Evaluation of acute and long-term outcomes after implantation of a supera stent in the femoropopliteal artery
- Conditions
- I70.22
- Registration Number
- DRKS00031244
- Lead Sponsor
- niversitäts-Herzzentrum Campus Bad Krozingen - Uniklinikum Freiburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 650
Inclusion Criteria
Patients with peripheral arterial disease (CAD) in clinical stage 1-5 according to Rutherford-Becker classification.
Stenosis (=70% diameter reduction) or occlusion in the femoropopliteal vessel segment confirmed by duplex sonography and/or angiography.
At least one follow-up examination (including duplex sonography and/ or angiography), in a period of at least 12 months after re-intervention.
Exclusion Criteria
Patients with stage 6 PAOD according to Rutherford-Becker classification.
No relevant stenosis of the target lesion (<70% diameter reduction).
No follow-up examinations (including duplex sonography) of the target lesion available for at least 12 months after the index procedure (lost-to-follow-up)
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pimary patency- and Target-Revascularisation rate in a follow-up period of at least 12-50 months
- Secondary Outcome Measures
Name Time Method Time to first TLR<br>Minor and/or major amputation on the treated leg in the follow-up period.<br>Amputation free survival<br>Change in clinical symptoms according to the Rutherford-Becker classification <br>Severe cardiovascular events (myocardial infarction, stroke, major amputation, death) in the follow-up period <br>Predictors for re-intervention