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

Vesalio

Status: Enrolling

Conditions: Segment Elevation Myocardial Infarction (STEMI)

Treatments: Device: enVast stent; Procedure: conventional treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT04969471

VS-008

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 148 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 2 patient groups

Thrombectomy Arm

Experimental group

Description:

enVast stent deployed at occlusion site as first measure to obtain reperfusion and withdraw the clot

Treatment:

Device: enVast stent

Conventional Treatment Arm

Experimental group

Description:

Treatment strategies may include balloon angioplasty, manual aspiration thrombectomy and/or coronary stenting.

Treatment:

Procedure: conventional treatment