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Completed

NCT Number: NCT04462315

10-Years Follow-up of the EXAMINATION Trial

The EXAMINATION trial was a superiority trial that compared everolimus-eluting stents (EES) versus bare-metal stents (BMS) in an all-comer ST-segment elevation myocardial infarction (STEMI) population. The patient-oriented endpoint was not superior at 1-year, but it was at 5-year. However, very-long term follow-up is unknown. The study had an independent Clinical event Committee (CEC). All events were adjudicated by an independent clinical committee, according to the Academic Research Consortium 1.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Disease Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliera Bolognini, Seriate, Bergamo, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who were enrolled in the EXAMINATION trial (NCT00828087).

Exclusion criteria

  • None.

Treatment and study plan

Everolimus Eluting Coronary Stent System

Drug

Everolimus Eluting Coronary Stent System (Everolimus Arm) implantation

Other names: N/H

Cobalt chromium balloon expandable stent (non-drug-eluting stent Arm)

Device

Cobalt chromium balloon-expandable stent (non-drug-eluting stent Arm) implantation

Other names: N/H

Primary outcomes

  1. Patient-oriented Composite Endpoint (PoCE)

    Time frame: 10 years

    Rate of composite endpoint of all-cause death, any myocardial infarction, and any revascularization. Defined according to the Academic Research Consortium 1.

Secondary outcomes

  1. Device-oriented Composite Endpoint (DoCE)

    Time frame: 10 years

    Rate of composite endpoint of cardiac death, Target vessel myocardial infarction, and Target lesion revascularization. Defined according to the Academic Research Consortium 1.

  2. Rate of all cause and cardiac mortality

    Time frame: 10 years

    Defined according to the Academic Research Consortium 1.

  3. Rate of recurrent myocardial infarction

    Time frame: 10 years

    Defined according to the Academic Research Consortium 1.

  4. Rate of target lesion revascularization

    Time frame: 10 years

    Defined according to the Academic Research Consortium 1.

  5. Rate of stent thrombosis

    Time frame: 10 years

    Defined according to the Academic Research Consortium 1.

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

Ten-year Follow-up of the Clinical Evaluation of Everolimus-Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction: EXAMINATION-EXTEND Trial

Acronym: EXAMINAT10N

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jul 8, 2020
Registry last updated
Sep 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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