The Paclitaxel-Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) - Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions
NCT00670436 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2014-06-10
Summary
The aim of the study is to assess the safety and efficacy of a Paclitaxel-eluting PTCA-balloon in combination with bare-metal stenting for treatment of chronic total occlusions in native coronary arteries with reference diameters between 2.5 mm and 4.0 mm.
Conditions
- Coronary Artery Disease
- Chronic Total Occlusion
- Native Coronary Artery
Interventions
- DEVICE
-
paclitaxel eluting PTCA balloon catheter (SeQuent Please)
paclitaxel eluting PTCA balloon catheter after bare-metal stenting of chronic total occlusion in a native coronary artery
- DEVICE
-
paclitaxel eluting Taxus stent (Boston Scientific)
paclitaxel-eluting Taxus stents (Boston Scientific) in chronic total occlusion in native coronary arteries
Sponsors & Collaborators
-
B. Braun Melsungen AG
collaborator INDUSTRY -
University of Ulm
lead OTHER
Principal Investigators
-
Jochen Wöhrle, MD; FESC · University of Ulm, Ulm, Germany
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-02-29
- Primary Completion
- 2009-09-30
- Completion
- 2014-03-31
Countries
- Germany
Study Locations
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