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

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00381420
First received: September 26, 2006
Last updated: October 30, 2008
Last verified: October 2008
  Purpose

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 Intervention Phase
Coronary Artery Disease
Device: drug-eluting stent
Device: bare-metal 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 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.

Resource links provided by NLM:


Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • in-stent minimum lumen diameter (MLD) [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • angiographic binary restenosis (³50% diameter stenosis) [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
  • in-lesion MLD [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
  • target lesion revascularization [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • target vessel revascularization [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization [ Time Frame: 9 months ] [ 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 [ Time Frame: up to hospital discharge ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: March 2001
Study Completion Date: June 2008
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

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%.
  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: NCT00381420

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Hans-Peter Stoll, Cordis
ClinicalTrials.gov Identifier: NCT00381420     History of Changes
Other Study ID Numbers: P01-6307
Study First Received: September 26, 2006
Last Updated: October 30, 2008
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014