A Post-Market Registry for the Evaluation of the CorPath® GRX System Effectiveness in Peripheral Vascular Interventions
Conditions: Peripheral Arterial Disease, Peripheral Vascular Diseases, Renal Artery Disease, Carotid Artery Diseases
Sponsor: Corindus Inc.

 
 
Version Date: July28, 2020 
This confidential document is the property of Corindus, Inc. and shall not be reproduced, distributed, disclosed or used without the express writ- 
ten consent of Corindus, Inc 
Procedure Title: ACHIEVE GRX Registry 
Doc Number:  104-09200 
Revision:  A 
Page: 5 of 43 
ACHIEVE GRX Registry Summary 
 
TITLE 
A Post-Market Registry for the Evaluation of the CorPath® 
GRX System Effectiveness in Peripheral Vascular Interven-
tions 
 
 
SHORT TITLE: 
ACHIEVE GRX Registry 
 
 
DEVICE 
CorPath GRX System: 
• 
The Bedside Components consist of an Extended 
Reach Arm, Robotic Drive and Single-use Cassette  
• 
Interventional Cockpit  
• 
Control Console 
 
 
REGULATORY STATUS 
The CorPath GRX was granted 510K clearance (K173288) for 
use in peripheral interventions on February 15, 2018, and was 
CE Marked effective March 07, 2018 (CE 549879). 
 
 
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 
To collect data on the routine patterns of use, safety and effec-
tiveness, including the clinical and technical performance of 
the CorPath GRX System, in the delivery and manipulation of 
guidewires and rapid exchange catheters and manipulation of 
guide catheters during peripheral vascular intervention (PVI) 
procedures.  
 
 
STUDY DESIGN 
This is a prospective, single-arm, open-label, multi-center pa-
tient registry of the CorPath GRX System to examine its per-
formance during peripheral vascular interventions and patient 
outcomes through 24 hours post-procedure or hospital dis-
charge, whichever occurs first.   
 
 
CO-PRINCIPAL  
INVESTIGATORS 
Dr. Jon George  
Einstein Medical Center 
5501 Old York Road 
Philadelphia, PA 19141 
 
Dr. John Phillips 
Riverside Methodist Hospital 
3705 Olentangy River Rd, Suite 100 
Columbus, OH 43214 
 
 
SAMPLE SIZE 
It is expected that up to 200 subjects shall be enrolled in the 
study. 
 
 

 
 
Version Date: July28, 2020 
This confidential document is the property of Corindus, Inc. and shall not be reproduced, distributed, disclosed or used without the express writ- 
ten consent of Corindus, Inc 
Procedure Title: ACHIEVE GRX Registry 
Doc Number:  104-09200 
Revision:  A 
Page: 6 of 43 
EVALUATION PERIOD 
Estimated date of first patient enrolled: October 2020 
Anticipated enrollment period: 24 months 
Estimated date of last patient enrolled: October 2022 
INVESTIGATIONAL 
SITES 
It is expected that up to 10 centers (USA and International) 
may participate in this study. 
 
STUDY DURATION/  
FOLLOW-UP PERIOD 
All subjects will be followed post-CorPath percutaneous vascu-
lar intervention through 24 hours post-procedure or hospital 
discharge, whichever occurs first. 
 
SUBJECT  
POPULATION 
Subjects with a clinical indication for Peripheral Vascular Inter-
vention (PVI).   
 
 
PATIENT GENERAL IN-
CLUSION CRITERIA 
 
Candidates will be included in the study only if all the following 
conditions are met:  
1. Age ≥ 18 years. 
2. Subject has a clinical indication for Peripheral Vascular 
Intervention (PVI). 
3. Subject is deemed appropriate for robotic-assisted PVI. 
4. The subject has been informed of the nature of the 
study, agrees to its provisions and has provided written 
informed consent. 
5. Individual monitoring of radiation dose, using the 
pocket dosimeter, was initiated at start of procedure.  
 
