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

August 17, 2026 updated by: Vesalio

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
148

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Thrombectomy Arm
enVast stent deployed at occlusion site as first measure to obtain reperfusion and withdraw the clot
Device: 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.
Experimental: Conventional Treatment Arm
Treatment strategies may include balloon angioplasty, manual aspiration thrombectomy and/or coronary stenting.
Procedure: conventional treatment
Treatment strategies may include balloon angioplasty, manual aspiration thrombectomy and/or coronary stenting.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Infarct size
Time Frame: At 3 days
size assessed by measurements of CK-MB (U/L)
At 3 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
MRI core lab Infarct size outcome
Time Frame: At 3 days
Infarct size (% of LV mass)
At 3 days
CK
Time Frame: at 3 days
AUC for CK
at 3 days
hsTroponin T
Time Frame: at 3 days
AUC for hsTroponin T
at 3 days
ECG core lab outcome measures
Time Frame: At Procedure
The cumulative ST-segment deviation/elevation resolution and residual ST-segment elevation (calculated as the sum in mm of any ST-elevation and depression)
At Procedure
Angio core lab TIMI Flow
Time Frame: At Procedure
TIMI flow
At Procedure
Echo core lab LVEF outcome measures
Time Frame: At discharge (an average of 3 days)
Left ventricular ejection fraction (LVEF)
At discharge (an average of 3 days)
BNP
Time Frame: At discharge (an average of 3 days)
Kinetics of B-type natriuretic peptide/NT proBNP
At discharge (an average of 3 days)
Diuretic treatment
Time Frame: At discharge (an average of 3 days)
Need for diuretic treatment
At discharge (an average of 3 days)
Histopathology
Time Frame: During procedure
Histopathological evaluation of the retrieved thrombotic material (if feasible)
During procedure
Additional MRI analysis
Time Frame: At procedure
Additional analyses will include the assessments of hemodynamic forces and radiomics at MRI
At procedure
Primary safety endpoint
Time Frame: Day 3
MACE
Day 3
CEC outcome measures
Time Frame: at 1-year follow-up
SAEs will be described according to severity and to their relationship with the study device and procedure.
at 1-year follow-up
Other important safety endpoints
Time Frame: throughout 1-year follow-up
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
throughout 1-year follow-up
MRI Core Lab myocardial salvage index
Time Frame: At 3 days
myocardial salvage index
At 3 days
MRI Core Lab microvascular obstruction outcome
Time Frame: At 3 days
microvascular obstruction
At 3 days
MRI Core Lab LV volume outcome
Time Frame: At 3 days
LV volume
At 3 days
MRI Core lab intramyocardial haemorrhage outcome
Time Frame: At 3 days
intramyocardial hemorrhage
At 3 days
MRI core Lab left ventricle and right ventricle thrombosis outcome
Time Frame: At 3 days
left ventricle and right ventricle thrombosis
At 3 days
MRI Core Lab RV function outcome
Time Frame: At 3 days
RV function assessment
At 3 days
Core lab T2 mapping of the left ventricle
Time Frame: At 3 days
T2 mapping of the left ventricle
At 3 days
MRI Core Lab wall motion score index
Time Frame: At 3 days
wall motion score index
At 3 days
Angio Core Lab Corrected TIMI frame count
Time Frame: At Procedure
Corrected TIMI frame count
At Procedure
Angio Core Lab Myocardial Blush Grade
Time Frame: At Procedure
Myocardial Blush Grade
At Procedure
Echo Core Lab LV volume
Time Frame: 12 months
LV volume
12 months
Echo Core Lab wall motion score index
Time Frame: 12 months
wall motion score index,
12 months
Echo Core Lab wall thickness
Time Frame: At discharge (an average of 3 days)
wall thickness
At discharge (an average of 3 days)
Echo Core lab myocardial deformation Outcome
Time Frame: At discharge (an average of 3 days)
Myocardial deformation
At discharge (an average of 3 days)
Echo Core lab right ventricle function assessment
Time Frame: At discharge (an average of 3 days)
Right ventricle function
At discharge (an average of 3 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vesalio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 9, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VS-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual participant data underlying the primary and secondary efficacy and safety endpoints reported in this article (CK-MB AUC, CMR measures, biomarkers, electrocardiographic and angiographic outcomes, adverse events), after removal of direct and indirect identifiers.

IPD Sharing Time Frame

Beginning 12 months (due to ongoing 12-month data collection) and ending 36 months following article publication

IPD Sharing Access Criteria

With researchers who provide a methodologically sound proposal, reviewed and approved by an independent scientific review committee, to achieve the aims of the approved proposal, via a signed data access agreement, to achieve the aims of the approved proposal, via a signed data access agreement. Proposals should be directed to [datasharing@vesalio.com]. Data requestors will be required to submit a methodologically sound research proposal; requests will be reviewed by Vesalio to confirm consistency with the aims of the approved proposal. Approved requestors will be required to sign a data access agreement prior to receiving deidentified data, which will be made available through a Vesalio-managed secure data portal

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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