Bypass or Thurpass for Superficial Femoral Artery Occlusion? Scandinavian Thurpass Study
NCT ID: NCT00810134
Last Updated: 2008-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
44 participants
INTERVENTIONAL
2003-01-31
2008-04-30
Brief Summary
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Detailed Description
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A randomised multicentre trial aims to enrol a pilot group of 60 + 60 patients to be followed for 3 years. Patients are treated either with Viabahn thrupass endoprosthesis (Gore corp.) or with 6 mm PTFE-prosthesis bypass graft surgery. Primary patency at three years is the primary end point and secondary patency, functional success, costs and quality of life are the secondary end points.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Thrupass
Endovascular treatment (Thrupass) is performed as a femoropopliteal above knee endovascular recanalisation and Viabahn introduction with 6-7 mm Viabahn endo-prosthesis.
Thrupass
Endovascular treatment (Thrupass) is performed as a femoropopliteal above knee endovascular recanalisation and Viabahn introduction with 6-7 mm Viabahn endo-prosthesis.
Bypass
Surgical procedure is performed as a femoropopliteal above knee by-pass with 6 mm non-coated PTFE-graft
Bypass
Surgical procedure is performed as a femoropopliteal above knee by-pass with 6 mm non-coated PTFE-graft
Interventions
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Thrupass
Endovascular treatment (Thrupass) is performed as a femoropopliteal above knee endovascular recanalisation and Viabahn introduction with 6-7 mm Viabahn endo-prosthesis.
Bypass
Surgical procedure is performed as a femoropopliteal above knee by-pass with 6 mm non-coated PTFE-graft
Eligibility Criteria
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Inclusion Criteria
2. Patient must be equally eligible for both procedures.
3. Patient must present intermittent claudication with resistance to medical therapy and exercise or critical ischaemia.
4. Normal adjacent vessel diameter must be between 4.8 and 6.5 mm.
5. 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.
6. Patient must be 18 years or older.
7. Women of childbearing age must have negative pregnancy test prior to inclusion.
Exclusion Criteria
2. Bleeding diatheses
3. Presence of one or several previously placed endoprosthesis or grafts in the superficial femoral artery segment.
4. Planned other endovascular therapy of the same segment.
5. Other than 6-7 mm diameter endoprosthesis or 6 mm PTFE-prosthesis is needed.
6. Presence of evolving malignant cancer or any other illness posing an immediate threat to life.
7. Life-expectancy less than 2 years due to co-morbidity or other situation that would make the patient unlikely candidate for follow-up visits.
8. Participation in another vascular clinical study less than 30 days prior to inclusion.
9. Patients unable to fill out the prescribed quality of life questionnaires themselves or unable to understand the full meaning of the informed consent.
18 Years
ALL
No
Sponsors
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W.L.Gore & Associates
INDUSTRY
University of Helsinki
OTHER
Responsible Party
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Department of Vascular Surgery, Helsinki University Central Hospital
Principal Investigators
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Mauri Lepantalo, M.D., PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Vascular Surgery, Helsinki University Central Hospital
Locations
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Department of Vascular Surgery, Helsinki University Central Hospital
Helsinki, , Finland
Countries
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Other Identifiers
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Version 1.7 - Oct 15th 2002
Identifier Type: -
Identifier Source: org_study_id