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

N/AActive Not RecruitingNCT04969471

Vesalio148 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

148

Conditions

Segment Elevation Myocardial Infarction (STEMI)

Interventions

enVast stentDEVICE

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 treatmentPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

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

Outcomes

Primary Outcomes

Infarct size

size assessed by measurements of CK-MB (U/L)

Time frame: At 3 days

Secondary Outcomes

MRI core lab Infarct size outcome

Infarct size (% of LV mass)

Time frame: At 3 days

AUC for CK

Time frame: at 3 days

hsTroponin T

AUC for hsTroponin T

Time frame: at 3 days

ECG core lab outcome measures

The cumulative ST-segment deviation/elevation resolution and residual ST-segment elevation (calculated as the sum in mm of any ST-elevation and depression)

Time frame: At Procedure

Angio core lab TIMI Flow

TIMI flow

Time frame: At Procedure

Echo core lab LVEF outcome measures

Left ventricular ejection fraction (LVEF)

Time frame: At discharge (an average of 3 days)

BNP

Kinetics of B-type natriuretic peptide/NT proBNP

Time frame: At discharge (an average of 3 days)

Diuretic treatment

Need for diuretic treatment

Time frame: At discharge (an average of 3 days)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

...and 1 more locations

Histopathology

Histopathological evaluation of the retrieved thrombotic material (if feasible)

Time frame: During procedure

Additional MRI analysis

Additional analyses will include the assessments of hemodynamic forces and radiomics at MRI

Time frame: At procedure

Primary safety endpoint

MACE

Time frame: Day 3

CEC outcome measures

SAEs will be described according to severity and to their relationship with the study device and procedure.

Time frame: at 1-year follow-up

Other important safety endpoints

The composite of CV death, MI, and any CVA, including TIA/stroke; Death from CV causes; Overall death as stand-alone endpoint and in combination with MI, and/or CVA; Definite or probable stent thrombosis; New onset cardiogenic shock requiring inotropes or mechanical assist device; MI; Any stroke, any ischemic stroke with or without TIA; Bleeding events (access site or non-access site related) according to the BARC classification; Rehospitalization for HF in isolation and in association with CV death and/or, resuscitated cardiac arrest or ICD implantation at follow-up; Bailout use of parenteral anti-platelet agents (GPI or cangrelor) defined as any use during or after the procedure in subjects in whom no intention to use a parenteral anti-platelet agent was declared at the time of randomization; Any urgent or non-urgent TVR

Time frame: throughout 1-year follow-up

MRI Core Lab myocardial salvage index

myocardial salvage index

Time frame: At 3 days

MRI Core Lab microvascular obstruction outcome

microvascular obstruction

Time frame: At 3 days

MRI Core Lab LV volume outcome

LV volume

Time frame: At 3 days

MRI Core lab intramyocardial haemorrhage outcome

intramyocardial hemorrhage

Time frame: At 3 days

MRI core Lab left ventricle and right ventricle thrombosis outcome

left ventricle and right ventricle thrombosis

Time frame: At 3 days

MRI Core Lab RV function outcome

RV function assessment

Time frame: At 3 days

Core lab T2 mapping of the left ventricle

T2 mapping of the left ventricle

Time frame: At 3 days

MRI Core Lab wall motion score index

wall motion score index

Time frame: At 3 days

Angio Core Lab Corrected TIMI frame count

Corrected TIMI frame count

Time frame: At Procedure

Angio Core Lab Myocardial Blush Grade

Myocardial Blush Grade

Time frame: At Procedure

Echo Core Lab LV volume

LV volume

Time frame: 12 months

Echo Core Lab wall motion score index

wall motion score index,

Time frame: 12 months

Echo Core Lab wall thickness

wall thickness

Time frame: At discharge (an average of 3 days)

Echo Core lab myocardial deformation Outcome

Myocardial deformation

Time frame: At discharge (an average of 3 days)

Echo Core lab right ventricle function assessment

Right ventricle function

Time frame: At discharge (an average of 3 days)