Phase
Condition
Coronary Artery Disease
Hypercholesterolemia
Angina
Treatment
conventional treatment
enVast stent
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 years
Chest pain for > 20 min with an electrocardiographic ST-segment elevation ≥ 1 mm intwo or more contiguous electrocardiogram (ECG) leads or an infero-lateral myocardialinfarction (MI) with ST segment depression of ≥ 1 mm in ≥ 2 of leads V1-3 with apositive terminal T wave.
TIMI Thrombus Grade ≥ 3 in the infarct related artery. In cases where TIMI ThrombusGrade is equal to 5 (i.e. TIMI 0 flow in the infarcted artery), TIMI Thrombus Gradeof at least 3 has to be re-confirmed with AWI. Patients showing TIMI Thrombus Gradeof less than 3 upon AWI are no longer eligible for randomization.
Start of intervention within 8 h of symptom onset
Subject is willing and able to provide informed consent prior to the intervention
Exclusion
Exclusion Criteria:
Unconscious patients
Infarct related artery diameter, at visual assessment, smaller than 2.5 mm
Presence of severely calcified plaque(s) proximal to or at the site of the culpritlesion(s)
Presence of extreme vessel tortuosity proximal to or at the site of the culpritlesion(s)
Women of child-bearing potential (e.g. below 55 years of age, who have not undergonetubal ligation, ovariectomy or hysterectomy and last menstruation within the last 12months)
Stent thrombosis as culprit lesion
Previous myocardial infarction in the same territory (i.e. same target vessel)
Participation in another interventional clinical trial
Study Design
Study Description
Connect with a study center
Istituto Cardiocentro Ticino
Lugano,
SwitzerlandActive - Recruiting
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