CoStar Catheter System Evaluation

Conor Medsystems1 site in 1 country58 target enrollmentFebruary 2007

Overview

To evaluate product performance and safety of the Catheter Design for the treatment of a single coronary lesion.

Registry

clinicaltrials.gov

Start Date

February 2007

End Date

April 2008

Last Updated

16 years ago

Study Type

Interventional

Sex

All

Sponsor

Conor Medsystems

•Patient is ≥18 years of age.
•Eligible for percutaneous coronary intervention (PCI).
•Documented stable or unstable angina pectoris (Canadian Cardiovascular Society Classification \[CCS\] 1, 2, 3, or 4), documented ischemia, or documented silent ischemia.
•Left ventricular ejection fraction (LVEF) ≥25% documented within the last 6 weeks.
•Acceptable candidate for coronary artery bypass graft surgery (CABG).
•Patient understands the study requirements and the treatment procedures and provides written Informed Consent using a form that has been approved by the local Institutional Review Board or Ethics Committee before any study-specific tests or procedures are performed.
•Willing to comply with all specified follow-up evaluations.
•Inclusion Criteria (Angiographic):
•A single de novo lesion per study subject may be treated with the study device.
•Each target lesion may be composed of multiple lesions but must be completely coverable by one (1) study stent.

•Known sensitivity to cobalt chromium, paclitaxel or polymeric matrices: PLGA.
•Planned treatment with any other PCI device in the target vessel(s).
•Acute MI within 72 hours prior to the index procedure as defined by the presence of a new pathologic Q wave, or creatinine kinase (CK) \>2 times the laboratory upper limits of normal and elevated MB.
•The 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 clopidogrel.
•Thrombocytopenia (platelet count \<100, 000/mm3).
•Active gastrointestinal (GI) bleeding within the past three months.
•Any prior true anaphylactic reaction to contrast agents.