Segment Elevation Myocardial Infarction (STEMI)
Conditions
Brief 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).
Interventions
DEVICEenVast 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.
PROCEDUREconventional treatment
Treatment strategies may include balloon angioplasty, manual aspiration thrombectomy and/or coronary stenting.
Sponsors
Vesalio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 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
1. Unconscious patients 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infarct size | At 3 days | size assessed by measurements of CK-MB (U/L) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CEC outcome measures | at 1-year follow-up | SAEs will be described according to severity and to their relationship with the study device and procedure. |
| Echo core lab LVEF outcome measures | At discharge (an average of 3 days) | Left ventricular ejection fraction (LVEF) |
| BNP | At discharge (an average of 3 days) | Kinetics of B-type natriuretic peptide/NT proBNP |
| Diuretic treatment | At discharge (an average of 3 days) | Need for diuretic treatment |
| Histopathology | During procedure | Histopathological evaluation of the retrieved thrombotic material (if feasible) |
| Additional MRI analysis | At procedure | Additional analyses will include the assessments of hemodynamic forces and radiomics at MRI |
| MRI core lab Infarct size outcome | At 3 days | Infarct size (% of LV mass) |
| CK | at 3 days | AUC for CK |
| hsTroponin T | at 3 days | AUC for hsTroponin T |
| ECG core lab outcome measures | At Procedure | The cumulative ST-segment deviation/elevation resolution and residual ST-segment elevation (calculated as the sum in mm of any ST-elevation and depression) |
| Angio core lab TIMI Flow | At Procedure | TIMI flow |
| Other important safety endpoints | throughout 1-year follow-up | The composite of CV death, MI, and any CVA, including TIA/stroke; Death from CV causes; Overall death as stand-alone endpoint and in combination with MI, and/or CVA; Definite or probable stent thrombosis; New onset cardiogenic shock requiring inotropes or mechanical assist device; MI; Any stroke, any ischemic stroke with or without TIA; Bleeding events (access site or non-access site related) according to the BARC classification; Rehospitalization for HF in isolation and in association with CV death and/or, resuscitated cardiac arrest or ICD implantation at follow-up; Bailout use of parenteral anti-platelet agents (GPI or cangrelor) defined as any use during or after the procedure in subjects in whom no intention to use a parenteral anti-platelet agent was declared at the time of randomization; Any urgent or non-urgent TVR |
| MRI Core Lab myocardial salvage index | At 3 days | myocardial salvage index |
| MRI Core Lab microvascular obstruction outcome | At 3 days | microvascular obstruction |
| MRI Core Lab LV volume outcome | At 3 days | LV volume |
| MRI Core lab intramyocardial haemorrhage outcome | At 3 days | intramyocardial hemorrhage |
| MRI core Lab left ventricle and right ventricle thrombosis outcome | At 3 days | left ventricle and right ventricle thrombosis |
| MRI Core Lab RV function outcome | At 3 days | RV function assessment |
| Core lab T2 mapping of the left ventricle | At 3 days | T2 mapping of the left ventricle |
| MRI Core Lab wall motion score index | At 3 days | wall motion score index |
| Angio Core Lab Corrected TIMI frame count | At Procedure | Corrected TIMI frame count |
| Angio Core Lab Myocardial Blush Grade | At Procedure | Myocardial Blush Grade |
| Echo Core Lab LV volume | 12 months | LV volume |
| Echo Core Lab wall motion score index | 12 months | wall motion score index, |
| Echo Core Lab wall thickness | At discharge (an average of 3 days) | wall thickness |
| Echo Core lab myocardial deformation Outcome | At discharge (an average of 3 days) | Myocardial deformation |
| Primary safety endpoint | Day 3 | MACE |
| Echo Core lab right ventricle function assessment | At discharge (an average of 3 days) | Right ventricle function |
Countries
Italy, Netherlands, Switzerland
Outcome results
None listed