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

Last updated: December 20, 2024
Sponsor: Vesalio
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Hypercholesterolemia

Angina

Treatment

conventional treatment

enVast stent

Clinical Study ID

NCT04969471
VS-008
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years

  2. Chest pain for > 20 min with an electrocardiographic ST-segment elevation ≥ 1 mm intwo or more contiguous electrocardiogram (ECG) leads or an infero-lateral myocardialinfarction (MI) with ST segment depression of ≥ 1 mm in ≥ 2 of leads V1-3 with apositive terminal T wave.

  3. TIMI Thrombus Grade ≥ 3 in the infarct related artery. In cases where TIMI ThrombusGrade is equal to 5 (i.e. TIMI 0 flow in the infarcted artery), TIMI Thrombus Gradeof at least 3 has to be re-confirmed with AWI. Patients showing TIMI Thrombus Gradeof 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

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 culpritlesion(s)

  4. Presence of extreme vessel tortuosity proximal to or at the site of the culpritlesion(s)

  5. Women of child-bearing potential (e.g. below 55 years of age, who have not undergonetubal ligation, ovariectomy or hysterectomy and last menstruation within the last 12months)

  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

Study Design

Total Participants: 148
Treatment Group(s): 2
Primary Treatment: conventional treatment
Phase:
Study Start date:
December 09, 2021
Estimated Completion Date:
September 30, 2026

Study 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).

Connect with a study center

  • Istituto Cardiocentro Ticino

    Lugano,
    Switzerland

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.