NATURE (EnVast As an Adjunct PPCI in Subjects Presenting with STEMI)
NCT ID: NCT04969471
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
148 participants
INTERVENTIONAL
2021-12-09
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Thrombectomy Arm
enVast stent deployed at occlusion site as first measure to obtain reperfusion and withdraw the clot
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 Arm
Treatment strategies may include balloon angioplasty, manual aspiration thrombectomy and/or coronary stenting.
conventional treatment
Treatment strategies may include balloon angioplasty, manual aspiration thrombectomy and/or coronary stenting.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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.
4. Start of intervention within 8 h of symptom onset
5. Subject is willing and able to provide informed consent prior to the intervention
Exclusion Criteria
2. Infarct related artery diameter, at visual assessment, smaller than 2.5 mm
3. Presence of severely calcified plaque(s) proximal to or at the site of the culprit lesion(s)
4. Presence of extreme vessel tortuosity proximal to or at the site of the culprit lesion(s)
5. 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)
6. Stent thrombosis as culprit lesion
7. Previous myocardial infarction in the same territory (i.e. same target vessel)
8. Participation in another interventional clinical trial
18 Years
ALL
No
Sponsors
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Vesalio
INDUSTRY
Responsible Party
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Locations
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Istituto Cardiocentro Ticino
Lugano, , Switzerland
Countries
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Central Contacts
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Other Identifiers
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VS-008
Identifier Type: -
Identifier Source: org_study_id