Cardiac Cath Lab Staff Radiation Exposure During Chronic Total Occlusion PCI: CorPath GRX vs. Manual
Conditions: Coronary Artery Disease, Chronic Total Occlusion of Coronary Artery, Percutaneous Coronary Intervention
Sponsor: Corindus Inc.

Procedure Title: SAFE-T Study Protocol 
Doc Number:  104-08553 
Revision:  B 
Page: 7 of 29 
 
Revision Date February 8, 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 
 
 
 
SYNOPSIS 
 
STUDY TITLE 
Cardiac Cath Lab Staff Radiation Exposure During Chronic Total 
Occlusion PCI: CorPath®GRX vs. Manual 
SHORT TITLE 
SAFE-T Study 
PRINCIPAL 
INVESTIGATOR 
William Lombardi, MD (Acting) 
University of Washington 
Seattle, WA  
 
William Nicholson, MD (Emeritus) 
WellSpan York Hospital  
York, PA 
STUDY SPONSOR 
Corindus, Inc Waltham, MA USA 
RATIONALE 
The PRECISE pivotal trial showed that operators sitting at the CorPath’ s 
shielded cockpit had a median 92.5% reduction in radiation exposure when 
compared to published results.  To date there have been no direct 
randomized comparisons of patient safety and staff radiation exposure 
comparing robotic-assisted (CorPath GRX) CTO PCI to conventional 
manual CTO PCI. This study will be a randomized evaluation comparing 
patient outcomes and radiation exposure of Cardiac Catheterization 
Laboratory staff in similarly matched coronary CTO PCI procedures. 
REGULATORY 
STATUS 
The CorPath GRX System was granted 510(k) clearance (K160121) on 
October 27, 2016. 
FDA CLEARED 
INDICATION FOR USE 
The CorPath GRX 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 
The objective of this randomized safety and observational study is to 
demonstrate CorPath GRX CTO PCI is safe, and that Cardiac 
Catheterization Laboratory staff have no additional exposure to radiation 
when compared to conventional manual CTO PCI procedures without 
added procedure time. 
STUDY DESIGN 
This is prospective, dual-arm, randomized, multi-center, observational 
study comparing patient outcomes and staff radiation exposure in CTO PCI 
procedures through 48 hours post procedure or hospital discharge, 
whichever occurs first. 

Procedure Title: SAFE-T Study Protocol 
Doc Number:  104-08553 
Revision:  B 
Page: 8 of 29 
 
Revision Date February 8, 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 
 
 
 
SUBJECT 
POPULATION 
Subjects >18 years of age with symptoms suggestive of ischemic heart 
disease, with TIMI grade 0 flow and a lesion that is thought to be present 
for more than 3 months. 
NUMBER/LOCATION 
OF SITES 
This safety and observational study will be conducted at up to no less than 
three (3) centers. 
STUDY DURATION 
All subjects will be followed through 48 hours post CTO PCI procedure or 
hospital discharge, whichever occurs first. 
SAMPLE SIZE 
At least 90 CTO PCI procedures (45 CorPath GRX (robotic-assisted) / 45 
Manual) 
EFFECTIVENESS 
PERFORMANCE  
MEASURE 
Clinical Success  
Defined as successful CTO PCI revascularization with achievement of 
<30% residual diameter stenosis (visual estimate) within the treated 
segment and restoration of antegrade TIMI grade 3 flow, without in-
hospital major adverse events (MAE). 
SAFETY MEASURE 
In-hospital MAE 
MAE that occurs within 48 hours of the CTO PCI procedure or hospital 
discharge, whichever occurs first. 
OTHER  MEASURES 
Operator Radiation Exposure 
Cumulative dose the physician receives as recorded from electronic 
pocket dosimeter during procedure. 
Staff Radiation Exposure 
Cumulative dose the staff receives as recorded from electronic pocket 
dosimeter during procedure. 
Patient Radiation Exposure 
DAP (dose-area-product) and/or (AK) air kerma as recorded during the 
procedure  
Overall Procedure Time 
Defined as the time measured from the placement of the first guide catheter 
to last guide catheter removal.  
Manual Time 
Total amount of time away from the cockpit. 
Actual Time at Cockpit 
Defined as the time the physician operator spends in the robotic cockpit 
from first entering the cockpit to procedure end time (guide catheter 
removal). 
Fluoroscopy Time 
Total fluoroscopy (min.) utilized during the procedure as recorded by an 
Imaging System. 
Contrast Fluid Volume 
Total contrast (mL) used during the procedure. 

Procedure Title: SAFE-T Study Protocol 
Doc Number:  104-08553 
Revision:  B 
Page: 9 of 29 
 
Revision Date February 8, 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 
 
 
 
INCLUSION CRITERIA 
For a CTO PCI procedure to qualify for this study, the procedure must meet 
the following inclusion criteria:  
1. Age ≥ 18 years; 
2. One (1) CTO lesion, successfully crossed with conventional manual 
techniques; 
3. The Investigator deems the procedure appropriate for robotic-assisted 
CTO PCI with the CorPath GRX System; 
4. Individual monitoring of radiation dose, using the pocket dosimeter, 
was initiated at start of procedure; 
5. The subject has been informed of the nature of the study, agrees to its 
provisions and has provided written informed consent. 
EXCLUSION 
CRITERIA 
If any of the following criteria are met, the procedure cannot be included in 
this study: 
1. Failure/inability/unwillingness to provide informed consent, or 
2. Cardiogenic Shock; or 
3. Perforation which requires treatment (e.g. covered stent, coil and other 
embolization techniques, or pericardiocentesis). 
4. More than one lesion (CTO or non-CTO) to be treated. 
RANDOMIZATION 
The randomization scheme will utilize random block sizes of 4 or 6. Once 
the investigator has determined that the procedure is eligible based on 
inclusion/exclusion criteria, the procedure will be randomized in a 1:1 
fashion to either CorPath GRX robotic-assisted CTO PCI or conventional 
manual CTO PCI. To randomize the procedure, a member of the study staff 
will select the next sequential number from the electronic data capture 
(EDC) system and declare the procedure’s assignment. The assignment will 
be logged in the EDC. 
INVESTIGATIONAL 
DEVICE  
N/A: CorPath GRX will be used with accordance to the indication cleared 
by FDA.