Success in Comaneci-assist Coils Embolization Surveillance Study
Conditions: Intracranial Aneurysm
Sponsor: Rapid Medical

 
 
 
 
 
 
 
SUCCESS STUDY 
SUccess in Comaneci-assist Coils Embolization Surveillance Study 
SURVEILLANCE PLAN 
PS190001 
 
 
  ClinicalTrials.gov ID: CT04518670 
Protocol #: CLN-Co-001 
VERSION: 2.0 
DATE: March 6, 2023 
 
 
 
 
 
Study Sponsor: 
Rapid Medical 
P.O. Box 337 
Carmel Building 
Yokneam 2069205 
Israel 

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SURVEILLANCE PLAN (SP) APPROVAL 
 
 
Study Title: SUCCESS Study 
CIP Version: 2.0 
CIP Date: March 6, 2023 
 
 
Signatures: 
 
 
 
 
 
 
Dr. Walid Haddad 
VP Clinical Operations 
Rapid Medical 
Sponsor Representative 
 
Date 
 
 
 
 
 
 
 
 
 
Date 
Ricardo Hanel, Baptist Neurological 
Institute, Baptist Health System 
Jacksonville, FL 
 
Coordinating Principal Investigator 
 
 
Date 
Jason Davies, Jacobs School of 
Medicine and Biomedical Sciences, 
University at Buffalo, New York 
 
Co-Coordinating Principal Investigator 

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SP SIGNATURE PAGE 
 
 
Study Title: SUCCESS Study 
CIP Version: 2.0 
CIP Date: March 6, 2023 
 
I have read the Surveillance Plan and agree to adhere to the surveillance plan contained herein. 
Deviations from the surveillance plan will not be made prior to sponsor notification, except when 
necessary to protect the safety, rights, or welfare of study Subjects. 
I agree to conduct or supervise the conduct of the described Surveillance and ensure all 
participating investigators and research staff are appropriately trained regarding the study 
conduct prior to participating in any study related activities. 
I will ensure that the requirements relating to obtaining informed consent and Institutional 
Review Board (IRB) review and approval, as they pertain to 21 CFR Part 50, ICH E6 are met. 
I agree to maintain adequate and accurate records in accordance with 21 CFR 812.140 and to 
make those records available for inspection in accordance with 21 CFR 812.145 and ICH E6. 
I will ensure that the IRB complies with the requirements of 21 CFR Part 56 and ICH E6 and will 
be responsible for the initial and continuing review and approval of the clinical investigation. I 
also agree to promptly report to the IRB any changes in research activity and all unanticipated 
problems involving risks to human Subjects or others. Additionally, I will not make any changes 
in research without IRB approval, except where necessary to eliminate apparent immediate 
hazards to human Subjects. 
I agree to comply with all other clinical investigator obligations and pertinent requirements in 21 
CFR Part 812 and ICH E6. 
 
 
 
Site Principal Investigator (please print or use stamp) 
 
 
 
 
 
Site Principal Investigator Signature 
Date 

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LIST OF ABBREVIATIONS 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
A-P 
Anterior-Posterior 
CFR 
Code of Federal Regulations 
CIP 
Clinical Investigation Plan 
CRO 
Clinical Research Organization 
CTA 
Clinical Trial Agreement 
CT 
Computed Tomography 
CV 
Curriculum Vitae 
DSA 
Digital Subtraction Angiography 
DSMB 
Data Safety Monitoring Board 
eCRF 
Electronic Case Report Form 
eIC 
electronic Informed Consent 
EDC 
Electronic Data Capture 
EVT 
Endovascular Treatment 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
IA 
Intracranial Aneurysm 
ICF 
Informed Consent Form 
ICH 
Intracranial Hemorrhage 
ID 
Identification 
IFU 
Instructions for Use 
INR 
International Normalized Ratio 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
LAR 
Legally Authorized Representative 
MDR 
Medical Device Reporting 
MRI 
Magnetic Resonance Imaging 
mRS 
Modified Rankin Score 
NIH 
National Institutes of Health 
NIHSS 
National Institutes of Health Stroke Score 
PI 
Principal Investigator 
PT 
Prothrombin Time 
PTT 
Partial Thromboplastin Time 
RFA 
Rankin Focused Assessment 
SAE 
Serious Adverse Event 
SADE 
Serious Adverse Device Effect 
sICH 
Symptomatic Intracranial Hemorrhage 
SOC 
Standard of Care 

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PROTOCOL SUMMARY 
Postmarket Surveillance Plan (PS190001) 
-SUCCESS Study- 
 
Title 
SUccess in Comaneci-assist Coils Embolization Surveillance Study 
Short title 
SUCCESS Study 
Sponsor 
Rapid Medical 
Coordinating 
Principal 
Investigators 
Ricardo Hanel, Baptist Neurological Institute, Baptist Health System 
Jacksonville, FL 
 
Co-Investigator: Jason Davies, Jacobs School of Medicine and Biomedical 
Sciences, University at Buffalo, New York 
Product 
Comaneci Embolization Assist Device 
Objective 
The objective of the Postmarket Surveillance Plan is to assess safety and 
performance as used in postmarket clinical practice in the U.S. 
Study Design 
This study is a multicenter, single arm, open, prospective, postmarket safety 
surveillance in up to 30 US centers 
Device 
Description 
and Intended 
Use 
The Comaneci Embolization Assist Device is indicated for use in the 
neurovasculature as a temporary endovascular device used to assist in the 
coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 
10 mm. A wide-necked intracranial aneurysm (IA) defines the neck width as 
≥ 4 mm or a dome-to-neck ratio < 2. 
The Comaneci is comprised of a collapsible, fully retrievable, fine wire 
construction mounted on a wire shaft that expands to comply with the 
vessel diameter. It is delivered through a neurovascular microcatheter. The 
Comaneci is provided with a 3.5 French (F) peelable loading sheath. 
Endpoints 
Safety 
• 
Periprocedural events*: Rates of all adverse events occurring within 
24 hours post-procedure and hospital discharge status. 
• 
All adverse events at discharge and up to 30 days post procedure. 
• 
Functional status at discharge and 30 days assessed using the 
modified Rankin Scale (mRS). 
Secondary safety endpoint: evaluation of the extent of any relationship 
between adverse event rate to operator experience. 
(*) Including vessel perforation or dissection, intracranial aneurysm rupture, stroke, 
hemorrhage, death, inability to deploy or remove the device, and coil entanglement 
Efficacy 

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• 
Successful intracranial aneurysm occlusion (measured by Raymond 
Roy classification I or II) at the end of procedure, using digital 
subtraction angiography (DSA). 
• 
Successful intracranial aneurysm (IA) occlusion, that is a stable IA 
occlusion, measured by Raymond Roy classification I or II taken at 6 
months (± 21d) post procedure without the need for re-treatment of 
the target IA, using DSA. 
• 
Good clinical outcome- mRS shift @ 6 months (change @ 6 months 
from pre procedure) and tetrachotomized (0,1, 2, 3-6) mRS analysis. 
Number of Subjects: 
Surveillance is to continue until complete data 
on the deployment of 90 devices with 
complete 30-day patient status are obtained 
Number of Study Centers: 
Up to 30 centers total in the US 
Population 
The Postmarket Surveillance Study will include male or female patients 
with wide-necked ruptured and/or unruptured intracranial aneurysms that 
may require adjunctive assistance with coil embolization during the surgical 
procedure. 
Inclusion 
Criteria 
In order to assure that the probable benefits outweigh the probable risks for 
the Comaneci Embolization Assist Device, as indicated in the IFU, the 
subjects must meet all of the following inclusion criteria: 
 
1. Patient has a documented intracranial ruptured or unruptured 
aneurysm, suitable for embolization by coils. 
2. Patient is considered for treatment with coil embolization assisted by 
the Comaneci Device for wide-necked intracranial aneurysms with 
neck width ≤ 10 mm. A wide-necked intracranial aneurysm is defined 
by the neck width as ≥ 4 mm or a dome-to-neck ratio < 2. 
3. A signed informed consent by the patient or legally authorized 
representative 
Exclusion 
Criteria 
Patient should be treated by the Comaneci device in accordance with the 
approved device label. (i.e. doesn’t meet the contraindication criteria, as 
described in the IFU): 
 
1. Patient with known hypersensitivity to nickel-titanium 
Study Duration 
Enrolment: 30 months 
Follow-up period: 180 days 
Committees 
and Core lab 
• 
DSMB – Data Safety Monitoring Board 
• 
Imaging Core Lab- UCLA 

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Statistical 
Analysis 
The rates of all adverse events occurring within 24 hours post procedure, 
hospital discharge status and after discharge for all opened devices at each 
participating clinical site during the surveillance period will be summarized. 
The numbers of individual adverse events of each type and the per subject 
incidence rate for each type of adverse event will be determined and 
reported along with 90% two-sided exact binomial confidence intervals. 
Separate event counts and incidence rates with corresponding confidence 
intervals will be summarized for adverse events determined to be serious, 
device-related, serious and device-related, procedure-related, serious and 
procedure-related, and severe. Listings for all adverse events will be 
compiled that provide full descriptions of each adverse event including 
determination of the severity, seriousness, and relationship to the device or 
procedure. Discharge status will be described with counts and percentages. 
 
