CorPath GRX STEMI Study

Terminated

• Conditions: STEMI - ST Elevation Myocardial Infarction; CAD
• Interventions: Device: Robotic-PCI (CorPath GRX System)

• Registration Number: NCT04459299
• Lead Sponsor: Corindus Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-07-01
• Study First Submitted QC: 2020-07-01
• Study First Posted: 2020-07-07
• Study Start: 2020-09-28
• Primary Completion: 2020-11-26
• Study Completion: 2020-11-29
• Status Verified: 2022-01
• Last Update Submitted: 2023-12-14
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
STEMI patients with clinical indication for primary PCI	Robotic-PCI (CorPath GRX System)	Subjects with a clinical indication of STEMI.

Primary Outcome Measures

Name	Time	Method
Time from Catheterization Lab Arrival to Device Activation (CLADA) by CorPath GRX System.	Procedure	Time measured from arrival to Cath Lab to device activation by CorPath GRX System.

Secondary Outcome Measures

Name	Time	Method
Access to wire time	Procedure	Defined as time measured from sheath insertion to crossing the lesion with the coronary guidewire.
Freedom from MACE events	72-hours	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.
Access to device activation	Procedure	Time measured from access sheath insertion to device activation by CorPath GRX System.
Overall procedure time	Procedure	Defined as the time measured from sheath insertion to removal of the last device used to treat the culprit lesion.
Conversion to manual (Binary)	Procedure	Conversion from robotic technique to manual technique due to inability to successfully wire lesion or deliver first device.
Contrast fluid volume	Procedure	Total contrast volume (mL/cc) used during the procedure.
Serious adverse events	72-hours	All Serious Adverse Events (SAEs) from the start of the CorPath GRX procedure until the end of the study will be summarized.
First Medical Contact (FMC) to device activation time	Procedure	Time at which first patient evaluation.
Fluoroscopy time	Procedure	Total fluoroscopy time (min.) utilized during the procedure as recorded by the Imaging System.
Patient radiation exposure	Procedure	DAP (dose-area-product) and AK (air kerma) as recorded during the procedure.
Technical success	Procedure	Completion of the PCI procedure entirely robotically or with partial manual assistance.

Trial Locations

Locations (1)

Wellstar Kennestone Hospital; 🇺🇸 Marietta, Georgia, United States