Envast* thrombectomy device as adjunctive reperfusion modality in ST-segment elevation myocardial infarctio

• Conditions: Occlusive thrombus complicating a ruptured or eroded atherosclerotic plaque; 10011082

• Registration Number: NL-OMON56525
• Lead Sponsor: Vesalio

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 70

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. Deferred consent after intervention signed by capable subject, signed by
legal representative in case of incapable subject (subject remains included if
deferred post-interventional consent was not signed before death).

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 childbearing potential (e.g. below 55 years of age, who have not
undergone tubal ligation, ovariectomy or hysterectomy)
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified