New device aims to limit heart damage during heart attacks
NCT ID NCT04969471
First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times
Summary
This study tests a new device called enVast that removes blood clots from heart arteries during a severe heart attack (STEMI). About 148 adults with large clots will either get standard care or standard care plus the enVast device. The goal is to see if the device reduces the size of heart muscle damage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- enVast coronary thrombectomy system (a device to remove blood clots from heart arteries)
- What this could lead to
- If successful, this device could reduce heart muscle damage during a heart attack, potentially improving recovery and long-term heart function.
- What could go wrong
- This is a mid-stage trial with 148 participants, so results may not apply to all patients. The device may not work better than standard treatment and carries risks like vessel injury or bleeding.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 148 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2021
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
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Amphia Hospital
Breda, Netherlands
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Azienda Ospedaliera Universitaria di Ferrara
Ferrara, Italy
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Geneva University Hospitals
Geneva, Switzerland
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IRCCS Humanitas Research Hospital
Milan, Italy
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Istituto Cardiocentro Ticino
Lugano, Switzerland
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Luzerner Kantonsspital
Lucerne, Switzerland
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Maasstad Hospital
Rotterdam, Netherlands
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University of Bern
Bern, Switzerland
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University of Groningen
Groningen, Netherlands
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University of Rome Tor Vergata
Roma, Italy