I70.22
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary patency rate and Target Lesion Revascularisation rate in a follow up period of at least 12 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first re-intervention at the target lesion. Minor and/or major amputation on the treated leg in the follow-up period. Amputationfree survivale during the follow-up period. Presence of predictors of re-stenosis or re-intervention (risk factors, atherectomy preparation, lesion characteristics). Change in clinical symptoms according to the Rutherford-Becker classification Severe cardiovascular events (myocardial infarction, stroke, major amputation, death) in the follow-up period | — |
Countries
Germany
Contacts
Universitäts-Herzzentrum Campus Bad Krozingen - Uniklinikum Freiburg