A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction: EXAMINATION Study
NCT ID: NCT00828087
Last Updated: 2015-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1504 participants
INTERVENTIONAL
2008-12-31
2015-05-31
Brief Summary
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Patient randomization will be to one of the two treatment arms: Everolimus arm or Non drug eluting stent arm. The objective of this study is to assess the safety and performance of the Everolimus Eluting Coronary Stent System versus a modified cobalt chromium balloon expandable stent in the setting of primary percutaneous coronary intervention for treatment of patients presenting with ST-segment elevation myocardial infarction.
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Detailed Description
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Recently, several studies showed that both sirolimus- and paclitaxel-eluting stents are more effective in reducing restenosis and the frequency of repeat interventions than bare metal stents, which rapidly resulted in an unrestricted use of drug-eluting stents, also in patients with ST segment elevation MI (STEMI). , , , Shortly after the introduction of the sirolimus-eluting stent in April 2002 the first studies appeared, hypothesizing that the therapeutic range of sirolimus-eluting stents could be extended to patients presenting with MI. When compared to bare metal stents, sirolimus-eluting stents were associated with less restenosis and target vessel revascularization (TVR) up until one year of follow-up. , At present, it is unclear whether this also holds for paclitaxel-eluting stents.4,
Everolimus is a sirolimus analogue, an effective anti-proliferative agent that inhibits growth factor-stimulated cell proliferation by causing cell cycle arrest in the late G1 stage in the cell cycle.
The objective of this study is to assess the safety and performance of the Everolimus Eluting Coronary Stent System versus a modified cobalt chromium balloon expandable stent in the setting of primary percutaneous coronary intervention for treatment of patients presenting with ST-segment elevation myocardial infarction.
This study is a prospective, randomized controlled, single blind, two-arm, multi center clinical evaluation. A total of 1500 patients will be enrolled in the study.
The primary endpoint is the combined endpoint of Composite endpoint of all-cause death, any myocardial infarction and any revascularization at 1 year (patient oriented endpoint suggested by the ARC definitions).
The following secondary endpoints will be examined:
* All cause and cardiac mortality at 1 year and yearly up to 5 years.
* Recurrent myocardial infarction at 1 year and yearly up to 5 years.
* Target lesion revascularization at 1 year and yearly up to 5 years.
* Target vessel revascularization at 1 year and yearly up to 5 years.
* Stent thrombosis (according to the new definitions proposed by the Academic Research Consortium) at 1 year and yearly up to 5 years.
* Clinical device success
* Clinical procedure success.
* Major and minor bleeding at 1 year and yearly up to 5 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Everolimus Arm
Everolimus Eluting Coronary Stent System
Everolimus Eluting Coronary Stent System
Everolimus Eluting Coronary Stent System (Everolimus Arm) implantation
non drug eluting stent Arm
cobalt chromium balloon expandable stent
cobalt chromium balloon expandable stent ( non drug eluting stent Arm)
cobalt chromium balloon expandable stent ( non drug eluting stent Arm)implantation
Interventions
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Everolimus Eluting Coronary Stent System
Everolimus Eluting Coronary Stent System (Everolimus Arm) implantation
cobalt chromium balloon expandable stent ( non drug eluting stent Arm)
cobalt chromium balloon expandable stent ( non drug eluting stent Arm)implantation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients presenting with a ST-elevation myocardial infarction \<12 hours after onset of symptoms who are treated with primary angioplasty + stent implantation
* Cardiogenic shock.
* Rescue PCI after failed thrombolysis.
* PCI indicated early (\<24h) after effective thrombolysis following current ESC guidelines.
* Patients presenting late ("latecomers") with ST-elevation myocardial infarction (\>12h-48h) after the onset of symptoms.
* Written informed consent.
* The patient or his/her family (in the event the patient can not be clinically available) accept clinical controls.
Angiographic:
* Vessel size has to range between 2.25-4.0 mm by visual estimation to allow the implantation of currently available stents.
Exclusion Criteria
* Pregnancy or breastfeeding.
* Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Everolimus, contrast material.
* Patients with absolute indication of being chronic treated with acenocoumarol
* Myocardial infarction due to a previously implanted stent thrombosis
* Patients with myocardial infarction that will require elective surgical coronary revascularisation within a 1 year period (example: inferior MI with severe disease in left main with surgical indication).
ALL
No
Sponsors
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Spanish Society of Cardiology
OTHER
Responsible Party
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Dr. Sabate
Doctor
Principal Investigators
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Prof. P.W. Serruys, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus MC, Rotterdam
Manuel Sabate, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clínic i Provincial de Barcelona
Locations
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Azienda Ospedaliera Bolognini
Seriate, Bergamo, Italy
Azienda Ospedaliero Universitaria S. Anna di Ferrara
Ferrara, Italy, Italy
Erasmus MC, Rotterdam
Rotterdam, Rotterdam, Netherlands
Complejo Hospitalario U. A Coruña
A Coruña, A Croruña, Spain
Hospital General de Alicante
Alicante, Alicante, Spain
Hospital Son Dureta
Palma de Mallorca, Balearic Islands, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Hospital Clínic i Provincial de Barcelona
Barcelona, Barcelona, Spain
Hospital de Bellvitge
Barcelona, Barcelona, Spain
Hospital Clínico San Carlos
Madrid, Madrid, Spain
Hospital do Meixoeiro
Vigo, Vigo, Spain
Countries
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References
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Costa F, Brugaletta S, Pernigotti A, Flores-Ulmanzor E, Ortega-Paz L, Cequier A, Iniguez A, Serra A, Jimenez-Quevedo P, Mainar V, Campo G, Tespili M, den Heijer P, Bethencourt A, Vazquez N, van Es GA, Backx B, Valgimigli M, Serruys P, Sabate M. Does Large Vessel Size Justify Use of Bare-Metal Stents in Primary Percutaneous Coronary Intervention? Circ Cardiovasc Interv. 2019 Sep;12(9):e007705. doi: 10.1161/CIRCINTERVENTIONS.118.007705. Epub 2019 Aug 27.
