The Study of the BX Velocity Stent in the Treatment of De Novo Artery Lesions.

Coronary Artery Disease Clinical Trial

— C-SIRIUS  

Official title:

A Canadian Multi-Center, Randomized, Double-Blind Study of the Sirolimus-Coated BX Velocity Balloon-Expandable Stent in the Treatment of Patients With de Novo Coronary Artery Lesions.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00381420
• Other study ID #: P01-6307
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2006
• Last updated: October 30, 2008
• Start date: March 2001
• Est. completion date: June 2008

Study information

• Verified date: October 2008
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to assess the safety and effectiveness of the sirolimus-coated Bx VELOCITY™ stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITY™ balloon-expandable stent. Both stents are mounted on the Raptor® Stent Delivery Systems.

The secondary objective is to assess cost-effectiveness expressed in incremental cost/life year gained or cost/quality adjusted life year gained at different time points (8 months, 1 year, 3 and 5 years).

Description:

This is a multicenter ,prospective, randomized double blind study. This study has a 2-arm design assessing the safety and effectiveness of the sirolimus-coated Bx VELOCITY™ stent to the uncoated Bx VELOCITY™ stent, both mounted on Raptor® Stent Delivery Systems. A total of 100 patients will be entered in the study and will be randomized on a 1:1 basis. Patients who meet the eligibility criteria will be either randomized to Treatment A or Treatment B. Neither the investigator nor the patient will know which stent will be implanted. Patients will be followed at 30 days, 6, 9, and 12 months, and at 2, 3, 4 and 5 years post-procedure, with all patients undergoing repeat angiography at 8 months. Additionally, medical costs associated with the index hospitalization and length of stay, and repeat hospitalizations and costs associated with other relevant medical resource use during the 5 years follow-up period will be collected and analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2008
• Est. primary completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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;

• Single treatment of de novo lesion in a major coronary artery in patients with single or multi-vessel disease; patients with multiple lesions can be included only if the other lesions do not require treatment;

• Target vessel diameter at the lesion site is >=2.50mm and <=3.0mm in diameter (visual estimate);

• Target lesion is >=15mm and <=32mm 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 and A I-II-III, or is having a peri infarction;

• Unprotected left main coronary disease with >=50% stenosis;

• Significant (>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;

• Have an ostial target lesion;

• Angiographic evidence of thrombus within target lesion;

• Heavily calcified lesion which cannot be successfully predilated;

• Documented left ventricular ejection fraction <=25%.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• drug-eluting stent
sirolimus-coated Bx VELOCITY Balloon-Expandable Stent
• bare-metal stent
un-coated Bx VELOCITY Stent

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

References & Publications (2)

Rinfret S, Cohen DJ, Tahami Monfared AA, Lelorier J, Mireault J, Schampaert E. Cost effectiveness of the sirolimus-eluting stent in high-risk patients in Canada: an analysis from the C-SIRIUS trial. Am J Cardiovasc Drugs. 2006;6(3):159-68. — View Citation

Schampaert E, Cohen EA, Schlüter M, Reeves F, Traboulsi M, Title LM, Kuntz RE, Popma JJ; C-SIRIUS Investigators. The Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries (C- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	in-stent minimum lumen diameter (MLD)		8 months	Yes
Secondary	composite of Major Adverse Cardiac Events defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization		30 days and 6, 9, and 12 months, and 2, 3, 4 and 5 years	Yes
Secondary	angiographic binary restenosis (³50% diameter stenosis)		8 months	Yes
Secondary	in-lesion MLD		8 months	Yes
Secondary	target lesion revascularization		9 months	Yes
Secondary	target vessel revascularization		9 months	Yes
Secondary	target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization		9 months	Yes
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		up to hospital discharge	Yes