Trials / Active Not Recruiting
Active Not RecruitingNCT04969471
NATURE (EnVast as an Adjunct PPCI in Subjects Presenting With STEMI)
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)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 148 (estimated)
- Sponsor
- Vesalio · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-12-09
- Primary completion
- 2026-06-01
- Completion
- 2027-08-01
- First posted
- 2021-07-20
- Last updated
- 2026-03-31
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT04969471. Inclusion in this directory is not an endorsement.