Effectiveness at six months will be descriptively summarized in terms of the 
number and percentage of subjects achieving successful aneurysm 
occlusion measured by Raymond scale grade I and II and by clinical 
outcome as measured by mRS shift analysis comparing preprocedure mRS 
(up to 24 h prior to treatment) with 6 month mRS. In addition, 
tetrachotomized (0,1, 2, 3-6) mRS analysis will also be performed. mRS will 
also be evaluated at discharge and 30 days. Successful aneurysm 
occlusion will also be evaluated at the end of procedure. Stability of 
occlusion will be evaluated by comparing the two angiographic studies that 
are 6 months apart. The distribution of scores will be summarized by counts 
and percentages. If only three month Raymond scale value is available but 
not the six month, the three month value will be used in these analyses. 
Similarly, the last available earlier mRS values will be used if the six month 
value is not available. 

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Schedule of Events 
 
Elapsed 
time/Study 
procedures 
Baseline/ 
Procedure 
 
24 hours 
(-6/+12) 
Discharge if 
different than 
24 hours (- 
6/+12) 
 
30 (±7) 
days 
180 
(±21) 
days** 
Informed 
Consent 
X 
 
 
 
 
Demographics 
X 
 
 
 
 
Medical History 
and Concomitant 
Medications 
X 
 
 
 
 
Brain CT Scan 
X 
X* 
 
 
 
Vital Signs 
X 
 
 
 
 
mRS score+ 
X 
 
X 
X 
X 
NIHSS 
X 
 
 
X 
 
Clinical 
Laboratory 
X 
 
 
 
 
Raymond scale 
X*** 
 
 
 
X*** 
Intraoperative 
data 
X 
 
 
 
 
Prior/concomitant 
medications 
X 
X 
X 
X 
X 
Adverse Events 
X 
X 
X 
X 
X 
 
(*) If performed as a standard of care any time up to 24 hours post procedure 
(**) Will be collected if performed also at 90 (±14) days as a standard of care. 
(***) Post-procedure and 6 months imaging should use Digital Subtraction Angiography (DSA) 
for Raymond scale assessments. 
(+) If in-person visits are not possible, mRS assessments may be performed remotely by 
structured telephone interviews. 

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Summary of Surveillance Plan Changes 
 
Version History 
Effective Date 
1.0 
June 29, 2020 
 
 
 
Version 2.0, March 6, 2023 
Section 
Change From 
Change To 
Rationale for Change 
Synopsis, 
section 6, 
section 8.1 
Sample size 120 
Sample size 90 
The primary effectiveness endpoint 
is successful intracranial aneurysm 
occlusion (measured by Raymond 
Roy classification I or II) at the end 
of procedure, using digital 
subtraction angiography (DSA). 
 
The performance goal (PG) for 
evaluating effectiveness is based 
on outcomes as reported in the 
Comaneci de novo, which was 
successful aneurysm occlusion of 
79.7%. 
 
With a hypothesized true incidence 
rate of 82.6% for successful 
intracranial aneurysm occlusion at 
the end of procedure and desired 
power of ≥ 80%, using a normal 
approximation test with a nominal 
0.025 one-sided significance level 
(equivalent to a two-sided 
alpha=0.05), the required evaluable 
sample size for primary efficacy 
is 90 evaluable patients with a 
power of 80%. 
Section 5.1 No maximum of 
enrolled subjects in 
each clinical center. 
No more than 13 subjects 
should be enrolled at 
each clinical center. 
In order to ensure reasonable 
patient diversity and user diversity. 
Synopsis 
Study duration: 
enrollment 24 
months 
Study duration: 
enrollment 30 months 
To reflect the actual rate of 
patients’ enrollment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of Contents 
1. 
INTRODUCTION AND BACKGROUND 
13 
1.1 
Background 
13 
1.2 
The Comaneci device 
15 
2. 
DEVICE DESCRIPTION 
16 
2.1 
Comaneci Device 
16 
2.1.1 
Device Versions: 
16 
2.1.2 
Microcatheter Compatibility: 
17 
2.1.3 
Device Indication Use 
17 
2.1.4 
Labeling 
17 
3. 
STUDY OBJECTIVES 
17 
3.1 
Endpoints 
17 
4. 
ENDPOINT JUSTIFICATION AND RATIONALE 
18 
5. 
SITES AND SUBJECTS 
18 
5.1 
Subjects 
18 
5.1.1 
Enrolment and Informed Consent 
18 
5.1.2 
Study Subject Numbering 
20 
5.1.3 
Subject Terminations 
20 
5.2 
Site Selection, Training and Initiation 
21 
5.2.1 
Selection 
21 
5.2.2 
Training 
21 
5.2.3 
Initiation 
22 
6. 
STUDY DESIGN 
22 
6.1 
Study Duration 
22 
6.2 
Subject Inclusion/Exclusion Criteria 
22 
6.2.1 
Inclusion Criteria 
22 
6.2.2 
Exclusion Criteria 
23 
7. 
Data Collection 
23 
7.1 
Study 
23 

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7.2 
Screening and Baseline Visit 
25 
7.2.1 
Patient Details: 
25 
7.2.2 
Medical History: 
25 
7.2.3 
Pre- Treatment Data: 
26 
7.2.4 
Screen Failures 
26 
7.3 
Procedure 
26 
7.3.1 
Angiography 
26 
7.3.2 
Intraoperative Data 
27 
7.4 
24 Hour (-6/+12) Follow-up 
27 
7.5 
Discharge, if different than 24 hours (-6/+12 hours) 
27 
7.6 
30 days (± 7 days), can be performed over the phone 
28 
7.7 
180 days (± 21 days) 
28 
7.8 
Unscheduled Visits 
28 
7.9 
Adverse Events 
28 
7.10 Clinical Outcomes Assessment 
29 
8. 
STATISTICAL ANALYSIS- 
30 
8.1 
General Principles 
30 
8.2 
Evaluation of Periprocedure Events 
31 
8.3 
30-day post-procedure status 
32 
8.4 
Six Month Effectiveness and Clinical Status 
32 
8.5 
Subgroup Analysis 
32 
8.6 
Missing Data 
32 
8.7 
Heterogeneity Among Investigational Sites 
33 
8.8 
Deviations from the Statistical Plan 
33 
8.9 
Software 
33 
9. 
RISK/BENEFIT ANALYSIS 
33 
10. DEVIATIONS FROM THE CLINICAL SURVEILLANCE PLAN 
34 
10.1 Surveillance Plan Deviations 
34 
11. SAFETY AND ADVERSE EVENTS 
34 
11.1 Adverse Event Data Collection 
34 
11.2 Definitions 
35 

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11.2.1 
Adverse Events 
35 
11.2.2 
Adverse Device Effect 
35 
11.2.3 
Serious Adverse Events 
35 
11.2.4 
Serious Adverse Device Effect 
36 
11.2.5 
11.2.7 Procedure-Related 
36 
11.2.6 
11.2.8 Device-Related 
36 
11.3 Determination of Event Severity and Relatedness 
37 
11.4 Event Notification 
37 
11.5 Data and Safety Monitoring Board 
37 
12. STUDY MONITORING 
38 
12.1 Source Documentation 
39 
12.2 Access to Source Documents 
39 
13. DATA COLLECTION AND OWNERSHIP 
39 
13.1 Protected Health Information and Confidentiality 
39 
13.2 Data Management 
39 
13.3 Electronic Case Report Forms 
39 
13.4 Record Retention and Storage 
40 
13.4.1 
Sponsor Record Retention 
40 
13.4.2 
Investigator Record Retention 
40 
13.5 Publication Policy 
40 
14. AUDITS OR INSPECTIONS 
41 
15. REFERENCES 
42 

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1. 
INTRODUCTION AND BACKGROUND 
1.1 Background 
 
An aneurysm is an abnormal local dilatation in the wall of a blood vessel, usually an artery, due 
to a defect, disease, or injury. A rupture is the main risk associated with an aneurysm. Other less 
common risk is thromboembolic events. A ruptured aneurysm can lead to bleeding, serious injury 
and death. This risk increases as the aneurysm increases in size1. 
 
Aneurysms are particularly risky when they occur in intracranial blood vessels. A ruptured 
aneurysm in the brain is one of the most common cause of hemorrhagic stroke; which is a serious 
medical condition often leading to severe neurological deficit or death (Two-thirds of patients with 
aneurysm rupture either die or have a disabling neurological deficit2). 
 
The incidence of intracranial aneurysms (IAs) is estimated to be between 1.8% and 2%3, a number 
that is supported by recent MRI investigations4..The yearly rupture rate for IAs was calculated to 
be as low as 0.05%5. Recent publications have raised the risk figure to 1.3-1.4%6,7. 
 
Intracranial aneurysms can be classified using several schemes. The most obvious division is 
considering the ruptured and unruptured lesions separately. With respect to morphology, 
aneurysms are classified as saccular or non-saccular. Saccular aneurysm refers to any aneurysm 
with a saccular outpouching. Non-saccular intracranial aneurysms involve widening of an entire 
blood vessel, such as a fusiform aneurysm. 
 
The primary treatment goal of cerebral aneurysms is prevention of rupture. Treatment methods 
include two major intervention options: clipping of the aneurysm neck and endovascular methods 
such as coiling and flow diversion as reconstructive therapy and permanent vessel occlusion 
(PVO) as deconstructive therapy (if the aneurysm is uncoilable). Traditionally, surgical clipping 
has been the only treatment modality for both ruptured and unruptured cerebral aneurysms until 
20 years ago; however, since the introduction of controlled detachable coils (GDC) for packing of 
aneurysms in 19918, endovascular aneurysm therapy has become an acceptable as well as 
preferable alternative to conventional neurosurgical treatment. There is well-established clinical 
evidence demonstrating that endovascular coiling is more likely to result in independent survival 
at 1 year when compared to neurosurgical clipping and that the survival 

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benefit continues for at least 7 years. After both treatment strategies the risk of late rebleeding is 
low, but is more common after endovascular coiling than after neurosurgical clipping9. 
 
The most common endovascular technique used to treat aneurysm is utilizing intrasaccular coils 
for embolization of the aneurysm. However, this technique is somewhat limited by the shape of 
some of these aneurysms. Wide-necked aneurysms (aneurysm absolute neck diameter of 4.0 
mm10 and/or dome-to-neck ratios of <2.011) are difficult to treat because of their unfavorable 
geometry, which reduces the possibility of achieving dense packing and elimination of the 
aneurysm from circulation. One of the major risks is the possibility of coil herniation through the 
broad neck into the parent vessel. This can cause thromboembolic events, which are serious 
complications associated with endovascular treatment (EVT) of intracranial aneurysms (IA). 
Thromboembolic events with partially or completely persisting neurological deficits are reported 
in 2.4% to 5.2% of endovascular-treated patients12,13,14. 
 
To overcome this complication, the use of an adjunctive device to support coil embolization 
treatment was introduced by Moret, et al. in 199715 16. In this groundbreaking study, Moret utilized 
an intracranial balloon to treat 52 wide neck or badly shaped aneurysms that were untreatable 
without this technique. The results of occlusion with the assistance of a balloon (“balloon 
remodeling technique” or ''balloon-assisted coiling'' - BAC) were better than those in the series of 
normal GDC treatment, and complications related to the technique were fewer. This technique 
thereby extended the spectrum of treatable aneurysms without increasing the risk recurrence or 
aneurysm regrowth and recanalization by treatment. 
 
The balloon remodeling technique (BAC) involves placing a balloon mounted to a microcatheter 
in the parent artery along the aneurysm neck. An additional microcatheter is positioned in the sac 
of the aneurysm, while the balloon deflated. The balloon is inflated during the deployment of the 
coil (Figure 1 - Balloon remodeling technique: the balloon is inflated during coil delivery) and 
deflated before its detachment to assess its stability inside the aneurysm. The balloon serves two 
purposes during embolization; to stabilize the microcatheter in the aneurysm during coil delivery, 
and to force the coil to assume the shape of the aneurysm without impinging on the parent vessel. 

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Figure 1 - Balloon remodeling technique: the balloon is inflated during coil delivery 
 
 
1.2 The Comaneci device 
 
Similar to a remodeling balloon the Comaneci is a temporary device intended to support 
neurovascular coil embolization procedure. Specifically, it is designed to provide visible 
temporary support during coil embolization of intracranial aneurysms. It integrates the 
advantages of existing adjuvant devices without the risk of parent vessel occlusion during 
coiling procedure or the need for long-term antiplatelet medication in case of permanent 
stenting. 
The Comaneci is comprised of a collapsible, fully retrievable, fine wire construction mounted 
on a wire shaft that expands to the vessel diameter. It is delivered through an intracranial 
microcatheter and is intended to prevent coil protrusion towards the vessel lumen during 
aneurysm closure. The long and soft atraumatic tip of the Comaneci protects the vessels 
wall from perforation and enables better deliverability and navigability. The Comaneci is 
manufactured from superelastic Nitinol wire with tantalum core and is fully radioopaque. It 
also includes a soft, floppy loading device, which enables easy insertion of the shaft and 
Comaneci to the micro catheter. The outer diameter of the mesh is controlled via a handle. 

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Figure 2 - Comaneci Temporary Support Aneurysm Coiling Device 
 
 
 
2. 
DEVICE DESCRIPTION 
2.1 Comaneci Device 
The Comaneci is intended for use in the neurovasculature to assist in the coil embolization of 
wide-necked intracranial aneurysms under fluoroscopic guidance. The Comaneci is comprised 
of a collapsible, fully retrievable, fine wire construction mounted on a wire shaft that expands to 
comply with the vessel diameter. It is delivered through a neurovascular microcatheter. The 
Comaneci is provided with a 3.5 French (F) peelable loading sheath. 
 
 
2.1.1 
Device Versions: 
Three versions of the Comaneci are available. The standard Comaneci has a length of 32 mm, 
which shortens to 25 mm when deployed in a straight vessel of 4 mm diameter. The Comaneci 
Petit measures 24 mm before deployment and contracts to 21 mm when fully deployed in a 
straight vessel of 3 mm diameter. The Comaneci 17 measures 22 mm before deployment and 
contracts to 16 mm when fully deployed in a straight vessel of 3 mm diameter. 

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2.1.2 
Microcatheter Compatibility: 
The Comaneci and Comaneci Petit should be introduced through a microcatheter with a 
minimum inner diameter of 0.021 inches. The Comaneci 17 should be introduced through a 
microcatheter with a minimum diameter of 0.017 inches. The Comaneci was introduced in a 
bench top model test using the following microcatheters shown in Table 1: 
Table 1: Sizes and Microcatheters Compatibility 
 
 
 
2.1.3 
Device Indication Use 
The Comaneci Embolization Assist Device is indicated for use in the neurovasculature 
as a temporary endovascular device used to assist in the coil embolization of wide- 
necked intracranial aneurysms with a neck width ≤ 10 mm. A wide-necked intracranial 
aneurysm defines the neck width as ≥ 4 mm or a dome-to-neck ratio < 2. 
 
2.1.4 
Labeling 
 
The Comaneci device is required to be used per the protocol and as specified in the 
Instructions for Use (IFU) document (attached as Appendix A). 
 
 
3. 
STUDY OBJECTIVES 
 
The objective of the Postmarket Surveillance Plan is to assess safety and performance as 
used in postmarket clinical practice in the U.S. 
3.1 Endpoints 
 
Safety 
o Periprocedural events*: Rates of all adverse events occurring within 24 hours 
post-procedure and hospital discharge status. 
o 
All adverse events at discharge and up to 30 days post procedure. 
o 
Functional status at discharge and 30-days assessed using the modified Rankin 
Scale (mRS). 
Secondary safety endpoint: evaluation of the extent of any relationship between adverse 
event rate to operator experience 
(*) Including vessel perforation or dissection, intracranial aneurysm rupture, stroke, hemorrhage, death, inability to 
deploy or remove the device, and coil entanglement 

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Efficacy 
o Successful intracranial aneurysm occlusion (measured by Raymond Roy 
classification I or II) at the end of procedure, using digital subtraction angiography 
(DSA). 
o Successful intracranial aneurysm (IA) occlusion, that is a stable IA occlusion, 
measured by Raymond Roy classification I or II taken at 6 months (± 21d) post 
procedure without the need for re-treatment of the target IA, using DSA. 
o Good clinical outcome- mRS shift @ 6 months (change @ 6 months from pre 
procedure) and tetrachotomized (0,1, 2, 3-6) mRS analysis. 
 
 
4. 
ENDPOINT JUSTIFICATION AND RATIONALE 
 
Due to the fundamental design of the Comaneci Embolization Assist Device and the novel 
use of a core wire to expand and contract the mesh region to set the size of the device in 
the target vessel, the purpose of this postmarket surveillance plan is to capture real world 
safety data as the device is used in practice by physicians in the United States (U.S.). 
 
 
5. 
SITES AND SUBJECTS 
5.1 Subjects 
 
5.1.1 
Enrolment and Informed Consent 
 
Ninety (90) subjects with device deployment will be enrolled in up to 30 US clinical 
centers, while no more than 13 subjects should be enrolled at each clinical center. 
Subject’s informed consent must be obtained and documented according to the 
principles of informed consent. 
Any subject who is consented for endovascular treatment of an IA that may potentially 
require use of the Comaneci device at the participating centers in the study will be 
approached for consenting prior to device use, using separate consent for the subject’s 
participation in and data collected to be included in the SUCCESS study. 
Subjects with ruptured aneurysms: due to the emergent nature of acutely ruptured 
aneurysms, informed consent may be obtained from the point of arrival at the 
medical treatment facility up to 72 hours after the study procedure. 
For all subjects, consent must be obtained before any data is captured in the eCRF. 
Accounting for all unsealed Comaneci devices in each IA case that may potentially 
require use of the Comaneci device at a clinical site for the period of enrollment to the 
study will be provided. The accounts will not provide patient information but will provide 
some indication of the device disposition. 
 
A patient informed consent form (ICF) will be given to each Subject or their Legally 

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Authorized Representative [(LAR); as defined by the local Institutional Review Board 
(IRB)]. The ICF will include an explanation of surveillance plan, duration, explanation of 

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medical record access and patient anonymity, and how their coded data may be 
transferred, used for publications or in submissions for reimbursement support. The ICF 
will contain language that is non-technical and understandable to the patient or his/her 
LAR. 
 
Consent can be obtained electronically (Electronic Informed Consent, eIC), and the 
eIC materials be provided for both on-site and remote access. The eIC process may 
take place at the study site when both the investigator and subject are at the same 
location, or it may take place remotely where the subject reviews the consent 
document in the absence of the investigator or other study personnel. If the entire 
process takes place at the study site, the study personnel can personally verify the 
subject’s identification, review the eIC content, answer questions about the material, 
have follow-up discussions, and witness the signing of the eIC. If any or all of the 
consent process takes place remotely and is not personally witnessed by study 
personnel, the electronic system must include a method to ensure that the person 
electronically signing the informed consent is the subject who will be participating in the 
research study or is the subject’s LAR (see 21 CFR 11.100(b)). 
 
Each potential Subject will be provided with written and verbal information regarding 
the nature of the study in an understandable manner. Adequate time will be allowed 
for the Subject to consider participation in the surveillance study. Signed, written 
consent will be obtained for each Subject prior to data collection and entry into the 
study. Coercion or undue influence of potential Subjects to participate will be 
avoided, and the Subject’s legal rights should not be waived. The Investigator or an 
appropriately designated member of the study staff shall co-sign the consent form, 
indicating they believe the Subject or LAR understands the nature and risks of the 
study and scope of the consent. 
If the Subject is not able to sign the ICF but has given his/her oral consent to participate, 
a third party can sign the informed consent for the Subject if allowable per IRB policy. The 
consenting process will be documented in the medical record and reason for Subject not 
signing the consent (in case of verbal confirmation). If the Subject is not able to give 
his/her informed consent to participate in the study, a LAR can sign the informed consent 
for the Subject if this is approved by the local IRB. If a LAR signs on behalf of a minor 
(12-17 years), a separate assent form must be given to the minor, and the minor must 
sign to acknowledge their understanding and willingness to participate. 
 
Short form informed consent may be utilized if approved by the IRB. Each institution 
must follow their institutional IRB policy for obtaining informed consent. If the short form 
informed consent is used, the summary must include all the basic elements of informed 
consent (21 CFR §50.25; ICH E6 4.8.10). 

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The signed consent forms will be retained by the Investigator and made available (for 
review only) to the study monitor and auditor upon request. 
Subjects are considered enrolled once appropriate informed consent has been 
obtained. 
 
5.1.2 
Study Subject Numbering 
 
Sites participating in the SUCCESS Study will each be assigned a site number prior to 
enrolling Subjects. Each enrolled Subject will be assigned a Subject number. Site 
study staff will use the electronic case report form (eCRF) assigned Subject number to 
complete documentation of the screening/enrolment log following appropriate 
consenting. Subject study identification numbers will consist of the aggregate of site 
number followed by a sequential number, where “01” is the first enrolled Subject as the 
corresponding site. 
 
5.1.3 
Subject Terminations 
Subjects will be considered discontinued from the study if any of the following occur: 
 
1. Subject voluntarily withdraws from the study. Participation in the SUCCESS Study 
is voluntary. Subjects may withdraw consent at any time by completing an informed 
withdrawal form. Reasonable attempts will be made to determine the reason for 
withdrawal of consent. Data obtained prior to withdrawal enrolled will be included in 
endpoint data analysis, but no data will be obtained subsequent to withdrawal. 
2. Investigator withdraws Subject from the study due to safety concerns. If, during the 
conduct of research, an Investigator determines that participation in the study may 
increase the hazard to a subject that is not acceptable, an Investigator may withdraw 
the Subject from the study due to safety concerns. 
3. Lost to Follow Up: In the event that a Subject fails to return for the 30 days and/ or 6 
months follow-up visits and is unable to be reached at the Subject’s last known 
telephone number, a certified letter will be sent to the Subject’s last known mailing 
address to remind the Subject of study obligations. Once all reasonable attempts to 
contact the Subject have been made, including contacting through the Subject’s general 
practitioner, the Subject is considered lost to follow-up. Each attempt to contact a 
Subject will be documented. 
 
If, during the conduct of the study, a Subject dies, all available information related to 
the event should be obtained. Within 24 hours from study staff becoming aware of the 
event, an appointed Rapid Medical representative/study monitor should be notified by 
completing the appropriate study termination forms in the Subject’s eCRF. 

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Maximal completeness of the CRF for subject that died should be attempted and 
ensured by the following: 
 
- If death occurs while the Subject is in the hospital, a copy of the death summary 
report should be submitted. In case of an autopsy, a copy of the autopsy report 
should also be submitted. 
 
- If death occurs outside the hospital setting, effort should be made to obtain all 
information related to the death along with an Investigator’s summary of the events 
associated with the death. 
5.2 Site Selection, Training and Initiation 
 
5.2.1 
Selection 
Sites will be selected by their ability to provide complete data sets with 
robust analyses for all safety and effectiveness outcomes with minimal risk to the 
subjects (i.e. CT up to 24h post procedure and 6 months angio to determine 
Raymond Scale score). 
 
5.2.2 
Training 
Investigators and Site Personnel will be trained on the surveillance plan prior 
to site initiation of enrollment. Training will be documented on the Training Log 
and cover the following topics: 
1. 
Study objectives 
2. 
Surveillance plan review 
3. 
Delegation of authority 
4. 
Process for Informed Consent as well as IRB requirements 
5. 
Electronic case report form use and completion guidelines 
6. 
Enrolment procedures 
7. 
Protocol Deviation documentation 
8. 
AE and SAE event reporting 
9. 
Device malfunction reporting 
10. Comaneci Instructions for Use 
11. Device traceability 
13. Image collection and core lab submission 
14. Investigator responsibilities and obligations 
15. General Good Clinical Practice (GCP) guidelines 
16. Regulatory requirements including essential documents 

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Changes to existing SUCCESS Study staff responsibilities, as documented on 
the Delegation Log, or addition of new study personnel will require 
investigational plan training, as appropriate. 
 
5.2.3 
Initiation 
Rapid Medical, or a representative of Rapid Medical, will conduct study 
training as described in section 5.2.2. 
 
Prior to actively recruiting/enrolling Subjects, Clinical sites must provide the 
following documentation to Rapid Medical: 
 
1. IRB approval for the Surveillance Plan 
2. IRB and sponsor approved Informed Consent Form for the study 
3. Investigator(s’) curriculum vitae (CV) 
4. Financial Disclosure(s) for the PI and Sub-I(s) 
5. Signed Clinical Trial Agreement (CTA) including Confidentiality Agreement 
6. Training Log documentation to verify the appropriate study staff has been 
trained on the protocol, device, eCRFs and study conduct. 
Sites will be officially notified of site activation through receipt of an activation 
letter or email. 
 
6. 
STUDY DESIGN 
The SUCCESS Study is a multi-center, prospective, postmarket safety surveillance study in 
up to 30 US centers. The Surveillance is to continue until complete data on the deployment 
of 90 devices with complete 30-day patient status are obtained in order to assess safety 
and performance as used in postmarket clinical practice in the U.S. 
 
 
6.1 Study Duration 
 
All patients who are treated with the Comaneci device and consented to allow data 
collection will be followed for 180 (±21) days post-procedure. 
6.2 Subject Inclusion/Exclusion Criteria 
Subjects are considered enrolled in the SUCCESS Study only after an attempt is made 
to introduce the Comaneci device through the arterial sheath and subject was properly 
consented. 
 
6.2.1 
Inclusion Criteria 
In order to assure that the probable benefits outweigh the probable risks for the 
Comaneci Embolization Assist Device, as indicated in the IFU, the subjects must meet 
all of the following inclusion criteria: 

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1. Patient has a documented intracranial ruptured or unruptured aneurysm, 
suitable for embolization by coils. 
2. Patient is considered for treatment with coil embolization assisted by the 
Comaneci Device for wide-necked intracranial aneurysms with neck width ≤ 10 
mm. A wide-necked intracranial aneurysm is defined by the neck width as 
≥ 4 mm or a dome-to-neck ratio < 2. 
3. A signed informed consent by the patient or legally authorized representative. 
 
6.2.2 
Exclusion Criteria 
Patient should be treated by the Comaneci device in accordance with the approved 
device label. (i.e. doesn’t meet the contraindication criteria, as described in the IFU): 
 
1. 
Patient with known hypersensitivity to nickel-titanium. 
 
 
 
7. 
Data Collection 
All procedures will be according to the standard practice at each site and determined by the 
treating physician including 6 months follow up. Procedures such as routine hospital 
examinations, brain CT scan or MRI will be performed according to each site’s standard 
management protocol and relevant data will be properly documented in the patient's medical 
records. 
7.1 Study 
Study flow of Subjects through the SUCCESS Study is illustrated in Figure 3. 

