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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00232752
• Other study ID #: P03-6319
• Status: Completed
• Phase: Phase 3
• First received: October 3, 2005
• Last updated: December 1, 2009
• Start date: September 2003
• Est. completion date: November 2009

Study information

• Verified date: December 2009
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2009
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or non-pregnant female patients minimum 18 years of age

2. 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;

3. Target lesions treatable with 4mm stent (visual estimate);

4. Target lesion is 30mm in length (visual estimate);

5. Target lesion stenosis is >50% and <100% (visual estimate);

Exclusion Criteria:

1. 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;

2. Has unstable angina classified as Braunwald III B or C, or is having a peri infarction;

3. Documented Left ventricular ejection fraction 25%;

4. Impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• 4.0 CYPHER Sirolimus-Eluting Coronary Stent
4.0 CYPHER Sirolimus-Eluting Coronary Stent

Locations

Country	Name	City	State
United States	Brigham & Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is in-lesion late loss at 6 months post-procedure by QCA.		6 months post-procedure	Yes
Secondary	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	Yes
Secondary	Angiographic in-stent and in-lesion binary restenosis (³50% diameter stenosis) 6 months post-procedure by QCA.		6 months post-procedure	Yes
Secondary	In-stent and in-lesion minimum lesion diameter (MLD) at 6 months post-procedure.		6 months post-procedure	Yes
Secondary	Target lesion revascularization (TLR) at 6 and 9 months post-procedure.		6 and 9 months post-procedure	Yes
Secondary	Target vessel revascularization (TVR) at 6 and 9 months post-procedure.		6 and 9 months post-procedure	Yes
Secondary	Target vessel failure (TVF) at 6 and 9 months post-procedure.		6 and 9 months post-procedure	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method.		End of Study	No
Secondary	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	Yes