An Evaluation of Effectiveness and Safety of the CorPath® GRX System in Endovascular Embolization Procedures of Cerebral Aneurysms
Phase: NA
Conditions: Intracranial Aneurysm, Subarachnoid Hemorrhage, Headache
Sponsor: Corindus Inc.

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ten consent of Corindus, Inc 
                   
 
Procedure Title: CorPath GRX Neuro Study 
Protocol 
Doc Number: 104-08660 
Revision: I 
Page: 1 of 69 
 
 
 
 
 
 
 
 
CorPath® GRX Neuro Study Protocol 
 
An Evaluation of Effectiveness and Safety of the CorPath® GRX System in 
Endovascular Embolization Procedures of Cerebral Aneurysms 
 
 
Clinical Protocol Number: 104-08660 
 
 
Sponsored by: 
Corindus, Inc. 
309 Waverley Oaks Road, Suite 105, 
Waltham, MA 02452 
USA 
 
 
Rev. I  
 
 

Version Date: May 21, 2021 
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: CorPath GRX Neuro Study 
Protocol 
Doc Number: 104-08660 
Revision: I 
Page: 2 of 69 
 
Table of Contents  
 
PROTOCOL SIGNATURE PAGE FOR PRINCIPAL INVESTIGATOR ............................................................................................. 5 
CORPATH GRX NEURO STUDY SUMMARY ........................................................................................................................... 6 
SCHEDULE OF ACTIVITIES................................................................................................................................................... 11 
1. 
INTRODUCTION ......................................................................................................................................................... 12 
1.1 
DEVICE NAME ....................................................................................................................................................... 12 
1.2 
BACKGROUND ...................................................................................................................................................... 12 
2. 
INTENDED USE & DEVICE DESCRIPTION..................................................................................................................... 15 
2.1 
INTENDED USE ...................................................................................................................................................... 15 
2.2 
DEVICE DESCRIPTION AND MODE OF OPERATION ................................................................................................ 16 
2.2.1 
BEDSIDE UNIT ....................................................................................................................................................... 16 
2.2.2 
INTERVENTIONAL COCKPIT ................................................................................................................................... 16 
2.2.3 
CONTROL CONSOLE .............................................................................................................................................. 17 
2.2.4 
DEVICE ACCOUNTABILITY ...................................................................................................................................... 17 
3. 
OBJECTIVES & ENDPOINTS ........................................................................................................................................ 18 
3.1 
STUDY OBJECTIVE ................................................................................................................................................. 18 
3.2 
PRIMARY EFFECTIVENESS ENDPOINT .................................................................................................................... 18 
3.3 
PRIMARY SAFETY ENDPOINT ................................................................................................................................. 18 
3.4 
SECONDARY ENDPOINTS....................................................................................................................................... 18 
4. 
INVESTIGATIONAL PLAN ........................................................................................................................................... 19 
4.1 
OVERVIEW OF TRIAL DESIGN ................................................................................................................................ 19 
4.2 
ROLL-IN SUBJECTS ................................................................................................................................................. 20 
4.3 
ENROLLMENT PLANS............................................................................................................................................. 20 
4.4 
INFORMED CONSENT PROCEDURES ...................................................................................................................... 20 
4.5 
SCREEN FAILURE ................................................................................................................................................... 21 
4.6 
PATIENT SELECTION .............................................................................................................................................. 22 
4.6.1 
INCLUSION CRITERIA ............................................................................................................................................. 22 
4.6.2 
EXCLUSION CRITERIA ............................................................................................................................................ 22 
4.6.3 
ELIGIBILITY COMMITTEE ....................................................................................................................................... 22 
4.7 
SUBJECT WITHDRAWAL AND REPLACEMENT ........................................................................................................ 23 
4.8 
DATA TO BE COLLECTED ........................................................................................................................................ 24 

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Procedure Title: CorPath GRX Neuro Study 
Protocol 
Doc Number: 104-08660 
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4.8.1 
PERI-PROCEDURAL STUDY MEDICATION REGIME ................................................................................................. 24 
4.8.2 
BASELINE DATE ..................................................................................................................................................... 24 
4.8.3 
DATA COLLECTION PRIOR TO INITIATING CORPATH PROCEDURE ......................................................................... 25 
4.8.4 
DATA COLLECTION DURING CORPATH PROCEDURE .............................................................................................. 25 
4.8.5 
CORPATH GRX ENDOVASCULAR PROCEDURE WORKFLOW ................................................................................... 25 
4.8.6 
SPECIFY DEVICE TO BE USED ROBOTICALLY ........................................................................................................... 27 
4.8.7 
CONVERSION TO MANUAL PROCEDURE DATA COLLECTION ................................................................................. 27 
4.8.8 
DEVICE MALFUNCTION DATA COLLECTION ........................................................................................................... 27 
4.8.9 
POST-CORPATH DATA COLLECTION....................................................................................................................... 28 
4.8.10 
FOLLOW-UP EVALUATIONS ............................................................................................................................... 29 
4.8.11 
SCHEDULE OF DATA COLLECTION ...................................................................................................................... 29 
TABLE 1: SCHEDULE OF ACTIVITIES ................................................................................................................................................. 30 
5. 
ADVERSE EVENTS AND COMPLICATIONS ................................................................................................................... 31 
5.1 
ADVERSE EVENT CLASSIFICATION AND DEFINITIONS ............................................................................................ 31 
5.2 
ADVERSE EVENT ASSESSMENTS ............................................................................................................................ 32 
5.3 
PROCEDURE-RELATED ADVERSE EVENT ................................................................................................................ 33 
5.4 
DEVICE-RELATED ADVERSE EVENT ........................................................................................................................ 33 
5.5 
EVENT REPORTING REQUIREMENTS ..................................................................................................................... 33 
5.6 
ANTICIPATED ADVERSE EVENTS ............................................................................................................................ 34 
5.7 
SUBJECT DEATH .................................................................................................................................................... 35 
5.8 
SURVEILLANCE COMMITTEE ................................................................................................................................. 36 
6. 
STATISTICAL CONSIDERATIONS AND ANALYSIS ......................................................................................................... 37 
6.1 
ANALYSIS OF PRIMARY EFFECTIVENESS ENDPOINT ............................................................................................... 37 
6.2 
ANALYSIS OF PRIMARY SAFETY ENDPOINT ........................................................................................................... 37 
6.3 
ANALYSIS OF SECONDARY ENDPOINTS ................................................................................................................. 37 
6.4 
DETERMINATION OF HISTORICAL CONTROLS ........................................................................................................ 38 
TABLE 2. RATES OF SAFETY FROM LITERATURE FOR ENDOVASCULAR TREATMENT OF UNRUPTURED AND RUPTURED ANEURYSMS. ...................... 38 
TABLE 3A-3C. RATES PRESENTED POOLED RESULTS FROM BOTH ARMS FROM THREE (3) FROM RANDOMIZED CONTROL TRIALS. ........................ 40 
TABLE 4. SUMMARY OF CONVERSION TO MANUAL BY CORINDUS CORPATH DEVICE IN PERCUTANEOUS CORONARY INTERVENTIONS. ................. 41 
TABLE 5. SAFETY AND EFFECTIVENESS DATA 180-DAY RATES PRESENTED. .............................................................................................. 41 
6.5 
PRIMARY ANALYSIS .............................................................................................................................................. 43 
6.6 
SAMPLE SIZE CALCULATION .................................................................................................................................. 43 
6.7 
ENDPOINT ANALYSIS AND REPORTING ................................................................................................................. 44 
6.8 
ANALYSIS OF BASELINE DEMOGRAPHICS AND PROCEDURAL CHARACTERISTICS .................................................. 44 

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Procedure Title: CorPath GRX Neuro Study 
Protocol 
Doc Number: 104-08660 
Revision: I 
Page: 4 of 69 
6.9 
HANDLING OF MISSING DATA ............................................................................................................................... 45 
7. 
DATA COLLECTION .................................................................................................................................................... 45 
7.1 
STUDY DATA REQUIREMENTS ............................................................................................................................... 45 
7.2 
DATA PROCESSING & QUALITY CONTROL ............................................................................................................. 45 
7.3 
DATA CLEANING ................................................................................................................................................... 45 
7.4 
DATA ENTRY ......................................................................................................................................................... 46 
7.5 
FINAL DATA ANALYSES .......................................................................................................................................... 46 
7.6 
CONFIDENTIALITY AND PROTECTION OF STUDY FILES ........................................................................................... 46 
7.7 
SOURCE DOCUMENTS ........................................................................................................................................... 47 
7.8 
RECORD RETENTION ............................................................................................................................................. 48 
8. 
MONITORING PROCEDURES AND AUDITING ............................................................................................................. 48 
8.1 
STUDY MONITORING PLAN ................................................................................................................................... 49 
8.2 
MONITORING RESPONSIBILITIES ........................................................................................................................... 50 
8.3 
PROTOCOL DEVIATIONS ........................................................................................................................................ 51 
8.4 
PROTOCOL CHANGES ............................................................................................................................................ 51 
8.5 
AUDITING AND REGULATORY INSPECTIONS ......................................................................................................... 51 
9. 
DATA QUALITY ASSURANCE ...................................................................................................................................... 52 
9.1 
ADVERSE EVENT HANDLING .................................................................................................................................. 52 
9.2 
STUDY ENDPOINT EVENT ADJUDICATION ............................................................................................................. 52 
10. 
SITE AND INVESTIGATOR SYSTEM TRAINING ........................................................................................................ 52 
10.1 
SITE TRAINING ...................................................................................................................................................... 53 
10.2 
INVESTIGATOR TRAINING ..................................................................................................................................... 53 
11. 
ADMINISTRATIVE RESPONSIBILITIES ..................................................................................................................... 53 
11.1 
ETHICAL CONSIDERATIONS ................................................................................................................................... 53 
11.2 
CONFIDENTIALITY ................................................................................................................................................. 54 
11.3 
STUDY REGISTRATION AND PUBLICATION ............................................................................................................ 54 
11.4 
ANGIOGRAPHIC CORE LAB .................................................................................................................................... 55 
12. 
FUNDING .............................................................................................................................................................. 55 
13. 
DEFINITIONS ......................................................................................................................................................... 56 
14. 
STUDY ADMINISTRATIVE STRUCTURE ................................................................................................................... 57 
15. 
REFERENCES .......................................................................................................................................................... 58 
APPENDIX A 
INVESTIGATORS, SITES AND ADMINISTRATIVE STRUCTURE ..................................................................... 61 
APPENDIX B 
REVISION HISTORY ................................................................................................................................... 64 

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Procedure Title: CorPath GRX Neuro Study 
Protocol 
Doc Number: 104-08660 
Revision: I 
Page: 5 of 69 
 
PROTOCOL SIGNATURE PAGE FOR PRINCIPAL INVESTIGATOR 
 
 
I agree to perform and conduct the clinical investigation as described in the protocol and in 
accordance with the relevant parts of the International Conference on Harmonization (ICH) Guide- 
lines for GCP, ISO 14155:2020(E), the Medical Device Regulation (2017/745) of 5 April, 2017, 
the Declaration of Helsinki, and the pertinent individual country laws/regulations. In addition, I 
agree to provide all the information requested in the case report forms presented to me by the 
Sponsor in a manner to ensure completeness, legibility, and accuracy. I agree to actively enroll 
subjects into this clinical investigation. 
 
I also agree that all information provided to me by the Sponsor, including pre-clinical data, proto- 
cols, case report forms, and any verbal and written information, will be kept strictly confidential 
and confined to the clinical personnel involved in conducting the clinical investigation. It is 
recognized that this information may be relayed in confidence to the Institutional Review 
Board/Ethics Committee and the Competent Authority. 
 
In addition, no reports or information about the clinical investigation or its progress will be provided 
to anyone not involved in the clinical investigation other than the Sponsor, the Institutional Review 
Board/Ethics Committee, and the Competent Authority. Any such submission will indicate that the 
material is confidential. 
 
 
 
 
 
Site Principal Investigator Name (print) 
 
 
 
 
 
Site Principal Investigator Signature 
Date 

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Procedure Title: CorPath GRX Neuro Study 
Protocol 
Doc Number: 104-08660 
Revision: I 
Page: 6 of 69 
 
CORPATH GRX NEURO STUDY SUMMARY 
 
TITLE 
An Evaluation of Effectiveness and Safety of the CorPath® GRX  
System in Endovascular Embolization Procedures of Cerebral  
Aneurysms 
SHORT TITLE 
CorPath GRX Neuro Study 
DEVICE 
CorPath GRX System: 
• 
Bedside Unit consists of the Extended Reach Arm, Robotic 
Drive and single-use Cassette. 
• 
Interventional cock pit 
• 
Control console 
REGULATORY STATUS 
The CorPath GRX System is CE Marked effective March 27, 2019 
(CE 549879). 
INDICATION FOR USE 
The CorPath GRX System is intended for use in the remote delivery 
and manipulation of devices during percutaneous coronary and 
vascular procedures, including the following commercial devices: 
• Guidewires 
• Rapid Exchange Catheters 
• Guide Catheters 
• Microcatheters 
• Embolization Coils 
• Coil Assist Stents 
STUDY OBJECTIVE 
The primary objective of this study is to evaluate the effectiveness and 
safety of robotic-assisted endovascular embolization procedures 
compared to objective performance criteria for traditional, manual 
operation based on the scientific literature. 
STUDY DESIGN 
This is a prospective, single-arm, international, multi- center, non-
inferiority study to evaluate the effectiveness and safety of the CorPath 
GRX System for endovascular cerebral aneurysm embolization 
compared to historical controls. Subject selection requires a clinical 
indication for endovascular coil and/or stent-assist coiling embolization 
of cerebral aneurysms. 
STUDY COORDINATING 
PRINCIPAL 
INVESTIGATOR 
Dr. Michel Piotin 
Service de Neuroradiologie Interventionnelle 
Hôpital de la Fondation Rothschild 
25-29 rue Manin 
F - 75940 Paris, France 

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Procedure Title: CorPath GRX Neuro Study 
Protocol 
Doc Number: 104-08660 
Revision: I 
Page: 7 of 69 
SAMPLE SIZE 
Up to 120 subjects will be enrolled in order to achieve at least 108 
subjects in the study; each site will try to recruit a maximum of 20 
subjects. If a site has the possibility to enroll more than 20 subjects, a 
written authorization will be required from the sponsor, Corindus, Inc.  
INVESTIGATIONAL SITES 
A maximum of up to 20 international sites may participate in this study.
This will depend on each active site’s recruitment rate and the possible 
travel restrictions due to the Covid-19 pandemic. 
STUDY DURATION/ 
FOLLOW-UP PERIOD 
The recruitment phase is 18 months, follow-up is 180-days, and total 
study duration is 24 months. All subjects will be followed post-
CorPath GRX endovascular embolization procedure through 180-
days. 
SUBJECT POPULATION: 
Subjects with a clinical indication for endovascular coil and/or stent- 
assisted coiling embolization of cerebral aneurysms. 
INCLUSION CRITERIA 
Candidates will be included in the study only if all the following  
conditions are met: 
 
1. Age ≥ 18 years. 
2. At least one cerebral aneurysm (unruptured) with indication 
for endovascular treatment; dome to neck ratio >1.5 or 
aneurysm neck width >4.0 mm. 
3. The Investigator deems the procedure appropriate for both 
manual or robotic-assisted endovascular treatment. 
4. The conscious subject has been informed of the nature of the 
study, agrees to its provisions and has provided written 
informed consent. 
EXCLUSION CRITERIA 
 
Candidates will be excluded from the study if any of the following 
conditions are present: 
1. Failure / unwillingness of the subject to provide informed
consent. 
2. The 
Investigator 
determines 
that 
the 
subject 
or 
the
neurovascular anatomy is not suitable for robotic-assisted 
endovascular treatment. 
3. Women who are pregnant.  
4. Persons under guardianship or curatorship. 