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Figure 3: Study Flow 

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7.2 Screening and Baseline Visit 
 
Any subject who is consented for endovascular treatment of an IA that may potentially 
require use of the Comaneci device at the participating centers in the study will be 
approached for consenting prior to device use, using separate consent for the subject’s 
participation in and data collected to be included in the SUCCESS study. 
Subjects with ruptured aneurysms: due to the emergent nature of acutely ruptured 
aneurysms, informed consent may be obtained from the point of arrival at the 
medical treatment facility up to 72 hours after the study procedure. 
For all subjects, consent must be obtained before any data is captured in the eCRF. 
To reduce selection bias, accounting for all unsealed Comaneci devices in each IA case 
that may potentially require use of the Comaneci device at a clinical site for the period of 
enrollment to the study will be provided. The accounts will not provide patient information 
but will provide some indication of the device disposition. 
 
An electronic Screening & Enrollment Log will include all IA patients treated at each site 
whether or not they are included in the study. Screening against study 
inclusion/exclusion criteria will be completed to determine potential eligibility. For each 
patient considered but not treated with Comaneci, the reason for not attempting to use 
Comaneci will be indicated. In addition, for patients where Comaneci was introduced into 
the body but who were not enrolled for follow up and data collection, or who denied post 
procedure consenting, the reason will be indicated in the electronic Screening & 
Enrollment Log by the attending physician. Sites will maintain this electronic log for the 
duration of the recruitment period of the study. 
 
7.2.1 
Patient Details: 
• 
Year of Birth 
• 
Gender 
• 
Date of Treatment 
 
7.2.2 
Medical History: 
• 
Presence or absence of multiple intracranial aneurysms 
• 
Smoking history 
• 
Presence or history of hypertension 
• 
History of prior rupture of an intracranial aneurysm 
• 
Family history of intracranial aneurysm 
• 
Vital Signs (Hight, Weight, Blood Pressure, Heart Rate) 
• 
Concomitant diseases 
• 
Laboratory- Standard Biochemistry and CBC, PT, PTT, INR 
• 
Prior/Concomitant Medications (Coagulation and Antiplatelet) 

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7.2.3 
Pre- Treatment Data: 
• 
Aneurysm size and location 
• 
Pre-procedure mRS score (modified Rankin Scale)-up to 24h prior to treatment. 
• 
Pre symptoms mRS 
• 
NIHSS 
• 
Pre op antiplatelet and/or coagulation medications 
NIHSS will be performed by certified Study personnel. 
mRS will be assessed by an independent clinician who is not a member of the 
investigational team. 
 
 
 
7.2.4 
Screen Failures 
 
Subjects who were consented and not treated with the Comaneci device (device was 
not introduced to the body) due to not meeting the indication of the device, such as 
aneurysm size and anatomy, will be considered screen failures and will not be 
followed up, but the reason for not introducing the Comaneci will be documented. 
Screen failures will not be included in the primary safety endpoint analysis. 
 
7.3 Procedure 
 
7.3.1 
Angiography 
 
Intraprocedural diagnostic catheter angiography will be conducted prior to device 
deployment to determine location and aneurysm morphological features. Diagnostic 
angiograms will be obtained as per standard of care. A final post-procedure 
angiogram (full A-P lateral image) will be obtained once all treatments have 
concluded, including rescue therapy, if necessary. CT of up to 24h postprocedure if 
performed as a standard of care will be analyzed for safety parameters, such as 
hemorrhage. 
Angiography at end of procedure and 6 months, will be analyzed to determine 
Raymonds scale at both time points and stability of Raymond Roy score. 
All images are to be de-identified and submitted to the core lab for review: 
 
The University of California at Los Angeles with the following address: 
Angiography and Noninvasive Imaging Core Lab 
David S Liebeskind, MD, FAAN, FAHA, FANA 
UCLA Department of Neurology 
Neuroscience Research Building 
635 Charles E Young Drive South, Suite 225 
Los Angeles, CA 90095-7334 
 
Procedure will be handled as standard of care, according to Comaneci device IFU, 
appendix A. 

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7.3.2 
Intraoperative Data 
Intraoperative data will be collected as described below: 
• 
Devices, Coils 
• 
Medications 
• 
Comaneci Performance (such as deployment/removal success, neck coverage) 
• 
Total procedure time 
• 
Total time Comaneci was inflated 
• 
Raymond Scale at the end of procedure, using post procedure DSA 
• 
Intra- Procedural Complications and AEs (including a determination of the 
severity, seriousness, and relationship to the device or procedure). These will 
specifically include vessel perforation or dissection, intracranial aneurysm 
rupture, stroke, hemorrhage, death, inability to deploy or remove the device, and 
coil entanglement. 
 
 
7.4 24 Hour (-6/+12) Follow-up 
 
24 hours (-6/+12 hours) from time of procedure 
• 
Complications and any AE’s (including a determination of the severity, 
seriousness, and relationship to the device or procedure). These will specifically 
include stroke, hemorrhage and death. 
• 
Concomitant antiplatelet and/or anticoagulant medications 
• 
mRS Score (if performed) mRS should be assessed by an independent clinician 
who is not a member of the investigational team. 
• 
CT (if performed up to 24 hours post procedure as a standard of care) 
• 
If subject discharged within 24 h- Discharge status (for example, by CMS Patient 
Discharge Status Code) 
 
Note: CT images will be sent to the Imaging Core Lab for evaluation. 
 
 
 
7.5 Discharge, if different than 24 hours (-6/+12 hours) 
 
If Subject is discharged in a time that is different than the 24 hours (-6/+12 hours), 
the following data will be collected: 
• 
Discharge status (for example, by CMS Patient Discharge Status Code) 
• 
mRS Score- should be assessed by an independent clinician who is not a 
member of the investigational team. 
• 
Complications and any AE’s (including a determination of the severity, 
seriousness, and relationship to the device or procedure). These will specifically 
include stroke, hemorrhage and death. 

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• 
Antiplatelet and/or anti-coagulant Medications, if was changed from previous visit 
 
7.6 
30 days (± 7 days), can be performed over the phone 
 
If an in-person visit cannot be performed, it is possible to perform via structured 
telephone interviews, with the exception of NIHSS. 
30 days (± 7 days) from time of procedure 
• 
mRS Score- should be assessed by an independent clinician who is not a 
member of the investigational team. 
• 
NIHSS 
• 
Complications and any AE’s (including a determination of the severity, 
seriousness, and relationship to the device or procedure). These will specifically 
include stroke, hemorrhage and death. 
• Antiplatelet and/or anti-coagulant Medications, if was changed from previous visit 
NIHSS will be performed by certified Study personnel. 
 
7.7 
180 days (± 21 days) 
 
• 
mRS Score (If an in-person visit cannot be performed, it is possible to perform 
via structured telephone interviews)-should be assessed by an independent 
clinician who is not a member of the investigational team. 
• 
Raymonds scale, using DSA 
• 
Complications and any AE’s (including a determination of the severity, 
seriousness, and relationship to the device or procedure). These will specifically 
include stroke, hemorrhage and death. 
• 
Antiplatelet and/or anti-coagulant Medications, if was changed from previous visit 
In some cases, this visit is also performed at 3 months (90 ± 14 days) as a standard of care, 
then the same information will be collected at 3 months as well. 
Also note, if in-person visits are not possible, mRS assessments may be performed remotely by 
structured telephone interviews. 
 
 
7.8 Unscheduled Visits 
When clinically indicated, unscheduled assessments should be completed with 
corresponding data documented in the eCRF. 
7.9 Adverse Events 
Adverse events that occur during participation in the SUCCESS Study will be 
recorded. See section 11 for more information on AEs. 

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Table 2: Schedule of Events 
 
Elapsed 
time/Study 
procedures 
Baseline/ 
Procedure 
 
24 hours 
(-6/+12) 
Discharge if 
different than 
24 hours (- 
6/+12) 
 
30 (±7) 
days 
180 
(±21) 
days** 
Informed 
Consent 
X 
 
 
 
 
Demographics 
X 
 
 
 
 
Medical History 
and Concomitant 
Medications 
X 
 
 
 
 
Brain CT Scan 
X 
X * 
 
 
 
Vital Signs 
X 
 
 
 
 
mRS score+ 
X 
 
X 
X 
X 
NIHSS 
X 
 
 
X 
 
Clinical 
Laboratory 
X 
 
 
 
 
Raymond scale 
X*** 
 
 
 
X*** 
Intraoperative 
data 
X 
 
 
 
 
Prior/concomitant 
medications 
X 
X 
X 
X 
X 
Adverse Events 
X 
X 
X 
X 
X 
(*) If performed as a standard of care any time up to 24 hours post procedure 
(**) Will be collected if performed also at 90 (±14) days as a standard of care. 
(***) Post-procedure and 6 months imaging should use Digital Subtraction Angiography (DSA) 
for Raymond scale assessments. 
(+) If in-person visits are not possible, mRS assessments may be performed remotely by 
structured telephone interviews. 
 
 
 
7.10 Clinical Outcomes Assessment 
 
Assessments to be performed as indicated in Table 2 are as follows: 
 
Modified Rankin Scale (mRS): Measures the global degree of disability or dependence of an 
individual on an ordinal scale. Must be assessed by an independent clinician who is not a 
member of the investigational team, who is trained to conduct the mRS assessment. 
To the extent possible, the same examiner should examine all subjects at a single site. 

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8. 
STATISTICAL ANALYSIS- 
8.1 General Principles 
 
The detailed hypothesis generation and statistical method is provided below: 
 
The primary effectiveness endpoint is successful intracranial aneurysm occlusion (measured by 
Raymond Roy classification I or II) at the end of procedure, using digital subtraction angiography 
(DSA). 
 
