Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety

Conor Medsystems120 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Coronary Disease

Interventions

CoStar Paclitaxel Drug-Eluting Coronary Stent SystemDEVICE

CoStar Paclitaxel Drug-Eluting Coronary Stent System

Eligibility

Sex: ALLMin age: 20 YearsMax age: 95 Years

Medical Language ↔ Plain English

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

Locations (1)

Shonan Kamakura General Hospital

Kamakura, Japan

Outcomes

Primary Outcomes

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

Time frame: 9 months

Secondary Outcomes

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

Time frame: MACE at 30 days and 8 months, Angiographic restenosis at 9 months; Clinically driven Target Lesion Revascularization at 8 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.