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Active, not recruiting Not applicable

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

NCT04969471 · tracked via the Priya Life Science Italy tracker
Sponsor
Phase
Not applicable
Started
2021-12-09
Last updated
2026-08-19

Condition(s) studied

Segment Elevation Myocardial Infarction (STEMI)

Investigational drug(s) / intervention(s)

enVast stentconventional treatment

enVast stent: In addition to conventional treatment, the treating physician will deploy as the first measure to obtain reperfusion, a enVast stent at the occlusion site in order to withdraw the clot.

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

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Infarct size — At 3 days
    size assessed by measurements of CK-MB (U/L)

Trial sites (11)

FacilityCityRegionStatus
Azienda Ospedaliera Universitaria di Ferrara Ferrara Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
IRCCS Humanitas Research Hospital Milan Italy
University of Rome Tor Vergata Roma Italy
Amphia Hospital Breda Netherlands
University of Groningen Groningen Netherlands
Maasstad Hospital Rotterdam Netherlands
University of Bern Bern Switzerland
Geneva University Hospitals Geneva Switzerland
Luzerner Kantonsspital Lucerne Switzerland
Istituto Cardiocentro Ticino Lugano Switzerland

More Vesalio trials in Italy

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04969471 on ClinicalTrials.gov ↗ ← All trials in Italy