Trials / Completed
CompletedNCT04462315
10-Years Follow-up of the EXAMINATION Trial
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,498 (actual)
- Sponsor
- Hospital Clinic of Barcelona · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
- Myocardial Infarction
- ST Elevation Myocardial Infarction
- Infarction
- Necrosis
- Heart Disease
- Cardiovascular Diseases
- Vascular Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2020-05-31
- Completion
- 2020-05-31
- First posted
- 2020-07-08
- Last updated
- 2022-09-01
Locations
11 sites across 3 countries: Italy, Netherlands, Spain
Source: ClinicalTrials.gov record NCT04462315. Inclusion in this directory is not an endorsement.