Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety

Not Applicable

Terminated

• Conditions: Coronary Disease
• Interventions: Device: CoStar Paclitaxel Drug-Eluting Coronary Stent System

• Registration Number: NCT00415961
• Lead Sponsor: Conor Medsystems

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.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-12-22
• Study First Submitted QC: 2006-12-22
• Study First Posted: 2006-12-27
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-08
• Last Update Posted: 2009-01-09
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	CoStar Paclitaxel Drug-Eluting Coronary Stent System	CoStar Paclitaxel drug eluting stent

Primary Outcome Measures

Name	Time	Method
In-segment late lumen loss at 9 months, as measured by QCA.	9 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Shonan Kamakura General Hospital; 🇯🇵 Kamakura City, Japan