Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety

Conditions
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Coronary Disease

Intervention / Treatment
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* Device: CoStar Paclitaxel Drug-Eluting Coronary Stent System


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: - Known sensitivity to paclitaxel or polymeric matrices. Planned treatment with any other PCI device in the target vessel(s). MI within 72 hours prior to the index procedure Patient is in cardiogenic shock Cerebrovascular Accident (CVA) within the past 6 months Acute or chronic renal dysfunction (creatinine >2.0 mg/dl or >150 µmol/L) Contraindication to ASA or to ticlopidine Thrombocytopenia Active GI bleeding within past three months Known allergy to cobalt chromium Any prior true anaphylactic reaction to contrast agents

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>CoStar Paclitaxel drug eluting stent | Device: CoStar Paclitaxel Drug-Eluting Coronary Stent System<br>* CoStar Paclitaxel Drug-Eluting Coronary Stent System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-segment late lumen loss at 9 months, as measured by QCA. |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous Coronary Intervention (PCI), Drug-eluting stent (DES)