Influence of the cutting balloon and drug-coated balloon angioplasty on the acute and long-term outcome of endovascular shunt interventions

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00023295

Enrollment

200

Registered

2020-10-13

Start date

2021-01-03

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

T82.4

Interventions

Group 1: Treatment of shunt stenoses with cutting balloon and paclitaxel-coated balloon angioplasty Group 2: Treatment of shunt stenoses with conventional balloon angioplasty

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with shunt interventions performed at the University Heart Center (Bad Krozingen site)

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Primary technical endpoint: freedom from target lesion revascularisation (TLR) at 6 months follow-up after the index procedure Primary safety endpoint: all-cause mortality after treatment with a paclitaxel-coated balloon compared to uncoated balloons	—

Secondary

Measure	Time frame
Secondary endpoints: freedom from re-intervention at the target lesion ("target lesion revascularisation", TLR) after 12 months and until the last follow-up restenosis rate after 6, 12 months and until last follow-up Revascularization-free survival Acute treatment success defined as residual stenosis < 50% and <30 Time of index intervention for a new shunt "Bail out" Stentrate	—

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