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

NCT04969471 | Active Not Recruiting

• 1 other identifier: VS-008
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Segment Elevation Myocardial Infarction (STEMI)

Outcome Measures

Primary Outcomes (1)

• Infarct size

  size assessed by measurements of creatine kinase

  three days post intervention

Study Arms (2)

Thrombectomy Arm

EXPERIMENTAL

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

Device: enVast stent

Conventional Treatment Arm

EXPERIMENTAL

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

Procedure: conventional treatment

Interventions

enVast stent DEVICE

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.

Thrombectomy Arm

conventional treatment PROCEDURE

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

Conventional Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vesalio: lead

Study Sites (1)

Istituto Cardiocentro Ticino

Lugano, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 41820070 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 20, 2021
• Study Start: December 9, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

CH (1)