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

Study Overview
=================
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).

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)

Conditions
-----------------
Segment Elevation Myocardial Infarction (STEMI)

Intervention / Treatment
-----------------
* Device: enVast stent
* Procedure: conventional treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years 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. 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. Start of intervention within 8 h of symptom onset Subject is willing and able to provide informed consent prior to the intervention Exclusion Criteria: Unconscious patients Infarct related artery diameter, at visual assessment, smaller than 2.5 mm Presence of severely calcified plaque(s) proximal to or at the site of the culprit lesion(s) Presence of extreme vessel tortuosity proximal to or at the site of the culprit lesion(s) 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) Stent thrombosis as culprit lesion Previous myocardial infarction in the same territory (i.e. same target vessel) Participation in another interventional clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thrombectomy Arm<br>enVast stent deployed at occlusion site as first measure to obtain reperfusion and withdraw the clot | Device: enVast stent<br>* 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.<br>|
| Experimental: Conventional Treatment Arm<br>Treatment strategies may include balloon angioplasty, manual aspiration thrombectomy and/or coronary stenting. | Procedure: conventional treatment<br>* Treatment strategies may include balloon angioplasty, manual aspiration thrombectomy and/or coronary stenting.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct size | size assessed by measurements of creatine kinase | three days post intervention |