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

Primary Purpose

Femoral Artery Occlusion

Status

Terminated

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

Thrupass

Bypass

About this trial

This is an interventional treatment trial for Femoral Artery Occlusion focused on measuring Superficial femoral artery occlusion (TASC II B or C)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Vascular Surgery, Helsinki University Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Thrupass

Bypass

Arm Description

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

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

Outcomes

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.

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.

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

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.

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

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.

Limb salvage is defined as retention of the leg without any major amputation or death.

Full Information

NCT ID

NCT00810134

First Posted

December 15, 2008

Last Updated

December 16, 2008

Sponsor

University of Helsinki

Collaborators

W.L.Gore & Associates

1. Study Identification

Unique Protocol Identification Number

NCT00810134

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2008

Overall Recruitment Status

Terminated

Why Stopped

Due to the results of interim analysis at the time 44 patients were recruited.

Study Start Date

January 2003 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Helsinki

Collaborators

W.L.Gore & Associates

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Femoral Artery Occlusion

Keywords

Superficial femoral artery occlusion (TASC II B or C)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Thrupass

Arm Type

Other

Arm Description

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

Arm Title

Bypass

Arm Type

Other

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Thrupass

Intervention Description

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

Intervention Name(s)

Bypass

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Frame

At three years after intervention

Secondary Outcome Measure Information:

Title

Time Frame

At any time of the study

Title

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

Time Frame

At any time of the study

Title

Time Frame

At any time of the study

Title

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

Time Frame

At any time of the study

Title

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

Title

Limb salvage is defined as retention of the leg without any major amputation or death.

Time Frame

At any time of the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mauri Lepantalo, M.D., PhD

Organizational Affiliation

Department of Vascular Surgery, Helsinki University Central Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Vascular Surgery, Helsinki University Central Hospital

City

Helsinki

ZIP/Postal Code

00029

Country

Finland

12. IPD Sharing Statement

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

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