A Prospective, Multi-center, Single Arm Study to Evaluate the Safety and Effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device Used in Conjunction With Endovascular Coil Embolization in the Treatment of Wide-Neck Bifurcation Intracranial Aneurysm
Phase: PHASE3
Conditions: Unruptured Wide-neck Intracranial Aneurysms
Sponsor: Pulsar Vascular

 
 
 
Pulsar Vascular, Inc. 
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CONFIDENTIAL 
 
 
 
CLINICAL STUDY PROTOCOL 
 
A PROSPECTIVE, MULTI-CENTER, SINGLE ARM STUDY  
TO EVALUATE THE SAFETY AND EFFECTIVENESS OF THE 
PULSERIDER® ANEURYSM NECK RECONSTRUCTION DEVICE  
USED IN CONJUNCTION WITH ENDOVASCULAR COIL 
EMBOLIZATION IN THE TREATMENT OF WIDE-NECK 
BIFURCATION INTRACRANIAL ANEURYSMS 
 
NAPA STUDY 
 
 
Protocol Number:  CLIN-0034 
Version: 3.0 
November 13, 2017 
 
History of Changes 
Version Date 
Description 
Version 1.0— 23AUG2017 
Original Document – not implemented 
Version 2.0— 22SEP2017 
Amendment per FDA Feedback 
Version 3.0—13NOV2017 
Amendment per FDA Study Considerations 
 
 
 
Sponsor:  Pulsar Vascular, Inc. 
  
   130 Knowles Drive, Suite E  
   Los Gatos, CA  95032 USA 
 
 
 
 
 
This document is a confidential communication of Pulsar Vascular, Inc.  The recipient agrees that no 
information contained herein will be published or disclosed without written approval of Pulsar Vascular.  This 
document may be disclosed to appropriate institutional review boards or duly authorized representatives of 
regulatory authorities as appropriate; under the condition that confidentiality is requested. 

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Table of Contents 
1. 
BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE .......................................................... 17 
1.1. 
BACKGROUND INFORMATION ................................................................................................................ 17 
1.2. 
CURRENT OPTIONS .............................................................................................................................. 19 
1.3. 
PREVIOUS EXPERIENCE WITH PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE ....................... 21 
1.3.1. Bench and Animal Studies ............................................................................................................ 21 
1.3.2. PulseRider HDE Clinical Study ..................................................................................................... 21 
1.4. 
RATIONALE .......................................................................................................................................... 21 
1.5. 
POTENTIAL RISKS AND BENEFITS .......................................................................................................... 22 
1.5.1. Known Potential Risks ................................................................................................................... 22 
1.5.2. Minimization of Risk ...................................................................................................................... 23 
1.5.3. Known Potential Benefits .............................................................................................................. 24 
2. 
OBJECTIVES AND PURPOSE ................................................................................................................. 24 
2.1. 
OBJECTIVES ........................................................................................................................................ 24 
3. 
STUDY DESIGN AND ENDPOINTS .......................................................................................................... 24 
3.1. 
DESCRIPTION OF THE STUDY DESIGN .................................................................................................... 25 
3.2. 
STUDY ENDPOINTS............................................................................................................................... 25 
3.2.1. Primary Endpoint - Safety ............................................................................................................. 25 
3.2.2. Primary Endpoint - Effectiveness .................................................................................................. 25 
3.2.3. Secondary Endpoints - Effectiveness ........................................................................................... 26 
3.2.4. Additional Endpoints ...................................................................................................................... 26 
4. 
STUDY POPULATION ............................................................................................................................... 26 
4.1. 
PARTICIPANT INCLUSION CRITERIA ........................................................................................................ 27 
4.2. 
PARTICIPANT EXCLUSION CRITERIA....................................................................................................... 27 
4.3. 
STRATEGIES FOR RECRUITMENT AND RETENTION .................................................................................. 28 
4.4. 
PARTICIPANT WITHDRAWAL OR TERMINATION ........................................................................................ 29 
4.4.1. Reasons for Withdrawal or Termination ........................................................................................ 29 
4.4.2. Handling of Participant Withdrawals or Termination ..................................................................... 29 
5. 
STUDY DEVICE ......................................................................................................................................... 29 
5.1. 
STUDY DEVICE DESCRIPTION ............................................................................................................... 29 
5.1.1. Device Acquisition ......................................................................................................................... 29 
5.1.2. Device Appearance, Packaging, and Labeling Description .......................................................... 29 
5.1.3. Device Training Requirements and Investigator Experience ........................................................ 31 
5.1.4. Device Storage and Stability ......................................................................................................... 31 
5.1.5. Device Preparation ........................................................................................................................ 31 
5.1.6. Instructions for Use ....................................................................................................................... 31 
5.1.7. Specific Considerations ................................................................................................................. 31 
5.1.8. Duration of Implant Exposure ........................................................................................................ 32 
5.1.9. Investigational Device Accountability ............................................................................................ 32 
5.1.10. 
Device Returns .......................................................................................................................... 33 
6. 
STUDY PROCEDURES AND EVALUATION ........................................................................................... 33 
6.1. 
STUDY PROCEDURES AND EVALUATIONS .............................................................................................. 33 
6.1.1. Study Specific Procedures ............................................................................................................ 33 
6.1.2. Standard Care Procedures ............................................................................................................ 33 
6.2. 
LABORATORY PROCEDURES/EVALUATIONS ........................................................................................... 33 
6.2.1. Clinical Laboratory Evaluations ..................................................................................................... 34 
6.2.2. Other Procedures – Angiograms ................................................................................................... 34 
6.2.3. Core Laboratory for Image Evaluation .......................................................................................... 34 
6.2.4. Angiogram Shipment ..................................................................................................................... 34 

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6.3. 
CONCOMITANT MEDICATIONS, TREATMENTS, AND PROCEDURES ............................................................ 34 
6.4. 
PROHIBITED MEDICATIONS, TREATMENTS, AND PROCEDURES ................................................................ 34 
6.5. 
PROPHYLACTIC MEDICATIONS, TREATMENTS, AND PROCEDURES ........................................................... 35 
7. 
STUDY SCHEDULE................................................................................................................................... 35 
7.1. 
SCREENING ......................................................................................................................................... 35 
7.2. 
ENROLLMENT, BASELINE EVALUATION, AND PROCEDURES ..................................................................... 35 
7.2.1. Pre-Procedure/Baseline Assessments .......................................................................................... 35 
7.3. 
TREATMENT ......................................................................................................................................... 37 
7.4. 
PROCEDURE ASSESSMENTS ................................................................................................................. 38 
7.5. 
PROCEDURAL AND POST-PROCEDURAL MEDICATIONS ........................................................................... 39 
7.6. 
FOLLOW-UP IN THE EVENT OF STROKE OR SUSPECTED STROKE ............................................................ 39 
7.7. 
POST-PROCEDURE FOLLOW-UP ............................................................................................................ 39 
7.7.1. Medical Resource Utilization and Health Economics (HECON) ................................................... 40 
7.7.2. Study Participation and Information Card ..................................................................................... 41 
7.8. 
FOLLOW-UP ANGIOGRAPHY .................................................................................................................. 41 
7.9. 
FINAL STUDY VISIT ............................................................................................................................... 41 
7.10. 
UNSCHEDULED VISIT ............................................................................................................................ 41 
7.11. 
RETREATMENT ..................................................................................................................................... 42 
7.12. 
EARLY TERMINATION ............................................................................................................................ 42 
7.13. 
LOST TO FOLLOW-UP............................................................................................................................ 43 
7.14. 
SCHEMATIC OF STUDY DESIGN ............................................................................................................. 44 
7.15. 
SCHEDULE OF ASSESSMENTS TABLE .................................................................................................... 45 
8. 
ASSESSMENT OF SAFETY ..................................................................................................................... 46 
8.1. 
SPECIFIC SAFETY PARAMETERS ........................................................................................................... 46 
8.1.1. Adverse Event (AE) ....................................................................................................................... 46 
8.1.2. Serious Adverse Event (SAE) ....................................................................................................... 46 
8.1.3. Adverse Device Effect (ADE) ........................................................................................................ 47 
8.1.4. Serious Adverse Device Effect (SADE) ........................................................................................ 47 
8.1.5. Unanticipated Serious Adverse Device Effect (USADE) ............................................................... 47 
8.1.6. Unanticipated Adverse Device Effect (UADE) .............................................................................. 47 
8.1.7. Device Deficiency, Device Malfunction, and Use Error ................................................................. 47 
8.2. 
CLASSIFICATION OF AN ADVERSE EVENT ............................................................................................... 48 
8.2.1. Severity of Event ........................................................................................................................... 48 
8.2.2. Relationship to Study Device and/or Procedure ........................................................................... 48 
8.2.3. Outcome ........................................................................................................................................ 49 
8.3. 
TIME PERIOD AND FREQUENCY FOR ADVERSE EVENT ASSESSMENT AND FOLLOW-UP ............................. 50 
8.4. 
REPORTING PROCEDURES.................................................................................................................... 50 
8.4.1. Adverse Event Documentation and Reporting Requirements ...................................................... 50 
8.4.2. Serious Adverse Event Reporting ................................................................................................. 51 
8.4.3. Unanticipated Adverse Device Effect Reporting ........................................................................... 52 
8.5. 
CLINICAL EVENTS COMMITTEE .............................................................................................................. 52 
8.6. 
DATA MONITORING COMMITTEE ............................................................................................................ 52 
9. 
CLINICAL MONITORING .......................................................................................................................... 53 
10. STATISTICAL METHODOLOGY .............................................................................................................. 53 
10.1.2. 
Secondary Endpoints ................................................................................................................ 56 
10.1.3. 
Additional Endpoints ................................................................................................................. 57 
10.1.4. 
Adverse Events and Clinical Complications ............................................................................. 57 
10.1.5. 
Levels of Significance ............................................................................................................... 57 
10.1.6. 
Analysis Datasets ...................................................................................................................... 57 
10.2. 
SAMPLE SIZE JUSTIFICATION ................................................................................................................ 58 
10.3. 
ANALYSES TO BE CONDUCTED .............................................................................................................. 58 
10.3.1. 
General Conventions ................................................................................................................ 58 
10.3.2. 
Disposition of Study Subjects ................................................................................................... 59 
10.3.3. 
Demographics, Baseline, and Procedural Characteristics........................................................ 59 

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10.3.4. 
Primary Endpoint Analyses ....................................................................................................... 59 
10.3.5. 
Secondary Endpoint Analyses .................................................................................................. 60 
10.3.6. 
Additional Endpoint Analyses ................................................................................................... 60 
10.3.7. 
Safety Analyses ........................................................................................................................ 61 
10.3.8. 
Plans for Interim Analyses ........................................................................................................ 61 
10.3.9. 
Handling of Missing Data .......................................................................................................... 61 
10.3.10. 
Sensitivity Analyses .................................................................................................................. 61 
10.3.11. 
Sub-Group Analyses ................................................................................................................. 62 
10.3.12. 
Assessment of Site Homogeneity ............................................................................................. 62 
10.4. 
MEASURES TO MINIMIZE BIAS ............................................................................................................... 62 
11. ETHICS AND PROTECTION OF HUMAN SUBJECTS ............................................................................ 63 
11.1. 
ETHICAL STANDARD ............................................................................................................................. 63 
11.2. 
INSTITUTIONAL REVIEW BOARD ............................................................................................................. 64 
11.3. 
INFORMED CONSENT PROCESS ............................................................................................................ 64 
11.3.1. 
Consent and Other Informational Documents Provided to Participants ................................... 64 
11.3.2. 
Consent Procedures and Documentation ................................................................................. 65 
11.4. 
PARTICIPANT AND DATA CONFIDENTIALITY ............................................................................................ 65 
12. QUALITY ASSURANCE AND QUALITY CONTROL ............................................................................... 66 
13. DATA HANDLING AND RECORD KEEPING ........................................................................................... 66 
13.1. 
DATA COLLECTION AND MANAGEMENT RESPONSIBILITY ......................................................................... 66 
13.1.1. 
Electronic Case Report Forms .................................................................................................. 66 
13.1.2. 
Source Documentation ............................................................................................................. 66 
13.1.3. 
Study Records ........................................................................................................................... 67 
13.1.4. 
Health Economic Data .............................................................................................................. 67 
13.1.5. 
Data Reporting .......................................................................................................................... 68 
13.1.6. 
Data Verification and Review .................................................................................................... 68 
13.1.7. 
Final Data Analysis ................................................................................................................... 68 
13.2. 
STUDY RECORD RETENTION AND ARCHIVING ........................................................................................ 68 
14. PROTOCOL DEVIATIONS ........................................................................................................................ 69 
15. DATA AND PUBLICATION POLICY......................................................................................................... 69 
16. STUDY ADMINISTRATION ....................................................................................................................... 69 
16.1. 
STUDY LEADERSHIP ............................................................................................................................. 69 
16.2. 
STEERING COMMITTEE ......................................................................................................................... 70 
17. CONFLICT OF INTEREST ........................................................................................................................ 70 
18. REFERENCES ........................................................................................................................................... 71 
 
 
 
 
 

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List of Figures and Tables 
FIGURE 1.1A – ILLUSTRATION OF NECK SIZE AND BIFURCATION ANEURYSM ..................................... 18 
FIGURE 1.1B ANEURYSM SIZING ................................................................................................................... 18 
TABLE 1.5.1A ANTICIPATED RISKS ............................................................................................................... 22 
FIGURE 3.2.2A RAYMOND SCALE [ROY 2001] .............................................................................................. 26 
FIGURE 5.1.2A.  PULSERIDER T AND Y SHAPES ......................................................................................... 30 
FIGURE 5.1.2B. IMPLANT PLACED AT A VESSEL BIFURCATION AND RETAINING EMBOLIC COILS ... 30 
FIGURE 7.14A SCHEMATIC OF STUDY DESIGN ........................................................................................... 44 
TABLE 7.15A  SCHEDULE OF ASSESSMENTS ............................................................................................. 45 
TABLE 8.2.1A INTENSITY OR SEVERITY DEFINITIONS ............................................................................... 48 
TABLE 8.2.2A  ADVERSE EVENT CAUSALITY CLASSIFICATIONS............................................................. 49 
TABLE 8.2.3A ADVERSE EVENT OUTCOME CLASSIFICATIONS ................................................................ 49 
TABLE 8.4.1A ADVERSE EVENT REPORTING REQUIREMENTS ................................................................ 51 
FIGURE 10.1.1A FOREST PLOT: SEVEN REFERENCES WITH USABLE DATA TO ESTIMATE THE 
ANTICIPATED PRIMARY SAFETY ENDPOINT AT 12 MONTHS .................................................................... 55 
 
