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

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: Active, not recruiting
• Conditions: Segment Elevation Myocardial Infarction (STEMI)
• Intervention / Treatment: Device: enVast stent; Procedure: conventional treatment

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: Interventional
• Enrollment (Estimated): 148
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Infarct size	size assessed by measurements of CK-MB (U/L)	At 3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI core lab Infarct size outcome	Infarct size (% of LV mass)	At 3 days
CK	AUC for CK	at 3 days
hsTroponin T	AUC for hsTroponin T	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)	At Procedure
Angio core lab TIMI Flow	TIMI flow	At Procedure
Echo core lab LVEF outcome measures	Left ventricular ejection fraction (LVEF)	At discharge (an average of 3 days)
BNP	Kinetics of B-type natriuretic peptide/NT proBNP	At discharge (an average of 3 days)
Diuretic treatment	Need for diuretic treatment	At discharge (an average of 3 days)
Histopathology	Histopathological evaluation of the retrieved thrombotic material (if feasible)	During procedure
Additional MRI analysis	Additional analyses will include the assessments of hemodynamic forces and radiomics at MRI	At procedure
Primary safety endpoint	MACE	Day 3
CEC outcome measures	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	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	myocardial salvage index	At 3 days
MRI Core Lab microvascular obstruction outcome	microvascular obstruction	At 3 days
MRI Core Lab LV volume outcome	LV volume	At 3 days
MRI Core lab intramyocardial haemorrhage outcome	intramyocardial hemorrhage	At 3 days
MRI core Lab left ventricle and right ventricle thrombosis outcome	left ventricle and right ventricle thrombosis	At 3 days
MRI Core Lab RV function outcome	RV function assessment	At 3 days
Core lab T2 mapping of the left ventricle	T2 mapping of the left ventricle	At 3 days
MRI Core Lab wall motion score index	wall motion score index	At 3 days
Angio Core Lab Corrected TIMI frame count	Corrected TIMI frame count	At Procedure
Angio Core Lab Myocardial Blush Grade	Myocardial Blush Grade	At Procedure
Echo Core Lab LV volume	LV volume	12 months
Echo Core Lab wall motion score index	wall motion score index,	12 months
Echo Core Lab wall thickness	wall thickness	At discharge (an average of 3 days)
Echo Core lab myocardial deformation Outcome	Myocardial deformation	At discharge (an average of 3 days)
Echo Core lab right ventricle function assessment	Right ventricle function	At discharge (an average of 3 days)

Collaborators and Investigators

• Sponsor: Vesalio

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2021
• Primary Completion (Actual): June 1, 2026
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: July 13, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Actual): August 19, 2026
• Last Update Submitted That Met QC Criteria: August 17, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Myocardial Ischemia; Ischemia; ST Elevation Myocardial Infarction; Myocardial Infarction; Infarction
• Other Study ID 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