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Arm veins versus contralateral greater saphenous vein for lower extremity bypass reconstruction in patients with absent ipsilateral greater saphenous vein

Arm veins versus contralateral greater saphenous vein for lower extremity bypass reconstruction in patients with absent ipsilateral greater saphenous vein: a randomized trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN25666105
Enrollment
628
Registered
2014-02-12
Start date
2010-06-01
Completion date
Unknown
Last updated
2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral arterial occlusive disease of the lower extremity Circulatory System

Interventions

Standard vein bypass techniques for lower limb revascularization in patients suffering from peripheral arterial occlusive disease. For Group A patients arm veins (basilic and/or cephal

Sponsors

Paracelsus Medical University (PMU) (Austria)
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026