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Coronary Artery DiseasePhase 3E-SIRIUSNCT00235144

The Study of the BX VELOCITY Stent In Patients With De Novo Coronary Artery Lesions.

A Phase 3 study testing sirolimus-coated Bx Velocity stent and uncoated Bx Velocity stent in people with Coronary Artery Disease, run by Cordis US Corp. at 2 sites in Germany.

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?
sirolimus-coated Bx Velocity stent and uncoated Bx Velocity stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
353 participants
Where
2 sitesGermany
Study dates
Mar 2001to Sep 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;
  • Treatment of a single de novo native coronary artery 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 and/or calcified lesion which cannot be successfully predilated;
  • Documented left ventricular ejection fraction <=25%;

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Herzkatheterlabor und Praxisklinik

    Hamburg

  • Med. Klinik und Poliklinik

    Münster

Other trials in Germany

About this study

Official title: E-Sirius Study: a European, 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® Rapid Exchange Stent Delivery System.

Read the detailed description

This is a multicenter (up to 35 centers), 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 the Raptor Rapid Exchange Stent Delivery System. A total of 350 patients will be entered in the study and will be randomized on a 1:1 basis. Patients will be either randomized to the sirolimus coated or uncoated BX-VELOCITY stent. Patients will be followed at 30 days, 6, 9, and 12 months, and at 2, 3, 4, 5, 6, 7, and 8 years post-procedure, with all patients undergoing repeat angiography at 8 months. Medical resource use during the 5 years follow-up period will be collected and analyzed.

Being tested
sirolimus-coated Bx Velocity stent, uncoated Bx Velocity 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.

  • sirolimus-coated Bx Velocity stentDevice

    drug-eluting stent

  • uncoated Bx Velocity stentDevice

    bare-metal stent

Study groups in NCT00235144
Study groupRoleWhat they receive
1Experimentaldrug-eluting stent
Receives: Device: sirolimus-coated Bx Velocity stent
2Active comparatorbare-metal stent
Receives: Device: uncoated Bx Velocity 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 MACE defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat TLR.

    Measured: 1, 6, 9, and 12 months; 2, 3, 4, 5, 6, 7 and 8 years post procedure.

  2. Angiographic binary restenosis (>=50% 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. Device success (final residual diameter stenosis of < 50%).

    Measured: any time post-procedure.

Timeline

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

  1. First posted10 Oct 2005 (estimated)
  2. Study startMar 2001
  3. Primary completionOct 2002
  4. Study completionSep 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
353 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00235144
Sponsor's protocol ID
EC00-07
Acronym
E-SIRIUS
Status last verified
May 2009
First submitted
4 Oct 2005
Last updated
11 May 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Hoffmann R, Morice MC, Moses JW, Fitzgerald PJ, Mauri L, Breithardt G, Schofer J, Serruys PW, Stoll HP, Leon MB. Impact of late incomplete stent apposition after sirolimus-eluting stent implantation on 4-year clinical events: intravascular ultrasound analysis from the multicentre, randomised, RAVEL, E-SIRIUS and SIRIUS trials. Heart. 2008 Mar;94(3):322-8. doi: 10.1136/hrt.2007.120154. Epub 2007 Aug 29.

    PubMed 17761505

  • Schampaert E, Moses JW, Schofer J, Schluter M, Gershlick AH, Cohen EA, Palisaitis DA, Breithardt G, Donohoe DJ, Wang H, Popma JJ, Kuntz RE, Leon MB; SIRIUS, E- and C-SIRIUS Investigators. Sirolimus-eluting stents at two years: a pooled analysis of SIRIUS, E-SIRIUS, and C-SIRIUS with emphasis on late revascularizations and stent thromboses. Am J Cardiol. 2006 Jul 1;98(1):36-41. doi: 10.1016/j.amjcard.2006.01.049. Epub 2006 May 4.

    PubMed 16784917

  • Schluter M, Schofer J, Gershlick AH, Schampaert E, Wijns W, Breithardt G; E- and C-SIRIUS Investigators. Direct stenting of native de novo coronary artery lesions with the sirolimus-eluting stent: a post hoc subanalysis of the pooled E- and C-SIRIUS trials. J Am Coll Cardiol. 2005 Jan 4;45(1):10-3. doi: 10.1016/j.jacc.2004.09.046.

    PubMed 15629365

  • Schofer J, Schluter M, Gershlick AH, Wijns W, Garcia E, Schampaert E, Breithardt G; E-SIRIUS Investigators. Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: double-blind, randomised controlled trial (E-SIRIUS). Lancet. 2003 Oct 4;362(9390):1093-9. doi: 10.1016/S0140-6736(03)14462-5.

    PubMed 14550694

  • 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 sirolimus-coated Bx Velocity stent and uncoated Bx Velocity stent in people with Coronary Artery Disease, run by Cordis US Corp. at 2 sites in Germany.

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 11 May 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

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 NCT00235144, which also lists 5 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 11 May 2009.

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