- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00232765
Study of Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in Treatment of de Novo Native Coronary Artery Lesions (SIRIUS)
September 15, 2009 updated by: Cordis Corporation
A Multicenter, Randomized, Double-Blind Study of the Sirolimus-Coated BX VELOCITYTM Balloon-Expandable Stent in the Treatment of Patients With de Novo Coronary Artery Lesions
The main objective of this study is to assess the safety and effectiveness of the sirolimus-coated Bx VELOCITYTM stent in reducing target vessel failure in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITYTM balloon-expandable stent.
Both stents are mounted on the Raptorâ over-the-wire (OTW) Stent Delivery System.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a multicenter (55 sites), prospective, 2-arm randomized, double-blind study designed to assess the safety and effectiveness of the sirolimus-coated Bx VELOCITYTM stent as compared to the uncoated Bx VELOCITYTM stent.
A total of 1100 patients will be entered in the study and will be randomized on a 1:1 basis.
Patients with de novo native coronary artery lesions >/=15mm and </=30mm in length and >/=2.50mm to </=3.5mm in diameter by visual estimate who meet all eligibility criteria will be either randomized to the sirolimus-coated Bx VELOCITYTM stent or the uncoated Bx VELOCITYTM stent.
Patients will be followed at 30 days, 3, 6, 9 and 12 months, and 2, 3, 4, 5, 6, 7, and 8 years post-procedure, with approximately 850 patients having repeat angiography at 8 months.
A subset of approximately 17 centers will participate in an intravascular ultrasound (IVUS) sub study, in which all patients at these centers will be enrolled in the sub study.
Additionally, data will be collected for a medical economic analysis.
These data will include costs associated with the index hospitalization and length of stay, and rehospitalizations during the 12-month follow-up period.
This is a single lesion treatment study.
Patients who have had interventions of other lesions within 30 days of the study procedure or have interventions planned after the index procedure are excluded.
It is anticipated that the total length of the study will be 101 months: 5 months to complete patient enrollment and 8 years for follow-up.
Study Type
Interventional
Enrollment (Actual)
1058
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- New York Presbyterian Hospital/Columbia University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 lesion is 2.50mm and 3.5mm in diameter (visual estimate);
- Target lesion is 15mm and 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;
- Target lesion involves bifurcation including a diseased side branch 2.5mm in diameter (either stenosis of both main vessel and major branch or stenosis of just major branch) that would require treatment;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Cypher Bx Velocity
|
CYPHER Sirolimus-Eluting Stent
|
Active Comparator: 2
Uncoated Bx Velocity
|
Uncoated BX VELOCITY Balloon-Expandable Stent
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization at 9 months post-procedure.
Time Frame: 9 months post procedure
|
9 months post procedure
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Composite of MACE defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target vessel revascularization at 30 dys and 3, 6, 9, and 12 mo, and 2, 3, 4, 5, 6, 7, and 8 yrs post-procedure;
Time Frame: 30 dys and 3, 6, 9, and 12 mo, and 2, 3, 4, 5, 6, 7, and 8 yrs post-procedure
|
30 dys and 3, 6, 9, and 12 mo, and 2, 3, 4, 5, 6, 7, and 8 yrs post-procedure
|
Angiographic binary restenosis (>/=50% diameter stenosis) 8 mo post-procedure;
Time Frame: 8 months post-procedure
|
8 months post-procedure
|
In-stent and in-lesion MLD at 8 mo post-procedure;
Time Frame: 8 months post-procedure
|
8 months post-procedure
|
Target lesion revascularization at 9 mo post-procedure;
Time Frame: 9 months post-procedure
|
9 months post-procedure
|
Target vessel revascularization at 9 mo post-procedure;
Time Frame: 9 months post-procedure
|
9 months post-procedure
|
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;
Time Frame: Study Completion
|
Study Completion
|
Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method;
Time Frame: Study Completion
|
Study Completion
|
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;
Time Frame: During the hospital stay
|
During the hospital stay
|
Costs associated with the index hospitalization and length of stay, and repeat hospitalizations during the 12-month post-procedure follow-up period.
Time Frame: 12-month post-procedure
|
12-month post-procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Martin B. Leon, MD, New York Presbyterian Hospital/Columbia University Medical Center
- Principal Investigator: Jeffrey Moses, MD, New York Presbyterian Hospital/Columbia University Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE; SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003 Oct 2;349(14):1315-23. doi: 10.1056/NEJMoa035071.
- 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.
- Weisz G, Leon MB, Holmes DR Jr, Kereiakes DJ, Popma JJ, Teirstein PS, Cohen SA, Wang H, Cutlip DE, Moses JW. Five-year follow-up after sirolimus-eluting stent implantation results of the SIRIUS (Sirolimus-Eluting Stent in De-Novo Native Coronary Lesions) Trial. J Am Coll Cardiol. 2009 Apr 28;53(17):1488-97. doi: 10.1016/j.jacc.2009.01.050.
- Popma JJ, Tiroch K, Almonacid A, Cohen S, Kandzari DE, Leon MB. A qualitative and quantitative angiographic analysis of stent fracture late following sirolimus-eluting stent implantation. Am J Cardiol. 2009 Apr 1;103(7):923-9. doi: 10.1016/j.amjcard.2008.12.022.
- Chacko R, Mulhearn M, Novack V, Novack L, Mauri L, Cohen SA, Moses J, Leon MB, Cutlip DE. Impact of target lesion and nontarget lesion cardiac events on 5-year clinical outcomes after sirolimus-eluting or bare-metal stenting. JACC Cardiovasc Interv. 2009 Jun;2(6):498-503. doi: 10.1016/j.jcin.2009.03.013.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2001
Primary Completion (Actual)
May 1, 2002
Study Completion (Actual)
November 1, 2008
Study Registration Dates
First Submitted
October 3, 2005
First Submitted That Met QC Criteria
October 3, 2005
First Posted (Estimate)
October 5, 2005
Study Record Updates
Last Update Posted (Estimate)
September 16, 2009
Last Update Submitted That Met QC Criteria
September 15, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Sirolimus
Other Study ID Numbers
- P00-6302
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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