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Coronary Artery DiseasePhase 3C-SIRIUSNCT00381420

The Study of the BX Velocity Stent in the Treatment of De Novo Artery Lesions.

A Phase 3 study testing drug-eluting stent and bare-metal stent in people with Coronary Artery Disease, run by Cordis US Corp..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
drug-eluting stent and bare-metal stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
Mar 2001to Jun 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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);

Who cannot join

  • 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%.

About this study

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.

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).

Read the 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.

Being tested
drug-eluting stent, bare-metal stent
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • drug-eluting stentDevice

    sirolimus-coated Bx VELOCITY Balloon-Expandable Stent

  • bare-metal stentDevice

    un-coated Bx VELOCITY Stent

Study groups in NCT00381420
Study groupRoleWhat they receive
1Experimentalsirolimus-coated Bx Velocity stent
Receives: Device: drug-eluting stent
2Active comparatoruncoated Bx Velocity stent
Receives: Device: bare-metal stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. in-stent minimum lumen diameter (MLD)

    Measured: 8 months

Secondary outcomes (7)

  1. 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

    Measured: 30 days and 6, 9, and 12 months, and 2, 3, 4 and 5 years

  2. angiographic binary restenosis (³50% diameter stenosis)

    Measured: 8 months

  3. in-lesion MLD

    Measured: 8 months

  4. target lesion revascularization

    Measured: 9 months

  5. target vessel revascularization

    Measured: 9 months

  6. target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization

    Measured: 9 months

  7. 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

    Measured: up to hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2006 (estimated)
  2. Study startMar 2001
  3. Primary completionDec 2002
  4. Study completionJun 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00381420
Sponsor's protocol ID
P01-6307
Acronym
C-SIRIUS
Status last verified
Oct 2008
First submitted
26 Sep 2006
Last updated
31 Oct 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • Schampaert E, Cohen EA, Schluter M, Reeves F, Traboulsi M, Title LM, Kuntz RE, Popma JJ; C-SIRIUS Investigators. The Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries (C-SIRIUS). J Am Coll Cardiol. 2004 Mar 17;43(6):1110-5. doi: 10.1016/j.jacc.2004.01.024.

    PubMed 15028375

  • Rinfret S, Cohen DJ, Tahami Monfared AA, Lelorier J, Mireault J, Schampaert E. Cost effectiveness of the sirolimus-eluting stent in high-risk patients in Canada: an analysis from the C-SIRIUS trial. Am J Cardiovasc Drugs. 2006;6(3):159-68. doi: 10.2165/00129784-200606030-00003.

    PubMed 16780389

  • 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.

    PubMed 17296825

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing drug-eluting stent and bare-metal stent in people with Coronary Artery Disease, run by Cordis US Corp..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

in-stent minimum lumen diameter (MLD) (time frame: 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00381420, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2008.

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