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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thrombectomy Arm | Experimental | enVast stent deployed at occlusion site as first measure to obtain reperfusion and withdraw the clot |
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| Conventional Treatment Arm | Experimental | Treatment strategies may include balloon angioplasty, manual aspiration thrombectomy and/or coronary stenting. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Infarct size | size assessed by measurements of creatine kinase | three days post intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Cardiocentro Ticino | Lugano | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41820070 | Derived | 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. |
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| conventional treatment | Procedure | Treatment strategies may include balloon angioplasty, manual aspiration thrombectomy and/or coronary stenting. |
|