An Evaluation of Performance of the CorPath® GRX System in Robotic-PCI During Acute STEMI
Conditions: STEMI - ST Elevation Myocardial Infarction, CAD
Sponsor: Corindus Inc.

Procedure Title: TREAT GRX Study 
Protocol
Doc Number:  104-09062 
Revision:  A 
Page: 6 of 34 
 
Revision Date June 3, 2020 
This confidential document is the property of Corindus, Inc. and shall not be reproduced, distributed, disclosed, or used without 
the express written consent of Corindus, Inc 
 
 
 
TREAT GRX STUDY SUMMARY 
 
TITLE 
An Evaluation of Performance of the CorPath® GRX System in 
Robotic-PCI during Acute STEMI
 
 
SHORT TITLE 
TREAT GRX Study
 
 
DEVICE 
CorPath® GRX System: 
• 
Bedside Unit consists of the Extended Reach Arm, 
Robotic Drive, and single-use Cassette. 
• 
Interventional cockpit 
•
Control console
 
 
REGULATORY STATUS 
The CorPath GRX System was granted 510(k) clearance 
(K160121) on October 27, 2016.
 
 
INDICATION FOR USE 
The CorPath GRX System is intended for use in the remote 
delivery and manipulation of guidewires and rapid exchange 
catheters, and remote manipulation of guide catheters during 
percutaneous coronary and vascular procedures. 
 
 
STUDY OBJECTIVE 
This study will evaluate the performance of the CorPath GRX 
System in Robotic Primary PCI (RPPCI) in the treatment of 
STEMI.
 
 
 
 
STUDY DESIGN 
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).
 
 
 
PRINCIPAL INVESTIGATOR 
 
Salvatore F. Mannino, DO, MA, FACC, FSCAI 
Interventional Director, Short Term Mechanical Circulatory 
Support Program 
WellStar Health System 
55 Whitcher St  
Suite 350 
Marietta, GA 30060 USA
 
 
SAMPLE SIZE 
Up to 100 subjects shall be enrolled in the study. 
 
 
INVESTIGATIONAL SITES 
A maximum of five (5) sites may participate.  

Procedure Title: TREAT GRX Study 
Protocol
Doc Number:  104-09062 
Revision:  A 
Page: 7 of 34 
 
Revision Date June 3, 2020 
This confidential document is the property of Corindus, Inc. and shall not be reproduced, distributed, disclosed, or used without 
the express written consent of Corindus, Inc 
 
 
 
 
 
 
EVALUATION PERIOD 
Estimated date of first patient enrolled: August 2020 
Anticipated enrollment period: 12 months 
Estimated date of last patient enrolled: August 2021 
 
STUDY DURATION/ 
FOLLOW-UP PERIOD 
All subjects will be followed post-CorPath GRX PCI procedure 
through 72-hours post-procedure or hospital discharge, 
whichever occurs first.
 
 
SUBJECT POPULATION 
Subjects with a clinical indication of STEMI. 
 
 
INCLUSION CRITERIA 
Candidates will be included in the study only if all the following 
conditions are met:  
• 
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 
Candidates will be excluded from the study if any of the 
following conditions are present: 
• 
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
 
 
PRIMARY ENDPOINT 
Time from Catheterization Lab Arrival to Device Activation 
(CLADA) by CorPath GRX System.  
 
 
 
 
 
 
 

Procedure Title: TREAT GRX Study 
Protocol
Doc Number:  104-09062 
Revision:  A 
Page: 8 of 34 
 
Revision Date June 3, 2020 
This confidential document is the property of Corindus, Inc. and shall not be reproduced, distributed, disclosed, or used without 
the express written consent of Corindus, Inc 
 
 
 
SECONDARY ENDPOINTS 
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. 
 
First Medical Contact (FMC) to device activation time 
Time at which the patient was first evaluated by Emergency 
Medical System (EMS) or Emergency Department arrival to 
device activation. 
 
Access to device activation 
Time from initial sheath insertion to device activation. 
 
Access to wire time 
Defined as time measured from sheath insertion to crossing the 
lesion with the coronary guidewire. 
 
Overall procedure time 
Defined as the time measured from sheath insertion to removal 
of the last device used to treat the culprit lesion. 
 
Fluoroscopy time 
Total fluoroscopy time (min.) utilized during the procedure as 
recorded by the Imaging System. 
 
Patient radiation exposure  
DAP (dose-area-product) and AK (air kerma) as recorded 
during the procedure. 
 
Contrast fluid volume 
Total contrast volume (mL/cc) used during the procedure. 
 
Conversion to manual (Binary) 
Conversion from robotic technique to manual technique due to 
inability to successfully wire lesion or deliver first device. 
 
Technical success 
Completion of the PCI procedure entirely robotically or with 
partial manual assistance. 
 
 
 

Procedure Title: TREAT GRX Study 
Protocol
Doc Number:  104-09062 
Revision:  A 
Page: 9 of 34 
 
Revision Date June 3, 2020 
This confidential document is the property of Corindus, Inc. and shall not be reproduced, distributed, disclosed, or used without 
the express written consent of Corindus, Inc 
 
 
 
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.
 
 
STUDY SPONSOR 
Corindus, Inc. 
309 Waverley Oaks Road, Suite 105 
Waltham, MA 02452 USA 
 
 
MANUFACTURER 
Corindus, Inc. 
309 Waverley Oaks Road, Suite 105 
Waltham, MA 02452 USA
 
 
DATA COORDINATING  
CENTER 
MedNet Solutions, Inc. 
110 Cheshire Lane, Suite 300 
Minnetonka, MN 55305
 
 
MONITORING SERVICE 
Corindus, Inc. 
309 Waverley Oaks Road, Suite 105 
Waltham, MA 02452 USA
 
 
STATISTICAL ANALYSIS 
SERVICES 
TBD