Bioabsorbable stent implantation versus endarterectomy for atherosclerotic lesions in the common femoral artery

Completed

• Conditions: Atherosclerosis. Peripheral arterial occlusive disease. Fontaine stages IIb-IV; Circulatory System; Arteriosclerosis

• Registration Number: ISRCTN81656089
• Lead Sponsor: Paracelsus Medical University (PMU) (Paracelsus Medizinische Privatuniversität) (Austria)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-04
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

Patients with peripheral arterial occlusive disease in the common femoral artery due to atheroscloerosis

Exclusion Criteria

1. Pregnancy
2. Active malignancy
3. Infectious diseases (hepatitis, HIV)
4. Inability to comply with study requirements (e.g. regular follow up)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measures as of 28/01/2014:<br>1. Surgical site infections (SSI, local groin complications associated with intervention, i.e. wound healing, bleeding, infection)<br><br>Outcomes are measured regularly at baseline, one month, 3 months, 6 months and biannually thereafter<br><br>Previous primary outcome measures:<br>1. Intervention patency<br>2. Effect of intervention (improvement of circulation as measuerd by the ankle/brachial index)<br>3. Limb salvage<br>4. Survival<br><br>Outcomes are measured regularly at baseline, 1 month, 3 months, 6 months and biannually thereafter