029