Comparing enVast thrombectomy with standard treatment for heart attack patients
An Interventional, Prospective, Randomized, Multi-Center, Assessor-Blinded Study 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)
This study is testing whether a new thrombectomy system can help heart attack patients feel better compared to standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vesalio Industry-sponsored |
| Locations | 1 site (Lugano) |
| Trial ID | NCT04969471 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of the enVast coronary thrombectomy system as an additional treatment for patients experiencing ST-segment elevation myocardial infarction (STEMI). It is a prospective, multi-center, randomized trial that will compare outcomes between patients receiving the enVast system and those undergoing conventional intervention. The study focuses on patients who present with specific criteria related to chest pain and thrombus grade in the infarct-related artery. The intervention must begin within 8 hours of symptom onset to ensure timely treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who present with chest pain and meet specific electrocardiographic and thrombus grade criteria.
Not a fit: Patients who are unconscious, have a small infarct-related artery diameter, or present with severely calcified plaques may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve outcomes for patients suffering from STEMI by enhancing blood clot removal during treatment.
How similar studies have performed: While the enVast system is a novel approach, similar studies have shown promise in improving outcomes for patients with STEMI using advanced thrombectomy techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lugano
- Istituto Cardiocentro Ticino — Lugano, Switzerland (Recruiting)
Study contacts
- Study coordinator: Antoine Cuijpers
- Email: acuijpers@vesalio.com
- Phone: +31 6 51 55 99 37
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.