LIST OF ABBREVIATIONS.................................................................................................................................. 6 
 
 
 
 
 

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LIST OF ABBREVIATIONS 
ACOM  
Anterior Communicating Artery 
ADE 
 
Adverse Device Effect  
AE 
 
Adverse Event 
ASADE  
Anticipated Serious Adverse Device Effect 
CEC 
 
Clinical Events Committee 
CFR 
 
Code of Federal Regulations 
CT 
 
Computed Tomography 
CTA 
 
Computed Tomography Angiography 
DAPT 
 
Dual Anti-Platelet Therapy 
DMC 
 
Data Monitoring Committee 
DSA 
 
Digital Subtraction Angiography 
eCRF  
 
Electronic Case Report Form 
EDC 
 
Electronic Data Capture 
EDH 
 
Epidural Hemorrhage 
EVT 
 
Endovascular Treatment 
FDA 
 
Food and Drug Administration 
GCP 
 
Good Clinical Practice 
HDE 
 
Humanitarian Device Exemption 
HECON  
Health Economics 
HIPAA  
Health Insurance Portability and Accountability Act 
HUD 
 
Humanitarian Use Device 
ICF 
 
Informed Consent Form 
ICH 
 
International Council for Harmonization  
IDE 
 
Investigational Device Exemption  
IFU 
 
Instructions for Use 
IPH 
 
Intraparenchymal Hemorrhage 
IRB 
 
Institutional Review Board 
ISAT 
 
International Subarachnoid Aneurysm Trial 
mITT 
 
Modified Intent-to-Treat 
MCA 
 
Middle Cerebral Artery 
MRA 
 
Magnetic Resonance Angiography 
MRI 
 
Magnetic Resonance Imaging 
mRS 
 
Modified Rankin Scale 
NIHSS  
National Institutes of Health Stroke Scale 
PG 
 
Performance Goal 
PHI 
 
Protected Health Information 
PP 
 
Per Protocol 
PI 
 
Principal Investigator 
RHV 
 
Rotating Hemostasis Valves 
SADE 
 
Serious Adverse Device Effect  
SAE 
 
Serious Adverse Event 
SAH 
 
Subarachnoid Hemorrhage 
SC 
 
Surgical Clipping 
SAP 
 
Statistical Analysis Plan 
SAS 
 
Statistical Analysis Software 
SDV 
 
Source Data Verification 
SDH 
 
Subdural Hemorrhage 
SOC 
 
Standard of Care 
SOP 
 
Standard Operating Procedure 
TIA 
 
Transient Ischemic Attack 
UADE  
Unanticipated Adverse Device Effect 
US 
 
United States 
USADE  
Unanticipated Serious Adverse Device Effect 
WBC 
 
White Blood Cell 
WNBA  
Wide Neck Bifurcation Aneurysms 
 

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 KEY ROLES AND RESPONSIBILITIES 
 
 
Sponsor: 
Pulsar Vascular, Inc. 
130 Knowles Drive, Suite E  
Los Gatos, CA  95032 USA  
Tel: 408-260-9264 
Fax: 408-232-3805 
 
Contacts: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Coordinating 
Investigator: 
 
 
 
 
 
Medical 
Monitor/Safety 
Contact: 
 
 
Christopher Hendricks 
Associate Director, Neurovascular Clinical Research 
Johnson & Johnson Medical Devices Companies 
33 Technology 
Irvine, CA 92618 USA  
Tel: 415-656-6565 
CHendric@its.jnj.com 
 
Stephanie Plaza 
Staff Scientist, Clinical Franchise 
Johnson & Johnson Medical Devices Companies 
33 Technology 
Irvine, CA 92618 USA  
Tel: 626-253-9698 
splaza@its.jnj.com 
 
Alejandro Spiotta, MD 
Medical University of South Carolina 
96 Jonathan Lucas St. 301 CSB 
Charleston, SC 29425 USA 
Tel: 216-409-7024 
spiotta@musc.edu 
 
Sean Lilienfeld, MD 
Vice President, Medical Operations 
Johnson & Johnson Medical Devices 
325 Paramount Drive 
Raynham, MA 02767 USA 
Tel: 781-363-2111 
slilien1@its.jnj.com 
 
 
 

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PROTOCOL AGREEMENT AND STATEMENT OF COMPLIANCE FORM 
STUDY NAME AND NUMBER: NAPA - CLIN-0034 (CSC_2017_01) 
 
STUDY TITLE:  A Prospective, Multi-Center, Single Arm Study to Evaluate the Safety and 
Effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device Used in Conjunction 
with Endovascular Coil Embolization in the Treatment of Wide-Neck Bifurcation Intracranial 
Aneurysms 
 
VERSION NUMBER: 3.0 
 
VERSION DATE: November 13, 2017 
 
I have read this protocol and agree to conduct this clinical study in accordance with the design and specific 
provisions outlined herein. I understand the protocol, and I understand I am solely responsible to ensure the 
investigation is conducted in accordance with Good Clinical Practice (GCP), applicable FDA regulations (21 
CFR Parts 812, 11, 50, 54 and 56), local regulations, the Declaration of Helsinki, the signed clinical study 
contract with Sponsor and with the protocol outlined herein. I will conduct this study as outlined therein and will 
make reasonable effort to complete the study within the time period designated by the Sponsor.    
I will provide copies of the protocol and all pertinent information to all individuals responsible to me who will 
assist in the conduct of this study. I will discuss this material with them to ensure they are fully informed 
regarding the device and the conduct of the study.  
I will fulfill the requirements of my Institutional Review Board (IRB), or other oversight committee, to ensure 
complete and continual oversight of this clinical investigation. I will use an Informed Consent Document 
approved by the Sponsor and my reviewing IRB.  
I agree to report all information or data in accordance with the protocol and, in particular, I agree to report any 
serious adverse events, device related adverse events, or procedure related adverse events as defined in this 
protocol to the Sponsor, and comply with all adverse event reporting requirements of my reviewing IRB.  I agree 
to permit the Sponsor, its authorized representatives, my reviewing IRB, the FDA, and any regulatory 
authority/body access to all records relating to the clinical investigation. 
The below signature confirms I have read and understood this protocol and its associated amendments or 
attachments, and will accept respective revisions or amendments provided by the Sponsor. 
      
 
 
 
 
 
Principal Investigator (PI) 
Name (PRINT) 
 
 
 
 
Signature 
 
Date 
 
 
 

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PROTOCOL SUMMARY 
Title of Study: 
A Prospective, Multi-Center, Single Arm Study to Evaluate the 
Safety and Effectiveness of the PulseRider® Aneurysm Neck 
Reconstruction Device Used in Conjunction with Endovascular Coil 
Embolization in the Treatment of Wide-Neck Bifurcation 
Intracranial Aneurysms 
Study Name 
NAPA 
Study Device: 
PulseRider® Aneurysm Neck Reconstruction Device 
Indication Under 
Investigation: 
Indicated for use with neurovascular embolic coils in patients ≥ 18 
years of age for the treatment of unruptured wide-neck intracranial 
aneurysms with neck widths ≥ 4 mm or dome to neck ratio < 2 
originating on or near a vessel bifurcation of the basilar artery, 
middle cerebral artery, anterior communicating artery or carotid 
terminus with at least a portion of the aneurysm neck overlapping 
the lumen of the parent artery.  The inflow vessels should have 
diameters from 2.0 mm to 4.5 mm. 
Comparator Device: 
This is a single arm study with no comparator device   
Study Sponsor:  
Pulsar Vascular, Inc.                                                                             
130 Knowles Drive, Suite E                                                                  
Los Gatos, CA  95032 USA 
Study Objectives: 
The objective of this study is to evaluate the safety and effectiveness 
of the PulseRider® Aneurysm Neck Reconstruction Device in 
conjunction with coil embolization in the endovascular treatment of 
unruptured wide-neck intracranial aneurysms located at the 
bifurcation of the basilar artery, carotid terminus, middle cerebral 
artery (MCA), and anterior communicating artery (ACOM). 
Study Design: 
This is a prospective, multi-center, single arm, clinical study in 
which 160 subjects will be enrolled and followed at 30 days, 180 
days, 1 year, 2 years, 3 years, 4 years and 5 years post-procedure.   
Sample Size: 
A total of 160 subjects will be enrolled into the study.  
Number of Sites: 
Up to 28 clinical sites in the US 
Study Population: 
 
 
Subjects with unruptured, angiographically confirmed wide-neck (≥ 
4 mm or a dome-to-neck ratio < 2) intracranial aneurysms located at 
the bifurcation of the basilar artery, carotid terminus, MCA and 
ACOM arising from the parent vessel for the target aneurysm with a 
diameter of 2.0 mm to 4.5 mm will be eligible for the study. 

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Study Procedures: 
The study evaluation time points include:  
1. Screening/Baseline 
2. Procedure 
3. Hospital Discharge 
4. 30 Day Follow-up (Clinic Visit) 
5. 180 Day Follow-up (Clinic Visit) 
6. 1 Year Follow-up (Clinic Visit and DSA) 
7. 2 Year Follow-up (Telephone Call) 
8. 3 Year Follow-up (Clinic Visit and DSA or MRA) 
9. 4 Year Follow-up (Telephone Call) 
10. 5 Year Follow-up (Clinic Visit and DSA or MRA) 
 
Primary Safety 
Endpoint: 
Composite of Neurological Death or Major Ipsilateral Stroke (in 
downstream territory) up to 1 year post-procedure: 
 
• Stroke is defined as rapidly developing clinical signs of focal 
(or global) disturbance of cerebral function lasting more 
than 24 hours with no apparent cause other than of vascular 
origin, including ischemic stroke and/or hemorrhagic stroke 
(i.e., intraparenchymal hemorrhage (IPH), subarachnoid 
hemorrhage (SAH), subdural hemorrhage (SDH), epidural 
hemorrhage (EDH)).  [Hatano 1976]. 
• Major Stroke is defined as stroke with symptoms persisting 
for more than 24 hours AND a sudden increase in the NIHSS 
of the subject by > 4. 
 
Primary Effectiveness 
Endpoint: 
 
Complete Occlusion: 
Rate of complete aneurysm occlusion (Raymond I) without 
significant parent artery stenosis (> 50% stenosis) or prior 
retreatment at 1 year post-procedure. 
 
Secondary Effectiveness 
Endpoints: 
 
 
 
 
 
 
 
• Technical Success is defined as successful implantation of 
device— physician able to access target aneurysm, deploy 
PulseRider® device at the neck of aneurysm and device was 
detached successfully 
• Ability to retain embolic coils within aneurysm immediately 
post-procedure (as evaluated by the core lab) 
• Complete aneurysm occlusion at 3 years and 5 years 
• Adequate aneurysm occlusion (defined as Raymond I and II 
combined) at 1 year, 3 years and 5 years 

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Additional Endpoints: 
 
 
 
Sample Size Justification 
 
• The percentage of target aneurysms that are retreated 
through 1 year, 3 years and 5 years  
• The percentage of subjects with significant stenosis defined 
as > 50% at implant site at 1 year, 3 years and 5 years.  
• The percentage of subjects with mRS 0-2 at 1 year, 3 years 
and 5 years 
 
 
 
• The percentage of target aneurysm rupture up to 1 year, 3 
years and 5 years  
• No migration (defined as ≤ 2 mm) of the device at 1 year, 3 
years and 5 years  
 
A meta-analysis was executed to determine the Performance Goal 
(PG) for the primary safety endpoint of a clinical study of the 
PulseRider®.   Based on this meta-analysis, a rate of 9.9% rounded 
to 10% (95% CI: 5.9% - 16.1%) for death due to neurological causes 
or major ipsilateral stroke was calculated. A 5% margin of 
indifference for the primary safety endpoint is proposed, resulting in 
a PG of 15% for this endpoint. Based on the 1 year results of the 
ANSWER HDE Study, the anticipated rate for the primary safety 
endpoint is 7%. Results from a recently published meta-analysis 
[Fiorella 2017] indicate that the rate of complete occlusion at 1 year 
of wide-neck bifurcated aneurysms treated with conventional 
therapies is 46.3% (95% CI: 39.2% - 53.4%) whereas the ANSWER 
HDE Study described above reports the rate of complete occlusion 
is 58.8% with the PulseRider® device. With Sponsor’s desire to seek 
strict superiority to a PG of 46.3% for the primary effectiveness 
endpoint and an expected attrition rate of 10%, one hundred sixty 
(160) subjects will provide 80% power for the primary safety 
endpoint and 85% power for the primary effectiveness endpoint. 
Statistical Analysis 
The primary safety endpoint will be evaluated on all subjects for 
whom implantation of the PulseRider® device was attempted.  
Subjects with a missing endpoint will be imputed with a multiple 
imputation method that will make use of the similarities between the 
subject’s demographic, procedural, and aneurysm characteristics 
with those of the subjects with a non-missing endpoint.  The 
endpoint will be considered successful if the upper bound of the two-
sided 95% confidence interval for its rate is less than a performance 
goal of 15%.  
 
The primary effectiveness endpoint will be evaluated on all subjects 
for whom implantation of the PulseRider® device was successful. 
Subjects with a missing endpoint will be imputed using a multiple 
imputation method that will make use of the subject’s own past 

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occlusion evaluations and the similarities between the subject’s 
demographic, procedural, and aneurysm characteristics with those of 
the subjects with a non-missing endpoint. The endpoint will be 
considered successful if the lower bound of the two-sided 95% 
normal approximation based confidence interval for its rate is greater 
than a performance goal of 46.3%.  
 
The study will be deemed a success if the primary safety and 
effectiveness endpoints are met. 
If the primary endpoints are met, the secondary effectiveness 
endpoint of technical success will be tested against a PG of 79%.  
 
Inclusion Criteria 
1. Subject with an angiographically confirmed digital subtraction 
angiogram (DSA) or computed tomography angiogram (CTA), of 
wide- neck (≥ 4 mm or dome to neck ratio < 2) intracranial 
aneurysm located at a bifurcation of the basilar artery, carotid 
terminus, MCA or ACOM  
2. The parent vessel for the target aneurysm has a diameter of 2.0 
mm to 4.5 mm 
3. The subject is between 18 and 80 years of age the time of consent  
4. Informed consent is obtained and the subject signs the 
Institutional Review Board (IRB) approved consent prior to 
beginning any study procedures along with the HIPAA 
Authorization for the release of PHI 
5. In the opinion of the treating physician, placement of the 
PulseRider® device is technically feasible and clinically indicated  
6. Subject has the mental capacity, willingness and ability to 
comply with protocol requirements and follow-up through 5 years 
for the clinical study 
 
Exclusion Criteria 
1. Unstable neurological deficit (condition worsening within the 
last 90 days)  
2. Subarachnoid Hemorrhage within the last 60 days 
3. Irreversible bleeding disorder 
4. Modified Rankin Score (mRS) score ≥ 3 
5. Patient has another intracranial aneurysm that in the 
Investigator’s opinion, may require treatment within the 1 year 
follow up period  

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6. Patient has previously had two or more (≥ 2) procedures to treat 
the target aneurysm  
7. Patient with an untreated target aneurysm that is partially 
thrombosed 
8. Platelet count < 100 x 103 cells/mm3 
9. Inability to tolerate, adverse reaction to or any contraindication 
to taking aspirin or P2Y12 inhibitor  
10. A history of contrast allergy that cannot be medically controlled 
11. Known allergy to nickel 
12. Relative contraindication to angiography (e.g. serum creatinine 
> 2.5 mg/dL) 
13. Woman of child-bearing potential who cannot provide a 
negative pregnancy test 
14. Evidence of active systemic infection (e.g. fever with 
temperature > 38°C/100.4°F and/or white blood cell (WBC) > 
15,000) 
15. Conditions that carry a high risk of neurological events or 
stroke (e.g., uncontrolled hypertension, prior ischemic stroke, 
Moya moya disease) 
16. Evidence of disease or condition expected to compromise 
survival or ability to complete follow-up assessments during the 5 
year follow-up period 
17. Vessel tortuosity or stenosis that prohibits safe endovascular 
access to the target aneurysm to allow for treatment with the study 
device  
18. Current involvement in a study for another investigational 
product  
19. Patient and / or family considering a move from this 
geographical location at the time of consent 
20. Categorized as a vulnerable population and require special 
treatment with respect to safeguards of well-being (e.g. cognitively 
impaired, veteran, prisoner, etc.) 
 
Investigational 
Device: 
PulseRider® Aneurysm Neck Reconstruction Device  
 

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Study Duration: 
The study duration is expected to be 6.5 years (including enrollment 
phase). The enrollment phase is expected to take 18 months following 
enrollment of the first subject.  
Participant 
Duration: 
It will take each participant approximately 5 years to complete the 
protocol required follow-up visits. 
 
 
 

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Schedule of Assessments 
 
 
Assessments 
Pre-procedure* (0-60 days 
of the procedure) 
Immediately Pre-Procedure 
Procedure 
Immediately Post-
procedure 
 Discharge 
30 Day Follow-up  
(+/- 7 days) 
180 Day Follow-up  
(+/- 42 days) 
1 Year Follow-up  
(+/- 60 days) 
2 Year Telephone Call (+/-
60 days) 
3 Year Follow-up  
(+/- 60 days) 
4 Year Telephone Call (+/-
60 days) 
5 Year Follow-up  
(+/- 60 days) 
Unscheduled Visit 
Informed 
Consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Labs (CBC & 
Blood 
Coagulation 
Tests) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Neurological 
Exam 
X 
 
 
 
X 
X 
X 
X 
 
X 
 
X 
X 
NIH Stroke Scale 
Assessment  
 
X 
 
 
X 
X 
X 
X 
 
X 
 
X 
X 
Modified Rankin 
Scale  
 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Pregnancy Test 
 
X‡ 
 
 
 
 
 
 
 
 
 
 
 
Conventional 
Catheter 
Angiography – 
DSA 
**X 
***X 
 
Oβ 
Oβ 
X†$ 
Oβ 
X†† 
Oβ 
X†† 
 
MR 
Angiography 
 
 
 
 
 
Oβ 
Oβ 
 
Oβ 
X†† 
Oβ 
X†† 
Oβ 
CT Angiography 
**X 
 
 
 
 
Oβ 
Oβ 
 
Oβ 
 
Oβ 
 
Oβ 
Review of 
Adverse Events 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Review of 
Medications 
Taken 
X 
 
X  
X  
X 
X 
X 
X 
X 
X 
X 
X 
X 
Medical 
Resource 
HECON 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
*With the exception of the baseline DSA or CTA and the pregnancy test, all baseline evaluations must be completed within 60 days prior to the 
index procedure and may occur on the procedure day prior to the procedure. 
**Baseline imaging may be either CTA or DSA and must be completed within 180 days prior to the index procedure. 
***Three treatment angiograms: 1) Immediately pre-procedure image is before PulseRider implant to confirm eligibility 2) Procedure image 
immediately after PulseRider placement 3) Immediately post-procedure is after coiling.   
β Any imaging related to the target aneurysm conducted post-procedure and prior to the final study visit, per standard of care, will be collected. 
† Imaging for 1 year post-procedure must be DSA. 
†† Imaging for 3 and 5 years post-procedure must be DSA or Magnetic Resonance Angiography (MRA). 
‡ Pregnancy test must be completed on day of procedure for women of childbearing potential. 
$ Subjects who were not implanted with the PulseRider device are not required to undergo DSA imaging at 1 year. 

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SCHEMATIC OF STUDY DESIGN 
 
 
 
 
 
 
 
 
 
Day of 
Procedure 
30 Day 
Follow-up 
Pre-Procedure 
 Obtain informed consent. Screen potential subjects by inclusion and exclusion criteria 
Discharge: neurologic exam, NIHSS, mRS, review of AE/meds taken 
Follow-up visit: neurologic exam, NIHSS, mRS, imaging per SOC,*  review of AE/meds taken 
Pregnancy test if applicable, DSA, NIHSS, mRS, (pre-procedure) 
Subject considered enrolled upon DSA confirming eligibility; AE reporting begins. 
Procedure 
(Review of AE/meds taken immediately post-procedure) 
Perform baseline assessments: medical history, labs, neurologic exam, DSA or CTA, review of meds 
Final Assessment: DSA or MRA, neurologic exam, 
NIHSS, mRS, review of AE/meds taken. 
Follow-up visit: neurologic exam, NIHSS, mRS, imaging per SOC,* review of AE/meds taken 
Follow-up visit: DSA, neurologic exam, NIHSS, mRS, review of AE/meds taken 
Follow-up visit: (Telephone call) review of AEs/meds taken, mRS 
3 Year 
Follow-up 
Discharge  
*All imaging performed per standard of care (SOC) after the study procedure 
and prior to the final visit will be submitted to the core lab. 
180 Day 
Follow-up 
1 Year 
Follow-up 
2 Year 
Follow-up 
Follow-up visit: DSA or MRA, neurologic exam, NIHSS, mRS, review of AE/meds taken 
Follow-up visit: (Telephone call) review of AEs/meds taken, mRS 
4 Year 
Follow-up 
5 Year 
Follow-up 
Image Screening Committee Review 

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1. 
Background Information and Scientific Rationale 
1.1. 
Background Information 
An intracranial aneurysm is an abnormal dilatation that occurs in an artery as the result of 
a weakening in the wall of the vessel. This balloon like outpouching fills with blood and 
may enlarge over time; most commonly this occurs at the junctions or bifurcations of major 
arteries. As the aneurysm increases in size, the vessel wall becomes thinner and more 
fragile and is at risk of rupture. Many intracranial aneurysms remain silent and are never 
diagnosed unless they rupture resulting in a subarachnoid hemorrhage (SAH) or gradually 
enlarge over time and exert pressure on the surrounding brain tissue resulting in a variety 
of morbidities. These aneurysms are typically diagnosed because of the associated 
symptoms e.g. cranial neuropathies, visual disturbances, etc.  Asymptomatic, unruptured 
aneurysms may also be discovered incidentally as a result of some other suspected 
pathology e.g. migraine headache, dizziness, etc. that requires diagnostic imagining. The 
most common presentation of an intracranial aneurysm however, is SAH, which is a life-
threatening event. Even with prompt medical attention there is a high incidence of 
morbidity and mortality. Between 40% and 67% of ruptured aneurysms result in death 
within one month and 10% to 20% of the survivors have major morbidities [Woo 2002].  
The primary goal of surgery or endovascular treatment of any aneurysm is to reduce the 
risk of initial or recurrent subarachnoid hemorrhage by excluding the lesion from the 
cerebral circulation. 
Risk factors for the formation of aneurysms include a family history, various inherited 
disorders such as polycystic kidney disease, age greater than 50 years, female gender, 
hypertension, trauma, atherosclerosis, abnormal flow at a vessel bifurcation and current 
cigarette smoking [Vega 2002]. A strong female predilection has been observed in patients 
with aneurysms, especially those with multiple aneurysms.  There are other rare causes of 
aneurysms such as infections of the artery wall and drug abuse, especially cocaine, which 
can cause the artery walls to become inflamed and weakened. 
The two most common types of intracranial aneurysms are saccular or berry and fusiform. 
The saccular aneurysm has a general dilation of one side of the artery and accounts for 
most of the aneurysms.  In contrast, a fusiform aneurysm is a ballooning of the entire 
circumference of an artery.  Saccular aneurysms exhibit a variety of sizes and complex 
shapes; they are categorized according to neck size, location in a sidewall or at a bifurcation 
(see Figure 1.1A), shape, and the absolute size of the dome (the widest diameter within the 
aneurysm sac) as shown in Figure 1.1B.   
Some aneurysms have a large absolute neck or a large neck relative to the dome size; these 
are categorized as wide neck.  From the point of view of the endovascular surgeon, the 
diameter of the aneurysm neck as opposed to the dimensions of the sac is the critical factor, 
particularly in assessing if endovascular treatment is a viable option [Zubillaga 1994].  
Even with the advances of neuro-interventional devices and techniques, wide neck 
aneurysms (defined as a neck diameter ≥ 4 mm or dome to neck ratio < 2 mm) [McLaughlin 

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2013, Wanke 2003, Kwon 2012, Parlea 1999, Zhoa 2012, Kim 2013] at a bifurcation 
represent a difficult subset of aneurysms to treat [Spiotta 2014, Gentric 2013, Pierot 2015]. 
These aneurysms occur at the junction of two essential branching arteries that must remain 
patent after the embolization procedure [Spiotta 2014]. 
 
Figure 1.1A – Illustration of Neck Size and Bifurcation Aneurysm  
    
 
            
 
 
 
 
 
 
Figure 1.1B Aneurysm Sizing 
 
 
 
 
X = Neck 
Y = Dome 
Y/X = Dome to Neck Ratio 
Prior to the International Subarachnoid Aneurysm Trial (ISAT), which compared 
endovascular therapy to surgical clipping, the traditional treatment for aneurysms was open 
 
Narrow Neck Aneurysm 
 
                        Wide Neck Aneurysm  
Bifurcation Aneurysm  
Y
X
Parent 
Vessel 
Aneurysm

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surgery.  However, open surgery is highly invasive and requires a significant recovery 
period even for those who are medically stable and can tolerate the procedure. In many 
cases, surgery may be contraindicated for patients with co-morbidities. 
Following the release of the ISAT data, endovascular therapy was established as a viable 
alternative method for treating intracranial aneurysms [ISAT 2003, Molyneux 2005, 
Fiorella 2004].  Endovascular treatment is associated with fewer adverse outcomes (6.6% 
versus 13.2%) and decreased mortality (0.9% versus 2.5%) compared with open surgery 
[Higashida 2007].  However, even with current endovascular technologies some lesions 
are not suitable for endovascular treatment [Kato 2009]. Therefore, it is anticipated that 
advances in endovascular technologies will continue in order to develop effective treatment 
options for complex cerebral aneurysms, including wide-neck aneurysms that have been 
considered poor candidates for endovascular treatment. Patient selection for either surgery 
or endovascular coil embolization should include the risks weighed against the probability 
for adequate aneurysm occlusion.  Other key factors to consider are aneurysm location and 
size, patient comorbidities, and relative contraindications e.g. allergy to contrast media, 
renal disease, etc. [Johnston 2002]. 
The concept of using a neck bridge to support coils and to improve endovascular treatment 
for bifurcation aneurysms was first reported in 2001 with the initial introduction of the 
TriSpan device (Target Therapeutics/Boston Scientific, Fremont, CA) in Europe and 
Canada [Raymond 2001].  More recently physicians have been treating unruptured 
aneurysms using stents as adjunctive devices to support the coil mass. For bifurcation 
aneurysms, the Y-stent technique involves the passage of a second stent through the 
interstices of the first deployed stent.  This technique is technically demanding and requires 
multiple steps, each with the possibility of technical complication [Fargen 2013, Spiotta 
2011, Akgul 2011].  Y-stenting has become quite prevalent for wide neck aneurysms since 
endovascular therapy requires high packing density as there is a relationship between 
aneurysm volume, packing and compaction [Sluzewski 2004].  Dense packing aids in 
preventing recanalization of the lesion and SAH post-procedure.  However, it has been 
noted, that over time, about 25% of cerebral aneurysms treated with embolic coils do show 
evidence of some refilling of the aneurysm sac [Slob 2005] which has furthered the need 
for new technology.  Incomplete occlusion, incomplete packing, coil compaction, or coil 
migration into the intra-aneurysmal thrombus may contribute to recurrence and subsequent 
(re)bleeding [Henkes 2005]. 
1.2. 
Current Options  
The use of balloon remodeling involves the temporary inflation of a balloon across the 
aneurysm neck, allowing coil deployment into an aneurysm with an unfavorable dome-to-
neck ratio [Spiotta 2012].  The balloon inflation can lead to local anterograde flow arrest 
in the territory involved. Other risks of balloon remodeling include perforator occlusion 
and parent vessel dissection or rupture [Cottier 2001, Shapiro 2008].  
Geometrically complex aneurysms that pose a technical challenge are sometimes treated 
with endovascular stent assisted coiling [McDougall 1996, van Rooij 2007].  Use of a 

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single stent involves deploying the stent across a vessel lumen at the neck of the lesion to 
provide mechanical support and prevent potential coil prolapse into the vessel lumen.  Y-
stenting, mentioned previously, involves placing two stents in the adjacent arteries in a Y 
configuration [Spiotta 2017]. The disadvantages of this technique are significant and 
include a high risk of rupture or vessel perforation. This procedure is technically difficult 
and there is an increased risk of thromboembolic events due to abnormal turbulent flow 
resulting from the intraluminal stent overlap and lack of apposition to the vessel wall 
[Chow 2004, Tumialán 2008, Cho 2006].  Additionally, there is a high procedural cost and 
the patient must remain on long term anti-platelet medications. Based on the published 
literature there are ongoing efforts in the physician community to utilize current 
endovascular stents as makeshift neck bridges despite the documented clinical risks.  
The use of current endovascular technologies in wide-neck bifurcation aneurysms can be 
challenging as they may not be safely deployed across the aneurysm neck without 
introducing abnormal turbulent flow, conformability to the vessel wall may be suboptimal, 
and there is potential for embolic device herniation into the parent vessel, “jailing” of 
adjacent vessels, and device migration.  Despite advances and rapid adoption of new 
devices and techniques, significant unmet clinical needs still exist, creating a demand for 
innovation and new interventional tools for aneurysm occlusion. This is especially true for 
wide-neck aneurysms at a terminal bifurcation as the possibility to achieve dense packing 
is reduced in these lesions [McDougall 1996, Spiotta 2013]. 
The PulseRider was specifically designed to resolve the shortcomings of current 
endovascular devices that are being used to treat wide neck bifurcation aneurysms.  The 
PulseRider device provides a bridge across the aneurysm neck and support along the vessel 
wall in wide-neck bifurcation aneurysms.  The device has a very low metal-to-artery ratio 
with the majority of metal concentrated where it is needed, at the aneurysm neck to support 
the coil mass, rather than circumferentially. The device is delivered in a standard method 
through a 0.21” microcatheter, is easily recaptured and repositioned for desired placement 
prior to detachment and there is no need to access the daughter vessels during placement.  
The PulseRider supports embolic agents and may allow more dense packing of the 
aneurysm while preserving luminal patency and hemodynamic flow, minimizes exposed 
metal to encourage early device endothelialization, and securely retains embolic agents 
within the aneurysm sac while maintaining vessel apposition in the parent vessel 
bifurcation.   
Although the PulseRider is specifically designed for treatment of wide-neck aneurysms at 
or near vessel bifurcations, the Humanitarian Use Device (HUD) classification limits 
treatment to carotid terminus and basilar aneurysms only. Consequently, compelling 
reasons still exist to expand the PulseRider indication to other intracranial aneurysms. 
There are currently no approved endovascular options in the US for treating all wide neck 
aneurysms at a bifurcation and open surgery is not always a viable option, especially for 
patients that are elderly or medically unstable. The PulseRider provides a treatment option 
for these challenging aneurysms, previously believed not appropriate for coiling, because 

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it is designed to provide support for the coil mass at the wide neck, prevent coil herniation, 
and preserve the blood flow in the daughter vessels.   
Since the PulseRider has been shown to be safe and easily delivered to basilar artery 
aneurysms, in the more difficult to treat posterior circulation, a logical expansion of the 
indications would be to include middle cerebral artery (MCA) and anterior communicating 
artery (ACOM) artery. 
The NAPA Study sponsored by Pulsar Vascular, Inc. will be a prospective, multi-center, 
single-arm clinical study of the PulseRider Aneurysm Neck Reconstruction Device in the 
minimally invasive treatment of bifurcation intracranial aneurysms. This investigational 
device exemption (IDE) proposes a similar study design to the ANSWER IDE study, which 
supported the Humanitarian Device Exemption (HDE), with the addition of the MCA and  
ACOM aneurysms. 
1.3. 
Previous Experience with PulseRider Aneurysm Neck Reconstruction Device 
1.3.1. 
Bench and Animal Studies 
Bench and animal testing has been performed using the PulseRider Aneurysm Neck 
Reconstruction Device.  Please refer to the Investigator Brochure for detailed summaries 
of the test protocols and corresponding reports. 
1.3.2. 
PulseRider HDE Clinical Study 
Pulsar Vascular Inc. sponsored a HDE clinical study to evaluate the safety and probable 
benefit of the PulseRider Aneurysm Neck Reconstruction Device under IDE G130268.  
The Adjunctive Neurovascular Support for Wide-Neck Aneurysm Embolization and 
Reconstruction Study (ANSWER) was a prospective, multi-center, non-randomized study 
designed to evaluate the safety of the PulseRider device in patients undergoing treatment 
for intracranial bifurcation aneurysms of the carotid terminus or basilar artery.  Thirty-four 
subjects were enrolled in the clinical study at 10 clinical sites in the US.  
The PulseRider is an adjunctive device to support the neck of the aneurysm and it is 
intended to be used with embolic coils. The device was placed at the neck of the intended 
target aneurysm and detached in 34/34 cases, a 100% success rate. The blinded core lab 
adjudicated Raymond I and II combined score was 87.9% at 180 days post-procedure.  
There were two secondary procedures performed during the course of the study. The HDE 
study was limited to basilar and carotid terminus aneurysms only and although the safety 
profile of the device is favorable and reported data is encouraging, a larger study in 
additional territories is desired.  
A report of the full data set with six-month follow-up was submitted to the Food and Drug 
Administration (FDA) in June 2016.  The HDE was approved on June 19, 2017 for use in 
bifurcation aneurysms in the carotid terminus and basilar arteries.  Further detail on the 
ANSWER Study is located in the Investigator Brochure. 
1.4. 
Rationale 

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The PulseRider is designed to allow for the treatment of wide-neck intracranial aneurysms 
at a bifurcation of the basilar artery, carotid terminus, MCA and ACOM. The PulseRider 
device, when used in combination with embolic agents, should enable endovascular 
treatment and occlusion of aneurysms that previously were untreatable or could only be 
treated with an open procedure. This potentially could result in higher rates of aneurysm 
occlusion, lower patient mortality and an acceptable rate of short-term and long-term 
morbidity. 
1.5. 
Potential Risks and Benefits 
1.5.1. 
Known Potential Risks 
Risks that may be associated with the use of the PulseRider, the procedure, antiplatelet 
medications or general anesthesia are described in this section. Common risks (with 
anticipated frequency of < 20 %) include headache, dizziness, nausea and vomiting, groin 
injury or hemorrhage, pain at the insertion site, or insertion site hematoma/bleeding.  All 
other risks are uncommon or rare and are expected to occur with frequency < 10% [Naggara 
et al. 2010]. 
Table 1.5.1A Anticipated Risks 
 
Common risks with anticipated frequency of < 20% 
Dizziness 
Insertion site hematoma/bleeding 
Groin injury or hemorrhage 
Nausea and vomiting 
Headache 
Pain at insertion site 
Uncommon or rare risks with anticipated frequency of < 10% 
Adverse reaction to antiplatelet/anticoagulation 
agents 
Hypertension 
Adverse tissue reaction 
Hypoesthesia 
Allergic reaction and anaphylaxis from device 
and contrast media 
Hypotension 
Allergy to nickel 
Hypothermia 
Allergy to nitinol  
Incomplete aneurysm occlusion 
Aneurysm perforation or rupture 
Increase in intracranial pressure 
Aneurysm recanalization or regrowth 
Infarction 
Arteriovenous fistula 
Infection including urinary tract infection 
Blurry vision 
Infection at insertion site 
Cardiac arrhythmia 
Intracerebral hemorrhage 
Cardiac failure 
Intracranial hemorrhage 
Cerebral edema 
Ischemia 
Cerebral infarct 
Laboratory abnormality 
Coagulopathy 
Mass Effect 
Cognitive impairment 
Myocardial infarction 
Coil migration 
Neurological deficits 
Coil prolapse or herniation into normal vessel 
through or around device 
Perforation 
Coma 
Perforator occlusion 

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Confusion 
Phlebitis 
Cortical blindness 
Pneumonia 
Cranial nerve deficit(s) 
Post-procedure bleeding 
Cranial nerve palsy 
Pseudo-aneurysm formation 
Death 
Renal failure 
Deep vein thrombosis 
Retroperitoneal hematoma 
Device delivery failure 
Ruptured or perforated vessel or aneurysm 
Device deployment difficulty 
Seizure 
Device fracture 
Stenosis or occlusion within the device 
Device migration 
Stenosis or occlusion of parent vessel 
Device misplacement 
Stenosis or occlusion of perforator 
Diplopia 
Stenosis or occlusion of side branch 
Dissection 
Stenosis or occlusion of treated segment 
Disseminated intravascular coagulation 
Stroke 
Ecchymosis 
Thromboembolism 
Edema 
Tissue necrosis 
Emboli (air, tissue, thrombotic and device) 
Transient ischemic attack (TIA) 
Embolic stroke 
Vasospasm 
Emergent neurosurgery 
Vessel dissection  
Facial numbness 
Vessel occlusion 
Fever 
Vessel perforation 
Fracture of delivery wire 
Vessel thrombosis 
Hematoma 
Visual field deficit 
Hemorrhage 
Vision impairment 
Hydrocephalus 
Weakness left or right side 
 
1.5.2. 
Minimization of Risk 
Efforts will be made to minimize the potential risks through the following: 
1. 
Investigators who participate in the study will be experienced and skilled in neuro-
intervention surgery and will have adequate resources to conduct the clinical study.    
2. 
The study has been designed to ensure treatment and follow-up of subjects are 
consistent with current medical practice. 
3. 
Each investigator will ensure oversight and approval of the study by the IRB prior to 
initiation of the study at the investigation site.   
4. 
The investigator and study personnel will be trained on the study protocol.   
5. 
The investigators and appropriate personnel will undergo training on the use of the 
PulseRider device prior to first use during the study. 
6. 
Subjects will be carefully evaluated against the inclusion/exclusion criteria prior to 
being enrolled in the study to ensure that their diagnosis and medical status are 
appropriate for participation.   
7. 
Subject status will be monitored by the investigator or designee throughout the 
follow-up period as defined in the study protocol.     

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8. 
The investigator or designee will evaluate the subject for any adverse events 
potentially related to the procedure or to the device.  Device status will also be 
assessed using appropriate imaging modalities defined in the study protocol.     
9. 
All reportable adverse events for the study will be reviewed and adjudicated by a 
CEC. 
10. 
Data from all investigation sites will be monitored throughout the study to evaluate 
protocol compliance and identify any issues that may affect the safety and welfare of 
the subjects.  
11. 
De-identified angiograms will be reviewed by an independent core laboratory to 
assess PulseRider device placement and occlusion of the aneurysm.  Sites are 
requested to provide de-identified images to the core lab.  In the event, images are 
received with any patient identifiers, the core lab’s proprietary software removes all 
patient protected health information (PHI) as images are processed through their 
system.  Each image is then reviewed by a radiology technician to ensure that all PHI 
was adequately removed.  This two-fold process is completed before image exam is 
uploaded and reviewed. The radiology technician/assessor will also be blinded to the 
subject’s previous medical history.  
1.5.3. 
Known Potential Benefits 
The potential benefits of the PulseRider device are that it may decrease or stop the blood 
flow into the aneurysm and thus decrease or eliminate the symptoms that the aneurysm is 
causing (if any) or decrease or eliminate the chance of future aneurysm rupture which 
often leads to stroke or death.  The specific benefits of the device include that it may be a 
safer and faster procedure than currently used methods to treat bifurcation aneurysms and 
it may be possible to treat patients whose aneurysms previously could not be treated or 
have been incompletely treated with other techniques (e.g. previously placed coils). By 
changing the flow in the blood vessel and aneurysm, it is hoped that the PulseRider device 
will lead to a more lasting cure of the aneurysm.  Although there may be no direct benefits 
of study participation, subject participants will undergo an enhanced level of clinical 
scrutiny compared to routine clinical care, which may provide some indirect health 
benefits. The potential benefits of the device outweigh the anticipated risks. 
2. 
Objectives and Purpose  
2.1. 
Objectives 
The primary objective of this study is to determine the safety and efficacy of the PulseRider 
as an adjunctive therapy in conjunction with coil embolization in the minimally invasive 
endovascular treatment of intracranial aneurysms at a bifurcation of the basilar artery, 
carotid terminus, MCA, and ACOM.  The data will be generated under an IDE and will be 
used to support a Pre-market Approval Application.  
3. 
Study Design and Endpoints 

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3.1. 
Description of the Study Design 
This study is designed as a prospective, multi-center, single-arm investigation of the 
PulseRider Aneurysm Neck Reconstruction Device used in conjunction with coil 
embolization in the treatment of unruptured wide-neck bifurcation intracranial aneurysms 
of the basilar artery, carotid terminus, MCA and ACOM.  Up to 160 evaluable subjects 
will be enrolled at up to 28 clinical sites throughout the United States.   
For this study, a single-arm design is deemed appropriate as there are currently no approved 
comparator devices indicated for the treatment of wide-neck bifurcation aneurysms 
available in the US.  Subjects with unruptured, angiographically confirmed wide-neck (≥ 
4 mm or a dome-to-neck ratio < 2) intracranial aneurysms located at the bifurcation of the 
basilar artery, carotid terminus, MCA and ACOM arising from the parent vessel for the 
target aneurysm with a diameter of 2.0 mm to 4.5 mm will be enrolled and expected to be 
followed through five year post-procedure.   
3.2. 
Study Endpoints 
3.2.1. 
Primary Endpoint - Safety 
Composite of Neurological Death or Major Ipsilateral Stroke (in downstream territory) up 
to 1 year post-procedure: 
Stroke is defined as rapidly developing clinical signs of focal (or global) 
disturbance of cerebral function lasting more than 24 hours with no apparent cause 
other than of vascular origin, including ischemic stroke and/or hemorrhagic stroke 
(i.e., intraparenchymal hemorrhage (IPH), subarachnoid hemorrhage (SAH), 
subdural hemorrhage (SDH), epidural hemorrhage (EDH)) [Hatano 1976]. 
Major Stroke is defined as stroke with symptoms persisting for more than 24 hours 
AND a sudden increase in the NIHSS of the subject by > 4. 
Minor Stroke is defined as stroke with symptoms persisting for more than 24 hours 
and a sudden increase in the NIHSS of the subject by 1-3. 
TIA is defined as stroke symptoms resolving within ≤ 24 hours. 
This endpoint will be adjudicated by the independent Clinical Events Committee (CEC). 
3.2.2. 
Primary Endpoint - Effectiveness 
Complete Occlusion: 
Rate of complete aneurysm occlusion (Raymond I) without significant parent artery 
stenosis (> 50% stenosis) or prior retreatment at 1 year post-procedure. 
The aneurysm occlusion and parent artery stenosis assessments in this endpoint will be 
evaluated by the independent core laboratory.  Retreatment will be reported by the site. 
 
 

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Figure 3.2.2A Raymond Scale [Roy 2001] 
 
 
• Class I: Complete = Complete obliteration 
• Class II: Residual Neck = Persistence of any portion of the original defect of the arterial 
wall but without opacification of the aneurysmal sac 
• Class III: Residual Aneurysm = any opacification of the aneurysm sac 
3.2.3. 
Secondary Endpoints - Effectiveness 
The secondary effectiveness endpoints are pre-specified below and have been identified as 
outcomes meaningful to evaluate the effectiveness of aneurysm treatment with a device 
that is an adjunct to embolic coiling. 
• Technical Success is defined as successful implantation of device— physician able to 
access target aneurysm, deploy PulseRider device at the neck of aneurysm and device 
was detached successfully. This endpoint will be reported by the investigator. 
• Ability to retain embolic coils within aneurysm immediately post-procedure. This 
endpoint will be evaluated by the independent core laboratory.  
• Complete aneurysm occlusion at 3 years and 5 years. 
• Adequate aneurysm occlusion (defined as Raymond I and II combined) at 1 year, 3 years 
and 5 years. 
• The percentage of target aneurysms that are retreated through 1 year, 3 years and 5 years. 
Retreatment will be reported by the investigator. 
• The percentage of subjects with significant stenosis defined as > 50% at implant site at 
1 year, 3 years and 5 years. This endpoint will be evaluated by the independent core 
laboratory. 
• The percentage of subjects with mRS 0 – 2 at 1 year, 3 years and 5 years. 
3.2.4. 
Additional Endpoints 
• The percentage of target aneurysm rupture up to 1 year, 3 years and 5 years. This 
endpoint will be evaluated by the independent core laboratory. 
• No migration (defined as ≤ 2mm) of the device at 1 year, 3 years and 5 years. This 
endpoint will be evaluated by the independent core laboratory. 
4. 
Study Population 

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4.1. 
Participant Inclusion Criteria 
Investigators will assess potential subjects who are candidates for the study. In addition, an 
image of the subject’s aneurysm and branch arteries must be reviewed and approved by the 
Image Screening Committee. Candidates who meet the protocol inclusion/exclusion 
criteria with at least one bifurcation intracranial aneurysm that is acceptable for minimally 
invasive treatment and approved by the Image Screening Committee may be enrolled.  The 
subject selection criteria are in place for protection of participants and to address factors 
that may compromise the outcome of the investigation or interpretation of the results. 
Candidates for this study must meet ALL of the following criteria: 
1. 
Subject with an angiographically confirmed digital subtraction angiogram (DSA) or 
computed tomography angiogram (CTA) of wide neck (> 4 mm or dome to neck 
ratio < 2) intracranial aneurysm located at a bifurcation of the basilar artery, carotid 
terminus, MCA or ACOM 
2. 
The parent vessel for the target aneurysm has a diameter of 2.0 mm to 4.5 mm 
3. 
The subject is between 18 and 80 years of age the time of consent  
4. 
Informed consent is obtained and the subject signs the Institutional Review Board 
(IRB) approved consent prior to beginning any study procedures along with the 
HIPAA Authorization for the release of PHI 
5. 
In the opinion of the treating physician, placement of the PulseRider device is 
technically feasible and clinically indicated  
6. 
Subject has the mental capacity, willingness and ability to comply with protocol 
requirements and follow-up through 5 years for the clinical study 
4.2. 
Participant Exclusion Criteria 
Candidates will be excluded from participation if ANY of the following apply: 
1. 
Unstable neurological deficit (condition worsening within the last 90 days)  
2. 
Subarachnoid Hemorrhage within the last 60 days 
3. 
Irreversible bleeding disorder 
4. 
Modified Rankin Score (mRS) score ≥ 3 
5. 
Patient has another intracranial aneurysm that in the Investigator’s opinion, may 
require treatment within the 1 year follow up period  
6. 
Patient has previously had two or more (≥ 2) procedures to treat the target aneurysm  
7. 
Patient with an untreated target aneurysm that is partially thrombosed 
8. 
Platelet count < 100 x 103 cells/mm3 
9. 
Inability to tolerate, adverse reaction to or any contraindication to taking aspirin or 
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10. 
A history of contrast allergy that cannot be medically controlled 
11. 
Known allergy to nickel 
12. 
Relative contraindication to angiography (e.g., serum creatinine > 2.5 mg/dL) 
13. 
Woman of child-bearing potential who cannot provide a negative pregnancy test 
14. 
Evidence of active systemic infection (e.g. fever with temperature > 38°C/100.4°F 
and/or white blood count (WBC) > 15,000) 
15. 
Conditions that carry a high risk of neurological events or stroke (e.g., uncontrolled 
hypertension, prior ischemic stroke, Moya moya disease). 
16. 
Evidence of disease or condition expected to compromise survival or ability to 
complete follow-up assessments during the 5 year follow-up period 
17. 
Vessel tortuosity or stenosis that prohibits safe endovascular access to the target 
aneurysm to allow for treatment with the study device  
18. 
Current involvement in a study for another investigational product  
19. 
Patient and /or family considering a move from this geographical location at the time 
of consent 
20. 
Categorized as a vulnerable population and require special treatment with respect to 
safeguards of well-being (e.g. cognitively impaired, veteran, prisoner, etc.) 
4.3. 
Strategies for Recruitment and Retention 
The study will enroll a total of 160 subjects in the United States at up to 28 clinical sites. 
Once enrolled, each subject will participate in the study for 5 years post-procedure.  A 
recruitment packet, that can be customized, may be provided to each clinical site. The 
packet may include a sample email/letter to referring physicians, a slide deck explaining 
the clinical study for presentation at grand rounds or other meeting of referring physicians 
and a patient information booklet describing the device, the indications, the clinical study 
and the necessary commitment to completing all study visits.  
The Sponsor’s intention is for the enrolled subject population to be as representative as 
possible of the well-defined study population. Investigators will be encouraged to evaluate 
all unruptured and bifurcation aneurysm patients for participation in the study, and to offer 
enrollment to all who meet preliminary eligibility criteria. 
Clinical sites will be selected for participation in the study based on experience with similar 
stenting technologies, ample unruptured bifurcation aneurysm patient population, the 
capacity to screen and enroll a reasonable number of eligible patients, and the ability to 
perform the required study procedures, per this protocol. Sponsor will attempt to include a 
diversified group of investigational sites engaging a variety of academic and private 
institutions geographically located throughout the US.  To ensure generalizability of results 
and minimize the influence of any single site, no more than approximately 20% of the total 

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enrollment will be allowed at a single site (i.e., a maximum of 32 subjects enrolled per 
site). 
In order to enhance participant retention and compliant follow-up visits, site coordinators 
will be encouraged to schedule their subject follow-up visits early in the visit windows 
with ample opportunity to reschedule as needed, before the visit window closes. 
4.4. 
Participant Withdrawal or Termination 
4.4.1. 
Reasons for Withdrawal or Termination 
Subjects are free to withdraw from participation in the study at any time upon request.  The 
investigator may terminate participation in the study if any adverse event or other medical 
condition or situation occurs such that continued participation would not be in the best 
interest of the participant.  A subject may be terminated if they meet an exclusion criterion 
(either newly developed or not previously recognized) that precludes further study 
participation. 
4.4.2. 
Handling of Participant Withdrawals or Termination 
Subjects that withdraw consent after treatment are not required to undergo follow-up after 
withdrawal.   They will not be replaced and will be considered part of the subject cohort.  
The reason for early withdrawal will be documented in the source documents and case 
report forms.   
In the event a subject withdraws from the study, their data will be excluded from the data 
analysis from the time of withdrawal going forward. All data collected prior to withdrawal 
will be included in the data analysis. 
5. 
Study Device  
5.1. 
Study Device Description 
5.1.1. 
Device Acquisition 
The PulseRider investigational device is manufactured by Pulsar Vascular, Inc., in Los 
Gatos, California.  The device will be provided to the clinical study sites by the Sponsor, 
Pulsar Vascular, Inc. after obtaining the fully executed clinical study agreement and IRB 
approval at each site.  
5.1.2. 
Device Appearance, Packaging, and Labeling Description 
The PulseRider Aneurysm Neck Reconstruction Device is a self-expanding nitinol implant 
designed to retain embolic coils within an aneurysm occurring at a vessel bifurcation.  The 
PulseRider is comprised of the torque device, delivery wire, introducer, and implant. 
There are three defining attributes of the implant: shape, arch width and parent vessel 
diameter.  The PulseRider is available in T and Y shapes (see Figure 5.1.2A) with 8 mm 
and 10 mm wide arches.  The anchor base is available in sizes to treat parent arteries from 
2.0 mm to 4.5 mm.  Depending on the size of the aneurysm neck and parent vessel, the 
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anatomical fit. Figure 5.1.2B illustrates the implant placed in a vessel bifurcation 
supporting embolic coils. 
Figure 5.1.2A.  PulseRider T and Y Shapes 
 
There are three defining attributes of the implant:  
shape, arch width, and parent vessel diameter. 
 
T Shape                      Y Shape 
IMPLANT ARCH WIDTH
 
IMPLANT ARCH WIDTH
 
 
Figure 5.1.2B. Implant Placed at a Vessel Bifurcation and Retaining Embolic Coils 
  
              
                
 

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The PulseRider device shall be placed according to the IDE Instructions for Use (IFU) 
using standard endovascular techniques.  The IFU is packaged with each investigational 
device.  The unique open cell frame configuration conforms to the vessel walls with a 
profoundly patent lumen profile. The device is retrievable and may be repositioned by 
retracting into the microcatheter at any time during or after deployment, but prior to 
detachment.  The implant is deployed at the parent vessel bifurcation and across the 
aneurysm neck to provide a supporting framework, bridging the aneurysm neck while 
retaining embolic agents within the aneurysm.  Platinum and radiopaque markers are 
located at the proximal end, the middle, and the distal tips for fluoroscopic visualization 
during placement. 
5.1.3. 
Device Training Requirements and Investigator Experience 
In addition to the clinical protocol training, all investigators who will be performing 
procedures for this study will be required to undergo training via a device in-service, which 
includes detailed reviews of the PulseRider IFU and device (specifications, indications for 
use, procedural components, etc.) as well as benchtop training under fluoroscopy.  A 
proctored first case or prior human case experience is required.  The combination of the 
didactic and hands-on portions of the device training will document and provide the 
investigator with the experience necessary to perform the protocol specified procedures for 
the study. 
PulseRider should only be used by investigators who have received appropriate training in 
interventional neuroradiology and the treatment of intracranial aneurysms.  Additionally, 
only the attending treating physicians who have completed device training will be able to 
perform the placement of the PulseRider and coils in the study procedure. 
5.1.4. 
Device Storage and Stability 
The PulseRider device should be stored in a cool dry place. Devices are to be stored in a 
secure location and in accordance with the IDE IFU.  Do not use this device after the “Use 
By” date. 
5.1.5. 
Device Preparation 
Detailed preparation instructions for the PulseRider device are provided in the IDE IFU. 
5.1.6. 
Instructions for Use 
A comprehensive IDE IFU for the PulseRider is available with each device.   
5.1.7. 
Specific Considerations 
In addition to the PulseRider, the following commercially available items are required for 
the procedure and will be provided by the site:  
• An electrolytic detachment power supply (refer to the power supply Directions for Use) 
• Fresh batteries for the power supply for each procedure 
• A second power supply to be used as back-up 

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• One non-tapered 6F (2.0 mm) guide catheter with a 90 cm minimum effective length 
• A continuous flush setup including two rotating hemostasis valves (RHVs), heparinized 
saline, one 3-way stopcock, and one 1-way stopcock 
• One sterile 20 gauge (0.9 or 0.7 mm) uncoated stainless steel hypodermic needle to 
provide electrical ground during implant detachment.  (Warning: DO NOT use Teflon 
coated needles) 
• Alcohol-dampened gauze to clean delivery wire proximal end before connecting power 
supply detachment cable 
5.1.8. 
Duration of Implant Exposure 
The PulseRider is a permanent implant. In the event the PulseRider device needs to be 
removed during the course of a procedure for any reason, i.e. wrong size or shape, device 
malfunction or device failure, the PulseRider shall be returned to Pulsar Vascular, Inc. per 
standard institutional practices for biohazard waste. Please refer to Section 5.1.10 regarding 
complaint handling. 
5.1.9. 
Investigational Device Accountability  
Access to investigational device will be controlled and thorough records of investigational 
devices shipped to each site will be maintained by the Sponsor and investigator.  Study 
devices will be labeled as ‘Investigational Device’ and are only to be used for subjects 
enrolled in this clinical study. Investigational devices will be shipped to the clinical sites 
upon completion of required documentation and as necessary to treat enrolled subjects. 
The investigator is responsible for device accountability at the study site. The investigator 
may assign device accountability to an appropriate staff member who must be listed on the 
Delegation of Authority Log.  
It is the responsibility of the Investigator to ensure that: 
• All study devices received are inventoried and accounted for  
• The disposition of each device is recorded 
• The investigational device will not be supplied to any person except those named as 
sub-investigators on the Delegation of Authority Log 
• The investigational devices are used in accordance with the IDE IFU and study protocol 
• Only subjects enrolled in the study will be treated with the investigational device 
• The investigational devices are stored in a secured storage facility to which only the 
investigator or designated personnel will have access. 
Authorized study personnel will maintain device accountability records.  Upon receipt of 
the study devices, the shipment will be inventoried to ensure the information on the packing 
slips matches what has been sent to the site.  A copy of shipping documents and packing 
slips shall be filed in the site regulatory file. The device accountability log shall be 

