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NATURE (EnVast as an Adjunct PPCI in Subjects Presenting With STEMI)
Sponsor: Vesalio
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
2026-08-19
Healthy Volunteers
No
Interventions
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.
conventional treatment
Treatment strategies may include balloon angioplasty, manual aspiration thrombectomy and/or coronary stenting.
Locations (11)
Azienda Ospedaliera Universitaria di Ferrara
Ferrara, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
IRCCS Humanitas Research Hospital
Milan, Italy
University of Rome Tor Vergata
Roma, Italy
Amphia Hospital
Breda, Netherlands
University of Groningen
Groningen, Netherlands
Maasstad Hospital
Rotterdam, Netherlands
University of Bern
Bern, Switzerland
Geneva University Hospitals
Geneva, Switzerland
Luzerner Kantonsspital
Lucerne, Switzerland
Istituto Cardiocentro Ticino
Lugano, Switzerland