NATURE (EnVast As an Adjunct PPCI in Subjects Presenting with STEMI)

Launched by VESALIO · Jul 13, 2021

Keywords

ClinConnect Summary

The NATURE clinical trial is exploring a new approach to treating patients who have experienced a heart attack known as STEMI (ST-segment elevation myocardial infarction). Specifically, the study is comparing the safety and effectiveness of a specialized device called the enVast coronary system to the standard method of removing blood clots from the arteries. The goal is to see if this new technique can help patients recover better and faster after a heart attack.

To participate in this trial, individuals must be at least 18 years old and have experienced chest pain for more than 20 minutes, along with specific heart changes detected on an ECG (a test that measures the heart's electrical activity). Participants should also be treated within 8 hours of their symptoms starting. However, certain individuals may not be eligible, such as those who are unconscious or have specific complications with their heart arteries. If you or someone you know is interested in participating, you can expect to receive close monitoring and care during the study. This research could potentially lead to improved treatment options for heart attack patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years
• • 2. 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.
• • 3. 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.
• • 4. Start of intervention within 8 h of symptom onset
• • 5. Subject is willing and able to provide informed consent prior to the intervention
• Exclusion Criteria:
• • 1. Unconscious patients
• • 2. Infarct related artery diameter, at visual assessment, smaller than 2.5 mm
• • 3. Presence of severely calcified plaque(s) proximal to or at the site of the culprit lesion(s)
• • 4. Presence of extreme vessel tortuosity proximal to or at the site of the culprit lesion(s)
• • 5. 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)
• • 6. Stent thrombosis as culprit lesion
• • 7. Previous myocardial infarction in the same territory (i.e. same target vessel)
• • 8. Participation in another interventional clinical trial