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maintained throughout the study including information such as the person in receipt of 
devices, date received, quantity received, lot numbers, expiration date, implant date, 
subject ID, and device disposition/date.  Traceability shall be achieved during and after the 
clinical investigation through device lot numbers and accurate accounting records. 
One PulseRider device will be implanted per subject treated in the study for an anticipated 
total of 160 devices implanted.  The PulseRider is a single use device and one PulseRider 
is used to treat a single aneurysm.  
5.1.10. 
Device Returns 
Unused investigational devices being reclaimed for excess inventory, following study 
completion or due to product expiration, damage, or defect should be returned to Pulsar 
Vascular, Inc. or designee.  Opened and unused devices should also be returned to the 
Sponsor.  Any suspected device malfunction, treatment failure or device associated with 
an adverse event (device related or possibly device related) will undergo a thorough 
complaint analysis and must be properly documented on the Electronic Case Report Forms 
(eCRFs).  In the event of a suspected malfunction or device observation, the device shall 
be returned to Pulsar Vascular, Inc. for analysis if the device was not implanted.  All 
returned devices must be properly decontaminated per hospital policy and properly labeled 
with the subject identification number, date of event, identified as a defective return, non-
defective return, or adverse event. Retain tracking information. All investigational devices 
should be returned to:  
ATTN: Complaints  
Pulsar Vascular, Inc. 
130 Knowles Drive, Suite E 
Los Gatos, CA 95032 
6. 
Study Procedures and Evaluation 
6.1. 
Study Procedures and Evaluations 
6.1.1. 
Study Specific Procedures 
The procedures that are study specific and not part of standard care for treatment of 
intracranial aneurysms include a pre-procedure pregnancy test for pre-menopausal women 
and placement of the PulseRider device at the aneurysm neck. 
6.1.2. 
Standard Care Procedures 
Most of the procedures completed as part of this study are standard practice and include 
relevant medical history, relevant medication history, complete blood count, blood 
coagulation tests, neurological examination, NIHSS, mRS, DSA, CTA, MRA, review of 
any adverse events and review of relevant concomitant medications. This may vary from 
site to site. 
6.2. 
Laboratory Procedures/Evaluations  

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6.2.1. 
Clinical Laboratory Evaluations  
Clinical laboratory evaluations will include a complete blood count, serum creatinine, 
anticoagulation tests, and a pregnancy test, if applicable. 
6.2.2. 
Other Procedures – Angiograms  
A DSA will be done immediately prior to the PulseRider placement.  Selection of the artery 
and angiography will follow standard techniques. This image evaluation is done to define 
the size and shape of the aneurysm, to note how the PulseRider is intended to be placed 
and to confirm that the subject remains eligible for the study and a candidate for PulseRider 
placement. A DSA will be taken immediately post-implantation of the device to evaluate 
placement success, and a DSA will be taken at the conclusion of the procedure to evaluate 
occlusion. 
6.2.3. 
Core Laboratory for Image Evaluation 
An independent radiographic core laboratory shall be utilized to provide an unbiased and 
standardized assessment of all imaging. All subject PHI will be removed before an image 
is uploaded and evaluated.  The core lab assessor will be blinded to subjects’ previous 
medical history. The core lab will evaluate the following:  
• Aneurysm and vessel dimensions 
• Ability to retain embolic coils without coil protrusion/herniation (yes/no) 
• Aneurysm occlusion: evaluated per the Raymond– Roy scale referenced in Section 3.2.2 
• Parent and branch vessel stenosis: evaluated on a scale of 0-50% and > 50-100%  
• Device migration: migration is defined as > 2mm  
All imaging shall be performed in accordance to the core laboratory recommended protocol 
provided to the sites. A copy of the study angiograms will be submitted to the core lab. 
6.2.4. 
Angiogram Shipment 
De-identified images may be sent via DICOM format on a CD (that contains the subject 
ID, study visit, Sponsor name, and protocol number), or electronically to the core lab 
website, if available.   
6.3. 
Concomitant Medications, Treatments, and Procedures 
Dual anti-platelet medications will be reviewed and updated at each visit and changes will 
be recorded in the electronic data capture (EDC).  Other concomitant medications to be 
recorded include anti-hypertensives, sedatives, hypnotics, hemolytic modifiers, 
anticoagulant medications, antibiotics and any other medications to treat neurological 
adverse events. 
6.4. 
Prohibited Medications, Treatments, and Procedures 

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If a subject has more than one aneurysm, the one not being treated with a PulseRider device 
should be treated first prior to the subject’s enrollment in the study or the treating physician 
should document that he/she believed in his/her best judgment the non-PulseRider 
aneurysm is unlikely to need treatment within one year of the PulseRider procedure.  
6.5. 
Prophylactic Medications, Treatments, and Procedures 
Dual anti-platelet medication is required and should be initiated prior to the PulseRider 
procedure.  The antiplatelet and anticoagulation regimen used for interventional 
intracranial procedures as part of this study is at the discretion of the treating physician.  
Each center will provide the standard dual anti-platelet therapy regimen followed at their 
institution to Pulsar Vascular, Inc.  
7. 
Study Schedule 
7.1. 
Screening 
During the initial screening phase, the investigator will perform an initial evaluation of 
potential study subjects for study eligibility.  This initial screening phase may include 
review of existing patient information (e.g. previously performed angiography, 
radiographs, laboratory studies, medical history, physical examination, etc.)   For subjects 
who meet the eligibility criteria and agree to participate, informed consent will be obtained 
and the informed consent form will be signed.  Informed consent is a process that is 
initiated prior to an individual agreeing to participate in a study and continues throughout 
the individual’s study participation. The investigator, or designee, will explain the research 
study to the patient and answer any questions that may arise. The possible risks and possible 
benefits of participation will be discussed. The patient will be asked to read, review and 
sign the IRB-approved consent form.  Informed consent is mandatory and must be obtained 
from all subjects prior to their participation in the study.  The informed consent process is 
detailed further in Section 11.3. 
All patients who provide written informed consent will be entered into EDC regardless of 
whether or not they participate in the study. 
7.2. 
Enrollment, Baseline Evaluation, and Procedures 
7.2.1. 
Pre-Procedure/Baseline Assessments 
The following baseline data will be collected and assessments performed after providing 
informed consent and prior to the index procedure.  
• Baseline anti-platelet medication will be administered using a regimen that is 
according to the investigators standard of care anti-platelet regimen.   
• Relevant medical history will be collected from a subject interview and a review of 
the subject’s medical records with specific attention to neurological deficits/sequelae, 
bleeding disorders, cardiac conditions that carry a high risk of neurological events, or 
conditions that may compromise survival or ability to complete follow-up. 

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• Relevant medication history will be collected from a subject interview and a review 
of the subject’s medical records if necessary.  Antithrombotic (including anticoagulants 
and fibrinolytics), inhibitors of ADP-induced platelet aggregation medications, anti-
hypertensives, sedatives, hypnotics and any medication used to treat neurological events 
the subject has taken within 7 days prior to the index procedure will be recorded.  Dual 
anti-platelet therapy (DAPT) will be collected within 30 days prior to the index 
procedure. 
• Please note that only the following medications should be recorded in the 
Medication Log eCRF: 
o DAPT 
o Anti-hypertensives 
o Sedatives 
o Hypnotics 
o Hemolytic modifiers 
o Antiplatelet and anticoagulant medications 
o Antibiotics 
o Any other medications to treat adverse events collected in this study 
• Clinical laboratory tests will include a complete blood count, serum creatinine, and 
blood coagulation tests.  Subject laboratory values will be screened against the exclusion 
criteria for study eligibility.  
• A pregnancy test will be done immediately before the procedure, if applicable.  
Pregnancy may also be ruled out by medical history (e.g. menopause, surgical sterility). 
• Neurological exam – A standard neurological exam includes evaluations of cerebral 
function, cerebellar function, motor and sensory function, reflex function, gait and 
stance, and cranial nerve function.  The neuro exam will be performed by qualified 
personnel. 
• National Institutes of Health Stroke Scale – NIHSS.  The NIHSS is a standardized 
clinical assessment tool that provides a quantitative measure of stroke-related 
neurologic deficit. It is widely used to evaluate stroke severity, determine appropriate 
treatment, and predict patient outcome. The NIHSS will be performed by qualified 
personnel. All study personnel performing the NIHSS assessment will be required to 
have training on the administration of the NIHSS assessment. A valid certification of 
completion of training will be stored in the site study files.  
• Modified Rankin Scale – mRS.  The mRS is a scale commonly used to measure the 
degree of disability or dependence in the daily activities in patients following stroke or 
other neurologic event and is conducted by qualified personnel. It is a scale with six 
categories ranging from no symptoms to severe disability and death. All study personnel 

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performing the mRS assessment will be required to have training on the administration 
of the mRS assessment. Documentation of completion of training will be stored in the 
site study files and updated at least every 2 years.  
• Baseline aneurysm imaging evaluation.  The baseline imaging evaluation may be a 
DSA or CTA. The baseline imaging must be reviewed and approved by the Image 
Screening Committee. As the status of the target aneurysm may change between the 
baseline image and procedure, a DSA is required prior to enrollment on the procedure 
day to confirm that the subject remains eligible for the study.  
• Image Screening Committee.  During initial subject screening, the site will submit a 
de-identified image (either DSA or CTA) to the core lab.  Core lab personnel will submit 
the de-identified baseline image to the Image Screening Committee who will review the 
image for approval or disapproval.  The decision of the committee will be based on their 
review of the appropriateness as outlined in the Image Screening Committee charter.  
Upon decision from the Image Screening Committee, the site will be informed of the 
subject approval/disapproval. 
The schedule of assessments is listed in Table 7.15A.  The baseline imaging must be 
completed within 180 days of the index procedure. All baseline tests should be completed 
within 60 days prior to the device placement procedure. This 60 days is inclusive of the 
procedure day, prior to the index procedure.  The NIHSS, mRS, pregnancy test (if 
required), and the imaging study confirming anatomic eligibility criteria are required on 
the day of the index procedure 
Final eligibility cannot be determined until the immediate pre-procedure DSA is 
completed.  This takes place immediately prior to the index procedure and it is expected 
that some subjects may be excluded at that time.  Excluded subjects will undergo routine 
clinical care for their aneurysm treatment and will be considered a screen failure for the 
study.   
A patient is considered enrolled in this study after the patient is consented, approval 
of imaging screening committee is received, pre-procedure angiogram is completed 
and the treating physician confirms the subject meets all eligibility criteria on the 
day of the study procedure. 
7.3. 
Treatment 
The subject should be prepared for the planned interventional procedure according to 
standard hospital procedures.  
Peri-procedural heparin will be administered according to the institutional standard of care 
protocol. Dual anti-platelet therapy will be administered prior to and post-procedure 
according to the institutional standard of care. 
Immediately prior to PulseRider placement, the physician will perform a DSA of the 
affected intracranial arteries.  Selection of the artery and DSA will be done using standard 
techniques.  The purpose of the pre-procedure angiogram is to define the size and shape of 

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the aneurysm and bifurcation arteries, to note how the PulseRider is intended to be placed 
and to confirm that the subject remains a candidate for PulseRider placement and study 
eligibility. 
The PulseRider device will be used according to the IDE IFU.   
A DSA will be taken immediately after implantation of the PulseRider device to evaluate 
placement success.  The DSA will be repeated at the conclusion of the procedure to 
evaluate occlusion.  The procedure images will provide a pre-treatment and post-treatment 
comparison. 
7.4. 
Procedure Assessments 
Index procedure start/end times will be recorded and the following definitions apply to the 
index procedure: 
• Procedure start time is defined as the point when the guiding catheter is introduced 
into the subject. 
• Procedure end time is defined as the time the last catheter is removed from the 
subject. 
Procedural assessments – pre-treatment, intra-treatment and post-treatment include:  
• Procedural medications 
• Event assessment  
o Adverse events 
o Protocol deviations 
o Device malfunctions/deficiency 
o Angiogram  
o Post-treatment aneurysm occlusion per Raymond– Roy scale 
o Send the pre-treatment, intra-procedure, and post-treatment DSA to the core 
lab  
At a minimum, the following data will also be captured during the procedure: 
• Name of the implanting physician 
• Aneurysm and vessel dimensions 
• PulseRider device implanted 
• Device implant success 
• Adjunctive devices used including coils and balloons 
• Ancillary devices used including the microcatheter 
• Fluoroscopy time 

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• Presence of vasospasm (vessel and times of onset/resolution).  Vasospasm will be 
captured as an adverse event only if it leads to a subsequent thrombotic or ischemic 
event.  
7.5. 
Procedural and Post-Procedural Medications 
All vasoactive and anticoagulant medications that were administered intra-procedurally 
until the end of the index procedure will be recorded. 
Post-procedural medication collection will include the following medications: 
• DAPT  
• Anti-hypertensives 
• Sedatives 
• Hypnotics 
• Hemolytic modifiers 
• Antiplatelet and anticoagulant medications 
• Antibiotics 
• Any other medications to treat adverse events collected in this study 
7.6. 
Follow-up in the Event of Stroke or Suspected Stroke 
If a subject experiences a stroke, or if there is any symptom or suspicion of a stroke, in 
addition to the hospital/physician routine standard of care for stroke, the following 
instructions apply: 
1. Obtain Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) if 
indicated within 24 hours after the onset of symptoms. 
2. Contact the Sponsor about the event. 
3. Complete the stroke specific AE form and perform the neurological exams, NIHSS and 
mRS. 
In the event that the subject experiences a stroke but the investigator did not learn of the 
stroke at the time it occurred, and if a MRI was not done, the investigator should obtain a 
MRI as soon as possible upon learning of the stroke, and complete steps 2-3 above.  
7.7. 
Post-Procedure Follow-up 
The follow-up period begins immediately post-treatment. Site personnel will review the 
follow-up requirements with the subjects to help ensure compliance with the schedule.  
Follow up assessments occur at the following timepoints after the index procedure and are 
listed in Section 7.15: 
• At the time of hospital discharge  