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Procedure Title: CorPath GRX Neuro Study 
Protocol 
Doc Number: 104-08660 
Revision: I 
Page: 8 of 69 
ELIGIBILITY 
COMMITTEE 
 
 
PRIMARY EFFECTIVE- 
NESS ENDPOINT 
The Eligibility Committee will be responsible for the evaluation of 
CorPath GRX Neuro subjects for participation in the study. In 
advance of all study subject enrollment and treatment, the 
committee will use subject clinical history, Unruptured Intracranial 
Aneurysm Treatment Score (UIATS) data, the treatment plan, and 
at least 4 angiographic (DSA or CTA/MRA) images to approve for 
inclusion into the study or exclude and defer treatment of the 
cerebral aneurysm with the CorPath GRX Robotic system. 
 
The primary effectiveness endpoint will be defined as successful 
completion of the robotic-assisted endovascular procedure absent 
any unplanned conversion to manual for guidewire or microcatheter 
navigation, embolization coil(s) or intracranial stent(s) deployment, 
or an inability to navigate vessel anatomy. 
PRIMARY SAFETY 
END- POINT 
The primary safety endpoint will be a composite of intra- and peri-
procedural events, defined as vascular injury including intra-
procedural aneurysm rupture caused by robotically controlled 
catheters, wires, or devices and thromboembolic events with 
neurological decline (NIHSS score change ≥ 4)  within 24-hours 
post- procedure or hospital discharge, whichever occurs first. 
 
 
SECONDARY END- 
POINTS 
 
Clinical Outcome 
Clinical outcome as measured by Modified Rankin Scale. This 
is assessed at the 90-Day Follow-Up (± 14 days) and at the 180-
Day Follow-Up (± 30 days from the procedure date); 
Robotically Navigate Device to the Target Aneurysm 
Defined as successful advancement of device to the target 
aneurysm robotically; 
Robotically Navigate Device into the Target Aneurysm 
Defined as successful navigation of device into the target 
aneurysm robotically; 
Robotically Deploy Therapeutic Device into the Target 
Aneurysm Defined as successful deployment of therapeutic 
device into the tar- get aneurysm robotically; 
Overall Procedure Time 
Defined as the time measured from the insertion of the 
access 
sheath/catheter 
until 
the 
removal 
of 
the 
microcatheter; 
 
 

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Procedure Title: CorPath GRX Neuro Study 
Protocol 
Doc Number: 104-08660 
Revision: I 
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Robotic Procedure Time 
Defined as the time measured from the first device used 
robotically until the removal of the microcatheter; 
Fluoroscopy Time 
Total fluoroscopy utilized during the procedure as recorded by 
the Imaging System; 
Patient Radiation Exposure 
DAP (dose-area-product) and CD/AK (cumulative dose/air 
kerma) as recorded during the procedure; 
Contrast Volume 
Total contrast used during the procedure; 
Adverse Events 
All adverse events (AEs) from the start of the CorPath GRX 
procedure until the end of the study will be summarized; 
Thromboembolic Events 
Defined as rate of thromboembolic events occurring up to 180-
days following the robotic-assisted procedure. 
Devices Used Robotically 
All devices used will be recorded as successful or unsuccessful 
in conjunction with the CorPath GRX System; 
Aneurysm Occlusion 
Angiographic assessment of aneurysm occlusion grade 
according to the Raymond-Roy classification scale, parent-
vessel compromise, and occlusion durability as assessed from 
an independent core laboratory. This will be assessed post-
procedure and at a 180-day follow-up. 
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 

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Procedure Title: CorPath GRX Neuro Study 
Protocol 
Doc Number: 104-08660 
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MONITORING 
SERVICE 
 
Corindus, Inc. 
309 Waverley Oaks Road, Suite 105 
Waltham, MA 02452 USA 
 
Alan Cohen (Europe)  
Cohen’s Clinical Consultants 
Paul Parmentierlaan 180/01 
B – 8300 Knokke, Belgium 
 
Tracey Edinburg (Australia Manager Director)  
ReSQ Clinical Research 
2/40 Hardy St. 
Dover Heights, NSW, Australia 2030 
DATA 
COORDINATING & 
MONITORING 
CENTER 
MedNet Solutions, Inc. 
110 Cheshire Lane, Suite 300 
Minnetonka, MN 55305 USA 
ANGIOGRAPHIC CORE 
LABORATORY 
David S Liebeskind, MD 
Neurovascular Imaging Research Core 
UCLA Department of Neurology 
Las Angeles, CA 90095 USA 
STATISTICAL 
ANALYSIS SERVICES 
Technomics Research  
1815 Medina Rd. 
Long Lake, MN 55356 USA 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Procedure Title: CorPath GRX Neuro Study 
Protocol 
Doc Number: 104-08660 
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SCHEDULE OF ACTIVITIES 
Pre-
Procedure Procedure 
 
Post- 
Procedure 
90-day7 
BY 
PHONE 
180-day 
Un- 
Scheduled 
Visit 
 
Day (0) 
(24-hours post-
procedure or 
hospital 
discharge) 
±14-
days 
±30-
days 
 
Patient Eligibility Criteria 
X 
 
 
 
 
 
Submit to Eligibility Committee  
• 
Clinical history 
• 
Unruptured Intracranial Aneurysm 
Treatment Score 
• 
Treatment plan  
• 
≥ 4 angiographic (DSA or CTA/MRA) 
images 
X 
 
 
 
 
 
Medical History 
X1 
 
 
 
 
 
Digital Subtraction Angiography (DSA), 
Computed Tomography Angiography 
(CTA), or Magnetic Resonance 
Angiography (MRA)/Magnetic Resonance 
Imaging (MRI) of the brain/head 
X1 
 
 
 
X7 
 
Clinical assessment & Physical 
exam including: 
• 
Modified Rankin Scale (mRS) 
• 
National Institutes of Health 
Stroke Scale (NIHSS) scale 
X 
 
X 
X6 
X8 
X9 
Raymond Grade-Roy Occlusion 
Classification Scale 
X3 
X 
 
 
X 
 
Laboratory Tests: hemoglobin, hematocrit, 
activated partial thromboplastin time, platelet 
count, international normalized ratio, 
pregnancy test, serum creatinine and 
glomerular filtration rate. 
X1,2,4 
 
X2 
 
 
 
Procedure Parameters  
 
X 
 
 
 
 
Catheter Angiography 
 
X5 
 
 
 
 
Contrast volume 
 
X 
 
 
 
 
Record of AEs 
 
X 
X 
X 
X 
X 
Data for aneurysm assessment e.g. 
tortuosity, proximal & distal vessel diameter, 
target aneurysm measurements. 
 
X 
 
 
X 
 
1 Within 7 days of index procedure. 
2 If performed under standard hospital procedure. 
3 For previously coiled aneurysms. 
4 Female subjects of child-bearing potential must have negative pregnancy test (urine or serum). 
5 Includes angiograms in the anterior posterior, lateral and working positions for analysis by a core laboratory. 
6 Telephone assessment and mRS is required. Other post procedure clinical assessment (scales/scores/grades) is left to the 
discretion of the investigator and shall be dictated by the patient’s clinical symptoms. 
7 Post scans will be sent to the core laboratory for analysis. 
8 mRS is required. Other post procedure clinical assessment (scales/scores/grades) is left to the discretion of the investigator and 
shall be dictated by the patient’s clinical symptoms. 
9 If visit is related to target aneurysm or potentially associated AE/SAE 

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Procedure Title: CorPath GRX Neuro Study 
Protocol 
Doc Number: 104-08660 
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1. 
INTRODUCTION 
1.1 
Device Name 
CorPath® GRX System 
 
1.2 
Background 
Subarachnoid hemorrhage is a life-threatening form of stroke with an estimated fatality rate be- 
tween 26 and 36%.1–3  In approximately 80% of cases, subarachnoid hemorrhage is caused by 
the rupture of an intracranial saccular aneurysm.1  Aneurysms occur when structural abnormalities 
in the walls of the cerebral arteries cause weakening, thinning, and out-pouching of the vessel 
wall. They are frequently located at bifurcations within the proximal circle of Willis and 
approximately 20-50% of such aneurysms eventually rupture. While the incidence of 
subarachnoid hemorrhage varies widely from country to country and may be as high as 15 to 20 
per 100,000 in Finland and Japan, its overall worldwide incidence is estimated to be 9.1 per 
100,000 persons.4  As many as 30,000 Americans are affected per year.1–3,5–7 
 
Patients who survive subarachnoid hemorrhage long enough to be stabilized medically may  
experience cerebral vasospasm, delayed cerebral ischemia, hydrocephalus, deep venous 
thrombosis, and numerous medical sequelae, along with long-lasting neuropsychological 
changes, loss of productive years, and diminished quality of life.1–3,6–8  They are also at serious 
risk of re-rupture, and therefore it is usually appropriate for them to undergo treatment to minimize 
aneurysmal recurrence or re-rupture. 
Meanwhile, it has been estimated that the remaining 50% to 80% of intracranial aneurysms pre- 
sent in the general population never rupture.9,10 The prevalence of unruptured intracranial 
aneurysms (UIA) in the general adult population has been estimated at between 1% and 5%, 
based on autopsy studies.10 Many are asymptomatic and detected only as incidental findings 
during cerebral imaging for other conditions. Others may cause headaches, seizures, cranial 
nerve palsies, focal neurologic deficits, and distal embolic ischemic events.11 
Due to the severe consequences of aneurysmal rupture, once a UIA is detected, a decision must 
be made between managing the patient conservatively or treating the aneurysm to prevent future 
rupture. While current clinical evidence favors treatment for ruptured aneurysms,3,7  the 

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Procedure Title: CorPath GRX Neuro Study 
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decision to intervene for UIA is less straightforward 12,13  and must balance the risk-benefit profile 
of the available interventions against the risks and benefits of watchful waiting.9,10,14–17 
Whether to prevent primary rupture of a UIA or re-rupture following a subarachnoid hemorrhage 
event, the principal treatment options are open surgical clipping or endovascular coiling.3,7,8,10,13 
Surgical clipping involves a craniotomy, through which the aneurysmal sac is closed mechanically 
by placing a titanium clip over the neck. Endovascular coiling is achieved percutaneously by 
threading a catheter from the femoral artery, accessed at a site in the groin, up through the arterial 
circulation to the neck of the aneurysm. Using the catheter as a guide, a smaller microcatheter is 
then advanced through the guide catheter to the target aneurysm. After placement of the 
microcatheter, a metal wire is inserted into the microcatheter and advanced up to and into the 
aneurysmal sac, where the wire is gently pushed forward, causing it to coil around itself until it 
fills the volume of the sac. The presence of the metal coil induces thrombosis, occluding the 
aneurysm and preventing turbulent or high-pressure blood flow that is the precursor to 
thrombogenesis or rupture. 
Available evidence is not sufficient to definitively favor one technique over the other, but some 
randomized clinical trials have suggested that surgical clipping is effective and durable, while 
minimally invasive endovascular approaches result in better functional outcomes after 1 year.18,19 
Presumably this difference is a result of the higher overall risks of open surgery com- pared to 
minimally invasive procedures. Nonetheless, the pace of adoption of percutaneous aneurysm 
coiling and other neuro-endovascular techniques continues to accelerate, and therefore there is 
advantage to the continuous development of technical measures that can improve their safety. 
The risks of endovascular approaches generally fall into categories similar to those observed in 
percutaneous coronary and peripheral vascular intervention (PCI and PVI) and include 
intraprocedural rupture, arterial dissection, pseudoaneurysm, thromboembolism, occlusion of 
parent arteries, and groin hematomas and infections.10,14–16,20–25 Patients can also experience 
adverse reactions to the contrast material necessary for visualization of the procedure under 
fluoroscopy. 

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Procedure Title: CorPath GRX Neuro Study 
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As a radiation-dependent imaging technique, fluoroscopic navigation further poses occupational 
risks to the clinical staff performing the procedure. Data from studies on healthcare professionals 
working in cardiac catheterization labs have suggested that long-term exposure to low-dose 
ionizing radiation is linked to elevated risk of cataracts, skin lesions, thyroid disease, premature 
vascular aging, and cancer compared to healthcare professionals not routinely exposed to 
occupational fluoroscopy.26–28  Furthermore, the protective clothing worn to shield interventionalists 
from fluoroscopy is bulky, heavy, and puts the clinical staff at non-trivial risk of ergonomic strain 
and orthopedic injury.26 
The advent of the CorPath GRX Robotic System for PCI and later for PVI has begun to address 
some of the limitations of endovascular intervention.29–37 
The CorPath GRX system translates the manual movements of the interventionalist into 
precision micromovements during navigation and facilitates precision measurement of anatomy 
to determine lesion length.38,39 It also allows the procedure to be performed from a remote, 
radiation-shielded workstation, which may help to reduce the interventionalist’s exposure to 
ionizing radiation and orthopedic strain.34 
The field of neurosurgery also stands to benefit from the use of robotic assistance.40  To date, the 
ROSA robot (Zimmer Biomet, Warsaw IN, USA) has been FDA cleared and CE marked for 
epilepsy evaluation and spine surgery,41 the Modus V robotically operated exoscope (Synaptive 
Medical, Toronto, ON, Canada) is FDA cleared for subcortical surgery,42 and the Renaissance 
Surgical Guidance Robot (Mazor Robotics, Caesarea, Israel) is FDA cleared and CE marked for 
spine surgery.43 
However, until recently, no robotic platform has been designed to accommodate the micro 
guidewires, microcatheters, and micro-scale movements specific to successful neurovascular 
intervention. 
Based the findings of an initial evaluation of the system in in vitro and animal neurovascular 
models,44   Corindus has recently implemented software and engineering modifications to its Cor- 
Path GRX Robotic System to address neuro-endovascular-specific needs and indications. 
These modifications include: 

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Page: 15 of 69 
 
1) A software feature called “Active Device Fixation (ADF)”. When enabled, ADF 
maintains the placement of both the guidewire and device while the catheter is 
advanced or retracted by advancing or retracting the guidewire and device to off-set 
the motion of the catheter.  
2) A software feature called “Limited Speed”. When enabled, Limited Speed reduces 
the linear movement of the guidewire or device by half, capping its maximum speed 
at a rate of 6 mm/sec.  
3) Physical modifications to the hardware to securely and reliably accommodate 
the smaller gauge devices common to percutaneous neurosurgery. 
4) Software modifications to allow for increased working length to enable target access 
for microcatheters and an updated user interface to accommodate the new workflow 
and automated movements. These new features have been further evaluated in vitro 
and in vivo, with results that suggested that clinical development of the modified 
system is war- ranted (Britz et. al., 2019, Manuscript in Preparation). 
The present clinical study is a prospective, single-arm, international, multi-center, non-
inferiority study to evaluate the effectiveness and safety of the CorPath GRX System for 
endovascular cerebral aneurysm embolization compared to historical controls through 24-
hours post-procedure or hospital discharge, whichever occurs first. 
 
