Basel Stent Kosten Effektivitäts Trial Drug Eluting Balloons vs. Drug Eluting Stents in Small Vessel Interventions
NCT01574534 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 758
Last updated 2020-06-24
Summary
The investigators hypothesize that in a real-world population undergoing percutaneous coronary intervention (PCI) for de-novo stenoses in small native vessels with a diameter \<3 mm, drug eluting balloons (DEB) are non inferior to third-generation drug eluting stents (DES).
Conditions
Interventions
- DEVICE
-
Drug eluting balloon
PCI using paclitaxel-eluting SeQuent® Please balloon, B. Braun Melsungen AG, Berlin, Germany
- DEVICE
-
Drug eluting stent
PCI using paclitaxel-eluting Taxus Element® stent, Boston Scientific Corp, Natick MA
Sponsors & Collaborators
-
Clinical Trial Unit, University Hospital Basel, Switzerland
collaborator OTHER -
University Hospital, Basel, Switzerland
lead OTHER
Principal Investigators
-
Raban V Jeger, PD Dr · Cardiology, University Hospital Basel
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-04-30
- Primary Completion
- 2018-02-01
- Completion
- 2020-01-15
Countries
- Austria
- Germany
- Switzerland
Study Locations
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