The performance goal (PG) for evaluating effectiveness is based on outcomes as reported in the 
Comaneci de novo, which was successful aneurysm occlusion of 79.7% (51/64). The PG for the 
primary effectiveness is defined as success rate cited above minus a margin of 10%, therefore giving 
a PG of 69.7%. 
 
The resulting null and alternative statistical hypotheses are as follows: 
H0: p ≤ PG 
HA: p > PG 
The hypothesis test will be performed at an overall two-sided alpha level of 0.05 using Chi-square 
test, in which the lower confidence bound on the observed incidence of success is compared to the 
PG.   
With a hypothesized true incidence rate of 82.6% for successful intracranial aneurysm 
occlusion at the end of procedure and desired power of ≥ 80%, using a normal 
approximation test with a nominal 0.025 one-sided significance level (equivalent to a 
two-sided alpha=0.05), the required evaluable sample size for primary efficacy 
is 90 evaluable patients with a power of 80%. 
 
The objective of this postmarket surveillance study is to reduce uncertainty regarding 
the safety profile of the device and its real-world performance. This objective will be 
met by capturing safety data as the device is used in practice by physicians in the 
United States. As specified by FDA’s order to conduct a postmarket surveillance study 
under section 522 of the Federal Food, Drug and Cosmetic Act (the act), 21 U.S.C. 
360l, a total N=120 deployed devices with complete 30 day post procedure patient 
status. This number of deployments was later adjusted and approved by the FDA to 
90 in the current version of the protocol (version 2.0) as explained above. The focus 
of the study is to characterize the incidence and nature of periprocedural events 
occurring within 24 hours post-procedure as well as hospital discharge status and to 
characterize 30-day post-procedure status including 30-day functional status and all 
adverse events after discharge to day 30 for each use of the Comaneci Embolization 
Assist Device. Longer terms effectiveness at six months will be also descriptively 
summarized in terms of the Raymond scale and mRS. 
Attempt to use the Comaneci device is defined as: in each IA case that may potentially 
require use of the Comaneci device where the sterile seal on the packaging was 
broken, whether or not the device is ever delivered to the target site of its intended 
use. The procedural case report form (CRF) will record all attempts to use the 
Comaneci device. All reasons the device may not have been used after the sterile seal 

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has been broken, including whether consent was obtained or not, will be provided. 
 
Accounting for all unsealed Comaneci devices in each IA case that may potentially 
require use of the Comaneci device at a clinical site for the period of enrollment to the 
study will be provided: for devices unsealed and not used in the SUCCESS intent to 
treat (ITT) group described below, the accounts will not provide patient information but 
will provide some indication of the device disposition. There will be a separate CRF to 
track the disposition of all devices for which the sterile seal has been broken, including 
whether the device was used in a subject in the ITT group. 
 
Any patient who is consented for endovascular treatment of an intracranial aneurysm 
(IA) that may potentially require use of the Comaneci device at the participating 
centers in the study, and a Comaneci device’s package sterile seal was broken will 
form the basis of ITT. ITT patients that Comaneci device was not introduced to the 
body will be considered screen failure, and will not be followed up, but the reason for 
not introducing the Comaneci will be documented. 
The primary safety endpoint analysis will be performed using the ITT 
population without screen failures. 
 
All patients who meet all of the inclusion criteria and no exclusion criteria will form the 
basis for FAS primary analysis- for whom primary safety and efficacy analysis will be 
performed. 
 
Descriptive summaries of the peri-operative and post-operative adverse events in both 
the ITT cohort and the FAS cohort will be reported. 

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8.2 Evaluation of Periprocedural Events 
The rates of all adverse events occurring within 24 hours post procedure and hospital 
discharge status for all opened devices at each participating clinical site during the 
surveillance period will be summarized. Adverse events of special interest include 
vessel perforation or dissection, intracranial aneurysm rupture, stroke, hemorrhage, 
death, inability to deploy or remove the device, and coil entanglement. The numbers of 
individual adverse events of each type and the per subject incidence rate for each type 
of adverse event will be determined and reported along with 90% two-sided exact 
binomial confidence intervals. The upper bounds of 90% two-sided exact binomial 
confidence intervals are equivalent to the upper bounds of 95% one-sided exact 
binomial confidence intervals. While the estimated incidence rates for each type of 
adverse event will be taken as the most likely value of the true incidence rate, the 
corresponding upper bound of the one-sided 95% exact binomial confidence interval 
will be taken as the largest possible incidence rate consistent with the observed 
sample results. 
Separate event counts and incidence rates with corresponding confidence intervals will 
be summarized for adverse events determined to be serious, device-related, serious 
and device-related, procedure-related, serious and procedure-related, and severe. 
Listings for all adverse events will be compiled that provide full descriptions of each 
adverse event including determination of the severity, seriousness, and relationship to 
the device or procedure. The following listings will be compiled: 
• 
AE Listing 1 All AEs Sorted by Event Type 
• 
AE Listing 2 All AEs Sorted by Subject and Relative Time of Onset 
• 
AE Listing 3 Serious AEs 
• 
AE Listing 4 Severe AEs 
• 
AE Listing 5 Device-Related AEs 
• 
AE Listing 6 Procedure-Related AEs 
• 
AE Listing 7 Serious Device or Procedure Related AEs 
• 
AE Listing 8 Severe Device or Procedure Related AEs 
 
Discharge status will be described with counts and percentages. 
Evaluation of the extent of any relationship between adverse event rate to operator 
experience will be evaluated. Operator experience will be evaluated by credentialing 
the investigators by years of training, number of aneurysms treated endovascularly in 
the last two years. 
 
 
In addition, Successful intracranial aneurysm occlusion (measured by Raymond Roy 
classification I or II) at the end of procedure will be descriptively summarized in terms 
of the number and percentage of subjects. 

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8.3 30-day post-procedure status 
30-day functional status will be assessed using the modified Rankin Scale (mRS). This 
scale runs from 0-6, from no symptoms to death as follows: 
 
• 
0 - No symptoms 
• 
1 - No significant disability. Able to carry out all usual activities, despite some 
symptoms. 
• 
2 - Slight disability. Able to look after own affairs without assistance, but unable to 
carry out all previous activities. 
• 
3 - Moderate disability. Requires some help, but able to walk unassisted. 
• 
4 - Moderately severe disability. Unable to attend to own bodily needs without 
assistance, and unable to walk unassisted. 
• 
5 - Severe disability. Requires constant nursing care and attention, bedridden, 
incontinent. 
• 
6 - Dead. 
 
The frequency distribution and cumulative frequency distribution of the 30-day mRS 
will be summarized using counts and percentages. 
All adverse events after discharge (device-related and non device-related) for each 
use of the Comaneci Embolization Assist Device will be summarized similarly to how 
periprocedural events will be summarized as described above. This includes counts, 
per subject incidence rate, exact binomial confidence intervals, and a separate set of 
adverse event listings that contain full descriptions of each adverse event including 
determination of the severity, seriousness, and relationship to the device or procedure. 
8.4 Six Month Effectiveness and Clinical Status 
Effectiveness at six months will be descriptively summarized in terms of the number 
and percentage of subjects achieving stable IA occlusion, measured by Raymond Roy 
classification I or II without the need for re-treatment of the target IA and good clinical 
outcome defined by mRS and shift tetrachotomized (0,1, 2, 3-6) analysis. 95% two- 
sided confidence intervals will be provided to evaluate the statistical precision of the 
estimates. If these endpoints are available at three months but not at six months, the 
three month values will be used for these analyses. 
8.5 Subgroup Analysis 
Selected adverse event rates will be provided for subgroups including wide-necked 
ruptured versus unruptured intracranial aneurysms. 
8.6 Missing Data 
Since the primary safety endpoint is defined immediately post-procedure and up to 30 
days, the amount of missing data for this study is anticipated to be low and so no 
imputation of missing data will be performed. For the analysis of six month 
effectiveness, if the six month Raymond score or mRS values are missing and any 
earlier data are available, the most recent earlier value will be used. 

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8.7 Heterogeneity Among Investigational Sites 
An objective of this study is to evaluate variability in outcome among ‘real world’ users. 
To this end, an evaluation of heterogeneity among investigational sites may be 
important for this evaluation. Key summary adverse event endpoints such the per 
subject occurrence of any serious event, any device-related event, and any serious 
device-related event will be stratified by investigational site. If there is sufficient data, 
the site stratified event rates will be subjected to a random effects analysis on arcsine 
transformed proportions. Sites contributing fewer than 5 subjects will be pooled. True 
site-effects are assumed to be normally distributed with mean M and variance t2. By 
imposing a specified distribution on the site-to-site variability, i.e., a normal distribution 
with mean M and variance t2, sensitivity to small sample sizes in individual sites is 
reduced, and the parameters reflecting the magnitude of site-to-site variability are 
naturally derived. The quantitative measure of the magnitude of heterogeneity is I2. I2 is 
the fraction of total site-to-site variance that is due to event rate heterogeneity across 
sites, as opposed to sampling variance. If σ2 is the total variance, then I2 = t2 / σ2 . 
Fractions of 25% and less are considered small and not clinically significant (Higgins 
and Thompson 2002)1. Site variability will be visually evaluated using a Forrest plot. If 
these analyses reveal specific sites that are outliers, further quantitative and qualitative 
analyses will be performed to investigate potential reasons. 
8.8 Deviations from the Statistical Plan 
Any departure or deviation from these planned statistical methodologies will be 
documented and discussed in the Clinical Study Report summarizing the results from this 
study. 
8.9 Software 
Statistical analyses will be performed using SAS version 9.4 or later and/or R version 
3.4 or later. 
 
