Evaluation of mortality after drug-coated balloon angioplasty of loew leg arteries

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00021262

Enrollment

600

Registered

2020-04-15

Start date

2020-02-15

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I70.2

Interventions

Group 1: Patients with drug-coated balloon angioplasty of the lower leg Group 2: Patients, with uncoated balloon angioplasty of the lower leg

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Mortality after treatment of lesions in the lower leg arteries with paclitaxel-coated balloon angioplasty and uncoated balloon angioplasty	—

Secondary

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

Countries

Germany

Contacts

Public ContactTanja Böhme

Universitäts-Herzzentrum Bad Krozingen

Tanja.Boehme@universitaets-herzzentrum.de004976334020

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026