The PreCiSE Trial: CoStar™ Paclitaxel-Eluting Coronary Stent Catheter System Evaluation

Conor Medsystems1 site in 1 country107 target enrollmentJanuary 2007

Overview

This study is designed to evaluate the performance and safety of a new catheter system.

This study is designed to evaluate acute Device Success, defined as attainment of \<50% residual stenosis of the target lesion.

Registry

clinicaltrials.gov

Start Date

January 2007

End Date

May 2008

Last Updated

17 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Conor Medsystems

•Patient ≥18 years of age
•Eligible for percutaneous coronary intervention
•Documented stable or unstable angina pectoris (Canadian Cardiovascular Society Classification 1, 2, 3, or 4), documented ischemia, or documented silent ischemia
•Left ventricular ejection fraction ≥25% documented within the last 6 wks
•Acceptable candidate for coronary artery bypass graft surgery
•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 1 study stent
•Cumulative target lesion length per vessel ≤30 mm based on a visual estimate
•RVD ≥2.5 mm to ≤3.0 mm based on a visual estimate
•Target lesion diameter stenosis ≥50% and \<100% based on a visual estimate

•Known sensitivity to cobalt chromium, paclitaxel or polymeric matrices: Translute or PLGA
•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 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 bleeding within the past three months
•Any prior true anaphylactic reaction to contrast agents