PaneLux PTCA : Proposing an Alternative Treatment to patiEnts for Whom DES Implantation is Not Indicated, Thanks to Pantera LUX Drug Eluting Balloon
NCT01930903 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500
Last updated 2015-04-30
Summary
The propose of this study is to demonstrate, whenever using Drug Eluting Stent is not possible, the clinical security at 12 months, of the combinaison Bare Metal Stent plus Drug Eluting Balloon.
Conditions
- Coronary Artery Disease
- High Bleeding Risk Patients
Interventions
- DEVICE
-
Pantera Lux Drug Eluting Balloon
All patients are treated with the PRO-Kinetic Energy Stent and Pantera Lux drug eluting balloon for the last post dilatation.
Sponsors & Collaborators
-
MedPass International
collaborator INDUSTRY -
Biotronik France
lead INDUSTRY
Principal Investigators
-
Jérôme Roncalli, Prof · CHU Toulouse, Hôpital Rangueil, TSA 50032, 31059 TOULOUSE Cedex 9
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-09-30
- Primary Completion
- 2015-12-31
- Completion
- 2015-12-31
Countries
- France
Study Locations
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