Back to results

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

Primary Purpose

Segment Elevation Myocardial Infarction (STEMI)

Status

Recruiting

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

enVast stent

conventional treatment

About this trial

This is an interventional treatment trial for Segment Elevation Myocardial Infarction (STEMI)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Istituto Cardiocentro TicinoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Thrombectomy Arm

Conventional Treatment Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

Infarct size

size assessed by measurements of creatine kinase

Secondary Outcome Measures

Full Information

NCT ID

NCT04969471

First Posted

July 13, 2021

Last Updated

May 15, 2023

Sponsor

Vesalio

1. Study Identification

Unique Protocol Identification Number

NCT04969471

Brief Title

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

Acronym

NATURE

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 9, 2021 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vesalio

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Segment Elevation Myocardial Infarction (STEMI)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

148 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Thrombectomy Arm

Arm Type

Experimental

Arm Description

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

Arm Title

Conventional Treatment Arm

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

enVast stent

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

conventional treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

Infarct size

Description

size assessed by measurements of creatine kinase

Time Frame

three days post intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Antoine Cuijpers

Phone

+31 6 51 55 99 37

acuijpers@vesalio.com

Facility Information:

Facility Name

Istituto Cardiocentro Ticino

City

Lugano

Country

Switzerland

Individual Site Status

Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs