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 ]
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.