NATURE (EnVast as an Adjunct PPCI in Subjects Presenting With STEMI) (NCT04969471) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
NATURE (EnVast as an Adjunct PPCI in Subjects Presenting With STEMI)
Switzerland148 participantsStarted 2021-12-09
Plain-language summary
This study is designed to compare the safety and effectiveness of blood clot (thrombus) removal in subjects presenting with ST-segment elevation myocardial infarction (STEMI) with the enVast coronary system versus conventional intervention.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years
✓. Chest pain for \> 20 min with an electrocardiographic ST-segment elevation ≥ 1 mm in two or more contiguous electrocardiogram (ECG) leads or an infero-lateral myocardial infarction (MI) with ST segment depression of ≥ 1 mm in ≥ 2 of leads V1-3 with a positive terminal T wave.
✓. TIMI Thrombus Grade ≥ 3 in the infarct related artery. In cases where TIMI Thrombus Grade is equal to 5 (i.e. TIMI 0 flow in the infarcted artery), TIMI Thrombus Grade of at least 3 has to be re-confirmed with AWI. Patients showing TIMI Thrombus Grade of 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 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 culprit lesion(s)
✕. Presence of extreme vessel tortuosity proximal to or at the site of the culprit lesion(s)
✕. Women of child-bearing potential (e.g. below 55 years of age, who have not undergone tubal ligation, ovariectomy or hysterectomy and last menstruation within the last 12 months)