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The main objective of this study is to assess the effectiveness and safety of the CYPHERâ„¢ (CYPHER SELECTâ„¢) (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.
This is an international, multicenter (up to 52 sites), randomized, single-blind study in patients with an acute myocardial infarction treated with the CYPHERâ„¢ (Sirolimus-eluting) stent as compared to the bare stents.
Patients with de novo native coronary artery lesions will be treated with the CYPHERâ„¢ (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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Cypher Sirolimus-eluting Coronary Stent |
|
| 2 | Active Comparator | Bare-metal stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| drug-eluting stent | Device | Cypher Sirolimus-eluting Coronary Stent |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 and 6 months and at 1, 3, 4, and 5 years post-procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| cardiac death | 1, 3, 4 and 5 years post-procedure | |
| recurrence of myocardial infarction | 1, 3, 4 and 5 years post-procedure | |
| revascularization of the target vessel (TVR) |
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Inclusion Criteria:
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Spaulding, MD | HOPITAL COCHIN, René Descartes University | Principal Investigator |
| Christoph Bode, MD | University of Freiburg, Albert-Ludwigs-Universitätskliniken | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HOPITAL COCHIN, René Descartes University | Paris | 75014 | France | |||
| University of Freiburg, Albert-Ludwigs-Universitätskliniken |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16971716 | Result | 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. | |
| 19527979 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D054855 | Drug-Eluting Stents |
| ID | Term |
|---|---|
| D015607 | Stents |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| bare-metal stent |
| Device |
any bare-metal stent brand |
|
| 1, 3, 4 and 5 years post-procedure |
| recurrence of ischemia | 1, 3, 4 and 5 years post-procedure |
| Freiburg im Breisgau |
| 79106 |
| Germany |
| 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. |
| 21251624 | Derived | 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. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |