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

This study has been terminated.
(Due to the results of interim analysis at the time 44 patients were recruited.)
Sponsor:
Collaborator:
W.L.Gore & Associates Scandinavia Ab
Information provided by:
Helsinki University
ClinicalTrials.gov Identifier:
NCT00810134
First received: December 15, 2008
Last updated: December 16, 2008
Last verified: December 2008
  Purpose

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.


Condition Intervention
Femoral Artery Occlusion
Procedure: Thrupass
Procedure: Bypass

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Secondary patency is defined by procedures required to re-establish or maintain blood flow after occlusion. [ Time Frame: At any time of the study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • A procedural death will be any death that will occur within 30 days of the procedure. [ Time Frame: At any time of the study ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Limb salvage is defined as retention of the leg without any major amputation or death. [ Time Frame: At any time of the study ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: January 2003
Study Completion Date: April 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Thrupass
Endovascular treatment (Thrupass) is performed as a femoropopliteal above knee endovascular recanalisation and Viabahn introduction with 6-7 mm Viabahn endo-prosthesis.
Procedure: 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
Procedure: Bypass
Surgical procedure is performed as a femoropopliteal above knee by-pass with 6 mm non-coated PTFE-graft

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810134

Locations
Finland
Department of Vascular Surgery, Helsinki University Central Hospital
Helsinki, Finland, 00029
Sponsors and Collaborators
Helsinki University
W.L.Gore & Associates Scandinavia Ab
Investigators
Principal Investigator: Mauri Lepantalo, M.D., PhD Department of Vascular Surgery, Helsinki University Central Hospital
  More Information

No publications provided

Responsible Party: Mauri Lepantalo, Department of Vascular Surgery, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT00810134     History of Changes
Other Study ID Numbers: Version 1.7 - Oct 15th 2002
Study First Received: December 15, 2008
Last Updated: December 16, 2008
Health Authority: Sweden: Institutional Review Board

Keywords provided by Helsinki University:
Superficial femoral artery occlusion (TASC II B or C)

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014