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

Not Applicable

Completed

• Conditions: Peripheral arterial occlusive disease of the lower extremity; Circulatory System

• Registration Number: ISRCTN25666105
• Lead Sponsor: Paracelsus Medical University (PMU) (Austria)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-12
• Study Completion: 2016-06-01
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 628

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
<br> 1. Local complications (e.g., surgical site infections)<br> 2. Systemic complications (e.g., myocardial infarction, stroke)<br> 3. Clinical and hemodynamic improvement<br> 4. Limb salvage<br> 5. Survival<br><br> Measured at baseline, 1 month, 3 months , 6 months after discharge and then at 6-month intervals for 2 years.<br>