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A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction: EXAMINATION Study

NCT00828087 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1504

Last updated 2015-05-19

No results posted yet for this study

Summary

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.

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.

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

  • Spanish Society of Cardiology

    lead OTHER

Principal Investigators

  • Prof. P.W. Serruys, MD,PhD · Erasmus MC, Rotterdam

  • Manuel Sabate, MD,PhD · Hospital Clínic i Provincial de Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • Italy
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT00828087 on ClinicalTrials.gov