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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00381420
Recruitment Status : Completed
First Posted : September 27, 2006
Last Update Posted : October 31, 2008
Information provided by:
Cordis Corporation

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).

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: drug-eluting stent Device: bare-metal stent Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : March 2001
Actual Primary Completion Date : December 2002
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Arm Intervention/treatment
Experimental: 1
sirolimus-coated Bx Velocity stent
Device: drug-eluting stent
sirolimus-coated Bx VELOCITY Balloon-Expandable Stent

Active Comparator: 2
uncoated Bx Velocity stent
Device: bare-metal stent
un-coated Bx VELOCITY Stent

Primary Outcome Measures :
  1. in-stent minimum lumen diameter (MLD) [ Time Frame: 8 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. angiographic binary restenosis (³50% diameter stenosis) [ Time Frame: 8 months ]
  3. in-lesion MLD [ Time Frame: 8 months ]
  4. target lesion revascularization [ Time Frame: 9 months ]
  5. target vessel revascularization [ Time Frame: 9 months ]
  6. target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization [ Time Frame: 9 months ]
  7. 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 [ Time Frame: up to hospital discharge ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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%.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00381420

Sponsors and Collaborators
Cordis Corporation
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Principal Investigator: Erick Schampaert, MD Hopital Sacreé-Coeur, Montréal, Canada

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Hans-Peter Stoll, Cordis Identifier: NCT00381420     History of Changes
Other Study ID Numbers: P01-6307
First Posted: September 27, 2006    Key Record Dates
Last Update Posted: October 31, 2008
Last Verified: October 2008

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs