Evaluation of mortality after drug-coated balloonangioplasty of loew leg arteries

• Conditions: I70.2; Atherosclerosis of arteries of extremities

• Registration Number: DRKS00021262
• Lead Sponsor: niversitäts-Herzzentrum Freiburg-Bad Krozingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-03-31
• Study Start: 2020-04-15
• Results First Posted: 2022-12-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 576

Inclusion Criteria

Patients with endovascular therapy of the lower leg arteries performed at the University Heart Centre Freiburg-Bad Krozingen (Bad Krozingen site)

Exclusion Criteria

Patients who only had iliacal or femoropopliteal intervention
Patients treated for femoropopliteal/crural bypass stenosis
Patients who have had a paclitaxel-coated catheter or stent iliacal or on the thigh in the same session

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality after treatment of lesions in the lower leg arteries with paclitaxel-coated balloon angioplasty and uncoated balloon angioplasty

Secondary Outcome Measures

Name	Time	Method
freedom from re-intervention at the target lesion (target lesion revascularisation, TLR)<br>Restenosis rate <br>Revascularization-free survival<br>Time of index intervention to reinvention<br>Cause of death<br>Correlation Paclitaxel Dose and Mortality<br>Number of Paclitaxel device TLRs in the follow-up