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• 30 days +/- 7 days 
• 180 days +/- 42 days 
• 1 year +/- 60 days 
• 2 years +/- 60 days 
• 3 years +/- 60 days 
• 4 years +/- 60 days 
• 5 years +/- 60 days 
The assessments to be completed at each in-office post-procedure follow-up are listed in 
Section 7.15 and include:  
• Neurological exam 
• National Institutes of Health Stroke Scale – NIHSS 
• Modified Rankin Scale – mRS 
• Imaging 
• Any imaging performed (DSA, MRA, CTA) per standard of care after the study 
procedure and prior to the final visit will be collected.  
• DSA is required at the 1 year follow-up visit 
• DSA or MRA is required at the 3 and 5 year follow-up visits 
• Review of relevant medications 
• Review of adverse events 
The assessments to be completed at the telephone follow-up are listed in Table 7.15A and 
include an evaluation of any potential adverse events, a review of the medications taken 
(particularly anti-platelet medication) and mRS.  For the mRS, note in source documents 
that the questions and assessment were done via telephone. 
It is important that the follow-up schedule be adhered as closely as possible for all subjects.  
Subjects may not be able to return for visits at exactly the date required therefore, a visit 
window is acceptable and is provided in Section 7.15.  Visits not completed within the 
window will be recorded as protocol deviations.  A study visit should be scheduled as close 
as possible to the earlier side of the visit window to allow for possible re-scheduling thereby 
minimizing deviations. 
Any study subject who does not attend a scheduled follow-up visit should be contacted by 
site personnel to determine the reason for the missed appointment and to reschedule.  The 
reason for the missed visit shall be recorded.  If the missed visit was due to an AE, an AE 
eCRF must be completed and any reporting and assessment requirements must be met. 
7.7.1. 
Medical Resource Utilization and Health Economics (HECON) 

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 Medical resource utilization and health economics data, associated with medical 
encounters, will be collected in the eCRF by the investigator and study-site personnel for 
all subjects throughout the study. Procedure and post-procedure healthcare resource 
utilization will be assessed at hospital discharge and at all scheduled post-procedure visits. 
Healthcare resource utilization will include length of hospitalization, re-hospitalization or 
prolongation of hospitalization, and unscheduled clinical visits for aneurysm treatment 
follow-up. 
7.7.2. 
Study Participation and Information Card 
The incidence of missing data can compromise any clinical study.  In an effort to retrieve 
all clinical data, even for evaluation(s) and therapy outside of the treating hospital or 
department, subjects enrolled in this study will be provided with a “Study Participation and 
Information Card.”   
Prior to discharge subjects will be counseled to provide a copy of this card when visiting 
any physician other than the interventional neuro-radiologist at the clinical site. This wallet 
size card will include a request for the study investigator to be notified of any hospital 
admission and/or an evaluation for anything neurological in nature, whether or not it 
involves hospitalization. If such an event takes place, the study investigator will be 
instructed to request other physician(s) not on the study team to conduct an NIHSS 
assessment when a study subject sees the physician for a non-study visit and to provide this 
data, along with any other relevant data collected as a part of standard of care during the 
visit (e.g. adverse events, mRS, neurological exam, imaging studies, etc.) to the study 
investigator’s site.   
7.8. 
Follow-up Angiography 
Any imaging performed (DSA, MRA, CTA) per standard of care after the study procedure 
and prior to the final study visit will be collected.  A DSA is required at the 1 year follow-
up. Either DSA or MRA is required at the 3 year and 5 year follow-up visits.  The intent is 
to evaluate aneurysm occlusion and the PulseRider implant.  The Investigator will grade 
aneurysm occlusion according to the Raymond Scale. Should any imaging be considered 
necessary at a non-study required time point, it is requested that an assessment of the treated 
aneurysm be performed and the appropriate eCRF including a reason for the unscheduled 
procedure should be completed. Any imaging performed as standard of care will be 
collected and sent to the core lab. 
7.9. 
Final Study Visit 
The final study visit should be done at 5 years (+/- 60 days) following the PulseRider 
procedure.  A DSA or MRA will be performed and all other post-procedure assessments 
will be completed.  Any ongoing AE/SAEs should be reviewed, assessed for resolution and 
any documentation completed.  Upon exit from the study, the subject will undergo standard 
follow-up with their doctor and data will not be collected. 
7.10. Unscheduled Visit 

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Subjects returning for an unscheduled visit indicating new or unresolved signs and/or 
symptoms will be documented as an unscheduled follow-up and, at the investigator’s 
discretion, be reported as an adverse event.  Information to be collected, at a minimum 
includes: 
• Neurological exam 
• National Institutes of Health Stroke Scale – NIHSS 
• Review of relevant medications 
• Review of adverse events 
This is provided in the Schedule of Assessments.  Radiographic imaging is completed at 
the discretion of the investigator based upon the subject’s condition and standard of care. 
If performed, the imaging should be sent to the core lab. 
7.11. Retreatment 
At the discretion of the investigator, a subject who has received a PulseRider device may 
be retreated (e.g. with coils, stent, etc.) at any time. All subjects who are retreated will 
remain in the study and will continue to receive all follow-up assessments based on the 
date of the index procedure per the Schedule of Assessments in Section 7.15. When a 
subject returns for a retreatment, this is considered an unscheduled visit and the evaluations 
noted for unscheduled visits must be completed.  Data from the retreatment procedure will 
be captured in the appropriate eCRF, and data from the remaining unscheduled assessments 
will also be captured in the eCRFs.  No pre-planned staged procedures on target aneurysms 
will be allowed in the study. 
7.12. Early Termination 
The study can be discontinued at the discretion of the investigator or study Sponsor for 
reasons including, but not limited to, the following: 
• Per recommendation of the Data Monitoring Committee (DMC) 
• Unanticipated adverse device effect (UADE) presenting an unreasonable risk to subjects 
(Sponsor may terminate the study immediately) 
• Obtaining new scientific knowledge that shows that the study is no longer valid or 
necessary 
• Insufficient recruitment of subjects 
• Persistent non-compliance of a site with the protocol, or IRB/regulatory requirements 
If the study is discontinued or suspended prematurely at a single clinical site (e.g. due to 
non-compliance or lack of enrollment), the Sponsor shall inform the clinical 
investigator/investigational center of the termination or suspension in enrollment and the 
reason for this. The Sponsor will also inform site personnel that although enrollment will 
be halted, the currently enrolled subjects will continue to be followed per protocol through 

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the five-year follow-up visit and then exited from the study. The Sponsor’s communication 
to the investigator/investigational center will also include instructions for the investigator 
to promptly inform the IRB regarding the change in study status, along with the reason for 
termination or suspension by the Sponsor.  Regulatory authorities may also need to be 
informed if deemed necessary.  
If the entire study is discontinued or suspended prematurely, the Sponsor shall promptly 
inform all clinical investigators/investigational centers of the termination or suspension in 
enrollment and the reason for this. The Sponsor will also inform site personnel that 
although enrollment will be halted, the currently enrolled subjects will continue to be 
followed per protocol until one year visit for safety. Once the subject has completed the 
one year follow-up visit for safety, they will be exited from the study.  The Sponsor’s 
communication to the investigators/investigational centers will also include instructions 
for the investigator or their delegated study staff to promptly inform all consented subjects 
at their center, as well as the IRB regarding the change in study status along with the reason 
for termination or suspension by the Sponsor or by the clinical investigator.  The Sponsor 
will notify the FDA in writing of the action, per regulations.  Regulatory authorities and 
the personal physicians of the subjects may also need to be informed if deemed necessary. 
7.13. Lost to Follow-up 
Every attempt will be made to have all subjects complete the follow-up visit schedule. A 
subject will not be considered lost to follow-up until the last study visit and unless efforts 
to obtain compliance are unsuccessful. At a minimum, the effort to obtain follow-up 
information will include three attempts to make contact via telephone/email and if 
unsuccessful, then a letter from the investigator, sent via FedEx or similar traceable 
method, will be sent to the subject’s last known address. Both contact logs and letter contact 
efforts to obtain follow-up will be recorded in the subject study files. 
 
 

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7.14. Schematic of Study Design  
Figure 7.14A Schematic of Study Design 
 
 
 

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7.15. Schedule of Assessments Table 
This table provides an overview of the procedures to be performed at each study visit and 
the visit window.   
Table 7.15A  Schedule of Assessments 
 
 
Assessments 
Pre-procedure* (0-60 days 
of the procedure) 
Immediately Pre-Procedure 
Procedure 
Immediately Post-
procedure 
 Discharge 
30 Day Follow-up  
(+/- 7 days) 
180 Day Follow-up  
(+/-42 days) 
1 Year Follow-up  
(+/-60 days) 
2 Year Telephone Call (+/-
60 days) 
3 Year Follow-up  
(+/-60 days) 
4 Year Telephone Call (+/-
60 days) 
5 Year Follow-up  
(+/-60 days) 
Unscheduled Visit 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Labs (CBC & 
Blood 
Coagulation 
Tests) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Neurological 
Exam 
X 
 
 
 
X 
X 
X 
X 
 
X 
 
X 
X 
NIH Stroke Scale 
Assessment  
 
X 
 
 
X 
X 
X 
X 
 
X 
 
X 
X 
Modified Rankin 
Scale  
 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Pregnancy Test 
 
X‡ 
 
 
 
 
 
 
 
 
 
 
 
Conventional 
Catheter 
Angiography – 
DSA$ 
**X 
***X 
 
Oβ 
Oβ 
X†$ 
Oβ 
X†† 
Oβ 
X†† 
Oβ 
MR Angiography$ 
 
 
 
 
 
Oβ 
Oβ 
 
Oβ 
X†† 
Oβ 
X†† 
Oβ 
CT Angiography$ 
**X 
 
 
 
 
Oβ 
Oβ 
 
Oβ 
 
Oβ 
 
Oβ 
Review of 
Adverse Events 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Review of 
Medications 
Taken 
X 
 
X  
X  
X 
X 
X 
X 
X 
X 
X 
X 
X 
Medical Resource 
HECON 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
*With the exception of the baseline DSA or CTA and the pregnancy test, all baseline evaluations must be completed within 60 days prior 
to the index procedure and may occur on the procedure day prior to the procedure. 
**Baseline imaging may be either CTA or DSA and must be completed within 180 days prior to the index procedure. 
***Three treatment angiograms: 1) Immediately pre-procedure image is before PulseRider implant to confirm eligibility 2) Procedure 
image immediately after PulseRider placement 3) Immediately post-procedure is after coiling.   
β Any imaging related to the target aneurysm conducted post-procedure and prior to the final study visit, per standard of care, will be 
collected. 
† Imaging for 1 year post-procedure must be DSA. 
†† Imaging for 3 year 5 years post-procedure must be DSA or MRA. 
‡ Pregnancy test must be completed on day of procedure for women of childbearing potential. 
$ Subjects who were not implanted with the PulseRider device are not required to undergo DSA imaging at 1 year. 

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8. 
Assessment of Safety 
8.1. 
Specific Safety Parameters 
8.1.1. 
Adverse Event (AE) 
An adverse event (AE) is defined as 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 (ISO 
14155:2011E). 
• Note 1: This definition includes events related to the investigational 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 the 
investigational medical devices 
For the purposes of this protocol, adverse events will be reported and recorded 
(via eCRF) if any of the following apply: 
• The event is neurological in nature 
• The event is a serious adverse event 
• Causality is related to: 
• the device  
• the procedure  
• dual antiplatelet medication  
• if causality is unknown  
Any medical condition that is present at the time the participant is screened or prior to the 
start of the study procedure will be considered as baseline and not reported as an AE. Such 
conditions should be added to medical history, if not previously reported.   
8.1.2. 
Serious Adverse Event (SAE) 
A serious adverse event (SAE) is defined (ISO 14155:2011E) as an adverse event that: 
• Led to death 
• Led to serious deterioration in the health of the subject, that either resulted in 
• a life-threatening illness or injury, or 
• a permanent impairment of a body structure or a body function, or 
• in-patient or prolonged hospitalization, or 

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• medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function 
• Led to fetal distress, fetal death or a congenital abnormality or birth defect 
Note: Planned hospitalization for a pre-existing condition, or a procedure required by the 
clinical investigation plan, without serious deterioration in health, is not considered a 
serious adverse event. 
8.1.3. 
Adverse Device Effect (ADE) 
An adverse device effect is defined as an adverse event related to the use of an 
investigational medical device (ISO 14155:2011E). 
• Note 1: This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any 
malfunction of the investigational medical device 
• Note 2: This definition includes any event resulting from use error or from intentional 
misuse of the investigational medical device 
8.1.4. 
Serious Adverse Device Effect (SADE) 
A serious adverse device effect is an adverse device effect that has resulted in any of the 
consequences characteristic of an SAE (ISO 14155:2011E). 
8.1.5. 
Unanticipated Serious Adverse Device Effect (USADE) 
Per ISO 14155:2011E, an unanticipated serious adverse device effect is a serious adverse 
device effect which by its nature, incidence, severity or outcome has not been identified in 
the current version of the risk analysis report. 
• Note: Anticipated serious adverse device effect (ASADE) is an effect which by its 
nature, incidence, severity or outcome has been identified in the risk analysis report 
8.1.6. 
Unanticipated Adverse Device Effect (UADE) 
Per 21 CFR 812.3(s), an unanticipated adverse device effect (UADE) is any serious adverse 
effect on health or safety or any life-threatening problem or death caused by, or associated 
with, a device, if that effect, problem, or death was not previously identified in nature, 
severity, or degree of incidence in the investigational plan or application (including a 
supplementary plan or application) or any other unanticipated serious problem associated 
with a device that relates to the rights, safety, or welfare of subjects. 
8.1.7. 
Device Deficiency, Device Malfunction, and Use Error 
All study device deficiencies shall be documented in the eCRF throughout the clinical 
investigation and appropriately managed by the Sponsor.  If a study device deficiency is 
detected or suspected that could have led to a SADE, it should be documented on the 
appropriate eCRF, and the device failure and AE (if applicable) must be reported to the 
Sponsor within 72 hours upon study site staff awareness.  All non-study device 
malfunctions should be reported via the manufacturer’s complaints handling process. 