9. 
RISK/BENEFIT ANALYSIS 
 
This is an observational study only; therefore, data collection does not introduce 
additional risks to the patients, apart from the procedure’s possible risks. 
The IFU attached as Appendix A, describes the procedure’s potential complications 
and technical success analysis. 
 
 
 
 
 
 
1 Higgins JPT and Thompson SG. Quantifying Heterogeneity in a Meta-Analysis. Statistics in Medicine 
21(11): 1539-1555. 

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10. DEVIATIONS FROM THE CLINICAL SURVEILLANCE PLAN 
10.1 Surveillance Plan Deviations 
 
A surveillance plan deviation is defined as any change or alteration from the procedures 
stated in the surveillance plan, consent document, recruitment process, or study 
materials that were originally approved by the IRB where the change or alteration itself is 
not IRB approved. Surveillance plan deviations can be either major or minor. 
 
 
All surveillance plan deviations must be reported to Rapid Medical or their authorized 
representatives (study monitors) through the eCRF surveillance plan deviation form. All 
deviations, regardless of whether medically justifiable (Subject’s safety) or pre- 
approved by Rapid Medical and/or the IRB of record, shall be reported. In addition, the 
Investigator is required to adhere to IRB of records’ procedures for reporting 
surveillance plan deviations. 
Prior approval for deviation from the surveillance plan shall be obtained by the 
Investigator from Rapid Medical, except in situations where necessary to protect the 
safety of a Subject (emergency) or for situations beyond the Investigator’s control such 
as Subjects missing scheduled follow-up visits. Approval for deviations shall be 
documented in writing and maintained in the Investigator and clinical study management 
files. 
Investigators are required to maintain accurate, complete and current records, 
including documentation showing the dates of, and reasons for, each deviation from 
the Surveillance Plan Deviations 
 
Any surveillance plan deviations will be reported to the study sponsor and IRB, as 
required. Deviations will be documented in the final study report. 
 
 
11. SAFETY AND ADVERSE EVENTS 
 
Safety of study Subjects is of critical importance for the SUCCESS study. Site Investigators 
are responsible for the safety of Subjects under his/her care. In order to more clearly 
understand data and potential confounders, assessment of all Adverse Events observed by 
the site investigators will be recorded in the case report form and reported to the Data and 
Safety Monitoring Board for period review. 
 
11.1 Adverse Event Data Collection 
Recording of adverse events commence from time that a Subject is appropriately 
consented and culminate through the 180-day (± 21) follow up. All available information 
related to the AE must be obtained by the Investigator so that proper determination of 

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causality and outcome can be made and classification as a SAE can be made if 
warranted. Adverse Events will be documented on the appropriate eCRF. Data 
captured include the event description, onset, resolution status, seriousness, severity, 
causality (if known), relationship to the device or procedure and treatment, if done. The 
Investigator will follow all AEs until resolution or completion of the 6 months follow-up. 
 
 
 
11.2 Definitions 
 
11.2.1 
Adverse Events 
Per ISO 14155:2011 section 3.2, an Adverse Event 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 Comaneci 
medical device. 
In the event that a Subject participates in the SUCCESS Study with signs of prior 
disease and/or symptoms, these conditions would not be considered AEs unless the 
condition recurs after the Subject has recovered from the previously occurring condition 
or the condition worsens in intensity or frequency during participation in the SUCCESS 
Study. 
 
11.2.2 
Adverse Device Effect 
Per ISO 14155:2011 Section 3.1, an Adverse Device Effect (ADE) is any AE related to 
the use of an investigational medical device. 
 
 
11.2.3 
Serious Adverse Events 
Per ISO 14155:2011 Section 3.37, an SAE is an AE that: 
 
1. Led to death, 
2. Led to serious deterioration in the health of the Subject, that resulted in: 
a. a life-threatening illness or injury, or 
b. a permanent impairment of a body structure or a body function, or 
c. in-patient or prolonged hospitalization, or 
d. medical or surgical intervention to prevent permanent life-threatening illness or 
injury or permanent impairment to a body structure or a body function. 
3. Led to fetal distress, fetal death or a congenital anomaly or birth defect 

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11.2.4 
Serious Adverse Device Effect 
Per ISO14155:2011 3.36, a Serious Adverse Device Effect (SADE) is an adverse 
device effect that has resulted in any of the consequences characteristic of a SAE. 
 
Examples of SADE for the SUCCESS Study include vessel dissections or 
perforations caused by the Comaneci Device. 
 
 
11.2.5 
11.2.7 Procedure-Related 
Definite Related: Must have all 3 of the following: 
 
1. Has a reasonable temporal relationship to the intervention procedure 
2. Could not possibly have been produced by the Subject’s clinical state or have 
been due to environmental or other interventions. 
3. Follows a known pattern of response to the intervention procedure. 
 
Possible Related: Must have at least 2 of the following 3 conditions: 
 
1. Has a reasonable temporal relationship to the intervention procedure 
2. Could not possibly have been produced by the Subject’s clinical state or have 
been due to environmental or other interventions. 
3. Follows a known pattern of response to intervention procedure. 
 
Unlikely Related: Has a reasonable or tenuous temporal relationship to intervention 
procedure, but also has BOTH of: 
1. Could readily have been produced by the subject’s clinical state, or 
environmental or other interventions. 
2. Does not follow known pattern of response to intervention procedure. 
 
Unrelated: The temporal relationship between intervention procedure and the 
adverse event is unreasonable or incompatible and/or adverse event is clearly due to 
extraneous causes (e.g., underlying disease, environment). 
 
 
 
11.2.6 
11.2.8 Device-Related 
Definite Related: Must have all 3 of the following: 
 
1. Has a reasonable temporal relationship to the intervention device 
2. Could not possibly have been produced by the Subject’s clinical state or have 
been due to environmental or other interventions. 
3. Follows a known pattern of response to the intervention device. 
 
Possible Related: Must have at least 2 of the following 3 conditions: 
 
1. Has a reasonable temporal relationship to the intervention device 

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2. Could not possibly have been produced by the Subject’s clinical state or have 
been due to environmental or other interventions. 
3. Follows a known pattern of response to intervention device. 
 
Unlikely Related: Has a reasonable or tenuous temporal relationship to intervention 
device, but also has BOTH of: 
1. Could readily have been produced by the subject’s clinical state, or 
environmental or other interventions. 
2. Does not follow known pattern of response to intervention device. 
 
Unrelated: The temporal relationship between intervention device and the adverse 
event is unreasonable or incompatible and/or adverse event is clearly due to 
extraneous causes (e.g., underlying disease, environment). 
 
11.3 Determination of Event Severity and Relatedness 
 
Using all available information, Site Investigators will independently categorize event 
severity as Serious or Non-serious, using the above definitions. 
Using all available information, Site Investigators will categorize the relationship of non- 
serious adverse events (NSAEs) and SAEs to study procedure and study device. In 
addition, a central Data and Safety Monitoring Board will independently adjudicate the 
relationship of all SAEs to study procedure and study device. 
 
11.4 Event Notification 
 
SUCCESS Study Investigators are required to report all deaths, serious injuries or 
malfunction at any time during the study to Rapid Medical, or Sponsor representative, 
within 24 hours after first learning of the event or as soon as they are known to 
investigators. In addition, the Investigator must follow the IRB of record’s policies for 
SAE. 
All Medical Device Reporting (MDR) reportable events will conducted in accordance with 
Rapid- Medical SOP 017-046- Vigilance System Procedure. 
 
 
11.5 Data and Safety Monitoring Board 
 
The DSMB will consist of at least one independent trained vascular neurologist, a 
neuroendovascular surgeon, and a Biostatistician. All DSMB members will not be 
affiliated with any of the participating sites. 
 
All AEs observed by the site investigators will be reported to the DSMB for quarterly 
review. 