PATIENT GENERAL EX-
CLUSION CRITERIA 
Candidates will be excluded from the study if any of the follow-
ing conditions are present: 
1. Failure/inability/unwillingness to provide informed con-
sent. 
2. The investigator determines the subject or the periph-
eral anatomy is not suitable for robotic-assisted PVI. 
3. Women who are pregnant. 
 
STAFF GENERAL IN-
CLUSION CRITERIA 
Staff members may participate in the study only if all the fol-
lowing conditions are met:  
1. Interventional lab staff, including the operating physi-
cian, secondary operator, and, if applicable, ancillary 
staff (technician and nurse). 
2. Interventional lab staff member has been informed of 
the nature of the study, agrees to its provisions, and 
has provided written informed consent. 
 
STAFF GENERAL EX-
CLUSION CRITERIA 
Staff members will be excluded from the study if any of the fol-
lowing conditions are present: 
 

 
 
Version Date: July28, 2020 
This confidential document is the property of Corindus, Inc. and shall not be reproduced, distributed, disclosed or used without the express writ- 
ten consent of Corindus, Inc 
Procedure Title: ACHIEVE GRX Registry 
Doc Number:  104-09200 
Revision:  A 
Page: 7 of 43 
1. Failure/inability/unwillingness to provide informed con-
sent 
2. Interventional lab staff members who are undergoing 
medical treatment involving additional radiation expo-
sure. 
3. Interventional lab staff members who have exceeded 
their hospital defined dose limits for radiation anytime 
during their participation in the study. 
 
PRIMARY  
EFFECTIVENESS END-
POINT  
Technical Success 
The primary effectiveness endpoint will be defined as suc-
cessful completion of the robotic-assisted endovascular proce-
dure absent any unplanned conversion to manual for guide-
wire or balloon/stent catheter inability to navigate vessel anat-
omy. 
 
Clinical Success 
Defined as <30% residual stenosis in all CorPath GRX Sys-
tem treated lesions at the completion of the interventional pro-
cedure in the absence of device-related serious adverse 
events (SAE), either within twenty-four (24) hours of the pro-
cedure or prior to hospital discharge, whichever occurs first. 
 
 
 
PRIMARY  
SAFETY  
ENDPOINT 
 
 
 
The primary safety endpoint will be a composite of intra- and 
peri-procedural events, including target vessel rupture, clini-
cally significant perforation or dissection, and distal emboliza-
tion, within 24-hours post-procedure or hospital discharge, 
whichever occurs first. 
SECONDARY  
ENDPOINTS 
PVI Procedure Time 
Defined as the time measured from the insertion of the guiding 
sheath until the removal of the guiding sheath. 
 
Manual time 
Defined as the total amount of time the procedure is completed 
using a manual technique. 
 
Robotic Time 
Defined as the total amount of time the procedure is com-
pleted robotically from the robotic cockpit. 
 
Fluoroscopy Time  
Total fluoroscopy utilized during the procedure as recorded by 
an Imaging System. 
 
 
 

 
 
Version Date: July28, 2020 
This confidential document is the property of Corindus, Inc. and shall not be reproduced, distributed, disclosed or used without the express writ- 
ten consent of Corindus, Inc 
Procedure Title: ACHIEVE GRX Registry 
Doc Number:  104-09200 
Revision:  A 
Page: 8 of 43 
Operator Radiation Exposure 
Cumulative dose the operator receives as recorded from an 
electronic pocket dosimeter during the procedure. 
 
Staff Radiation Exposure 
Cumulative dose the staff receives as recorded from an elec-
tronic pocket dosimeter during the procedure. 
 
Patient Radiation Exposure 
DAP (dose-area-product) and AK (air kerma) as recorded dur-
ing the procedure. 
 
Contrast Fluid Volume 
Total volume of contrast (mL) used during the procedure. 
 
 
 
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 
 
 
MONITORING  
SERVICE 
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 USA 
 
 
STATISTICAL  
ANALYSIS  
SERVICES 
Technomics Research 
1815 Medina Road 
Long Lake, MN 55356 USA