- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00810134
Bypass or Thurpass for Superficial Femoral Artery Occlusion? Scandinavian Thurpass Study
A Randomised Controlled Trial for the Treatment of 5 - 25 cm Superficial Femoral Artery oc-Clusions Comparing Femoropopliteal Bypass With 6 mm PTFE-Prosthesis and 6 - 7 mm Viabahn Endoprosthesis
Study Overview
Status
Conditions
Intervention / Treatment
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 artery occlusion. Preliminary results of a thrupass endoprosthesis in the treatment of femoral lesions are promising. Less morbidity and better cost-effectiveness are suggested to be achieved in treatment of chronic lower limb ischaemia with endovascular treatment comparing to surgical treatment.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Helsinki, Finland, 00029
- Department of Vascular Surgery, Helsinki University Central Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: Thrupass
Endovascular treatment (Thrupass) is performed as a femoropopliteal above knee endovascular recanalisation and Viabahn introduction with 6-7 mm Viabahn endo-prosthesis.
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Endovascular treatment (Thrupass) is performed as a femoropopliteal above knee endovascular recanalisation and Viabahn introduction with 6-7 mm Viabahn endo-prosthesis.
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Other: Bypass
Surgical procedure is performed as a femoropopliteal above knee by-pass with 6 mm non-coated PTFE-graft
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Surgical procedure is performed as a femoropopliteal above knee by-pass with 6 mm non-coated PTFE-graft
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Primary end point of the study will be primary patency. Patency should be demonstrated by duplex ultrasound or other imaging modality at every control visit. ABI measurements will be recorded to assess the haemodynamic effect of the procedure.
Time Frame: At three years after intervention
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At three years after intervention
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Suboptimal outcome is defined as the presence of any of the following: re-stenosis diagnosed by colour duplex ultrasonography, ankle-brachial index improvement of less than 0.15, or re-intervention at the treated site.
Time Frame: At any time of the study
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At any time of the study
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Secondary patency is defined by procedures required to re-establish or maintain blood flow after occlusion.
Time Frame: At any time of the study
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At any time of the study
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Complications will include post procedure haemorrhage, haematomas, cardiac, pulmonary and renal complications and infection. Technical problems or equipment failure in the endoprosthesis group will also be recorded.
Time Frame: At any time of the study
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At any time of the study
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A procedural death will be any death that will occur within 30 days of the procedure.
Time Frame: At any time of the study
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At any time of the study
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Immediate functional failure is one in which the threshold increase of ABI is not achieved within 24 hours. Early failure is any failure occurring within 30 days of the operation.
Time Frame: within 30 days of the operation
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within 30 days of the operation
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Limb salvage is defined as retention of the leg without any major amputation or death.
Time Frame: At any time of the study
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At any time of the study
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mauri Lepantalo, M.D., PhD, Department of Vascular Surgery, Helsinki University Central Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Version 1.7 - Oct 15th 2002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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