2. 
INTENDED USE & DEVICE DESCRIPTION 
 
2.1 
Intended Use 
 
The CorPath GRX System is intended for use in the remote delivery and manipulation of 
interventional devices during percutaneous coronary and vascular procedures, including the 
following commercial devices: 
• Guidewires 
• Rapid Exchange Catheters 
• Guide Catheters 
• Microcatheters 
• Embolization Coils 

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• Coil Assist Stents 
 
2.2 
Device Description and Mode of Operation 
 
The CorPath GRX System is designed to allow the operator to remotely manipulate 
interventional devices within a patient’s vasculature to perform vascular procedures in a 
precise and well-controlled fashion, without being exposed to radiation levels typically 
encountered during a conventional (i.e. manual) procedure. The complete CorPath GRX 
System includes the following major components: 
 
2.2.1 
Bedside Unit 
The Bedside Unit consists of an Extended Reach Arm, Robotic Drive, and Single-use Cassette. 
 
• 
Extended Reach Arm: Mounted on the rail of the procedure table and supports the 
Robotic Drive. 
• 
Robotic Drive: Receives inputs from the Control Console. These inputs actuate 
mechanical operations in the Single-use Cassette as movements to a loaded 
guidewire, device, and guide catheter/microcatheter. The Robotic Drive moves forward 
and backward to advance and retract the guide catheter or microcatheter. A Bedside 
Touchscreen on the Robotic Drive provides the user interface for the bedside operator 
during system set-up, loading, and device exchanges. 
• 
Single-use Sterile Cassette: Attaches to the Robotic Drive and can be loaded with 
commercially available guidewires, rapid exchange catheters, guide catheters, 
microcatheters, neuro- vascular stent retrievers, embolization coils, and intracranial 
stents. This Single-use Cassette advances and retracts the guidewire, device and 
catheter, with the ability to rotate the guidewire and catheter. 
Note: Refer to specific interventional device instructions for proper device use. 
 
2.2.2 
Interventional Cockpit 
The interventional cockpit houses the Control Console, X-ray Foot Pedal, and Monitor(s) to 
dis- play angiographic and hemodynamic data. It is designed to protect the physician from 
radiation exposure while maneuvering interventional devices. 
 

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2.2.3 
Control Console 
This component has a touchscreen and three joysticks (one joystick for device manipulation, 
one joystick for guidewire manipulation and one joystick for catheter manipulation). The device 
joystick allows for precise control of linear motion (advancement and retrieval) of its respective 
devices. The guidewire joystick allows for both linear and rotational movement (clockwise and 
counterclockwise) of the guidewire. The catheter joystick allows for precise control of linear 
motion (advancement and retrieval) and for rotational movement (clockwise and 
counterclockwise) of the guide catheter or microcatheter. The devices are controlled 
independently, which allows operations to be performed individually (by using one joystick at 
a time) or simultaneously (by activating multiple joysticks at once). For precise, discrete 
manipulation, the device, guidewire and catheter can also be manipulated in discreet 1-mm 
increments via the touch-screen buttons on the Control Console. 
CorPath GRX features technIQ Smart Procedural Automation, a set of automated movements 
unique to the system. These movements include: Rotate on Retract (RoR), Limited Speed, 
and Active Device Fixation (ADF). Users may enable a technIQ by pressing on the dropdown 
menu on the corresponding section of the touchscreen on the Control Console. 
Note: For a more detailed description of the CorPath GRX System please refer to the CorPath GRX 
System Operator’s Manual. 
2.2.4 
Device Accountability 
According to the ISO 14155:2020, Section I.7, part C, point 1, if a device is a market 
approved medical device being used within its approved indication, device accountability is 
not required. In addition, point 2 states that labelling specific for clinical investigations is also 
not required. 
 
 

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Procedure Title: CorPath GRX Neuro Study 
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3. 
OBJECTIVES & ENDPOINTS 
3.1 
Study Objective 
The primary objective of this study is to evaluate the effectiveness and safety of robotic-
assisted endovascular embolization procedures compared to objective performance criteria 
based on the scientific literature. 
 
3.2 
Primary Effectiveness Endpoint 
The primary effectiveness endpoint will be defined as successful completion of the robotic-
assisted endovascular procedure absent any unplanned conversion to manual for guidewire 
or microcatheter navigation, embolization coil(s) or intracranial stent(s) deployment, or an 
inability to navigate vessel anatomy. 
 
3.3 
Primary Safety Endpoint 
 
The primary safety endpoint will be a composite of intra- and peri-procedural events, defined 
as vascular injury including intraprocedural aneurysm rupture caused by robotically controlled 
catheters, wires, or devices and thromboembolic events with neurological decline (NIHSS 
score change ≥ 4) within 24-hours post-procedure or hospital discharge, whichever occurs 
first. 
3.4 
Secondary Endpoints 
Several secondary endpoints will be examined in this trial, including the following: 
1. Clinical Outcome - Clinical outcome as measured by Modified Rankin Scale. This is 
assessed at 90-Day Follow-Up (± 14 days) and 180-Day Follow-Up (± 30 days from the 
procedure date); 
2. Robotically Navigate Device to the Target Aneurysm - Defined as successful 
advancement of devices to the target aneurysm robotically; 
3. Robotically Navigate Device into the Target Aneurysm - Defined as successful 
navigation of device into the target aneurysm robotically; 
4. Robotically Deploy Therapeutic Device into Target Aneurysm - Defined as 
successful deployment of therapeutic device into the target aneurysm robotically; 
5. Overall Procedure Time - Defined as the time measured from the insertion of the  
access sheath/catheter until the removal of the microcatheter; 

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6. Robotic Procedure Time - Defined as the time measured from the first device used  
robotically until the removal of the microcatheter; 
7. Fluoroscopy Time - Total fluoroscopy utilized during the procedure as recorded by the 
Imaging System; 
8. Patient Radiation Exposure - DAP (dose-area-product) and CD/AK (cumulative 
dose/air kerma) as recorded during the procedure; 
9. Contrast Volume - Total contrast used during the procedure; 
10. Adverse Events - All adverse events (AEs) from the start of the CorPath GRX 
procedure until the end of the study will be summarized. 
11. Thromboembolic Events - Defined as rate of thromboembolic events occurring up to 
180-days following the robotic-assisted procedure; 
12. Devices Used Robotically - All devices used will be recorded as successful or 
unsuccessful in conjunction with the CorPath GRX System; 
13. Aneurysm Occlusion - Angiographic assessment of aneurysm occlusion grade 
according to the Raymond-Roy classification scale, parent-vessel compromise, and 
occlusion durability as assessed from an independent core laboratory. This will be 
assessed post-procedure and at a 180-day follow-up. 
 
 
4. 
INVESTIGATIONAL PLAN 
 
4.1 
Overview of Trial Design 
 
This is a prospective, single-arm, international, multi-center, non-inferiority study to gather real- 
world data on the effectiveness and safety of the CorPath GRX System for endovascular 
cerebral aneurysm embolization. Subject selection requires a clinical indication for endovascular 
coil and/or stent-assisted coiling embolization of cerebral aneurysms. After obtaining informed 
consent, performing eligibility confirmation, then screening and baseline assessments, 
qualifying subjects will be enrolled in the clinical investigation.  
The study will be conducted at a maximum of up to 20 investigational sites. This will depend on 
each active site’s recruitment rate and the possible travel restrictions due to the Covid-19 
pandemic. Up to 120 subjects will be enrolled in order to achieve at least 108 subjects in the 
study; each site will try to recruit a maximum of 20 subjects. If a site has the possibility to enroll 

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more than 20 subjects, a written authorization will be required from the sponsor, Corindus, Inc. 
The protocol does not dictate the therapeutic decisions of the Investigators. The total expected 
maximum clinical investigation duration, including completion of all follow-up requirements, is 
approximately 24 months: the recruitment phase is 18 months and follow-up is 180-days. No 
further follow-up or additional treatment is required per the protocol, and any additional follow-
up and/or treatment is at the discretion of the physician/standard hospital practices. 
 
All enrolled subjects will be followed post-CorPath GRX endovascular procedure through 180 
days post-procedure. 
 
4.2 
Roll-in Subjects 
The primary purpose of the roll-in subjects is to allow the Investigator to gain experience with 
the CorPath GRX System in the setting of the clinical trial. This will also ensure familiarity with 
protocol requirements. The first three (3) subjects for each primary Investigator will be 
considered as roll-in subjects. Subjects entered in the roll-in phase will complete all follow-up 
requirements of 180-days. 
 
4.3 
Enrollment Plans 
Each consecutive patient undergoing a CorPath GRX cerebral aneurysm endovascular 
procedure will be enrolled in the study after providing written informed consent for the provision 
of data. 
 
4.4 
Informed Consent Procedures 
 
This protocol requires written informed consent, in accordance with applicable country and clinical 
investigation site regulations. This consent shall be obtained from each conscious subject prior to 
the investigational procedure. The subject will have at least 24 hours to consider if he/she wants 
to participate in the study (if required by EC).  
 
Although not indicated in the Patient Information Sheet, in certain countries, the Ethics Committee 
requires that all subjects included in the clinical investigation be affiliated with their respective 
national social security system. It is up to the investigator to find out if the subject has this required 
affiliation. 
 
Prior to starting the clinical investigation, Corindus will provide the Principal Investigator with a 

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copy of the Informed Consent Document approved by the Ethics Committee (EC) and the 
Competent Authority (if applicable), with documented evidence that the protocol has received EC 
and Competent Authority (if applicable) approvals. 
 
A thorough written explanation will be provided to the subject as to the nature and objectives of 
this study. Details of the study should include (but are not limited to) the following terms: 
• 
Purpose of the study 
• 
Alternative treatments 
• 
Participation is voluntary, and there is no penalty for withdrawal 
• 
Potential risks/benefits for participation 
• 
Contact information to ask questions or voice concerns 
 
This discussion should highlight the fact that the patient is being asked solely to share the data 
collected from their endovascular robotic procedure and any related events through 24-hours 
post-procedure or discharge, whichever occurs first. The study investigator and/or staff are 
responsible for obtaining written informed consent from each potential subject before any study 
specific procedures required by the protocol are performed. Informed consent should be obtained 
in written format and using a form approved by the EC and Competent Authority. The form should 
contain standard language consistent with local policies for ensuring privacy of confidential 
information. All subjects must sign the informed consent prior to any procedures/tests that go 
beyond initial assessments associated with the standard care for subjects with cerebral 
aneurysms and before any study related treatment assessments are administered and subject-
related health information can be entered into the study database. 
Subjects are considered enrolled in the study once the subject signs the study Informed Consent 
Form. Failure to obtain signed informed consent, renders the subject ineligible. For those subjects 
that sign informed consent, a copy shall be kept in the subject’s medical records and study files. 
A copy of the fully executed informed consent form must be given to each subject enrolled in the 
study. 
 
4.5 
Screen Failure 
A subject who signs an informed consent form (ICF) and does not have a CorPath GRX endo- 
vascular procedure or is enrolled in the study but withdraws their consent will be considered a 
screen failure. However, all data collected from the enrolled subject prior to the time of consent 

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withdrawal will be included in the analysis. 
 
4.6 
Patient Selection 
Subjects with a clinical indication for endovascular coil and/or stent-assist coiling embolization of 
unruptured cerebral aneurysms. Subjects who meet all inclusion criteria while exhibiting none of 
the exclusion criteria (see below) and have signed the informed consent will be considered 
enrolled. All eligible subjects will be evaluated using the Corindus CorPath® GRX System in 
Endovascular Embolization Procedures of Cerebral Aneurysms. 
 
4.6.1  
INCLUSION CRITERIA 
 
1. Age ≥ 18 years. 
2. At least one cerebral aneurysm (unruptured) with indication for endovascular treatment; 
dome to neck ratio >1.5 or aneurysm neck width >4.0 mm. 
3. The Investigator deems the procedure appropriate for both manual or robotic-assisted 
endovascular treatment. 
4. The conscious subject has been informed of the nature of the study, agrees to its provisions 
and has provided written informed consent. 
 
4.6.2      EXCLUSION CRITERIA 
 
1. Failure / unwillingness of the subject to provide informed consent, unless the EC has waived 
informed consent. 
2. The Investigator determines that the subject or the neurovascular anatomy is not suitable 
for robotic-assisted endovascular treatment. 
3. Women who are pregnant. 
4. Persons under guardianship or curatorship. 
 
4.6.3  
Eligibility Committee 
 
The Eligibility Committee will be responsible for the evaluation of CorPath GRX Neuro subjects for 
participation in the study. In advance of all study subject enrollment and treatment, the committee 
will use subject clinical history, Unruptured Intracranial Aneurysm Treatment Score (UIATS) data, 
the treatment plan, and at least 4 angiographic (DSA or CTA/MRA) images to approve for inclusion 
into the study or exclude and defer treatment of the cerebral aneurysm with the CorPath GRX 

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Robotic system. 
 
The Eligibility Committee will be comprised of three neurovascular subject matter experts with 
experience in the treatment of cerebral aneurysm, data and imaging interpretation, and clinical 
research trials. They must be neurointerventionalists qualified by training, experience with the 
CorPath GRX robotic system, and CorPath GRX Neuro Study training. 
 
Once investigative sites are qualified to recruit study subjects, subject imaging, UIATS data, 
treatment plan, and clinical history will be uploaded to the Oculus Imaging Portal for the committee 
to review. Neuroimaging will be obtained within 3 months of the eligibility evaluation and will include 
at least 4 cerebrovascular images with measurements of the targeted cerebral aneurysm, as well 
as imaging of the parent vessel and aortic arch. Clinical evaluation of patients will include 
confirmation of all inclusion and no exclusion criteria being met, completion of an UIATS form with 
applicable treatment justification as needed, and any other applicable medical history required to 
allow the Eligibility Committee assessment. Additionally, planned procedural devices including 
Guidewire, Microcatheter, Stent, and Coils will be included. 
 
Upon completion of training on the use of the Oculus Imaging Portal, the Eligibility Committee 
members will assess the submitted subject data and make a determination on whether a subject 
qualifies for treatment in the CorPath GRX Neuro Study. 
 
4.7 
Subject Withdrawal and Replacement 
 
Subjects enrolled in the study can discontinue their participation at any time for any reason without 
prejudice or reduction in the quality of their medical care. The investigator can terminate a subject’s 
participation in the study to protect the subject’s health, if the subject fails to follow instructions or 
if the subject is unable to keep appointments. The Investigator must then document this notification 
of withdrawal from the study in the appropriate CRF and notify the sponsor. No replacements will 
be allowed. Up to 120 subjects will be enrolled in order to achieve data on 108 subjects. All data 
will be included in summaries. 
 
 

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4.8 
Data to Be Collected 
 
4.8.1 Peri-procedural Study Medication Regime 
 
Sites are to follow standard institutional and/or coil/stent manufacturer’s guidelines for recommended 
anticoagulation regimen. 
 
4.8.2 Baseline Date 
The following baseline data should be collected for all subjects prior to the planned index procedure 
(usually routinely done for endovascular robotic procedure subjects with cerebral aneurysms): 
• 
Patient Eligibility Criteria 
• 
Head CT angiography or MR angiography 
• 
Demographics 
• 
Medical history 
• 
Pre-endovascular Patient Assessment conducted by a trained person with appropriate 
qualifications to perform these evaluations: 
o Modified Rankin score 
o Raymond Grade for previously coiled aneurysms 
o National Institutes of Health Stroke Scale (NIHSS) scale 
• 
Laboratory tests, if performed under standard hospital procedure, should be collected for 
all subjects prior to planned index-procedure (usually routinely done for patients under- 
going cerebral aneurysm endovascular procedure *): 
o Hemoglobin (HGB) 
o Hematocrit (HCT) 
o Activated Partial Thromboplastin Time (aPTT) 
o Platelet count 
o International Normalized Ratio (INR) 
o Pregnancy test 
o Serum creatinine 
o Glomerular Filtration Rate (GFR) 
* Note: Pre-endovascular Patient Assessment and laboratory tests must be within 7 days of index 
procedure. Female patients of child-bearing potential must have a negative pregnancy test (serum 
or urine). 
 
