10-Years Follow-up of the EXAMINATION Trial

NCT04462315 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1498

Last updated 2022-09-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Everolimus Eluting Coronary Stent System

Everolimus Eluting Coronary Stent System (Everolimus Arm) implantation

DEVICE

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

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

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    lead OTHER

Principal Investigators

  • Salvatore Brugaletta, MD, PhD · Hospital Clinic of Barcelona

  • Josep Gómez-Lara, MD, PhD · Hospital Universitari de Bellvitge

  • Luis Ortega-Paz, MD, PhD · Hospital Clinic of Barcelona

  • Manel Sabaté, MD, PhD · Hospital Clinic of Barcelona

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-01
Primary Completion
2020-05-31
Completion
2020-05-31

Countries

  • Italy
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04462315 on ClinicalTrials.gov