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

NCT00232765 | Completed Phase 3 DMC

• 1 other identifier: P00-6302
• Study Type: interventional
• Target: 1,058
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization at 9 months post-procedure.

  9 months post procedure

Secondary Outcomes (9)

• 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

• Angiographic binary restenosis (>/=50% diameter stenosis) 8 mo post-procedure;

  8 months post-procedure

• In-stent and in-lesion MLD at 8 mo post-procedure;

  8 months post-procedure

• Target lesion revascularization at 9 mo post-procedure;

  9 months post-procedure

• Target vessel revascularization at 9 mo post-procedure;

  9 months post-procedure

Study Arms (2)

1

EXPERIMENTAL

Cypher Bx Velocity

Device: CYPHER Sirolimus-Eluting Stent

2

ACTIVE COMPARATOR

Uncoated Bx Velocity

Device: Uncoated BX VELOCITY Balloon-Expandable Stent

Interventions

CYPHER Sirolimus-Eluting Stent DEVICE

CYPHER Sirolimus-Eluting Stent

1

Uncoated BX VELOCITY Balloon-Expandable Stent DEVICE

Uncoated BX VELOCITY Balloon-Expandable Stent

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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;

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (1)

New York Presbyterian Hospital/Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (5)

• 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.

  PMID: 14523139 BACKGROUND

• 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.

  PMID: 19389558 RESULT

• 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.

  PMID: 19327417 RESULT

• 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.

  PMID: 19539252 RESULT

• 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.

  PMID: 17296825 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 3, 2005
• First Posted: October 5, 2005
• Study Start: February 1, 2001
• Primary Completion: May 1, 2002
• Study Completion: November 1, 2008
• Last Updated: September 16, 2009

Record last verified: 2009-09

Locations

US (1)