 

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4.8.3 Data Collection Prior To Initiating CorPath Procedure 
• 
Arterial access site 
• 
What devices will be planned for robotic delivery 
• 
Procedure Start Time (Sheath insertion) 
 
4.8.4 Data Collection During CorPath Procedure 
• 
Fluoroscopy time 
• 
Patient radiation exposure (dose-area-product [DAP] and air kerma [AK]) 
• 
Aneurysm Assessment 
• 
Contrast volume 
• 
Endovascular procedure End Time (microcatheter out-time) 
• 
Record of all Adverse Events (AE) 
 
Note: A de-identified copy of all the procedural angiograms will be sent directly to the imaging core 
lab. 
 
4.8.5 CorPath GRX Endovascular Procedure Workflow 
 
The protocol allows for the Investigator to perform the following with the CorPath GRX System: 
• 
Navigate a 0.014” guidewire in the neurovascular anatomy; 
• 
Navigate a microcatheter into the neurovascular anatomy robotically; 
• 
Navigate a microcatheter to the aneurysm robotically; 
• 
Navigate treatment devices (coils/stents) to the aneurysm robotically; 
• 
Deploy treatment devices into the aneurysm robotically. 
 
The Investigator should refer to the CorPath GRX System Operator’s Manual for a detailed 
description of the system and relevant techniques. 
 
After arterial access is obtained, the Investigator will specify what devices will used robotically 
prior to starting the robotic portion of the endovascular procedure. 
 
CorPath Use Technique 
To obtain proper data for analysis, the following procedure, with associated data collection mile- 
stones, is recommended, but in no case, dictates use of the CorPath GRX System in a manner 

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different from that presented in the Operator’s Manual. 
 
The following CorPath Use Technique guides the Investigator through coiling a 
cerebral aneurysm with the CorPath GRX System. 
1. Obtain arterial access using conventional technique. Record sheath insertion time. 
2. Once arterial access is obtained, insert a standard diagnostic catheter using 
conventional manual technique or guide catheter mounted coaxially over a 
diagnostic insert catheter. 
3. Manually advance the diagnostic select catheter to the parent vessel. 
4. Advance guide catheter to desired location in parent vessel and remove wire and 
diagnostic select catheter. If only diagnostic catheter was used, then remove 
standard wire and use exchange length guidewire; remove the diagnostic catheter 
over the exchange wire while maintaining distal wire position. Advance the guide 
catheter over the exchange wire to the desired location in parent vessel and remove 
wire. 
5. The Investigator will specify which devices will be delivered robotically. 
6. Manually advance microcatheter to tip of guide catheter in the parent vessel. 
7. Manually insert exchange length guidewire and attach COPILOT bleed back control 
valve to the microcatheter. 
8. Record microcatheter “insertion” time. 
9. Load the microcatheter and exchange length guidewire in the CorPath GRX cassette. 
10. Using the CorPath System, advance guidewire and microcatheter independently to 
tar- get treatment area. The Active Device Fixation (ADF) technIQ automated 
movement can be enabled to keep the guidewire in place during microcatheter 
movement. 
11. With microcatheter in place, remove guidewire. 
12. Advance stent into the COPILOT bleed back control valve and proximal 
microcatheter slowly and according to stent delivery IFU. 
13. Place the stent advancement wire into the Device Track of the CorPath GRX. 
14. Advance stent, robotically, to target area. The stent will remain completely 
sheathed in the microcatheter. 
15. Robotically position the stent across target aneurysm. 
16. Maintaining stent position with CorPath GRX, begin to robotically remove the 
microcatheter with ADF enabled on the microcatheter. This will unsheathe the stent 
in place. 
17. Using micro-millimeter movements with the CorPath GRX, continue to remove 
micro- catheter until stent is completely unsheathed and fully deployed. 
18. Remove stent deployment shaft robotically, reload exchange length guidewire, and 
re- advance guidewire to target aneurysm. 
19. Using robotic manipulation, advance the microcatheter and guidewire wire to 
position through the stent struts. 
20. Robotically retract guidewire. 
21. Remove guidewire from cassette and load embolization coils into Device Track. 
22. Using the CorPath System, advance embolization coils to target aneurysm. Slowly 
de-ploy embolization coils as per physician preference. The Limited Speed technIQ 
auto- mated movement may be enabled to slow maximum speed to 6mm/sec if 

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desired. De- tach and exchange embolization coils as per IFU. 
23. After embolization of target aneurysm, robotically remove coil delivery catheter and 
microcatheter. 
24. Perform final control angiography. 
25. Record final fluoroscopy time, DAP, AK and contrast volume. 
26. Record time of microcatheter “removal” time from the parent vessel. 
27. Record Operator pocket dosimeter reading. 
 
 
4.8.6 Specify Device to Be Used Robotically 
 
After arterial access prior to using the CorPath GRX System, the Investigator will specify which 
device he/she will plan to use robotically. If a device that is used robotically cannot be delivered to 
the target, cross the target or delivered into the target and conversion to manual is needed, it will 
be documented as an unplanned conversion to manual. 
 
4.8.7 Conversion to Manual Procedure Data Collection 
 
The Investigator shall determine if it is necessary to convert to standard manual techniques to 
complete the endovascular robotic procedure. The Investigator should make this decision based 
on his/her medical assessment of the situation in accordance with the best interest of the subject. 
It is recommended that conversion to manual operation be performed at the discretion of the 
Investigator or if any of the following occur: 
• 
The inability to navigate the guidewire(s), microcatheter(s), embolization coil(s) or stent- 
assist coiling using the CorPath GRX System as intended. 
• 
Any clinical condition that requires rapid medical intervention. Details of manual technique 
to be documented are: 
o Planned or unplanned (e.g. physician preference, use of equipment not compatible 
with CorPath GRX); 
o If unplanned (e.g. embolization coils were undeliverable due to severe tortuosity), 
specify why. 
 
4.8.8 Device Malfunction Data Collection 
 
All CorPath GRX System device malfunctions will be documented in the EDC. If the device 
malfunction is related to a Device-Related Adverse Event (AE), the AE will be entered into the EDC 
and each site will follow their internal policies for AE reporting. 
 

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4.8.9 Post-CorPath Data Collection 
 
Post-CorPath Procedure Medication Regimen 
Follow standard operator and institutional routines for recommended anticoagulation and anti-
platelet regimens. 
 
Post-CorPath Procedure Subject Evaluations 
 
• 
NIH Stroke Scale (NIHSS) and Modified Rankin Scale (mRS) conducted by a trained person 
with appropriate qualifications to perform these evaluations are required to be performed 
within 24-hours post procedure or prior to discharge, whichever occurs first. 
• 
Raymond Grade-Roy Occlusion Classification Scale conducted by a trained person with 
appropriate qualifications to perform this evaluation: 
o Class (I): Complete occlusion – complete obliteration of the aneurysm 
o Class (II): Residual neck – persistence of any portion of the original defect of the 
arterial wall as seen on any single projection, but without opacification of the 
aneurysmal sac. 
o Class (III): Residual aneurysm – opacification of the aneurysmal sac. 
o Class IIIa: contrast opacification within the coil mesh 
o Class IIIb: contrast opacification outside coil mesh 
 
• 
Additional post procedure clinical assessment (scales/scores) is left to the discretion of the 
investigator and shall be dictated by the patient’s clinical symptoms 
• 
Record of all Adverse Events (AEs) 
• 
If clinically indicated by the Investigator and/or if performed under standard hospital 
procedure, record lab values closet to 24-hours post-procedure or discharge: 
o Hemoglobin (HGB) 
o Hematocrit (HCT) 
o Activated Partial Thromboplastin Time (aPTT) 
o Platelet count 
o International Normalized Ratio (INR) 
o Serum Creatinine 
o Glomerular Filtration Rate (GFR) 

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• 
Before the subject is discharged from the hospital, it is recommended that telephone numbers 
and contact information be confirmed with the subject (and/or authorized legal guardian) to 
ensure the ability to contact him/her after discharge from the hospital for scheduling of the 90- 
day (± 14 days) telephone evaluation. 
 
4.8.10 
Follow-Up Evaluations 
The following assessments will be completed at the specified time points below. 
• 
90-Day Follow-Up (± 14 days) via a telephone evaluation 
o Functional outcomes assessment to include Modified Rankin Scale (mRS) 
o Record any adverse events or additional interventions since time of hospital 
discharge 
Note: If during the time of telephone contact, the subject reports any adverse events or additional interventions, the 
subject shall undergo an office visit, whereupon a neurological examination and any other additional testing 
deemed appropriate by the investigator shall be performed. 
• 
180-Day Follow-Up (± 30 days) 
o Digital Subtraction Angiography (DSA), Computed Tomography Angiography 
(CTA), or Magnetic Resonance Angiography (MRA) / Magnetic Resonance Imaging 
(MRI) of the brain/head 
o Functional outcomes assessment to include Modified Rankin Scale (mRS) 
o Raymond-Roy Occlusion Classification 
o Record any adverse events or additional interventions since time of hospital 
discharge. 
  
4.8.11 
Schedule of Data Collection 
 
Data collected for all subjects enrolled in this study should include the tests and procedures listed 
in the following Schedule of Activities (Table 1), many of which are part of routine data collection 
for all endovascular robotic procedures. 

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Table 1: Schedule of Activities 
Pre-
Procedure Procedure 
 
Post- 
Procedure 
90-day7 
BY 
PHONE 
180-day 
Un- 
Scheduled 
Visit 
 
Day (0) 
(24-hours post-
procedure or 
hosp. discharge) 
±14-
days 
±30-days 
 
Patient Eligibility Criteria 
X 
 
 
 
 
 
Submit to Eligibility Committee  
• 
Clinical history 
• 
Unruptured Intracranial Aneurysm 
Treatment Score 
• 
Treatment plan  
• 
≥ 4 angiographic (DSA or CTA/MRA) 
images 
X 
 
 
 
 
 
Medical History 
X1 
 
 
 
 
 
Digital Subtraction Angiography (DSA), 
Computed Tomography Angiography 
(CTA), or Magnetic Resonance 
Angiography (MRA)/Magnetic Resonance 
Imaging (MRI) of the brain/head 
X1 
 
 
 
X7 
 
Clinical assessment & Physical 
exam including: 
• 
Modified Rankin Scale (mRS) 
• 
National Institutes of Health 
Stroke Scale (NIHSS) scale 
X 
 
X 
X6 
X8 
X9 
Raymond Grade-Roy Occlusion 
Classification Scale 
X3 
X 
 
 
X 
 
Laboratory Tests: hemoglobin, hematocrit, 
activated partial thromboplastin time, platelet 
count, international normalized ratio, 
pregnancy test, serum creatinine and 
glomerular filtration rate. 
X1,2,4 
 
X2 
 
 
 
Procedure Parameters  
 
X 
 
 
 
 
Catheter Angiography 
 
X5 
 
 
 
 
Contrast volume 
 
X 
 
 
 
 
Record of AEs 
 
X 
X 
X 
X 
X 
Data for aneurysm assessment e.g. 
tortuosity, proximal & distal vessel diameter, 
target aneurysm measurements. 
 
X 
 
 
X 
 
1 Within 7 days of index procedure. 
2 If performed under standard hospital procedure. 
3 For previously coiled aneurysms. 
4 Female subjects of child-bearing potential must have negative pregnancy test (urine or serum). 
5 Includes angiograms in the anterior posterior, lateral and working positions for analysis by a core laboratory. 
6 Telephone assessment and mRS is required. Other post procedure clinical assessment (scales/scores/grades) is left to the 
discretion of the investigator and shall be dictated by the patient’s clinical symptoms. 
7 Post scans will be sent to the core laboratory for analysis. 
8 mRS is required. Other post procedure clinical assessment (scales/scores/grades) is left to the discretion of the investigator and 
shall be dictated by the patient’s clinical symptoms. 
9 If visit is related to target aneurysm or potentially associated AE/SAE 

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5. 
ADVERSE EVENTS AND COMPLICATIONS 
 
Throughout the course of the clinical investigation, all adverse events will be recorded on the 
applicable ADVERSE EVENT CRF and in the subject’s medical records. In this study, adverse 
events will be defined and classified per ISO 14155:2020(E) Clinical Investigations of Medical 
Devices in Human Subjects - Good Clinical Practice, and as further described in this protocol. 
The date of onset, date of resolution, severity, and action taken will be evaluated by the 
Investigator. The relationship to the device, relationship to the procedure, and clinical significance 
will be evaluated. The neurological outcomes and adverse events will be reported. 
 
5.1 
Adverse Event Classification and Definitions 
 
An Adverse Event (AE) is any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in subjects, users or other 
persons, whether or not related to the medical device (ISO 14155:2011). 
NOTE 1: This definition includes events related to the medical device or the comparator. 
NOTE 2: This definition includes events related to the procedures involved. 
NOTE 3: For users or other persons, this definition is restricted to events related to medical 
devices.  
 
Disease signs and symptoms that existed prior to study participation are not considered AEs 
unless the condition recurs after the subject has recovered from pre-existing condition, or the 
condition worsens in intensity or frequency during the study. 
 
A Serious Adverse Event (SAE), as per the European Standard ISO 14155:2020(E), is an AE that 
led to any of the following: 
a)  Death 
b).  Serious deterioration in the health of subject, users or other persons as defined by one or 
more of the following: 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or body function including chronic 
diseases, or 

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3) in-patient or prolonged hospitalization, or 
4) medical or surgical intervention to prevent life-threatening illness of injury, or 
permanent impairment to a body structure or body function, 
c) Foetal distress, foetal death, a congenital abnormality or birth defect including physical or 
mental impairment. 
 
Planned hospitalization for a pre-existing condition, or a procedure required by the protocol, 
without serious deterioration in health, is not considered a serious adverse event. 
 
In the current study indication, examples of a Serious Adverse Event (SAE) are: 
• 
Incidence of death 24-hours post procedure 
 
• 
Target aneurysm rupture 
 
• 
Vessel perforation 
 
• 
Vessel dissection 
 
• 
Thromboembolic complication 
 
• 
Failure to navigate to target 
 
• 
Device failure to respond to input, or other intra-operative device failure 
 
 
5.2 
Adverse Event Assessments 
Relatedness: 
 
• 
Procedure-related: Event has a strong temporal relationship to the study procedure. This 
includes AEs attributable to any device(s) used at procedure, such as access devices, 
delivery microcatheters, embolic coils, non-ionic contrast, guidewires, or any other ad- 
junctive, approved/cleared device for treatment of intracranial aneurysms. 
• 
Device-related: Event has a strong temporal relationship to the CorPath GRX System. 
• 
Unknown: Event relationship cannot be attributed to any of the above categories and re- 
mains undetermined. 
 
 
 

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5.3 
Procedure-Related Adverse Event 
An adverse event is procedure-related when, in the judgment of the Investigator; it is reasonable 
to believe that the event occurs from the endovascular robotic procedure, irrespective of the de- 
vice. 
 
