Coronary Disease
Conditions
Keywords
Percutaneous Coronary Intervention (PCI), Drug-eluting stent (DES)
Brief summary
This trial aims to demonstrate the non-inferiority of the CI-CMS-005 Coronary Stent System to the study device as well as to the TAXUS™ Express2™ Drug-Eluting Coronary Stent System in in-segment late lumen loss at 9 months after treatment of a single de novo lesion per vessel.
Detailed description
This is a complementary, multi-center, open-label, single-arm trial investigating angiographic and clinical patient outcomes in Japan. Historical data from the 2-arm randomized COSTAR II trial will be used for comparison.
Interventions
DEVICECoStar Paclitaxel Drug-Eluting Coronary Stent System
CoStar Paclitaxel Drug-Eluting Coronary Stent System
Sponsors
Getz Pharma
Conor Medsystems
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria * Eligible for percutaneous coronary intervention (PCI) * Documented stable or unstable angina pectoris (Class I, II, III or IV), documented ischemia, or documented silent ischemia * Documented LVEF ≥25% within the last 6 weeks. * Eligible for coronary artery bypass graft surgery (CABG)
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-segment late lumen loss at 9 months, as measured by QCA. | 9 months |
Secondary
| Measure | Time frame |
|---|---|
| Device, lesion and procedure success; MACE at 30 days and 8 months, Angiographic restenosis at 9 months; Clinically driven Target Lesion Revascularization at 8 months | MACE at 30 days and 8 months, Angiographic restenosis at 9 months; Clinically driven Target Lesion Revascularization at 8 months |
Countries
Japan
Outcome results
None listed