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

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00232765
First received: October 3, 2005
Last updated: September 15, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Device: CYPHER Sirolimus-Eluting Stent
Device: Uncoated BX VELOCITY Balloon-Expandable Stent
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Angiographic binary restenosis (>/=50% diameter stenosis) 8 mo post-procedure; [ Time Frame: 8 months post-procedure ] [ Designated as safety issue: Yes ]
  • In-stent and in-lesion MLD at 8 mo post-procedure; [ Time Frame: 8 months post-procedure ] [ Designated as safety issue: Yes ]
  • Target lesion revascularization at 9 mo post-procedure; [ Time Frame: 9 months post-procedure ] [ Designated as safety issue: Yes ]
  • Target vessel revascularization at 9 mo post-procedure; [ Time Frame: 9 months post-procedure ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method; [ Time Frame: Study Completion ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 1058
Study Start Date: February 2001
Study Completion Date: November 2008
Primary Completion Date: May 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cypher Bx Velocity
Device: CYPHER Sirolimus-Eluting Stent
CYPHER Sirolimus-Eluting Stent
Active Comparator: 2
Uncoated Bx Velocity
Device: Uncoated BX VELOCITY Balloon-Expandable Stent
Uncoated BX VELOCITY Balloon-Expandable Stent

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232765

Locations
United States, New York
New York Presbyterian Hospital/Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Cordis Corporation
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sid Cohen, MD, PhD, Cordis
ClinicalTrials.gov Identifier: NCT00232765     History of Changes
Other Study ID Numbers: P00-6302
Study First Received: October 3, 2005
Last Updated: September 15, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 10, 2014