A Multicenter, Non-Randomized Study of the CYPHER NxT Sirolimus-Eluting Coronary Stent on BX SONIC OVER-THE-WIRE (OTW) Stent Delivery System(SDS)for the Treatment of de Novo Native Coronary Artery Lesions

Cordis Corporation1 site in 1 country100 target enrollmentApril 2004

ConditionsCoronary Artery Disease

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Cordis Corporation
Enrollment: 100
Locations: 1
Primary Endpoint: Percentage of Participants Who Achieved Procedure Success From Post-procedure to Hospital Discharge
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate the effectiveness and safety of the CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-Wire (OTW) Stent Delivery System (SDS) in patients with de novo native coronary artery lesions.

Registry

clinicaltrials.gov

Start Date

April 2004

End Date

July 2005

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cordis Corporation

Eligibility Criteria

Inclusion Criteria

•Male or non-pregnant female patients 18 years of age
•Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II) OR patients with documented silent ischemia;
•Treatment of a single de novo target lesion in a major native coronary artery;
•Target lesion is 2.5 mm and 3.5 mm in diameter (visual estimate);
•Target lesion is 30mm in length (visual estimate);
•Target lesion stenosis is \> 50% and \< 100% (visual estimate);

Exclusion Criteria

•Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK \> 2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remain above normal at the time of treatment;
•Has unstable angina classified as Braunwald III B or C, or is having a peri-infarction angina;
•Significant (\> 50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
•Documented Left ventricular ejection fraction 25%;
•Totally occluded vessel (TIMI 0 level);
•Impaired renal function (creatinine \> 3.0 mg/dl) at the time of treatment;

Outcomes

Primary Outcomes

Percentage of Participants Who Achieved Procedure Success From Post-procedure to Hospital Discharge

Time Frame: From post-procedure up to hospital discharge

Procedure Success is defined as the final residual diameter stenosis \< 50 percent by Quantitative Coronary Angiography (QCA) using any percutaneous method, without the occurrence of death, Myocardial Infarction (MI), or repeat revascularization of the target lesion

Secondary Outcomes

Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 30 Days Later(From post-procedure up to 30 days)
Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to Hospital Discharge(From post-procedure up to hospital discharge)
Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 12 Months Later(From post-procedure up to 12 months)