Study of Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in Treatment of de Novo Native Coronary Artery Lesions (SIRIUS)

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00232765
• Other study ID #: P00-6302
• Status: Completed
• Phase: Phase 3
• First received: October 3, 2005
• Last updated: September 15, 2009
• Start date: February 2001
• Est. completion date: November 2008

Study information

• Verified date: September 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-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.

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 /=2.50mm to

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1058
• Est. completion date: November 2008
• Est. primary completion date: May 2002
• 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 lesion is 2.50mm and 3.5mm in diameter (visual estimate);

4. Target lesion is 15mm and 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;

5. 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 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:
• CYPHER Sirolimus-Eluting Stent
CYPHER Sirolimus-Eluting Stent
• Uncoated BX VELOCITY Balloon-Expandable Stent
Uncoated BX VELOCITY Balloon-Expandable Stent

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital/Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Country where clinical trial is conducted

United States, 

References & Publications (4)

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 — View Citation

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. — View Citation

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. — View Citation

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) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization at 9 months post-procedure.		9 months post procedure	Yes
Secondary	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;		30 dys and 3, 6, 9, and 12 mo, and 2, 3, 4, 5, 6, 7, and 8 yrs post-procedure	Yes
Secondary	Angiographic binary restenosis (>/=50% diameter stenosis) 8 mo post-procedure;		8 months post-procedure	Yes
Secondary	In-stent and in-lesion MLD at 8 mo post-procedure;		8 months post-procedure	Yes
Secondary	Target lesion revascularization at 9 mo post-procedure;		9 months post-procedure	Yes
Secondary	Target vessel revascularization at 9 mo post-procedure;		9 months post-procedure	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;		Study Completion	Yes
Secondary	Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method;		Study Completion	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 during the hospital stay;		During the hospital stay	Yes
Secondary	Costs associated with the index hospitalization and length of stay, and repeat hospitalizations during the 12-month post-procedure follow-up period.		12-month post-procedure	No