Study of the 4.0mm Sirolimus-Eluting Stent in the Treatment of Patients With Coronary Artery Lesions

Completed · Phase 3

Conditions studied: Coronary Artery Disease

In brief

The main objective of this study is to assess the safety and effectiveness of the sirolimus-eluting Bx VELOCITYTM stent in reducing in-lesion late loss in patients with de novo native coronary artery lesions.

Key facts

Study ID

NCT00232752

Run by

Cordis US Corp.

People needed

100

Starts

2003-09-01

Expected to finish

2009-11-01

Last updated by the study team

2009-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or non-pregnant female patients minimum 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;
• Target lesions treatable with 4mm stent (visual estimate);
• Target lesion is 30mm in length (visual estimate);
• Target lesion stenosis is >50% and <100% (visual estimate);

You may not qualify if…

• 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 remains above normal at the time of treatment;
• Has unstable angina classified as Braunwald III B or C, or is having a peri infarction;
• Documented Left ventricular ejection fraction 25%;
• Impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment;

Where it is running

• Brigham & Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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