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Segment Elevation Myocardial Infarction (STEMI)NATURENCT04969471

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

A study testing enVast stent and conventional treatment in people with Segment Elevation Myocardial Infarction (STEMI), run by Vesalio at 11 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
enVast stent and conventional treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
148 participants
Where
11 sitesin 3 countries
Study dates
9 Dec 2021to 1 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

11 sites in 3 countries.

11 sites in 3 countries

Italy4 sites

  • Azienda Ospedaliera Universitaria di Ferrara

    Ferrara

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan

  • IRCCS Humanitas Research Hospital

    Milan

  • University of Rome Tor Vergata

    Roma

Other trials in Italy

Switzerland4 sites

  • University of Bern

    Bern

  • Geneva University Hospitals

    Geneva

  • Luzerner Kantonsspital

    Lucerne

  • Istituto Cardiocentro Ticino

    Lugano

Other trials in Switzerland

Netherlands3 sites

  • Amphia Hospital

    Breda

  • University of Groningen

    Groningen

  • Maasstad Hospital

    Rotterdam

Other trials in Netherlands

About this study

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)

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.

Read the 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).

Being tested
enVast stent, conventional treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 or surgery

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

Study groups in NCT04969471
Study groupRoleWhat they receive
Thrombectomy ArmExperimentalenVast stent deployed at occlusion site as first measure to obtain reperfusion and withdraw the clot
Receives: Device: enVast stent
Conventional Treatment ArmExperimentalTreatment strategies may include balloon angioplasty, manual aspiration thrombectomy and/or coronary stenting.
Receives: Procedure: conventional treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Infarct size

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

    Measured: At 3 days

Secondary outcomes (28)

  1. MRI core lab Infarct size outcome

    Infarct size (% of LV mass)

    Measured: At 3 days

  2. CK

    AUC for CK

    Measured: at 3 days

  3. hsTroponin T

    AUC for hsTroponin T

    Measured: at 3 days

  4. 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)

    Measured: At Procedure

  5. Angio core lab TIMI Flow

    TIMI flow

    Measured: At Procedure

  6. Echo core lab LVEF outcome measures

    Left ventricular ejection fraction (LVEF)

    Measured: At discharge (an average of 3 days)

  7. BNP

    Kinetics of B-type natriuretic peptide/NT proBNP

    Measured: At discharge (an average of 3 days)

  8. Diuretic treatment

    Need for diuretic treatment

    Measured: At discharge (an average of 3 days)

  9. Histopathology

    Histopathological evaluation of the retrieved thrombotic material (if feasible)

    Measured: During procedure

  10. Additional MRI analysis

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

    Measured: At procedure

  11. Primary safety endpoint

    MACE

    Measured: Day 3

  12. CEC outcome measures

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

    Measured: at 1-year follow-up

  13. 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

    Measured: throughout 1-year follow-up

  14. MRI Core Lab myocardial salvage index

    myocardial salvage index

    Measured: At 3 days

  15. MRI Core Lab microvascular obstruction outcome

    microvascular obstruction

    Measured: At 3 days

  16. MRI Core Lab LV volume outcome

    LV volume

    Measured: At 3 days

  17. MRI Core lab intramyocardial haemorrhage outcome

    intramyocardial hemorrhage

    Measured: At 3 days

  18. MRI core Lab left ventricle and right ventricle thrombosis outcome

    left ventricle and right ventricle thrombosis

    Measured: At 3 days

  19. MRI Core Lab RV function outcome

    RV function assessment

    Measured: At 3 days

  20. Core lab T2 mapping of the left ventricle

    T2 mapping of the left ventricle

    Measured: At 3 days

  21. MRI Core Lab wall motion score index

    wall motion score index

    Measured: At 3 days

  22. Angio Core Lab Corrected TIMI frame count

    Corrected TIMI frame count

    Measured: At Procedure

  23. Angio Core Lab Myocardial Blush Grade

    Myocardial Blush Grade

    Measured: At Procedure

  24. Echo Core Lab LV volume

    LV volume

    Measured: 12 months

  25. Echo Core Lab wall motion score index

    wall motion score index,

    Measured: 12 months

  26. Echo Core Lab wall thickness

    wall thickness

    Measured: At discharge (an average of 3 days)

  27. Echo Core lab myocardial deformation Outcome

    Myocardial deformation

    Measured: At discharge (an average of 3 days)

  28. Echo Core lab right ventricle function assessment

    Right ventricle function

    Measured: At discharge (an average of 3 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2021
  2. Study start9 Dec 2021
  3. Primary completion1 Jun 2026
  4. Study completion1 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
148 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04969471
Sponsor's protocol ID
VS-008
Acronym
NATURE
Status last verified
Aug 2026
First submitted
13 Jul 2021
Last updated
19 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Valgimigli M, Frigoli E, Landi A, Covani M, Biscaglia S, Cuculi F, Erriquez A, Bossard M, Mangieri A, Meuwissen M, Iglesias JF, Sangiorgi G, Lipsic E, Oreglia JA, Haner JD, Paradies V, Pavon AG, Leo LA, Gragnano F, Fuentes F, Viccaro V, Colombo A, Branca S, Leonardi S, Garcia-Garcia HM; NATURE Investigators. Stent Retriever Thrombectomy in Patients With Myocardial Infarction: The Open-Label, Multicenter NATURE Superiority Trial. J Am Coll Cardiol. 2026 Aug 29:S0735-1097(26)07586-8. doi: 10.1016/j.jacc.2026.08.034. Online ahead of print.

    PubMed 42670735

  • Landi A, Biscaglia S, Cuculi F, Erriquez A, Bossard M, Colombo A, Mangieri A, Meuwissen M, Iglesias JF, Sangiorgi G, Lipsic E, Oreglia JA, Haner JD, Paradies V, Crimi G, Milzi A, Pavon AG, Leo LA, Frigoli E, Valgimigli M. The use of mechanical thrombectomy in patients with STEMI and large thrombus burden: design and rationale of the NATURE trial. Cardiovasc Revasc Med. 2026 Mar 4:S1553-8389(26)00082-5. doi: 10.1016/j.carrev.2026.03.002. Online ahead of print.

    PubMed 41820070

Questions about this trial

What is this clinical trial studying?

A study testing enVast stent and conventional treatment in people with Segment Elevation Myocardial Infarction (STEMI), run by Vesalio at 11 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Italy, Switzerland, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infarct size (time frame: At 3 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04969471, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

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