NATURE (EnVast as an Adjunct PPCI in Subjects Presenting With STEMI)

A prospective, multi-center, randomized clinical trial designed to assess the safety and effectiveness of the enVast coronary thrombectomy system as an adjunctive measure to conventional intervention in subjects presenting with ST-segment elevation myocardial infarction (STEMI).

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)
• Stent thrombosis as culprit lesion
• Previous myocardial infarction in the same territory (i.e. same target vessel)
• Participation in another interventional clinical trial