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CompletedNCT00232830TYPHOONUpdated Sep 16, 2009

The Study to Assess AMI Treated With Balloon Angioplasty.

A Phase 3 interventional study of drug-eluting stent and bare-metal stent in Coronary Artery Disease, sponsored by Cordis Corporation. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-09-16.

Sponsored by Cordis Corporation · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
715
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The main objective of this study is to assess the effectiveness and safety of the CYPHER™ (CYPHER SELECT™) (Sirolimus-eluting) stent in reducing the occurrence of a composite endpoint of target vessel failure (TVF) in subjects treated for acute myocardial infarction as compared to a bare metal stent.

Read the detailed description

This is an international, multicenter (up to 52 sites), randomized, single-blind study in patients with an acute myocardial infarction treated with the CYPHER™ (Sirolimus-eluting) stent as compared to the bare stents.

Patients with de novo native coronary artery lesions will be treated with the CYPHER™ (Sirolimus-eluting) stent or a bare stent. Subjects will be followed at 30 days, 6 months and at 1, 3, 4 and 5 years post-procedure. 200 subjects will have an angiographic follow-up at 8 months.

02

Conditions studied

  • Coronary Artery Disease
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 715 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Cordis Corporation is the lead sponsor of 70 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Have prolonged, continuous (lasting at least 20 minutes) chest pain despite administration of nitrates and onset within 12 hours of randomization, and one of the following:

    1. ST segment elevation >=1mm in standard leads and >=2mm in 2 or more contiguous precordial leads with reciprocal ST depression
    2. New or presumably new left bundle branch block (LBBB)
  2. The culprit lesion must be identified on a de novo native coronary artery and an emergency angioplasty must be possible. The culprit site must be visualized before the stent implantation;

Exclusion criteria

Exclusion Criteria:

  1. Killip class > 2 upon arrival to the cath-lab;
  2. Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede inflow or runoff;
  3. Evidence of massive thrombus in the infarct related artery distally to the culprit lesion;
  4. Documented left ventricular ejection fraction \<=30%;
  5. Target lesion is located in an arterial or venous by-pass graft;
  6. ECG documented evidence of prior myocardial infarction;
  7. Patient who received thrombolytic therapy for the current AMI before enrollment in this study.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
715 participants (actual)

Study arms

  • Experimental
    1

    Cypher Sirolimus-eluting Coronary Stent

    Device: drug-eluting stent

  • Active comparator
    2

    Bare-metal stent

    Device: bare-metal stent

Interventions

  • Devicedrug-eluting stent

    Cypher Sirolimus-eluting Coronary Stent

  • Devicebare-metal stent

    any bare-metal stent brand

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What researchers measure

Primary outcomes

  1. Composite of target vessel failure (TVF) defined as target vessel revascularization, recurrent myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vesselpost-procedure.

    Time frame: 1 and 6 months and at 1, 3, 4, and 5 years post-procedure.

Secondary outcomes

  1. cardiac death

    Time frame: 1, 3, 4 and 5 years post-procedure

  2. recurrence of myocardial infarction

    Time frame: 1, 3, 4 and 5 years post-procedure

  3. revascularization of the target vessel (TVR)

    Time frame: 1, 3, 4 and 5 years post-procedure

  4. recurrence of ischemia

    Time frame: 1, 3, 4 and 5 years post-procedure

07

Study locations

2 sites
  • HOPITAL COCHIN, René Descartes University
    Paris, 75014, France
  • University of Freiburg, Albert-Ludwigs-Universitätskliniken
    Freiburg, 79106, Germany
08

References and documents

Publications

  • Spaulding C, Henry P, Teiger E, Beatt K, Bramucci E, Carrie D, Slama MS, Merkely B, Erglis A, Margheri M, Varenne O, Cebrian A, Stoll HP, Snead DB, Bode C; TYPHOON Investigators. Sirolimus-eluting versus uncoated stents in acute myocardial infarction. N Engl J Med. 2006 Sep 14;355(11):1093-104. doi: 10.1056/NEJMoa062006. PubMed 16971716 ↗
  • Rozenman Y, Witzling V, Tamari I, Turkisher V, Kriviski M, Bode C, Henry P, Teiger E, Cebrian A, Stoll HP, Spaulding C. Impact of stent length on restenosis in patients with acute myocardial infarction treated with primary percutaneous coronary intervention: analysis based on data from the Trial to Assess the Use of the Cypher Stent in Acute Myocardial Infarction Treated with Balloon Angioplasty (TYPHOON). EuroIntervention. 2009 Jun;5(2):219-23. doi: 10.4244/eijv5i2a34. PubMed 19527979 ↗
  • Spaulding C, Teiger E, Commeau P, Varenne O, Bramucci E, Slama M, Beatt K, Tirouvanziam A, Polonski L, Stella PR, Clugston R, Fajadet J, de Boisgelin X, Bode C, Carrie D, Erglis A, Merkely B, Hosten S, Cebrian A, Wang P, Stoll HP, Henry P. Four-year follow-up of TYPHOON (trial to assess the use of the CYPHer sirolimus-eluting coronary stent in acute myocardial infarction treated with BallOON angioplasty). JACC Cardiovasc Interv. 2011 Jan;4(1):14-23. doi: 10.1016/j.jcin.2010.10.007. PubMed 21251624 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00232830
Lead sponsor
Cordis Corporation
First posted
Oct 5, 2005
Start date
Oct 2003
Primary completion
Feb 2009
Completion
Apr 2009
Last update
Sep 16, 2009

Study contacts

Christian Spaulding, MD
principal investigator · HOPITAL COCHIN, René Descartes University
Christoph Bode, MD
principal investigator · University of Freiburg, Albert-Ludwigs-Universitätskliniken

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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