5.4 
Device-Related Adverse Event 
 
An adverse event is device-related when, in the judgment of the Investigator, the clinical event 
has a reasonable time sequence associated with use of the CorPath GRX System and is un- 
likely to be attributed to concurrent disease or other procedures or medications. It is reasonable 
to believe that the CorPath GRX System directly caused or contributed to the adverse event. 
 
 
5.5 
Event Reporting Requirements 
 
Any adverse event that occurs during the course of the study must be recorded and reported 
using the appropriate Adverse Event eCRF and also recorded in the subject's medical records. 
These will include events occurring from the point of consent until a subject exits the study. The 
Investigator must sign each AE eCRF report. Investigators must obtain all information available 
to determine the causality and outcome of the AE and to assess whether it meets the criteria for 
classification as serious and the relationship of each adverse event to the procedure or device. 
This determines whether it requires notification to the Sponsor, regulatory agency, and as 
applicable, EC, within the specified reporting timeframe. AEs will be categorized using the 
definitions in Section 5.1 – 5.4. 
 
Pre-existing medical conditions or symptoms occurring prior to the start of the procedure should 
not be reported as adverse events. In the situation where there is a worsening of a pre-existing 
medical condition or symptom due to a study related procedure, an adverse event should be 
reported. 
 
In the case of any AE, the Investigator shall submit to Corindus a report within 10 working days 
after the Investigator first learns of the event. 
 
The Investigator is required to report all SAEs within 24-hours after first learning of the event to 

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the Sponsor. The primary method of reporting SAEs will be through the eCRFs. If the database 
is unavailable, the investigator may fax or email in the information. As soon as the database 
becomes available, the investigator must complete data entry. Depending upon the nature and 
seriousness of the adverse event, the Sponsor may request the Investigator to provide 
anonymous copies of the subject’s available supporting documentation (such as the subject’s 
laboratory tests, hospital records, discharge reports, autopsy reports, Investigator summaries, 
etc.) to document the adverse event. The Sponsor is responsible in Europe for ensuring that the 
required and adequate information concerning the reported SAE is relayed to the appropriate 
Ethics Committee and Competent Authority using the MEDDEV 2.7/3 SAE Report Table. All other 
adverse events (i.e. other than serious adverse events) must be recorded on the appropriate 
adverse event eCRF. 
 
Corindus, in cooperation with the Investigator, will assess all serious adverse events for potentially 
reporting to the Regulatory Authorities and EC. 
 
For any adverse event that is ongoing at the time of the initial report, periodic follow-up information 
is required until the adverse event is resolved or is judged to be chronically stable, or until the 
conclusion of the study for the subject. The site should submit relevant follow-up information 
related to the adverse event as soon as it is available. 
 
5.6 
Anticipated Adverse Events 
 
There are risks associated with endovascular embolization with or without stent-assist coiling 
procedure to treat cerebral aneurysms. These standard risks may include the following: 
• 
Adverse reaction to antiplatelet/anticoagulation agents or contrast media 
• 
Air embolus 
• 
Allergic reaction/toxic effects 
• 
Bleeding 
• 
Death 
• 
Device migration or misplacement 
• 
Device Fracture 
• 
Dissection of the parent artery 
• 
Embolism 
• 
Fever 
• 
Foreign material embolic event 
• 
Groin injury 

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• 
Headache 
• 
Hemolysis 
• 
Hemorrhage 
• 
Hydrocephalus 
• 
Infection 
• 
Intracerebral bleeding 
• 
Ischemia 
• 
Neurological deficits 
• 
Occlusion of unintended vessel 
• 
Parent Artery Stenosis 
• 
Perforator occlusion 
• 
Peripheral embolism 
• 
Post-procedure bleeding 
• 
Ruptured or perforated aneurysm 
• 
Recanalization 
• 
Residual flow 
• 
Seizure 
• 
Stroke/TIA 
• 
Surgical intervention 
• 
Thromboembolism 
• 
Vascular access site complication 
• 
Vasospasm 
• 
Vessel perforation 
• 
Vessel trauma/perforation/occlusion 
• 
Vision impairment 
 
5.7 
Subject Death 
 
Subject death during the investigation must be reported via eCRF within 24-hours of Investigator’s 
knowledge of the death. Notification of death must include a brief statement of the relevant details 
of the death and is required to be signed by the Investigator. In addition, all patient deaths must 
be reported to the specific Ethics Committee and Competent Authority in accordance with 
regulatory requirements. The method of declaration will conform to the current regulations. A copy 
of the death records, death certificates and an autopsy report (if performed) are required to be 
sent to Corindus or designee, within ten (10) days following the death. 
In the event of subject death, efforts should be made to perform an autopsy in order to assess 
the state of the heart. For subjects that do not undergo autopsy, written documentation from the 
Investigator will be required providing justification as to why an autopsy was not performed. 
 
 

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5.8 
Surveillance Committee 
 
A Surveillance Committee will be composed of three expert physicians in the field of interventional 
neuroradiology and/or neurosurgery, who are independent and not directly involved in the conduct 
of the trial. The purpose of the committee is to review and adjudicate all complications/adverse 
events as they occur over the course of the study (classify, identify causal relationship between 
event and device, procedure or subject). The committee will also review and adjudicate, as 
necessary, issues relating to classification of events as major (serious) or minor (non-serious), 
and attribution to system, treatment and/or disease. The neurological outcomes and adverse 
events will be reported under the clinical investigation and any imaging generated will be 
forwarded to the committee. The committee will analyze the relationship between the images and 
the cause of the neurological deterioration. Any overall trends or conclusions drawn from these 
analyses will be reported; however, no specific criteria will be applied. 
 
 

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6. 
STATISTICAL CONSIDERATIONS AND ANALYSIS 
Data for subjects that undergo an endovascular procedure where the Corindus GRX device is 
used (or attempted to be used) will be included in both primary and secondary endpoints where 
data are available. 
 
6.1 
Analysis of Primary Effectiveness Endpoint 
 
The primary effectiveness endpoint will be defined as successful completion of the robotic-
assisted endovascular procedure absent any unplanned conversion to manual operation for 
guidewire, microcatheter, embolization coil(s), intracranial stent(s), or inability to navigate vessel 
anatomy. The proportion of subjects with a successfully completed endovascular procedure will 
be summarized along with a 2-sided 95% exact binomial confidence interval to demonstrate that 
the effective-ness is not inferior to a performance goal based upon historical rates from recent 
literature for comparable procedures. 
 
6.2 
Analysis of Primary Safety Endpoint 
 
The primary safety endpoint will be a composite of intra- and peri-procedural events, including 
target aneurysmal rupture, vessel perforation or dissection, and major stroke within 24-hours of 
post-procedure or discharge, whichever occurs first. The proportion of subjects with a safety 
event as defined will be summarized along with a 2-sided 95% exact binomial confidence interval 
to demonstrate that safety not inferior to a performance goal based upon historical rates from 
the literature for comparable procedures. 
 
6.3 
Analysis of Secondary Endpoints 
 
Secondary endpoints will be analyzed with descriptive statistics along with a 95% confidence 
interval. Descriptive statistics for categorical variables will include the number and percentage of 
subjects in each category, with two-sided 95% confidence intervals of the percentage of subjects 
in each category. Descriptive statistics of continuous variables will include sample size, mean 
standard deviation, minimum, median, maximum, and 95% confidence interval of the mean. 
Summaries will be provided for the overall population and by type of aneurysm (ruptured or 
unruptured). 
 

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6.4 
Determination of Historical Controls 
 
Safety rates from key literature are presented in Table 2 below: 
 
 
Table 2. Rates of safety from literature for endovascular treatment of unruptured and 
ruptured aneurysms. 
N 
Aneu- 
rysms 
(Pts) 
Mortality 
at    
Discharge 
Overall 
Complication 
Rate 
Rupture/ 
perforation 
Rate 
(%) 
Embolism 
Rate 
(%) 
UNRUPTURED INTRACRANIAL ANEURYSMS 
Algra et al 2018* 
73066 
(71819) 
0.3% 
(0.2% - 0.4%) 
4.96% 
(4.00, 6.12%) 
0.9% 
(212/18520) 
95% CI 
(0.6%, 1.3%) 
2.82% 
(437/16000) 
95% CI 
(2.3, 3.5%) 
Advanced Endovascular 
Methods** 
2248 
0.4% 
6.1% 
(0.2 - 1.1%) 
(4.3, 8.7%) 
Kawbata et al 2017 
1406 
1.4% 
(1375) 
(20/1406) 
coil only 
340 
1.8% 
(6/340) 
stent-assisted coiling 
468 
0.9% 
(4/468) 
balloon-assisted coiling 
598 
1.7% 
(10/598) 
From Lit 
Review, Table 6 
in Kawbata 
7785 
0 
1.4% 
(108/7785) 
Zheng et al 2016 
1127 
1% 
(11/1127) 
Santillan et al 2013 
217 
0% 
5% 
(3/217) 
Shigematsu et al 2013 
4767 
1.4% 
(65/4767) 
Oishi et al 2012 
500 
0% 
1.4% 
(7/500) 
Im et al 2009 
435 
0% 
0.9% 
(4/435) 
Pierot et al 2008 
739 
0.3% 
2.4% 
(18/739) 
739 
2.4% 
7.3% 
Pierot et al 2008 
(649) 
(18/739) 
(29/308) 
(ATENA study) 
(700 
1 month 1.4% 
15.4% 
2.6% 
7.1% 
procs) 
(18/700) 
(per proc) 

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N 
Aneurys
ms 
(Pts) 
Mortality 
at    
Discharge 
Overall 
Complication 
Rate 
Rupture/ 
perforation 
Rate 
(%) 
Embolism 
Rate 
(%) 
Pierot et al 2009, 
(ATENA study, 
coil alone 
results) 
325 pts 
0.9% 
(3/325) 
10.8% 
(35/325) 
2.1% 
(7/325) 
6.2% 
(20/325) 
RUPTURED INTRACRANIAL ANEURYSMS 
Zhang et al 2019 
1004 
All cause 
9.5% 
(5.8%, 13.2%) 
proc related 
1.8% 
(0.9, 2.7%) 
22.7%*** 
95% CI 
(15.1, 30.3%) 
Cognard et al 2011 
(CLARITY GDC study) 
405 
1.50% 
3.7% 
(15/405) 
13.3% 
(54/405) 
Pierot et al 
2011 
(CLARITY) 
608 
5.1% 
(31/608) 
cum. TRT 
related 
morb/mort rate 
19.6% 
(119/608) 
cum. 
morb/mort 
rate) 
17.4% 
(106/608) 
4.6 
(28/608) 
* rates presented are pooled crude risk from meta-analysis modeling 
** Advanced = Stent-assisted coiling, balloon-assisted coiling, flow diverting stents or woven endo- 
bridge devices. 
*** definition not specified 
 
Additionally, there were three randomized controlled trials comparing different endovascular 
treatments that contained both ruptured and unruptured intracranial aneurysms: HELPS, MAPS, 
and Cerecyte Coil trial. Rates presented pooled results from both arms in the following three 
tables. 

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Table 3a-3c. Rates presented pooled results from both arms from three (3) from 
randomized control trials. 
HELPS Trial 
N 
Mortality 
Procedural 
aneurysm 
rupture* 
Thromboembolic complication* 
White et al 2008 
N=499 
RCT, covered vs uncovered coil 
499 
2.2% 
(11/499) 
At dis- 
charge 
3.4% 
(17/499) 
9.8% 
(39/499) 
53% ruptured 
* Article specifically called out that “some of these adverse events, especially procedural ones, did not result in permanent clinical 
sequalae. 
 
MAPS Study 
N 
Mortality 
Overall 
Complica- 
tion Rate 
Clinical Event Committee Adjudicated 
Technical 
Success 
Rupture/ 
re-rupture 
Ischemic 
Stroke 
Hemorrhagic 
Stroke* 
McDougall et al 2014 
0.2% 
(1/624) 
N=626 
RCT, Matrix coil vs 
GDC coil 
626 
Peri-proc 
2.4% 
14.9% 
(93/624) 
0.3% 
(2/626) 
3.4% 
(21/626) 
1.1% 
(7/626) 
97.1% 
(608/626) 
(15/626) 
Ruptured 36.4% 
30 day 
(22826) 
*Article notes hemorrhagic strokes due to rupture/re-rupture are not included in Hemorrhagic Stroke summary 
 
 
CERECYTE Coil 
Trial 
N 
Mortality 
Overall 
Complication 
Rate 
Rupture/ 
re-rupture 
Thrombo- 
embolic 
complica- 
tion 
Neuro- 
deterio- 
ration 
Technical 
Success 
Coley et al 2012 
N=500 
RCT, Cerecyte vs 
bare platinum coil 
Ruptured 46.9% 
(233/497) 
497 
0% within 
24-hr 
 
0.4% 
(2/497) 
before dis- 
charge 
12.3% 
(61/497) 
3.6% 
(18/497) 
5.6% 
(28/497) 
3.0% 
(15/497) 
97.2% 
(483/497) 
(14 “unable to 
place coil”) 
 
While Cerecyte and HELPS present overall complication rates in the 12-15% range, it was felt 
that the rates of stroke, rupture/re-rupture and death from the MAPS trial that were adjudicated 
by an independent clinical event committee were the most accurate to represent the expected 
rates of safety events for this trial. If we assume independence and add the individual rates, the 

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expected rate of safety events is 4.8% (30/626) but will be rounded to the nearest percent of 5% 
for sample size calculations. 
 
The performance endpoint is similar to a technical success measure. Zang et al 2019 provided a 
literature review that included technical success. The weighted average was 97.6% for ruptured 
aneurysms. McDougall et al 2014 reported a similar overall procedural success of 97.1% 
(608/626) and Coley et al 2012 report a success of 92.7%, but this number does not include 
conversion to manual as our performance endpoint does. 
 
For the conversion to manual aspect, there are not data available for treatment of intracranial 
aneurysms, but we can look at past Corindus CorPath performance for PCI. In Table 4 below, the 
premarket trial results 1.2% for unplanned conversions, but the rate was considerably higher in 
the real-world post-market trial with 10.4% unplanned conversions. 
 
To estimate the overall rate of success for the performance endpoint, we will use the highest rate 
of 10.4% rounded to the nearest percent of 10%, or in terms of success, 90% expected 
performance success rate. 
Table 4. Summary of conversion to manual by Corindus CorPath device in percutaneous 
coronary interventions. 
 
Trial 
Conversion to Manual 
PRECISE 
Pre-market trial for FDA clearance 
1.2% (2/164) 
PRECISION Registry* 
Post-market trial 
10.4% (99/948) 
CORA-PCI 
Post-market single site trial 
8.3% (9/108) 
* Unpublished data 
 
 
 
 
 
 
 

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For a few secondary endpoints intending to quantify performance at 180 days, safety and 
effectiveness rates from a key publication (The Pipeline Trial) related to 180-day follow-up are 
presented in table 550. 
 
