A Multicenter, Non-Randomized Study of the 4.0mm Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions

Cordis Corporation1 site in 1 country100 target enrollmentSeptember 2003

ConditionsCoronary Artery Disease

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Cordis Corporation
Enrollment: 100
Locations: 1
Primary Endpoint: The primary endpoint is in-lesion late loss at 6 months post-procedure by QCA.
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 2003

End Date

November 2009

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 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);

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 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;

Outcomes

Primary Outcomes

The primary endpoint is in-lesion late loss at 6 months post-procedure by QCA.

Time Frame: 6 months post-procedure

Secondary Outcomes

Angiographic in-stent and in-lesion binary restenosis (³50% diameter stenosis) 6 months post-procedure by QCA.(6 months post-procedure)
Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization at 30 days and 6, 9, and 12 months, and 2, 3, 4 and 5 years post-proced(30 days and 6, 9, and 12 months, and 2, 3, 4 and 5 years post-procedure)
In-stent and in-lesion minimum lesion diameter (MLD) at 6 months post-procedure.(6 months post-procedure)
Target lesion revascularization (TLR) at 6 and 9 months post-procedure.(6 and 9 months post-procedure)
Target vessel revascularization (TVR) at 6 and 9 months post-procedure.(6 and 9 months post-procedure)
Target vessel failure (TVF) at 6 and 9 months post-procedure.(6 and 9 months post-procedure)
Stent lumen and stent obstruction volume by intravascular ultrasound (IVUS) at post-procedure and six months in a subset of approximately 50 patients at selected centers.(post-procedure and six months in a subset of approximately 50 patients)
Device success defined as achievement of a final residual diameter stenosis of <50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used.(End of study)
Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method.(End of Study)
Procedure success defined as achievement of a final diameter stenosis of <50% (by QCA) using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay.(during the hospital stay)