Peripheral arterial occlusive disease of the lower extremity Circulatory System
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female aged 30 years and over 2. Claudication > 2 months 3. Critical leg ischemia > 2 months 4. Popliteal aneurysm 5. Absent ipsilateral greater saphenous vein 6. Usable arm vein (cephalic and/or basilic vein without signs of sclerosis or thrombosis and with diameter > 2.5 mm verified by preoperative duplex) 7. Usable contralateral greater saphenous vein (without signs of sclerosis or thrombosis and with diameter > 2.5 mm verified by preoperative duplex) 8. Atherosclerosis
Exclusion criteria
Exclusion criteria: 1. Urgent critical leg ischemia (thromboembolic event < 2 months) 2. Absent arm vein (e.g., due to prior operation) 3. Unusable arm vein (due to sclerosis and/or thrombosis and/or small (< 2.5 mm) diameter verified by preoperative duplex) 4. Absent contralateral greater saphenous vein (due to prior coronary bypass, peripheral bypass, vein stripping, trauma, etc) 5. Unusable contralateral greater saphenous vein (due to sclerosis and/or thrombosis and/or small (< 2.5 mm) diameter verified by duplex) 6. Arm veins should be saved for arterio-venous fistula 7. Deep vein thrombosis of the contralateral leg 8. Critical leg ischemia of the contralateral leg 9. Trauma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary and secondary bypass patency measured at baseline, 1 month, 3 months , 6 months after discharge and then at 6-month intervals for 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Local complications (e.g., surgical site infections) 2. Systemic complications (e.g., myocardial infarction, stroke) 3. Clinical and hemodynamic improvement 4. Limb salvage 5. Survival Measured at baseline, 1 month, 3 months , 6 months after discharge and then at 6-month intervals for 2 years. | — |
Countries
Austria