Table 5. Safety and Effectiveness data 180-day rates presented. 
Pipeline for Uncoilable or Failed Aneurysms Clinical Trial 
Becske et al 2013.50 
N 
180-day 
Results (%) 
SAFETY 
 
 
• 
Ischemic stroke (perioperative) related to PED-associated thrombosis 
(patient later experienced delayed fatal hemorrhage after traumatic fall in 
rehabilitation facility) 
107 
2.8% 
(3/107) 
• 
Ischemic stroke (delayed) secondary to major in-construct (PED) stenosis 
--- 
• 
Ischemic stroke (delayed) from noncompliance with the required oral 
antiplatelet regimen 
--- 
• 
Ipsilateral intraparenchymal hemorrhage (perioperative) 
1.9% 
(2/107) 
• 
Ipsilateral intraparenchymal hemorrhage (delayed) on day 14 (fatal) 
--- 
• 
Rapidly fatal event possibly neurologic in origin 
0.9% 
(1/107) 
EFFECTIVENESS 
N 
180-day 
Aneurysm 
• 
Angiographic evaluation that demonstrated complete aneurysm occlusion and 
absence of major stenosis at 180 days 
106 
 
o 
YES 
73.6% 
(78/106) 
o 
NO 
26.4% 
28/106 
 
The goal of the Pipeline trial safety analysis was to show the rate of ipsilateral stroke or neurologic 
death is statistically lower than 20%. The rate of complete aneurysm occlusion analysis goal was 
set at a threshold of 50%. The Pipeline trial demonstrates that treatment of large and giant 
cerebral aneurysms is feasible and effective, with a reasonable margin of safety. Patient follow-
up for the trial consisted of repeat neurologic examinations at 30 and 180 days after device 
placement and a follow-up telephone call evaluation at 90 days. Further periodic follow-up visits 
were scheduled (through 5 years). Patients underwent conventional angiography and a 
neurologic examination at 180 days. In this study, the 180-day follow-up data imply that fewer 
angiographic follow-up visits are required.  

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6.5 
Primary Analysis 
 
The goal of the primary analysis will be to demonstrate that cerebral aneurysm coiling treated with 
CorPath GRX is as effective and safe as compared to the combined historical control treatments 
for cerebral aneurysm coiling treated with traditional manual operation. 
 
For safety, if the upper bound of the 2-sided 95% confidence interval is less than the performance 
goal of 15%, we will conclude that the Corindus GRX system did not negatively impact safety. 
 
For performance, if the lower bound of the 95% confidence interval for the proportion of successful 
patients is greater than the performance goal of 80%, we will conclude that the Corindus GRX 
system did not negatively impact performance. 
 
6.6 
Sample Size Calculation 
 
Assuming that the expected safety for procedures performed with the Corindus GRX system do 
not differ from historical performance, we set up a performance goal using the historical rate of 
5% for safety and an 10% non-inferiority margin to set up a performance goal of 15% for safety. 
The safety hypothesis is: 
Ho: p ≥ 15% (5% + 10% NI margin) 
Ha: p < 15%, 
where p=proportion of patients with a safety event. 
 
 
A sample size of 96 subjects will have at least 90% power to test this safety hypothesis (PASS 
14, one-sample proportion, exact test, normal approximation for power). 
 
Assuming that the expected procedure success rate is similar to the 90% based on literature and 
our best estimate of possible conversion to manual procedures, we set up a performance goal 
using the historical rate of 90% for with a 10% non-inferiority margin to set up a goal of 80% for 
performance. 
The performance hypothesis is: 
Ho: p ≤ 80% (90% - 10% NI margin) 
Ha: p > 80%, 

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where p=proportion of patients with a successfully completed endovascular procedure. 
 
A sample size of 108 subjects will have at least 80% power to test this safety hypothesis (PASS 
14, one-sample proportion, exact test, normal approximation for power). 
 
The overall trial sample size for the trial will be driven by the performance endpoint with at least 
108 subjects enrolled. 
 
6.7 
Endpoint Analysis and Reporting 
 
All statistical analyses will be performed using SAS Version 9.4 or higher or other valid statistical 
software. Descriptive summary statistics will be provided for endpoints along with 95% confidence 
intervals as appropriate. Subject data listings and tabular and graphical presentations (e.g., bar 
graphs, pie charts, line graphs) of results may also be provided. 
 
The secondary endpoint at the nominal 90 days post-procedure (modified Rankin Score) will be 
reported with descriptive statistics. Secondary endpoints captured at the nominal 180-day visit 
will be presented in tabular format (see Table 5) where appropriate; and for Clinical assessment 
& Physical Exam variables, with descriptive statistics; data for Target Aneurysm Assessment will 
be presented in a tabular format (see Table 1).  
 
Adverse events occurring during or before the post procedure visit identified in Table 1 will be 
reported separately. Adverse events occurring after this visit will be reported (1) separately and 
(2) pooled with prior adverse events. 
 
An analysis of periprocedural data will be performed upon completion of the post-procedure visit 
of the 108th enrollment and/or enrollments that have closed. The final analysis will be performed 
after follow-up is completed for all enrolled subjects. A separate statistical analysis plan (SAP) will 
be prepared and will include additional details for planned analyses. 
 
6.8 
Analysis of Baseline Demographics and Procedural Characteristics 
 
All clinically relevant baseline variables will be tabulated using descriptive statistics. 
 
 

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6.9 
Handling of Missing Data 
 
It is assumed that because the primary and most secondary analyses are evaluated within 24-
hours of CorPath GRX procedure or prior to hospital discharge, whichever occurs first, there will 
be minimal missing data. For the 90-day and 180-day secondary endpoints (modified Rankin 
Scale, thromboembolic events, and aneurysm occlusion), all practical monitoring and follow-up 
steps will be taken to ensure complete and accurate data collection. Additionally, all data collected 
on safety or adverse events will be reported to the extent they are available. 
 
 
7. 
DATA COLLECTION 
 
7.1 
Study Data Requirements 
 
To ensure data quality and completeness, all required data will be recorded on standardized 
electronic case report forms (eCRFs). eCRFs must be completed for each subject and, once 
complete, electronically signed by the Investigator in the electronic data capture (EDC) system. 
The Investigator will electronically sign after all data has been entered, all queries have been 
resolved, and all monitoring is completed. The Investigator, or their authorized designee, is 
responsible for recording all study data in the eCRFs. If a paper CRF is used to capture any 
additional study related data, it must be signed and dated by the Investigator. 
 
7.2 
Data Processing & Quality Control 
 
A full-featured relational database on a central server, networked to data entry and data analytical 
workstations will be employed. Conventional data verification sub-routines will be extensively 
programmed to test entry and logical errors, while all individual (subject based) case report forms 
will be linked for cross-reference. Periodic analysis of each data field (a cross cases) will be 
performed to examine the expected distributions of data, and to identify outliers for possible data 
mistakes. 
 
7.3 
Data Cleaning 
 
All eCRFs will be subjected to inspection for completeness, data inconsistencies, clarity and 
deviations upon receipt. All deficiencies or deviations will be reported to the site as necessary. All 
data inconsistencies will be resolved with the revision of errant forms at the clinical site, by site 

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personnel. 
 
7.4 
Data Entry 
 
Study data will be collected using electronic case report forms and a 21 CFR Part 11-compliant 
electronic data capture system. Part 11, Title 21 of the US FDA's Code of Federal Regulations 
(CFR), or FDA 21 CFR Part 11, is particularly important because it details the regulations for the 
use of electronic documents and signatures. The application provides the capability of data col- 
lection remotely through the Internet so the participating site personnel may log on the system 
securely and enter the data. All subjects’ data collected in the system will be extensively verified 
through data validation programs, database integrity rules, and investigation-specific data entry 
conventions for data accuracy and logical meaningfulness. Periodic analysis of all subjects’ 
collected data will be performed in order to examine the expected distributions of data and to 
identify outliers for possible data entry errors. The investigator is responsible for reviewing all 
eCRF entries for completion and correctness. Changes in case report forms will be made 
electronically and the system used will keep an audit trail of changes. If necessary, an explanation 
for the change(s) may be provided. All study staff who will enter data into eCRFs will undergo 
appropriate training for use of electronic CRFs. Further information regarding eCRF navigation 
and use may be found in the eCRF Completion Guidelines. 
 
7.5 
Final Data Analyses 
 
All exported datasets for analyses will undergo a final data cleaning procedure unique to each exported 
dataset. 
 
7.6 
Confidentiality and Protection of Study Files 
Information about study subjects will be kept strictly confidential, including their personal identity 
and all personal medical information. Subjects will be identified by a unique study number 
consisting of site number – subject ID number. The patient’s consent to the use of records for 
data verification purposes will be obtained prior to enrollment in the trial. 
 
The Investigator Site File will be held in a secure area. Only personnel responsible for collecting 
the data and transcribing it onto the case report forms will have access to the data. Records will 
remain on site in secure areas. 
 

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Appropriate precautions will be taken to maintain confidentiality of subject medical records and 
personal information. However, the subject’s name may be disclosed to the Sponsor, Corindus, 
or health authorities if they inspect the clinical investigation records. A report of this clinical 
investigation may be published; however, the subjects’ identities will not be disclosed. 
 
Passwords will be issued to appropriate site, monitoring and Sponsor personnel to ensure 
confidentiality and protection of the data by allowing variable levels of access to the computer 
system. All data collection and reporting will follow strict adherence to the US Health Insurance 
Portability and Accountability Act (HIPAA) and EC guidelines for subject confidentiality. 
 
7.7 
Source Documents 
 
Source data is all information, original records of clinical findings, observations, or other activities 
in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are 
contained in source documents. Examples of these original documents, and data records include: 
hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or 
evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, 
copies or transcriptions certified after verification as being accurate and complete, X-rays, subject 
files, and records kept at the pharmacy, at the laboratories, and at medico-technical departments 
involved in the clinical trial. 
 
The site will make available all source documents for inspection. 
 
The following information should be included in the subject’s medical record: 
• 
Subject’s name and contact information 
• 
The fact that the subject is participating in an approved clinical investigation 
• 
The clinical investigation title and reference number 
• 
The date the subject was enrolled into the trial and the subject ID number 
• 
A statement that written informed consent was obtained; 
• 
Date of procedure and device lot number; 
• 
Dates of all visits; 
• 
Lists of medications; 
• 
Documentation of Adverse Events; 
• 
Date subject exited the clinical investigation, and a notation as to whether the subject 

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completed the clinical investigation or discontinued, with the reason for early termination. 
 
7.8 
Record Retention 
 
In order to constitute evidence with respect to product safety or regulatory or legal compliance, 
the Investigator agrees to retain clinical investigation-related documents in a location that is se- 
cure and to which access can be gained if required. The following documents must be archived: 
Investigator’s File containing all regulatory agency and required GCP documents, including, for 
example, signed Patient Informed Consent forms and subject-related materials, CRFs, and Data 
Clarification forms. 
 
Documents should be retained by the Investigator for the appropriate period (i.e., 15 years in 
Europe or according to the local country regulations). 
 
All clinical investigation-related correspondence, subject records, consent forms, records of the 
distribution and use of the investigational products, and copies of eCRFs should be maintained 
on file. Corindus requires notification in writing if the Investigator wishes to relinquish ownership 
of the data so that mutually agreed upon arrangements can be made for transfer of ownership to 
a qualified entity. 
 
 
8. 
MONITORING PROCEDURES AND AUDITING 
 
The study site will be monitored to ensure that the study is conducted in full compliance with the 
CorPath GRX Neuro Study protocol and GCP. 
The site initiation visits will include, but is not limited to: 
 
• 
Training in adherence to GCP 
• 
Review of the clinical protocol 
• 
Training on techniques for the identification of eligible subjects and in-hospital data 
collection 
• 
Data collection 
• 
Training on the proper and timely reporting of AEs 
• 
Use of the electronic data capture (EDC) system and eCRF completion 
 
 

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8.1 
Study Monitoring Plan 
 
Data from all investigational sites will be monitored as it is submitted to the Sponsor. Qualified 
employees of the Sponsor, or a qualified contract research organization (CRO) under contract 
with the Sponsor, will conduct periodic monitoring visits to perform source data verification, 
evaluate protocol compliance, and determine if there are any issues that could affect the safety 
or welfare of any subjects in the study. 
 
The Investigator will make subject and other study records available to the study monitor for 
periodic inspection, according to the Sponsor’s clinical monitoring procedure. The monitor will 
perform periodic on-site visits. These visits will be done prior to enrollment of the first subject and 
at intervals during the course of the study. The investigational site will allow the monitor access 
to thee CRFs and supporting source data (unless prohibited by national law). The monitor may 
also perform on-site review of medical records if there is a subject death, any unanticipated 
adverse events, or higher frequency of adverse events than expected. 
 
The study monitor is responsible for the conduct and administration of this clinical study. These 
responsibilities include maintaining regular contact with each investigational site and conducting 
on-site monitoring visits at each investigational site to ensure compliance with this Investigational 
Plan; to verify that accurate and complete data are being submitted in a timely manner; and to 
verify that the investigative site facilities continue to be adequate. Concerning completed eCRFs 
for all study patients, the monitor will perform 100% source document verification for all subjects. 
 
The name and address of the Corindus Study Director is: 
Tina Ridgeway 
Corindus Clinical Research Manager  
Corindus, Inc. 
309 Waverley Oaks Road, Suite 105 
Waltham, MA 02452 
USA 
tina.ridgeway@corindus.com 
 
The Corindus Study Director will: 
o Oversee performance of CRO (if contracted) including monitoring, to ensure compliance 

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with study protocol; and in accordance with scope of work and in accordance with Good 
Clinical Practice. 
o Resolve patient eligibility and protocol deviation issues. 
o Review monitoring reports for accuracy, completeness and conformance with SOPs. 
o Maintains frequent contact with and work effectively with Investigators and coordinators. 
o May monitor/audit clinical sites for adherence to protocol, GCP, including conducting site 
pre-qualification, initiation, monitoring visits, and close-out visits or co-monitoring visits 
conducted by CRO personnel. 
o Assurance of regulatory compliance of investigational sites with company SOPs and ICH 
guidelines. 
o Perform clinical data review of data listings and summary tables, including query 
generation. 
o 
Review and/or submission of research Ethics Committee/Regulatory documentation. 
o 
Identify, select, and monitor performance of investigational sites for clinical studies; pre- 
pare accurate and timely visit reports from all site interaction visits. 
 
8.2 
Monitoring Responsibilities 
 
Monitoring responsibilities performed by Corindus or its designees include, but are not limited to 
the following: 
• 
Site initiation visits; 
• 
Interim monitoring visits to: 
o Assess protocol compliance; 
o Conduct source document verification; 
o Assess case report forms accuracy and completeness; 
• 
Telephone contacts with site; 
• 
Maintenance of records of Investigator/monitor contacts; 
• 
Final site close-out visit. 
 
The study monitor is responsible for the conduct and administration of this clinical study. These 
responsibilities include maintaining regular contact with each investigational site and conducting 
on-site monitoring visits at each investigational site to ensure compliance with this Investigational 
Plan; to verify that accurate and complete data are being submitted in a timely manner; and to 
verify that the investigative site facilities continue to be adequate. Concerning completed eCRFs 

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for all study patients, they will be reviewed for accuracy during these visits and the monitor will 
perform 100% source document verification for all subjects. The trial progress will be discussed 
with the Investigator. 
 
8.3 
Protocol Deviations 
 
A protocol deviation is a failure to comply with the requirements of the clinical study as specified 
in the protocol. Examples of protocol deviations include late visits, required follow-up testing not 
completed, or enrollment of a study subject who fails to meet inclusion/exclusion criteria as 
specified in the protocol. Each Investigator shall conduct this clinical study in accordance with the 
study protocol and any conditions required by the reviewing Ethics Committee and Competent 
Authority. 
 
