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

NCT00810134 | Terminated

• 1 other identifier: Version 1.7 - Oct 15th 2002
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoral Artery Occlusion

Keywords

Superficial femoral artery occlusion (TASC II B or C)

Outcome Measures

Primary Outcomes (1)

• 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.

  At three years after intervention

Secondary Outcomes (6)

• 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.

  At any time of the study

• Secondary patency is defined by procedures required to re-establish or maintain blood flow after occlusion.

  At any time of the study

• 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.

  At any time of the study

• A procedural death will be any death that will occur within 30 days of the procedure.

  At any time of the study

• 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.

  within 30 days of the operation

Study Arms (2)

Thrupass

OTHER

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

Procedure: Thrupass

Bypass

OTHER

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

Procedure: Bypass

Interventions

Thrupass PROCEDURE

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

Thrupass

Bypass PROCEDURE

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

Bypass

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients unable to fill out the prescribed quality of life questionnaires themselves or unable to understand the full meaning of the informed consent.

Sponsors & Collaborators

• University of Helsinki: lead
• W.L.Gore & Associates: collaborator

Study Sites (1)

Department of Vascular Surgery, Helsinki University Central Hospital

Helsinki, 00029, Finland

Location

Study Officials

• Mauri Lepantalo, M.D., PhD

  Department of Vascular Surgery, Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 15, 2008
• First Posted: December 17, 2008
• Study Start: January 1, 2003
• Primary Completion: February 1, 2008
• Study Completion: April 1, 2008
• Last Updated: December 17, 2008

Record last verified: 2008-12

Locations

FI (1)