Evaluation of mortality after drug-coated balloon angioplasty of femoropopliteal lesions

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00019039

Enrollment

1500

Registered

2019-11-15

Start date

2019-07-01

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

I70.22

Interventions

Group 1: Treatment of femoropopliteal lesions with drug-coated balloon angioplasty Group 2: Treatment of femoropopliteal lesions with non-drug coated balloon angioplasty/stent implantation

Eligibility

Sex/Gender

All

Age

18 Years to 105 Years

Inclusion criteria

Inclusion criteria: Patients with interventions of the femoropopliteal arteries performed at the University Heart Center Freiburg-Bad Krozingen (Bad Krozingen site).

Exclusion criteria

Exclusion criteria: - Patients with an intervention iliacal or at the lower leg - Patients with an intervention due to stenosis of a femoropliteal/crural bypass - Patients who have been treated with a paclitaxel-coated catheter iliacally or on the lower leg in the same session

Design outcomes

Primary

Measure	Time frame
Mortality after treatment of femoropopliteal lesions with drug-coated balloon angioplasty and non-drug-coated balloon angioplasty/stent implantation	—

Secondary

Measure	Time frame
- Freedom from re-intervention at the target lesion ("target lesion revascularisation", TLR). - Restenosis rate - Revascularization-free survival - Time from index intervention to reinvention - cause of death - Number of Paclitaxel device TLRs in Follow-Up	—

Countries

Germany

Contacts

Public ContactThomas Zeller

Universitäts-Herzzentrum Bad Krozingen

Thomas.Zeller@universitaets-herzzentrum.de004976334020

Outcome results

None listed

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