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ACTIVE NOT RECRUITING
NCT04969471
NA

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

Sponsor: Vesalio

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

148

Start Date

2021-12-09

Completion Date

2027-08-01

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

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.

PROCEDURE

conventional treatment

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

Locations (1)

Istituto Cardiocentro Ticino

Lugano, Switzerland