Deviations from clinical protocol requirements will be reviewed and evaluated on an ongoing basis 
and, as necessary, appropriate corrective actions put into place. Corindus accepts the right of the 
Investigator to deviate from the protocol in an emergency when necessary to safeguard the life 
or the physical well-being of a study subject. The Investigator must give notice of any emergency 
deviations and justification for the deviation to Corindus as quickly as possible after the episode, 
in any event no later than 24-hours after the emergency. Corindus will report all deviations to the 
Ethics Committee and Competent Authority. 
 
8.4 
Protocol Changes 
 
The Investigator should not implement changes to the protocol without prior approval by Corindus 
and prior review and documented approval from the governing Ethics Committee and Competent 
Authority. The only exception to this requirement is the necessity to eliminate immediate hazards 
to subjects in the clinical investigation, or when changes involve only administrative aspects (e.g., 
change in monitors, telephone numbers, etc.). 
 
Any report of withdrawal of Ethics Committee or Competent Authority approval will be submitted 
to the Sponsor. 
 
8.5 
Auditing and Regulatory Inspections 
 
The site will permit study-related monitoring, audits, and inspections by the Sponsor and 
government regulatory bodies of all study related documents (e.g., source documents, regulatory 

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documents, data collection instruments, study data, etc.). The site will ensure the capability for 
inspections of applicable study-related facilities (e.g. interventional/surgery center, imaging 
facilities, etc.). 
 
Participation as an Investigator in this study implies acceptance of potential inspection by 
government regulatory authorities and applicable compliance and quality assurance offices. Each 
Investigator is required to execute an Investigator Agreement which delineates their 
responsibilities in this regard. 
 
It is important that the Investigator and relevant study personnel are available during the 
monitoring visits and possible audits and that sufficient time is devoted to the process. 
 
 
9. 
DATA QUALITY ASSURANCE 
 
9.1 
Adverse Event Handling 
 
The Sponsor will identify events associated with the study endpoints and additional event review 
may be performed, as described below. Clinical sites will follow their routine hospital procedures 
for adverse event handling, as necessary. 
 
9.2 
Study Endpoint Event Adjudication 
 
A site independent review of all clinical events associated with the study endpoints will be con- 
ducted. Adjudication will be based on narratives and source data supplied by the sites. Source 
data that may be collected for review include, but are not limited to, de-identified procedural 
angiograms, endovascular lab report, procedure report, discharge summary and lab reports. The 
sites may be contacted for queries and additional support documentation. 
 
 
10. 
SITE AND INVESTIGATOR SYSTEM TRAINING 
 
Both Investigators and clinical staff will undergo a comprehensive CorPath GRX System training 
to ensure they are ready to perform robotic procedures prior to enrollment into the study. Training 
will be per the CorPath GRX System Operator’s Manual. 
 

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10.1  Site Training 
 
All clinical site personnel participating in robotic endovascular procedures will successfully 
complete the CorPath GRX System training program. The site training will be conducted by 
Corindus or their representatives. All clinical staff training will be documented. 
 
10.2 Investigator Training 
CorPath GRX System should only be used by qualified personnel familiar with endovascular 
procedural techniques. Each Investigator will successfully complete the CorPath GRX System 
training program (which includes didactic and hands-on sessions with the CorPath GRX System) 
prior to subject enrollment. Training will be conducted by Corindus or their representatives. All 
Investigator training will be documented. 
 
 
11. 
ADMINISTRATIVE RESPONSIBILITIES 
 
The CorPath GRX Neuro Study will be conducted in accordance with GCP including the study 
protocol, the fully executed Clinical Study Agreement and all applicable regulations. 
 
11.1 Ethical Considerations 
 
This study will be conducted as a Post-Market study. The study will be conducted according to 
Good Clinical Practice (GCP) guidelines; with informed consent and independent Ethics Commit- 
tee review and approval as defined in the World Medical Association Declaration of Helsinki, 
Competent Authority review and approval (if applicable), ISO 14155:2020(E) and the Medical 
Device Regulations (2017/745) of 5 April, 2017. 
 
This protocol and any amendments will be submitted to a properly constituted Ethics Committee 
and Competent Authority (if applicable) for formal approval of the study conduct. The decision of 
the Ethics Committee and Competent Authority (if applicable) concerning the conduct of the study 
will be made in writing to the Sponsor and a copy of this decision will be provided to the 
Investigator before commencement of this study. 
 
All subjects for this study will be provided a consent form describing this study and providing 
sufficient information for subjects to make an informed decision about their participation in this 

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study. This document will be submitted with the protocol for review and approval by the Ethics 
Committee for the study and the Competent Authority (if applicable). The formal consent of a 
patient, using the EC-approved consent document must be obtained before that patient 
undergoes any study procedure. The consent document must be signed by the patient and the 
Investigator-designated research professional obtaining the consent. The Investigator will retain 
a copy of the signed informed consent document in each subject’s record and provide a copy to 
the subject. 
 
Although not indicated in the Patient Information Sheet, in certain countries the Ethics Committee 
requires that all subjects included in the clinical investigation must be affiliated with their 
respective national social security system. It is up to the investigator to find out if the subject has 
this required affiliation. 
 
11.2 Confidentiality 
 
All data sent to Corindus or their authorized designee, concerning subjects or their participation 
in this study will be considered confidential. All data used in the analysis and reporting of this 
evaluation will be used in a manner without identifiable reference to the subject. 
 
11.3 Study Registration and Publication 
 
The CorPath GRX Neuro Study will be registered with ClinicalTrials.gov prior to the start of 
enrollment. ClinicalTrials.gov is a registry of clinical trials and is a publically accessible database. 
It is run by the United States National Library of Medicine (NLM) at the National Institutes of 
Health, and is the largest clinical trials database in the world. The results of the clinical 
investigation will be made publically available. 
 
Corindus, as the Sponsor, has a proprietary interest in this clinical investigation. Authorship and 
manuscript composition will reflect joint cooperation between the Investigator, clinical 
investigation site, and Corindus. Authorship will be established prior to writing of the manuscript. 
No individual publications will be allowed prior to the completion of the final report for this clinical 
investigation and as agreed in writing by Corindus. 
 
A Publications Committee will be formed to review and publish the data from the clinical 
investigation. This committee will consist of investigators and representatives of Corindus. The 

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Publications Committee will write/review all drafts of abstracts, full-length manuscripts and/or oral 
congress presentations/posters and will choose the appropriate journal (for manuscripts) or 
meetings (for abstracts) for submission. 
 
The "Coordinating" Principal Investigator will submit copies of proposed materials to Corindus 
prior to submission for publication or presentation. Corindus will have an appropriate period of 
time for review. 
 
Corindus reserves the right to delete any confidential information or other proprietary information 
from the proposed publications or presentations. 
 
The Principal Investigator will properly acknowledge Corindus in all publications or presentations 
resulting from the clinical investigation. Corindus will have the royalty-free right to reproduce, 
translate, and use publications and presentations for any and all purposes. Written permission 
must be obtained from the Principal Investigator or Corindus to use the other’s name in any form 
of publicity. 
 
11.4 Angiographic Core Lab 
 
The following assessments will be made by the Angiography Core Lab from images submitted 
from the sites. The procedural angiograms will be submitted by site with all subject identifiers 
removed and only the assigned subject study number on the images. 
Procedural, pre, peri and post images: 
• 
Aneurysm location 
• 
Raymond-Roy Occlusion Classification grade (pre-procedure required only for previously coiled 
aneurysms) 
• 
Stenosis of parent and branch arteries(pre-procedure) 
 
 
12. 
FUNDING 
 
This clinical investigation is funded by Corindus, Inc. 
 
 
 
 

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13. 
DEFINITIONS 
 
TERM 
DEFINITION 
Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs 
(including abnormal laboratory findings) in subjects, users or other persons, whether or not 
related to the investigational medical device. 
Device-Related Adverse Event 
Event has a strong temporal relationship to the study device, and alternative etiology is less 
likely. 
Major Stroke 
A stroke, which increases the NIHSS of the subject by ≥ 4. 
Minor Stroke 
A stroke, which increases the NIHSS of the subject by ≤ 3 
Transient Ischemic Attack (TIA) 
A transient episode of neurologic dysfunction caused by focal brain, spinal cord, or retinal 
ischemia without acute infarction. 
Modified Rankin Scale (mRS) 
Scale for measuring general neurologic function. 
0. 
No symptoms at all 
1. 
No significant disability despite symptoms; able to carry out all usual duties and 
activities 
2. 
Slight disability; unable to carry out all previous activities, but able to look after own 
affairs without assistance 
3. 
Moderate disability; requiring some help, but able to walk without assistance 
4. 
Moderately severe disability; unable to walk without assistance and unable to at- 
tend to own bodily needs without assistance 
5. 
Severe disability; bedridden, incontinent and requiring constant nursing care and 
attention 
6. 
Dead 
NIHSS Scale 
The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used 
by healthcare providers to objectively quantify the impairment caused by a stroke. The 
NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. 
For each item, a score of 0 typically indicates normal function in that specific ability, while a 
higher score is indicative of some level of impairment.[1]The individual scores from each 
item are summed in order to calculate a patient's total NIHSS score. The maximum possible 
score is 42, with the minimum score being a 0 
Neurological Deterioration 
Defined as ≥ 4-point increase compared with baseline in the NIHSS at discharge. 
Procedural Related Adverse 
Event 
Defined as events that occur from the endovascular robotic procedure, irrespective of the 
device. 
Raymond-Roy Occlusion  
Classification Scale 
Angiographic classification tool for grading occlusion of aneurysms treated with 
embolization. 
• 
Class I: Complete Obliteration 
• 
Class II: Residual Neck 
• 
Class III: Residual Aneurysm 
o 
Class IIIa: contrast opacification within the coil mesh 
o 
Class IIIb: contrast opacification outside coil mesh 
Screen Failure 
A subject who signs an informed consent form (ICF) and does not have a CorPath GRX 
endovascular procedure or is enrolled in the study but withdraws their consent. 

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Serious Adverse Event 
All Serious Adverse Events are defined as an adverse event where the outcome is one of 
the following: 
1. 
Death 
2. 
Life-threatening, where the patient was at substantial risk of dying or continued use 
of product might have resulted in death 
3. 
Hospitalization or prolongation of an existing hospitalization 
4. 
Disability or permanent damage, interfering with the patient’s ability to conduct nor- 
mal life functions 
5. 
Congenital anomaly or birth defect 
6. 
Required intervention to prevent permanent impairment 
Stroke 
A focal neurological deficit of presumed vascular origin persisting more than 24-hours 
from symptom onset AND a neuro-imaging study or other quantitative study that does 
not indicate a different etiology. The 24-hour criterion is excluded if the subject 
undergoes cerebrovascular surgery or dies during the first 24-hours of symptom onset. 
The definition includes subjects presenting with clinical signs and symptoms suggestive 
of subarachnoid hemorrhage, intracerebral hemorrhage, or cerebral infarction. The 
definition also includes sudden loss or worsening of visual acuity due to retinal artery 
occlusion or retinal emboli. 
The definition excludes slowly progressive cranial nerve palsies or progressive visual 
field deficits due to continued aneurysm growth. The definition also excludes stroke 
events in cases of blood disorders such as leukemia or external events such as trauma. 
 
Stroke severity will be graded by the Investigator as major or minor: 
• 
Major Stroke: A stroke which increases the NIHSS of the subject by ≥4. 
• 
Minor Stroke: A stroke, which increases the NIHSS of the subject by ≤3. 
• 
TIA: a transient episode of neurologic dysfunction caused by focal brain, spinal cord, 
or retinal ischemia without acute infarction 
 
 
14. 
STUDY ADMINISTRATIVE STRUCTURE 
 
Please refer to Appendix A for names of Investigators, Sites and the study Administrative 
Structure. 

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15. 
REFERENCES 
 
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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 
                   
 
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Protocol 
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Revision: I 
Page: 59 of 69 
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Health Risks in Cardiac Catheterization Laboratory Workers. Circ Cardiovasc Interv. 
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Venneri L, Rossi F, Botto N et al. Cancer risk from professional exposure in staff working in 
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intervention for unprotected left main stenosis. Catheter Cardiovasc Interv. 
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34. 
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35. 
Weisz G, Smilowitz NR, Metzger DC et al. The association between experience and 
proficiency with robotic-enhanced coronary intervention-insights from the PRECISE multi-
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Smilowitz NR, Moses JW, Sosa FA et al. Robotic-Enhanced PCI Compared to the 
Traditional Manual Approach. J Invasive Cardiol.2014;26(7):318-321. 

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written consent of Corindus, Inc 
                   
 
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Revision: I 
Page: 60 of 69 
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Weisz G, Metzger DC, Caputo RP et al. Safety and feasibility of robotic percutaneous 
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Campbell PT, Kruse KR, Kroll CR, Patterson JY, Esposito MJ. The impact of precise 
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Bergman P, Blacker SJ, Kottenstette N, Saber O, Sokhanvar S. Robotic-Assisted 
Percutaneous Coronary Intervention (PCI). In: Abedin-Nasab MH, ed. Handbook of Robotic 
and Image-Guided Surgery. Amsterdam, Netherlands: Elsevier; InPress 
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Menaker SA, Shah SS, Snelling BM, Sur S, Starke RM, Peterson EC. Current applications 
and future perspectives of robotics in cerebrovascular and endovascular neurosurgery. J 
Neurointerv Surg.2018;10(1):78-82. 
41. 
De Benedictis A, Trezza A, Carai A et al. Robot-assisted procedures in pediatric 
neurosurgery. Neurosurg Focus.2017;42(5): E7. 
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Gonen L, Chakravarthi SS, Monroy-Sosa A et al. Initial experience with a robotically 
operated video optical telescopic-microscope in cranial neurosurgery: feasibility, safety, 
and clinical applications. Neurosurg Focus. 2017;42(5):E9. 
43. 
Ghasem A, Sharma A, Greif DN, Alam M, Maaieh MA. The Arrival of Robotics in Spine 
Surgery: A Review of the Literature. Spine (Phila Pa 1976).2018. 
44. 
Britz GW, Tomas J, Lumsden A. Feasibility of Robotic-Assisted Neurovascular 
Interventions: Initial Experience in Flow Model and Porcine Model. Neurosurgery.2019. 
45. 
Algra, A.M., et al., Procedural Clinical Complications, Case-Fatality Risks, and Risk Fac- 
tors in Endovascular and Neurosurgical Treatment of Unruptured Intracranial Aneurysms: 
A Systematic Review and Meta-analysis. JAMA Neurol,2018. 
46. 
McDougall, C., Johnston, S., Gholkar, A., Barnwell, S., Vazquez Suarez, J., & Masso 
Romero, J. et al. (2014). Bioactive versus Bare Platinum Coils in the Treatment of 
Intracranial Aneurysms: The MAPS (Matrix and Platinum Science) Trial. American Journal 
of Neuroradiology, 35(5),935-942. 
47. 
Mahmud, E., Naghi, J., Ang, L., Harrison, J., Behnamfar, O., &Pourdjabbar, A. et al. (2017). 
Demonstration of the Safety and Feasibility of Robotically Assisted Percutaneous Coronary 
Intervention in Complex Coronary Lesions. JACC: Cardiovascular Interventions, 10(13), 
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48. 
White, P., Lewis, S., Nahser, H., Sellar, R., Goddard, T., & Gholkar, A. (2008). Hydro Coil 
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49. Coley, S., Sneade, M., Clarke, A., Mehta, Z., Kallmes, D., &Cekirge, S. et al. (2011). 
Cerecyte Coil Trial: Procedural Safety and Clinical Outcomes in Patients with Ruptured 
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480. doi:10.3174/ajnr.a2836. 
50. Becske, T., Kallmes, D., Saatci, I., McDougall, C., Szikora, I., Lanzino, G., Moran, C., Woo, 
H., Lopes, D., Berez, A., Cher, D., Siddiqui, A., Levy, E., Albuquerque, F., Fiorella, D., 
Berentei, Z., Marősfoi, M., Cekirge, S. and Nelson, P., 2013. Pipeline for Uncoilable or 
Failed Aneurysms: Results from a Multicenter Clinical Trial. Radiology, 267(3), pp.858-868.

