Bypass or Thurpass for Superficial Femoral Artery Occlusion? Scandinavian Thurpass Study

NCT ID: NCT00810134

Last Updated: 2008-12-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2008-04-30

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 would be technically amenable for both treatments. The primary objective is to compare primary patencies of the two treatments. The secondary objective of the study is to evaluate secondary patency, functional status, the quality of life and costs of the new endovascular therapy.

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.

Conditions

Femoral Artery Occlusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Thrupass

Endovascular treatment (Thrupass) is performed as a femoropopliteal above knee endovascular recanalisation and Viabahn introduction with 6-7 mm Viabahn endo-prosthesis.

Group Type: OTHER

Thrupass

Intervention Type: PROCEDURE

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

Group Type: OTHER

Bypass

Intervention Type: PROCEDURE

Surgical procedure is performed as a femoropopliteal above knee by-pass with 6 mm non-coated PTFE-graft

Interventions

Thrupass

Endovascular treatment (Thrupass) is performed as a femoropopliteal above knee endovascular recanalisation and Viabahn introduction with 6-7 mm Viabahn endo-prosthesis.

Intervention Type: PROCEDURE

Bypass

Surgical procedure is performed as a femoropopliteal above knee by-pass with 6 mm non-coated PTFE-graft

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Superficial femoral artery occlusion from 5 to 25 cm in length above the knee joint.

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

1. Known allergy or contraindications to aspirin, clopidogrel, dipyridamole or anticoagulants.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

W.L.Gore & Associates

INDUSTRY

Sponsor Role: collaborator

University of Helsinki

OTHER

Sponsor Role: lead

Responsible Party

Department of Vascular Surgery, Helsinki University Central Hospital

Principal Investigators

Mauri Lepantalo, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Vascular Surgery, Helsinki University Central Hospital

Locations

Department of Vascular Surgery, Helsinki University Central Hospital

Helsinki, , Finland

Countries

Finland

Other Identifiers

Version 1.7 - Oct 15th 2002

Identifier Type: -

Identifier Source: org_study_id