Schur N, Brugaletta S, Cequier A, Iniguez A, Serra A, Jimenez-Quevedo P, Mainar V, Campo G, Tespili M, den Heijer P, Bethencourt A, Vazquez N, Valgimigli M, Serruys PW, Ademi Z, Schwenkglenks M, Sabate M. Cost-effectiveness of everolimus-eluting versus bare-metal stents in ST-segment elevation myocardial infarction: An analysis from the EXAMINATION randomized controlled trial. PLoS One. 2018 Aug 16;13(8):e0201985. doi: 10.1371/journal.pone.0201985. eCollection 2018.
Gomez-Lara J, Brugaletta S, Jacobi F, Ortega-Paz L, Nato M, Roura G, Romaguera R, Ferreiro JL, Teruel L, Gracida M, Martin-Yuste V, Freixa X, Masotti M, Gomez-Hospital JA, Sabate M, Cequier A. Five-Year Optical Coherence Tomography in Patients With ST-Segment-Elevation Myocardial Infarction Treated With Bare-Metal Versus Everolimus-Eluting Stents. Circ Cardiovasc Interv. 2016 Oct;9(10):e003670. doi: 10.1161/CIRCINTERVENTIONS.116.003670.
Sabate M, Brugaletta S, Cequier A, Iniguez A, Serra A, Jimenez-Quevedo P, Mainar V, Campo G, Tespili M, den Heijer P, Bethencourt A, Vazquez N, van Es GA, Backx B, Valgimigli M, Serruys PW. Clinical outcomes in patients with ST-segment elevation myocardial infarction treated with everolimus-eluting stents versus bare-metal stents (EXAMINATION): 5-year results of a randomised trial. Lancet. 2016 Jan 23;387(10016):357-366. doi: 10.1016/S0140-6736(15)00548-6. Epub 2015 Oct 29.
Taniwaki M, Stefanini GG, Raber L, Brugaletta S, Cequier A, Heg D, Iniguez A, Kelbaek H, Serra A, Ostoijic M, Hernandez-Antolin R, Baumbach A, Blochlinger S, Juni P, Mainar V, Sabate M, Windecker S. Predictors of adverse events among patients undergoing primary percutaneous coronary intervention: insights from a pooled analysis of the COMFORTABLE AMI and EXAMINATION trials. EuroIntervention. 2015 Aug;11(4):391-8. doi: 10.4244/EIJY14M07_12.
Fernandez-Rodriguez D, Regueiro A, Brugaletta S, Martin-Yuste V, Masotti M, Cequier A, Iniguez A, Serra A, Hernandez-Antolin R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vazquez N, Serruys PW, Sabate M; EXAMINATION investigators. Optimization in stent implantation by manual thrombus aspiration in ST-segment-elevation myocardial infarction: findings from the EXAMINATION trial. Circ Cardiovasc Interv. 2014 Jun;7(3):294-300. doi: 10.1161/CIRCINTERVENTIONS.113.000964. Epub 2014 May 27.
Sabate M, Brugaletta S, Cequier A, Iniguez A, Serra A, Hernadez-Antolin R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vazquez N, Backx B, Serruys PW. The EXAMINATION trial (Everolimus-Eluting Stents Versus Bare-Metal Stents in ST-Segment Elevation Myocardial Infarction): 2-year results from a multicenter randomized controlled trial. JACC Cardiovasc Interv. 2014 Jan;7(1):64-71. doi: 10.1016/j.jcin.2013.09.006. Epub 2013 Dec 11.
Sabate M, Cequier A, Iniguez A, Serra A, Hernandez-Antolin R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vazquez N, Gomez-Hospital JA, Baz JA, Martin-Yuste V, van Geuns RJ, Alfonso F, Bordes P, Tebaldi M, Masotti M, Silvestro A, Backx B, Brugaletta S, van Es GA, Serruys PW. Everolimus-eluting stent versus bare-metal stent in ST-segment elevation myocardial infarction (EXAMINATION): 1 year results of a randomised controlled trial. Lancet. 2012 Oct 27;380(9852):1482-90. doi: 10.1016/S0140-6736(12)61223-9. Epub 2012 Sep 3.
Sabate M, Cequier A, Iniguez A, Serra A, Hernandez-Antolin R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vazquez N, Brugaletta S, Backx B, Serruys P. Rationale and design of the EXAMINATION trial: a randomised comparison between everolimus-eluting stents and cobalt-chromium bare-metal stents in ST-elevation myocardial infarction. EuroIntervention. 2011 Dec;7(8):977-84. doi: 10.4244/EIJV7I8A154.
Other Identifiers
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EXAM-08
Identifier Type: -
Identifier Source: org_study_id
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