NATURE (EnVast as an Adjunct PPCI in Subjects Presenting With STEMI)

Segment Elevation Myocardial Infarction (STEMI) Clinical Trial

— NATURE  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04969471
• Other study ID #: VS-008
• Status: Recruiting
• Phase: N/A
• Start date: December 9, 2021
• Est. completion date: December 2024

Study information

• Verified date: January 2023
• Source: Vesalio
• Contact: Antoine Cuijpers
• Phone: +31 6 51 55 99 37
• Email: acuijpers[@]vesalio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Segment Elevation Myocardial Infarction (STEMI)
• ST Elevation Myocardial Infarction

Intervention

Device:
• 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.

Procedure:
• conventional treatment
Treatment strategies may include balloon angioplasty, manual aspiration thrombectomy and/or coronary stenting.

Locations

Country	Name	City	State
Switzerland	Istituto Cardiocentro Ticino	Lugano

Sponsors (1)

Lead Sponsor	Collaborator
Vesalio

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infarct size	size assessed by measurements of creatine kinase	three days post intervention