An Interventional, Prospective, Randomized, Multi-Center, Assessor-Blinded Study 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)

Vesalio1 site in 1 country148 target enrollmentDecember 9, 2021

ConditionsSegment Elevation Myocardial Infarction (STEMI)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Segment Elevation Myocardial Infarction (STEMI)
Sponsor: Vesalio
Enrollment: 148
Locations: 1
Primary Endpoint: Infarct size
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed 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).

Registry

clinicaltrials.gov

Start Date

December 9, 2021

End Date

September 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vesalio

Responsible Party

Sponsor

Eligibility Criteria

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