CorPath GRX STEMI Study

Study Overview
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Brief Summary
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This study will evaluate the performance of the CorPath GRX System in Robotic Primary PCI (RPPCI) in the treatment of ST-elevated myocardial infarction (STEMI).

Detailed Description
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This is a prospective, post-market, single-arm, multi-center, observational study to evaluate the performance of the CorPath GRX System during robotic-PCI for acute ST elevation myocardial infarction (STEMI).

Official Title
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An Evaluation of Performance of the CorPath® GRX System in Robotic-PCI During Acute STEMI

Conditions
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STEMI - ST Elevation Myocardial Infarction, CAD

Intervention / Treatment
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* Device: Robotic-PCI (CorPath GRX System)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 and ≤ 80 years Patients with STEMI<12 h of symptom onset Patient deemed appropriate for robotic-assisted PCI The subject has been informed of the nature of the study, agrees to its provisions, and has provided written consent Exclusion Criteria: Cardiogenic shock Cardiac arrest Need for manual or mechanical thrombectomy Failure/inability/unwillingness to provide informed consent The Investigator determines that the subject or the coronary anatomy is not suitable for robotic-assisted primary PCI treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| STEMI patients with clinical indication for primary PCI<br>Subjects with a clinical indication of STEMI. | Device: Robotic-PCI (CorPath GRX System)<br>* Robotic-PCI for acute ST elevation myocardial infarction (STEMI).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from Catheterization Lab Arrival to Device Activation (CLADA) by CorPath GRX System. | Time measured from arrival to Cath Lab to device activation by CorPath GRX System. | Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from MACE events | Completion of the STEMI procedure without in-hospital major adverse cardiovascular event MACE). MACE is defined as cardiac death, clinically driven target vessel revascularization (TVR) by repeat PCI, surgical bypass for any segment of the target vessel or stent thrombosis. | 72-hours | 
| First Medical Contact (FMC) to device activation time | Time at which first patient evaluation. | Procedure | 
| Access to device activation | Time measured from access sheath insertion to device activation by CorPath GRX System. | Procedure | 
| Access to wire time | Defined as time measured from sheath insertion to crossing the lesion with the coronary guidewire. | Procedure | 
| Overall procedure time | Defined as the time measured from sheath insertion to removal of the last device used to treat the culprit lesion. | Procedure | 
| Fluoroscopy time | Total fluoroscopy time (min.) utilized during the procedure as recorded by the Imaging System. | Procedure | 
| Patient radiation exposure | DAP (dose-area-product) and AK (air kerma) as recorded during the procedure. | Procedure | 
| Contrast fluid volume | Total contrast volume (mL/cc) used during the procedure. | Procedure | 
| Conversion to manual (Binary) | Conversion from robotic technique to manual technique due to inability to successfully wire lesion or deliver first device. | Procedure | 
| Technical success | Completion of the PCI procedure entirely robotically or with partial manual assistance. | Procedure | 
| Serious adverse events | All Serious Adverse Events (SAEs) from the start of the CorPath GRX procedure until the end of the study will be summarized. | 72-hours |