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The Study of the BX Velocity Stent in the Treatment of De Novo Artery Lesions. (C-SIRIUS)

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

drug-eluting stent

bare-metal stent

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

sirolimus-coated Bx Velocity stent

uncoated Bx Velocity stent

Outcomes

Primary Outcome Measures

in-stent minimum lumen diameter (MLD)

Secondary Outcome Measures

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

angiographic binary restenosis (³50% diameter stenosis)

in-lesion MLD

target lesion revascularization

target vessel revascularization

target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization

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

Full Information

NCT ID

NCT00381420

First Posted

September 26, 2006

Last Updated

October 30, 2008

Sponsor

Cordis Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00381420

Brief Title

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

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2008

Overall Recruitment Status

Completed

Study Start Date

March 2001 (undefined)

Primary Completion Date

December 2002 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Cordis Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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).

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

sirolimus-coated Bx Velocity stent

Arm Title

Arm Type

Active Comparator

Arm Description

uncoated Bx Velocity stent

Intervention Type

Device

Intervention Name(s)

drug-eluting stent

Intervention Description

sirolimus-coated Bx VELOCITY Balloon-Expandable Stent

Intervention Type

Device

Intervention Name(s)

bare-metal stent

Intervention Description

un-coated Bx VELOCITY Stent

Primary Outcome Measure Information:

Title

in-stent minimum lumen diameter (MLD)

Time Frame

8 months

Secondary Outcome Measure Information:

Title

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

Time Frame

30 days and 6, 9, and 12 months, and 2, 3, 4 and 5 years

Title

angiographic binary restenosis (³50% diameter stenosis)

Time Frame

8 months

Title

in-lesion MLD

Time Frame

8 months

Title

target lesion revascularization

Time Frame

9 months

Title

target vessel revascularization

Time Frame

9 months

Title

target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization

Time Frame

9 months

Title

Time Frame

up to hospital discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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%.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Erick Schampaert, MD

Organizational Affiliation

Hopital Sacreé-Coeur, Montréal, Canada

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

15028375

Citation

Schampaert E, Cohen EA, Schluter 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-SIRIUS). J Am Coll Cardiol. 2004 Mar 17;43(6):1110-5. doi: 10.1016/j.jacc.2004.01.024.

Results Reference

result

PubMed Identifier

16780389

Citation

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. doi: 10.2165/00129784-200606030-00003.

Results Reference

result

PubMed Identifier

17296825

Citation

Spaulding C, Daemen J, Boersma E, Cutlip DE, Serruys PW. A pooled analysis of data comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med. 2007 Mar 8;356(10):989-97. doi: 10.1056/NEJMoa066633. Epub 2007 Feb 12.

Results Reference

derived

Learn more about this trial

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

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