Prospective, Multi-Center, Random. Study of CoStar Paclitaxel-Eluting Coronary Stent(Direct Stenting vs. Pre-Dilatation)
NCT00440674 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2009-10-30
Summary
The primary objective of this study is to evaluate the safety and effectiveness of a direct stenting technique compared to conventional stenting with pre-dilatation strategy using the CoStar Paclitaxel-eluting coronary stent system for the treatment of a single de novo lesion in a native coronary artery ≤ 25 mm long in a native coronary artery 2.5-3.5 mm diameter.
Conditions
Interventions
- DEVICE
-
CoStar Paclitaxel-eluting coronary stent system
Sponsors & Collaborators
-
Conor Medsystems
lead INDUSTRY
Principal Investigators
-
Joachim Schofer · Universitäres Herz-und Gefäßzentrum Hamburg
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-02-28
- Primary Completion
- 2007-06-30
- Completion
- 2009-07-31
Countries
- Germany
Study Locations
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