CorPath GRX STEMI Study

Siemens Healthineers Endovascular Robotics, Inc.3 enrolled

Overview

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).

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

STEMI - ST Elevation Myocardial Infarction CAD

Interventions

Robotic-PCI (CorPath GRX System)DEVICE

Robotic-PCI for acute ST elevation myocardial infarction (STEMI).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Wellstar Kennestone Hospital

Marietta, Georgia, United States

Outcomes

Primary Outcomes

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.

Time frame: Procedure

Secondary Outcomes

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.

Time frame: 72-hours

First Medical Contact (FMC) to device activation time

Time at which first patient evaluation.

Time frame: Procedure

Access to device activation

Time measured from access sheath insertion to device activation by CorPath GRX System.

Time frame: Procedure

Access to wire time

Defined as time measured from sheath insertion to crossing the lesion with the coronary guidewire.

Time frame: Procedure

Overall procedure time

Defined as the time measured from sheath insertion to removal of the last device used to treat the culprit lesion.

Time frame: Procedure

Fluoroscopy time

Total fluoroscopy time (min.) utilized during the procedure as recorded by the Imaging System.

Time frame: Procedure

Patient radiation exposure

Data from ClinicalTrials.gov

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