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Major responsibilities of the DSMB are: 
 
1. Monitor the rates of all adverse events 
2. 3. Recommend revisions to the SUCCESS Study plan regarding safety of 
the study Subjects 
4. quarterly review and monitor aggregated and individual Subject data related 
to safety, data integrity, scientific validity and overall conduct of the study, to 
ensure the rights, safety, and welfare of the study participants 
5. Monitor Subject accrual and retention 
6. Consider factors external to the study when relevant information becomes 
available, such as scientific or therapeutic developments that may have an 
impact on the safety of the participants or on the ethical conduct of the study 
7. Ensure the confidentiality of trial data and the results of monitoring 
 
 
 
12. STUDY MONITORING 
 
The study will be monitored regularly by trained clinical trial monitors to ensure the 
protection of Subject rights and safety, as well as, data quality and integrity. 
The monitor will verify information entered into the eCRFs against source documents and 
the Subject’s medical records to ensure validity of data. Source documents may be 
photocopied if required but will be anonymized prior to a monitor leaving the performance 
site. The following on-site visits will occur: site initiation visit; first monitoring visit shortly 
after the first 1-3 subjects are enrolled; additional monitoring visits determined by site 
enrollment rates. 
On the occasion that a monitor requests additional data or clarification of data for the eCRF, 
the request must be addressed appropriately prior to the next monitoring visit. Once 
completed eCRF data are verified against source data, the study monitor will electronically sign off 
to indicate that data has been monitored for correctness. The Investigator must sign all 
eCRFs prior to site close. 
In the event that a monitor discovers potential SAEs or SADEs which were not previously 
reported, Rapid Medical or the appointed representative/study monitor will inform the 
Investigator for their review and submission to the IRB, if applicable. 
There will be a site close out visit to ensure all documentation is in place and all outstanding 
items have been addressed. Record retention policies will be reviewed, and post-study 
Investigator responsibilities discussed. 
Device traceability will also be conducted by the study monitor at each monitoring visit. 
damaged, malfunctioning, or expired devices will be returned to Rapid Medical. 

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12.1 Source Documentation 
Investigators are required to record and maintain adequate and accurate case histories 
for all Subject observations, assessments, and data pertinent to SUCCESS Study 
conduct. 
 
 
12.2 Access to Source Documents 
 
The Investigator and Institution, as participants in the SUCCESS Study, will be responsible for 
providing direct access to source data to Rapid Medical, their designated 
representatives, and to appropriate authorities for the purposes of monitoring, audit, 
IRB review or regulatory inspection. Subjects will be notified of such access to study 
records as part of the consenting process. 
 
 
13. DATA COLLECTION AND OWNERSHIP 
 
13.1 Protected Health Information and Confidentiality 
 
The Investigator and members of the IRB of record shall consider all data or findings 
generated during the conduct of the study, other than that information to be disclosed by 
law, as confidential. Disclosure of such data or findings to any third party shall not occur 
without the prior written consent of Rapid Medical. 
 
All reports and communications relating to Subjects in the study will identify Subjects by 
their Subject ID number only. 
13.2 Data Management 
 
Every effort will be taken to ensure the accuracy and reliability of data including the 
selection of qualified Investigators and appropriate study centers, review of protocol 
procedures with the Investigator and associated personnel before the study commences, 
and periodic onsite monitoring visits by the Sponsor, or their representatives, as deemed 
appropriate by the Sponsor. Guidance for eCRF completion will be provided and 
reviewed with the study personnel prior to the start of the study. The Sponsor will review 
eCRFs for accuracy and completeness and any discrepancies will be resolved with the 
Investigator or designee, as appropriate. 
 
13.3 Electronic Case Report Forms 

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Study staff, as indicated in the Delegation log, who will use the EDC system will have 
adequate training in order to perform assigned tasks (21 CFR §11.10(i)). Training will be 
conducted by Rapid Medical and/or their qualified designated appointee as part of the 
Site Initiation Visit or as needed. 
 
Data collected during the conduct of the SUCCESS Study will be entered into a 21CRF 
§11 compliant eCRF database. Accuracy and data quality will be ensured through 
implementation of data edit checks. Responses to requests for clarification of eCRF 
recorded data will be answered, dated, and electronically signed by the Investigator or 
designee. Any required changes to the Sponsor’s eCRF/database will be followed by data 
review and validation procedures. 
 
Once the study is closed and all data has been monitored and signed by study 
Investigators, the database will be locked and analyzed for statistical evaluation and 
reporting. 
 
13.4 Record Retention and Storage 
 
13.4.1 
Sponsor Record Retention 
 
Rapid Medical will retain all study documentation for a period of at least five (5) years 
or in accordance with GCP regulations in force in the Sponsor’s jurisdiction, whichever 
is greater, following formal discontinuation of the SUCCESS Study. 
 
13.4.2 
Investigator Record Retention 
 
The Investigator shall retain all study documentation for a period of at least (3) years or 
in accordance with retention policies of the IRB of record, whichever is longer. 
 
13.5 Publication Policy 
 
As part of the SUCCESS Study, information related to the Comaneci Device (such as 
pre-clinical data and other device materials) may be supplied to SUCCESS Study 
Investigators. Any information not previously published is considered confidential and 
shall remain the sole property of Rapid Medical. The Investigator agrees to use any such 
information as it pertains to study conduct and not use data generated from the study for 
other purposes without first obtaining the written consent of Rapid Medical. 
 
Every effort will be made to publish the results of this study regardless of whether the 
findings are in favor of the Comaneci device. To achieve this goal, and to avoid 
publication bias, the SUCCESS study will be registered, prior to enrollment commencing, 
on the clinicaltrials.gov database. 

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Rapid Medical will form a Publications Committee for the purpose of reviewing and 
publishing data from the study. This committee will include, at a minimum, the 
SUCCESS Study Principal Investigators (PIs) and a representative of Rapid Medical. 
The Publications Committee will be tasked with creating a publication policy describing 
the authorship criteria. Abstracts and manuscripts will be written and/or reviewed by the 
Publication Committee prior to submission for journal or meeting acceptance. 
 
 
 
14. 
AUDITS OR INSPECTIONS 
 
Representatives of Rapid Medical or any regulatory body reviewing study results may 
visit study sites to conduct a SUCCESS Study audit in compliance with company policy 
and regulatory guidelines. Audits will require access to all study related documentation 
for inspection. Investigators will immediately notify Rapid Medical upon learning of 
announced audits or inspections by regulatory agencies. 

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15. REFERENCES 
1 Cronenwett, et al (1985 Sep). Actuarial analysis of variables associated with rupture of small abdominal 
aortic aneurysms. Surgery 98 (3): 472–83. PMID 3898453. 
2 Stapf, C., Endovascular management of unruptured intracranial aneurysms: the dawn of a 
multidisciplinary treatment paradigm. J Neurol Neurosurg Psychiatry, 2006. 77(6): p. e1. 
3 Rinkel, G.J., et al., Prevalence and Risk of Rupture of Intracranial Aneurysms: a Systematic Review. 
Stroke, 1998. 29(1): p. 251-6. 
4 Vernooij, M.W., et al., Incidental Findings on Brain MRI in the General Population. N Engl J Med, 2007. 
357(18): p. 1821-8 
5 International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured Intracranial 
Aneurysms--Risk of Rupture and Risks of Surgical Intervention. N Engl J Med, 1998. 339(24): p. 1725-33 
6 Juvela, S., M. Porras, and K. Poussa, Natural History of Unruptured Intracranial Aneurysms: Probability 
of and Risk Factors for Aneurysm Rupture. J Neurosurg, 2000. 93(3): p. 379-87 
7 Ishibashi, T., et al., Unruptured Intracranial Aneurysms: Incidence of Rupture and Risk Factors. Stroke, 
2009. 40(1): p. 313-6 
8 Guglielmi, G., et al., Electrothrombosis of Saccular Aneurysms via Endovascular Approach. Part 1: 
Electrochemical Basis, Technique, and Experimental Results. J Neurosurg, 1991. 75(1): p. 1-7 
9 Molyneux, A.J., et al., International Subarachnoid Aneurysm Trial (ISAT) of Neurosurgical Clipping 
Versus Endovascular Coiling in 2143 Patients with Ruptured Intracranial Aneurysms: a Randomised 
Comparison of Effects on Survival, Dependency, Seizures, Rebleeding, Subgroups, and Aneurysm 
Occlusion. Lancet, 2005. 366(9488): p. 809-17 
10 Fernandez Zubillaga, A., et al., Endovascular Occlusion of Intracranial Aneurysms with Electrically 
Detachable Coils: Correlation of Aneurysm Neck Size and Treatment Results. AJNR Am J Neuroradiol, 
1994. 15(5): p. 815-20 
11 Debrun, G.M., et al., Selection of Cerebral Aneurysms for Treatment Using Guglielmi Detachable Coils: 
the Preliminary University of Illinois at Chicago Experience. Neurosurgery, 1998. 43(6): p. 1281-95 
12 Murayama, Y., et al., Guglielmi Detachable Coil Embolization of Cerebral Aneurysms: 11 years' 
Experience. J Neurosurg, 2003. 98(5): p. 959-66 
13 Gallas, S., et al., A Multicenter Study of 705 Ruptured Intracranial Aneurysms Treated with Guglielmi 
Detachable Coils. AJNR Am J Neuroradiol, 2005. 26(7): p. 1723-31 
14 Pelz, D.M., S.P. Lownie, and A.J. Fox, Thromboembolic Events Associated with the Treatment of 
Cerebral Aneurysms with Guglielmi Detachable Coils. AJNR Am J Neuroradiol, 1998. 19(8): p. 1541-7 
15 Moret, J., et al., Reconstruction technic in the treatment of wide-neck intracranial aneurysms. Long- 
term angiographic and clinical results. Apropos of 56 cases. J Neuroradiol, 1997. 24(1): p. 30-44. 
 
16 Moret, J., et al., The "Remodelling Technique" in the Treatment of Wide Neck Intracranial Aneurysms. 
Angiographic Results and Clinical Follow-up in 56 Cases. Interv Neuroradiol, 1997. 3(1): p. 21-35. 

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Appendix A- Instructions For Use