Safety and Efficacy Study of the DANUBIO Paclitaxel Eluting Balloon in Side Branches of de Novo Bifurcation Lesions (DEBSIDE)
NCT01485081 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2015-04-08
Summary
The purpose of this study is to assess the safety and efficacy of the Danubio Paclitaxel Eluting Balloon for the treatment of side branches of de novo bifurcation lesions in native coronary arteries.
Conditions
- Coronary Disease
Interventions
- DEVICE
-
Danubio paclitaxel-eluting balloon
Inflation of the Danubio Paclitaxel Eluting Balloon in the side branch of a de novo bifurcation lesion.
Sponsors & Collaborators
-
European Cardiovascular Research Center
collaborator NETWORK -
MINVASYS
lead INDUSTRY
Principal Investigators
-
Jacques BERLAND, MD · Clinique Saint Hilaire - ROUEN
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-05-31
- Primary Completion
- 2013-07-31
- Completion
- 2014-07-31
Countries
- France
Study Locations
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