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

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spanish Society of Cardiology
• Treatments: Chromium; Cobalt; Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• Patients presenting with a ST-elevation myocardial infarction who must meet at least one of the following 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:

• Age < 18 years.

• 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).