Evaluation of acute and long-term outcomes ofatherectomy in femoropoliteal and infrapopliteal lesions
- Conditions
- I70.22
- Registration Number
- DRKS00031245
- 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
- 1180
Inclusion Criteria
Patients with peripheral arterial disease (PAOD) in clinical stage 2-5 according to the Rutherford-Becker classification.
Patients treated by atherectomy.
Stenosis (=70% diameter reduction) or occlusion femoropopliteal or in the arteries of the lower leg.
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 PAOD who have not been treated with an atherectomy device.
No follow-up (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 Primary patency rate and Target Lesion Revascularisation rate in a follow up period of at least 12 Months
- Secondary Outcome Measures
Name Time Method Time to first re-intervention at the target lesion.<br>Minor and/or major amputation on the treated leg in the follow-up period.<br>Amputationfree survivale during the follow-up period.<br>Presence of predictors of re-stenosis or re-intervention (risk factors, atherectomy preparation, lesion characteristics).<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>