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Procedure Title: CorPath GRX Neuro Study 
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Doc Number: 104-08660 
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APPENDIX A 
INVESTIGATORS, SITES AND ADMINISTRATIVE STRUCTURE 
 
 
Study Coordinating Principal Investigator: Dr. Michel Piotin 
Service de Neuroradiologie Interventionnelle 
Hôpital de la Fondation Rothschild 
25-29 rue Manin 
F - 75940 Paris, France 
Designated Clinical/Regulatory Consult- 
ant(s): 
Alan Cohen (Europe) 
Cohen’s Clinical Consultants 
Paul Parmentierlaan 180/01 
B – 8300 Knokke, Belgium 
Mobile: +32 473 865091 
E-mail: alanscohen@skynet.be 
Tracey Edinburg (Australia Manager Director) 
ReSQ Clinical Research 
2/40 Hardy Street 
Dover Heights, NSW, Australia 
2030 Mobile: +61 414 242 817 
E-mail: tracey@resqclinical.com.au 
Study Centers: 
Dr. Michel Piotin 
Service de Neuroradiologie 
Interventionnelle 
Hôpital de la Fondation Rothschild 
25-29 rue Manin 
F - 75940 Paris, France 
 
Dr. Nader-Antoine Sourour  
Hôpital Pitié-Salpêtrière  
Service de Neuroradiologie 
Unité de Neuro-vasculaire Interventionnelle 
47/83 Boulevard de l'Hôpital 
F - 75013 Paris France 
Prof. Vincent Costalat 
Service de Neuroradiologie 
Unité Neuro-vasculaire 
CHU Montpellier – Hôpital Gui de Chauliac 
80 Avenue Augustin Fliche 
 F – 34295 Montpellier Cedex 5 France 
 
 

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Doc Number: 104-08660 
Revision: I 
Page: 62 of 69 
Dr. Hal Rice 
Gold Coast University 
Hospital 1 Hospital Blvd 
Southport, QLD, Australia 4215 
 
Dr. Marc Ribo 
Dr. Alejandro Tomasello Weitz 
Unidad Ictus 
Vall d'Hebron University Hospital 119-129, 
08035 Barcelona, Spain 
 
Dr. Mario Martínez Galdámez 
Hospital Clínico Universitario (Valladolid) 
Dept. Interventional Neuroradiology 
Ramón y Cajal 3  
E - 47003 Valladolid, Spain 
 
Dr. Pasquale Mordasini  
University Institute for Diagnostic and 
Interventional Neuroradiology 
Inselspital 
Freiburgstrasse 
3010 Bern, Switzerland 
Prof. Tommy Andersson 
Department of Neuroradiology 
Karolinska University Hospital in Solna 
17176 Stockholm, Sweden 
 
 
Dr. Vitor Mendes Pereira  
Division of Neuroradiology - Joint Department 
of Medical Imaging 
Division of Neurosurgery - Dept of Surgery  
Toronto Western Hospital - 3MCL-436 
399 Bathurst St. 
 Toronto, ON, M5T 2S8 Canada 
 
 Dr. Julian Spears 
 Head, Division of Neurosurgery 
 St. Michael’s Hospital, 
 30 Bond St 
 Toronto, ON M5B 1W8, Canada 

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Procedure Title: CorPath GRX Neuro Study 
Protocol 
Doc Number: 104-08660 
Revision: I 
Page: 63 of 69 
Angiographic Core Laboratory: 
David S Liebeskind, MD Neurovascular 
Imaging Research Core UCLA Department of 
Neurology 
Las Angeles, CA 90095 USA 
Phone: +1 310 963 5539 
E-Mail: davidliebeskind@yahoo.com 
 
Eligibility Committee 
 
Surveillance Committee 
Oculus Imaging, LLC 
602 Gay St. Suite 201 
Knoxville, TN 37902 USA 
Phone: +1 865 293-0355 
 
Syntactx 
4 World Trade Center 
150 Greenwich Street, 44th Floor 
New York, NY 10007 USA 
Phone: +1 (212) 228-9000 
Sponsor 
 
Corindus, Inc.  
309 Waverley Oaks Road, Suite 105 
Waltham, MA 02452 USA 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Procedure Title: CorPath GRX Neuro Study 
Protocol 
Doc Number: 104-08660 
Revision: I 
Page: 64 of 69 
APPENDIX B 
REVISION HISTORY 
Version 
Version Date 
Summary of Changes 
A 
October 15, 2019 
• 
Initial release 
A.1 
October 18, 2019 
• 
Summary 
• 
Clarified investigational site information 
• 
Clarified inclusion criteria 
• 
Updated secondary endpoints 
• 
Schedule of Activities 
• 
Removed complete blood count and platelet 
function testing 
• 
Added hematocrit (HCT), activated partial 
thromboplastin time (aPTT) and international 
normalized ratio (INR) 
• 
Section 3.4 Secondary Endpoints 
• 
Removed Operator Radiation Exposure and 
renumbering of secondary endpoints 
• 
Section 4.6 Inclusion Criteria 
• 
Clarification of robotic assisted endovascular 
treatment 
• 
Section 4.8.2 Baseline Data 
• 
Removed complete blood count and platelet 
function testing 
• 
Added hematocrit (HCT), activated partial 
thromboplastin time (aPTT) and international 
normalized ratio (INR) 
• 
Section 4.8.4 Data Collection During CorPath 
Procedure 
• 
Removed Operator Radiation Exposure  
• 
Section 4.8.11 Schedule of Data Collection 
• 
Removed complete blood count and platelet 
function testing 
• 
Added hematocrit (HCT), activated partial 
thromboplastin time (aPTT) and international 
normalized ratio (INR) 
• 
Appendix A 
• 
Added an additional Study Center 
• 
Updated general protocol formatting 
 
Rev. B 
October 31, 2019 
 
• 
Section Study Summary 
• 
Added that each site will recruit approximately 
20 subjects 
• 
Address change for Alan Cohen, Monitoring 
Services 
• 
Schedule of Activities 

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Procedure Title: CorPath GRX Neuro Study 
Protocol 
Doc Number: 104-08660 
Revision: I 
Page: 65 of 69 
• 
Clarified post procedure clinical assessment 
(scales/scores) is left to the discretion of the 
investigator 
• 
Section 4.1 Overview of Trial Design 
• 
Added each site will recruit approximately 20 
subjects 
• 
APPENDIX A - INVESTIGATORS, SITES AND 
ADMINISTRATIVE STRUCTURE 
• 
Address change for Alan Cohen, Monitoring 
Services 
 
Rev. C 
December 12, 2019 
ONLY FOR CANADA 
• 
Section Study Summary 
• 
Changed Site Investigator to Coordinating  
Principal Investigator  
• 
Added Local Site Principal Investigator – Dr.  
Vitor Pereira  
 
Rev. D 
January 31, 2020 
• 
Section Study Summary 
• 
Dr. Piotin is now the “Study” Coordinating 
Principal Investigator 
• 
Modified inclusion criteria #4 
• 
Added inclusion criteria #5 
• 
Modified exclusion criteria #1 
• 
Added exclusion criteria #2 and #4 
• 
Section 4.4 Informed Consent Procedures 
• 
Added that subject will have at least 24 hrs to 
consider participation in the study. 
• 
Added that this consent shall be obtained 
from each “conscious” subject prior to the 
investigational procedure. 
• 
Added that in the case of an unconscious 
subject due to a ruptured cerebral aneurysm 
where emergency intervention is required, a 
family member may sign the patient consent 
form for inclusion in the study. If and when the 
subject recovers and is conscious, the subject 
is required to sign the patient consent form. 
• 
Section 4.6 Patient Selection 
• 
INCLUSION Criteria 
 
Modified for #4: The “conscious” subject 
has been informed of the nature of the 
study, agrees to its provisions and has 
provided written informed consent. 
 
Added criteria #5: In the case of an 

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Procedure Title: CorPath GRX Neuro Study 
Protocol 
Doc Number: 104-08660 
Revision: I 
Page: 66 of 69 
unconscious subject due to a ruptured 
cerebral aneurysm where emergency 
intervention is required, a family member 
may sign the patient consent form for 
inclusion in the study. 
• 
EXCLUSION Criteria 
 
Modified for #1: “For a conscious 
subject, failure / unwillingness” to provide 
informed consent, unless the EC has 
waived informed consent. 
 
Added criteria #2: In the case of an 
unconscious subject due to a ruptured 
cerebral aneurysm, a family member 
may sign the patient consent form for 
inclusion in the study, however, if during 
the preliminary evaluation in the 
interventional suite the subject’s 
anatomic conditions do not meet the 
selection criteria, the subject will be 
excluded from the study. 
 
Added criteria #4: Women who are 
pregnant and persons under 
guardianship or curatorship. 
• 
Appendix A 
• 
Dr. Piotin is now the “Study” Coordinating 
Principal Investigator 
• 
Added to Study Centers Dr. Sourour (Paris, 
France), Dr. Galdamez (Valladolid, Spain), Dr. 
Holtmannspötter (Nürnberg, Germany), Dr. 
Gralla (Bern, Switzerland) and Dr. Brouwer 
(Leiden, Netherlands) 
 
Rev. E 
February 28, 2020 
• 
Appendix A 
• 
Added to Study Centers Prof. Costalat 
(Montpellier, France) 
 
Rev. F 
June 25, 2020 
ONLY FOR CANADA 
• CORPATH GRX NEURO STUDY SUMMARY 
• 
Added Secondary Endpoints 
 
Composite outcomes of procedure-
related complications AND permanent 
focal neurological deficits assessed at 
90-day and 180-day follow-up visits 
 
Aneurysm Occlusion Secondary 
Endpoint – changed duration from peri-

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Procedure Title: CorPath GRX Neuro Study 
Protocol 
Doc Number: 104-08660 
Revision: I 
Page: 67 of 69 
 
procedure to post-procedure 
 
Expanded Core Laboratory secondary 
endpoint to include assessment at 180-
day follow-up 
• Schedule of Activities Tables 
• 
Updated to reflect the addition of 90-day and 
180-day follow-up 
• 
Added Telephone Assessment 
• Section 3.4 Secondary End points 
• 
Added secondary end point - Composite 
Outcomes of   Procedure-Related 
Complications and Permanent Focal 
Neurological Deficits assessed at 90-day and 
180-days 
• 
Aneurysm Occlusion Secondary Endpoint – 
changed duration from peri-procedure to post-
procedure 
• 
Expanded Core Laboratory secondary 
endpoint to include Raymond-Roy Occlusion 
Classification at 180-days 
• Section 4.8.5 Data collection Post Procedure 
• 
Added NIHSS must be completed post 
procedure 
• 
Added recommended that telephone numbers 
and contact information be confirmed with the 
subject before discharge 
• Section 4.8.11 Follow-up 
• 
Added 90-day and 180-day follow-up 
assessment and testing requirements 
• Section 6.4 Determination of Historical Controls 
• 
Added new safety and efficacy data for 180-
day follow-up 
• 
Section 6.7 Endpoint Analysis and Reporting 
• 
Adding secondary endpoint reporting for the 
90-day and 180-day follow-up visits 
• Section 11.4 Angiographic Core Lab   
• 
Added 180-days ± 30 days post-procedure, 
assess Raymond-Roy Occlusion 
Classification  
• Section 15 References 
• 
Updated reference page 
• Formatting changes 
 
Rev. G 
November 11, 2020 
ONLY FOR CANADA  Rev F + Rev H combined 
Rev. H 
November 11, 2020 
• 
Update ISO reference to ISO 14155:2020(E) 

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Procedure Title: CorPath GRX Neuro Study 
Protocol 
Doc Number: 104-08660 
Revision: I 
Page: 68 of 69 
which became effective in July 2020 
• 
Added specific section 2.2.4 (Device 
Accountability) 
• 
Section 4.1 (Overview of Trial Design) – clarified 
• 
Section 4.6 Patient Selection 
• 
INCLUSION Criteria 
 
#2: removed ruptured intracranial 
aneurysms 
 
#5: removed unconscious subjects 
• 
EXCLUSION Criteria 
 
#2: removed unconscious subject with a 
ruptured aneurysm 
 
#4: clarified 
• 
Added specific section 4.6.3 (Eligibility 
Committee) 
• 
Section 4.8.10 (Follow-up) – clarified 
• 
Section 5.1 (Adverse Event Classification and 
Definitions) – updated to new ISO 14155:2020(E) 
• 
Section 11.3 (Study Registration and 
Publication) – clarified 
• 
Appendix A (Investigators, Sites & 
Administrative Structure) – updated 
Rev. I 
May 21, 2021 
 
All Sites 
• CORPATH GRX NEURO STUDY SUMMARY 
• 
Added Secondary Endpoints 
• 
Composite outcomes of procedure-related 
complications AND permanent focal 
neurological deficits assessed at 90-day and 
180-day follow-up visits 
• 
Aneurysm Occlusion Secondary Endpoint – 
changed duration from peri-procedure to post-
procedure 
• 
Expanded Core Laboratory secondary 
endpoint to include assessment at 180-day 
follow-up 
• Schedule of Activities Tables 
• 
Updated to reflect the addition of 90-day and 
180-day follow-up 
• 
Added Telephone Assessment 
• Section 3.4 Secondary End points 
• 
Added secondary end point - Composite 
Outcomes of   Procedure-Related 
Complications and Permanent Focal 
Neurological Deficits assessed at 90-day and 

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Procedure Title: CorPath GRX Neuro Study 
Protocol 
Doc Number: 104-08660 
Revision: I 
Page: 69 of 69 
180-days 
• 
Aneurysm Occlusion Secondary Endpoint – 
changed duration from peri-procedure to post-
procedure 
• 
Expanded Core Laboratory secondary 
endpoint to include Raymond-Roy Occlusion 
Classification at 180-days 
• Section 4.8.10 Data collection Post Procedure 
• 
Added NIHSS must be completed post 
procedure 
• 
Added recommended that telephone numbers 
and contact information be confirmed with the 
subject before discharge 
• Section 4.8.11 Follow-up 
• 
Added 90-day and 180-day follow-up 
assessment and testing requirements 
• Section 6.4 Determination of Historical Controls 
• 
Added new safety and efficacy data for 180-
day follow-up 
• 
Section 6.7 Endpoint Analysis and Reporting 
• 
Adding secondary endpoint reporting for the 
90-day and 180-day follow-up visits 
• 
Section 11.4 Angiographic Core Lab 
• 
Added 180-days ± 30 days post-procedure, 
assess Raymond-Roy Occlusion 
Classification  
• 
Section 15 References 
• 
Updated reference page 
• 
Appendix A 
• 
Added to Study Centers Dr. Spears (Toronto, 
Canada) 
• 
Removed Dr. Manning (Liverpool, Australia), 
Dr. Holtmannspötter (Nürnberg, Germany) 
• 
Added Dr. Tomasello as Co-Principal 
Investigator to Barcelona, Spain 
• 
Formatting changes