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A device deficiency is defined as inadequacy of a medical device with respect to its 
identity, quality, durability, reliability, safety or performance.  
• Note: Device deficiencies include malfunctions, use errors, and inadequate labeling.  
Device malfunction is defined as a failure of an investigational medical device to perform 
in accordance with its intended purpose when used in accordance with the instructions for 
use or clinical investigation plan.   
Use error is defined as the act or omission of an act that results in a different medical 
device response than intended by the manufacturer or expected by the user.   
• Note 1: Use error includes slips, lapses, and mistakes.  
• Note 2: An unexpected physiological response of the subject does not in itself constitute 
a use error  
(ISO 14155:2011E) 
8.2. 
Classification of an Adverse Event 
8.2.1. 
Severity of Event 
The intensity or severity of each AE must be assessed according to the following 
classifications: 
Table 8.2.1A Intensity or Severity Definitions 
Mild 
Awareness of signs, symptoms, or events that are otherwise easily 
tolerated that may result in minimal transient impairment of a body 
function or damage to a body structure, but do not require intervention 
other than monitoring. 
Moderate 
Any event that results in moderate transient impairment of a body 
function or damage to a body structure that causes interference with 
usual activities, or that warrants possible intervention, such as the 
administration of medication, to prevent permanent impairment of a 
body function or damage to a body structure. 
Severe 
Any event that is incapacitating (an inability to do usual activities) or is 
life-threatening and results in permanent impairment of a body function 
or damage to a body structure, or requires intervention, such as major 
surgery, to prevent permanent impairment of a body function or damage 
to a body structure. 
 
8.2.2. 
Relationship to Study Device and/or Procedure 
The clinician who examines and evaluates the participant will determine the AE’s causality 
based on temporal relationship and his/her clinical judgment. The degree of certainty about 
causality will be graded using the categories below.  Refer to Sections 8.5 and 8.6 regarding 
CEC and DMC interactions respectively.  

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Table 8.2.2A  Adverse Event Causality Classifications 
Caused By 
Relation 
Definition of Relation 
Device 
Causal 
relationship 
The event is associated with the investigational device 
beyond reasonable doubt  
Probable 
The relationship with the use of the investigational device 
seems relevant and/or the event cannot reasonably be 
explained by another cause, but additional information may 
be obtained  
Possible 
The relationship with the use of the investigational device 
is weak but cannot be ruled out completely  
Unlikely 
The relationship with the use of the investigational device 
seems not relevant and/or the event can be reasonably 
explained by another cause, but additional information may 
be obtained  
Not related  Relationship to the investigational device can be excluded  
Study 
Procedure 
Causal 
relationship 
The event is associated with the study procedure beyond 
reasonable doubt  
Probable 
The relationship with the study procedure seems relevant 
and/or the event cannot reasonably be explained by another 
cause, but additional information may be obtained  
Possible 
The relationship with the study procedure is weak but 
cannot be ruled out completely  
Unlikely 
The relationship with the study procedure seems not 
relevant and/or the event can be reasonably explained by 
another cause, but additional information may be obtained  
Not related  Relationship to the procedure can be excluded  
 
8.2.3. 
Outcome  
The outcome of each AE must be assessed according to the following classifications: 
Table 8.2.3A Adverse Event Outcome Classifications 

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Classification 
Definition 
Recovered/Resolved 
Subject fully recovered with no observable 
residual effects 
Recovered/Resolved with sequelae 
Subject recovered with observable residual 
effects 
Recovering/Resolving 
Improved 
Subject’s condition improved, but residual 
effects remain 
Unchanged 
AE is ongoing without changes in the overall 
condition 
Worsened 
Subject’s overall condition worsened 
Fatal 
Subject died as a result of the AE (whether or 
not the AE is related to the device or 
procedure) 
8.3. 
Time Period and Frequency for Adverse Event Assessment and Follow-up 
Adverse events shall be assessed and documented starting at the point the subject is 
considered enrolled (after the patient is consented, imaging screening committee approval 
is received, pre-procedure angiogram is completed and the treating physician confirms the 
subject meets all eligibility criteria) and at all study follow-up visits.  Each investigator 
shall provide source documentation as requested by the Sponsor to facilitate reporting and 
adjudication of these events. Adverse events that occur during this study should be treated 
by established standards of care which will protect the life and safety of the subject. Events 
will be followed for outcome information until resolution, stabilization or the subject exits 
the study, whichever occurs first.  Each investigator shall provide source documentation as 
requested by the Sponsor to facilitate reporting and adjudication of these events. 
8.4. 
Reporting Procedures 
8.4.1. 
Adverse Event Documentation and Reporting Requirements 
Reportable adverse events will be recorded and reported on the eCRFs throughout 
the study and provided to the Sponsor.  (In the event EDC is unavailable, adverse events 
can be notified via email to the NAPA IDE study mailbox: RA-BWIUS-
PulseRider@ITS.JNJ.com.  Note: the adverse event(s) will still need to be recorded on 
eCRFs once EDC is functional.)      
• If an adverse event occurs, all sections of the Adverse Event eCRF must be completed 
• In the case of serious device effects and device deficiencies that could have led to serious 
adverse device effects, the Sponsor will determine whether the risk analysis needs to be 
updated and whether corrective or preventative action is required. 

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• Copies of all relevant source documentation (i.e. procedure reports, physician/nursing 
notes, discharge summary, etc.) should be compiled and provided to the Sponsor for the 
adjudication process for all AEs recorded in the study.   
Timing for reporting the different types of AEs and Device Deficiencies is described in 
Table 8.4.1A. 
Table 8.4.1A Adverse Event Reporting Requirements 
Type of Adverse Event 
Reporting Requirements 
• SAE  
• SADE 
• USADE  
• Death 
• Any study device 
malfunctions that could have 
led to an SADE* 
 
Report to Sponsor immediately upon study 
site staff awareness of event but no later 
than 72 hours 
UADE 
Report to Sponsor immediately upon study 
site staff awareness of event but no later 
than 72 hours, followed by a written report 
within 10 working days after investigator 
first learns of the effect to Sponsor and 
IRB 
• All other adverse events  
• All other study device 
malfunctions* 
Report to Sponsor immediately upon study 
site staff awareness but no later than 14 
calendar days     
* Non-study device malfunctions should be reported via the manufacturer’s complaints handling process.  
The Investigator will report all of the above to the reviewing IRB according to the local 
reporting requirements. 
8.4.2. 
Serious Adverse Event Reporting 
All SAEs, whether or not they are related to the device or procedure, must be reported to 
the Sponsor, via eCRF, immediately upon study site staff awareness of event but no 
later than 72 hours by the study site personnel.  (In the event EDC is unavailable, adverse 
events can be notified via email to the NAPA IDE study mailbox: RA-BWIUS-
PulseRider@ITS.JNJ.com. Note: the adverse event(s) will still need to be recorded on 
eCRFs once EDC is functional.)    

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The study investigator shall report the SAE to the reviewing IRB in accordance with the 
local IRB requirements.  
8.4.3. 
Unanticipated Adverse Device Effect Reporting 
All UADE/SADE/USADEs must be reported to the Sponsor, via eCRF, immediately 
upon study site staff awareness of the event but no later than 72 hours after study site 
staff awareness of the event.  (In the event EDC is unavailable, adverse events can be 
notified 
via 
email 
to 
the 
NAPA 
IDE 
study 
mailbox: 
RA-BWIUS-
PulseRider@ITS.JNJ.com. Note: the adverse event(s) will still need to be recorded on 
eCRFs once EDC is functional.)  An investigator shall submit to the reviewing IRB and 
the Sponsor a written report of any unanticipated adverse device effect occurring during an 
investigation no later than 10 working days after the investigator first learns of the effect. 
Sponsor must immediately conduct an evaluation of a UADE and must report the results 
of the evaluation to FDA, all reviewing IRBs, and participating investigators within 10 
working days after the Sponsor first receives notice of the effect (§§ 812.46(b), 
812.150(b)(1). 
A Sponsor who determines that a UADE presents an unreasonable risk to subjects shall 
terminate all investigations or parts of investigations presenting that risk as soon as 
possible. Termination shall occur not later than 5 working days after the Sponsor makes 
this determination and not later than 15 working days after the Sponsor first received notice 
of the effect. 21 CFR 812.46(b(2). 
8.5. 
Clinical Events Committee 
The Clinical Events Committee (CEC) will consist of a minimum of three independent 
physicians with expertise in neurosurgery, neurology or interventional neuroradiology and 
who are not otherwise involved with the study.  The CEC will review all reportable adverse 
events to adjudicate the safety endpoint, in addition to AEs of interest specified in the CEC 
charter.  
8.6. 
Data Monitoring Committee 
An Independent DMC will be responsible for assessing all reported AEs and monitoring 
the accumulated interim data on a periodic basis as the study progresses to ensure subject 
safety. The DMC will be comprised of representatives from multiple disciplines including 
but not limited to neurosurgery, neurology, interventional neuroradiology and biostatistics. 
The DMC will advise the Sponsor regarding the continuing safety of subjects and those yet 
to be recruited to the study, as well as the continuing validity and scientific merit of the 
study. The DMC will provide recommendations to the Sponsor regarding stopping or 
continuing enrollment in the study. The DMC will operate according to an approved 
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9. 
Clinical Monitoring 
Clinical site monitoring is conducted to ensure that the rights and well-being of human 
subjects are protected, that study data are accurate, complete, and verifiable, and that study 
conduct is in compliance with 21 CFR 812 and 50, ISO 14155, the currently approved 
protocol, with Good Clinical Practices, and with applicable regulatory requirements. Each 
site will undergo periodic monitoring visits, and subject medical records shall be made 
available during the visits.   
Monitoring visits may include but are not limited to the following: 
• Protocol adherence 
• Source documentation verification and accuracy of the eCRFs  
• Verification that informed consent is being obtained for all subjects participating in the 
study in accordance with requirements described in the study protocol 
• Verification of completeness of the Regulatory Binder 
• Verification of accuracy of all study logs such as the Delegation of Responsibility Log, 
Device Accountability, etc.  
• Compliance with applicable regulations 
• Identification and action to resolve any issues or problems with the study. 
Data are to be submitted promptly via eCRF after collection. Missing or unclear data will 
be queried to be corrected as necessary throughout the study. Pulsar Vascular, Inc. will 
request further documentation such as physician notes, outside hospital records, etc. when 
further documentation is required to understand any adverse events.  Monitoring will be 
conducted in accordance with the monitoring plan. 
10. Statistical Methodology 
The following sections provide a general description of the statistical plan for the analysis 
of study data.  A separate Statistical Analysis Plan (SAP) document that provides greater 
detail on data derivations and the analyses to be performed will be developed and approved 
prior to the first DMC data analysis report.  The SAP will reflect the protocol and any 
amendments that have been implemented at the time the SAP is finalized.  Any deviations 
from the final SAP will be noted in the final clinical summary report. 
10.1. Primary and Secondary Endpoints, and Associated Hypotheses 
10.1.1. 
Primary Endpoints and Associated Hypotheses 
The primary safety endpoint is the composite of Neurological Death or Major Ipsilateral 
Stroke (in downstream territory) up to 1 year post-procedure. The primary effectiveness 
endpoint is the rate of complete aneurysm occlusion (Raymond I) without significant 
parent artery stenosis (> 50% stenosis) or re-treatment at 1 year post-procedure.  

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To establish performance goals for safety and effectiveness for the treatment of wide neck 
bifurcation aneurysms (WNBAs), Fiorella et al. conducted a meta-analysis of literature 
published from 2000 via PubMed. A complete description of the systematic literature 
review and analysis can be found in the article. In summary, articles were identified using 
predetermined search terms and subsequently screened for inclusion/exclusion resulting in 
43 unique references and 53 unique articles for effectiveness and safety, respectively. Sub-
group analyses by aneurysm location (anterior vs. posterior) and treatment modality 
(surgical clipping (SC) and endovascular treatment (EVT) was also performed. A 
composite safety endpoint of major adverse events was applied with effectiveness 
outcomes reported as complete occlusion (Raymond I) and adequate occlusion (Raymond 
I and II) with at least one follow-up image at 12 months (range 4-25 months) post 
procedure. Notably, a 12% adjustment for non-core laboratory adjudicated images was 
made.  The authors reported adequate occlusion rates for all therapies as 59.4% and 43.8% 
and 69.7% for EVT and SC, respectively. The rates of occurrence for pre-specified safety 
endpoints were 18.7% combined, and 21.1% and 24.3 % for EVT, and SC, respectively.  
Considering the similarities in the NAPA IDE target subject population and primary 
effectiveness endpoint (complete occlusion at 1 year post-procedure) to that which was 
evaluated in Fiorella et. al., the incidence of 46.3 % reported in the meta-analysis was used 
to generate a proposed NAPA IDE performance goal for effectiveness of 46.3%.  Based on 
the experience with the ANSWER study which evaluated the PulseRider device, the rate 
of adequate occlusion with the PulseRider device is expected to be at least 58.8%. 
The composite safety endpoint applied by Fiorella et al. is reasonably dissimilar to the 
NAPA IDE primary safety endpoint of major ipsilateral stroke or death due to neurological 
causes at 1 year post-procedure. As a result, the NAPA IDE performance goals for safety 
was determined from a systematic review of literature published in OVID and PubMed 
between January 1, 2012 and April 25, 2017. After de-duplication, a full text search in 
QUOSA was performed limiting results to WNBA located at NAPA IDE aneurysm 
locations. The following inclusion/ criteria were applied, yielding 7 unique articles for 
safety with Forest Plot shown in Figure 10.1.1A. [Brassel 2015, Fields 2011, Labeyrie 
2017, Pierot 2015, Peirot 2015 Sivan-Hoffman 2015, Zhao 2012]. 
Included articles: 
• Article reporting clinical performance and safety results on equivalent comparator(s) 
[WEB, pCONUS, BARREL, X/Y stenting]  
• Wide neck or complex bifurcation aneurysms found at MCA, ACOM, Basilar tip, 
carotid terminus with at least 80% or more unruptured aneurysms and where > 5 patients 
were included in a series  
• Clinical follow-up between 10 and 14 months;  
Excluded articles:  
• Technical or reviews (systematic and none) with non-extractable data by treatment 
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• No clinical performance and safety results on target device(s) and/or equivalent 
comparator(s) 
• Use of the target device(s) and/or equivalent comparator(s) was not the main focus of 
the study 
• Studies where the subject device was used in patients, but no safety or performance 
outcomes were reported 
• Abstract, report, or article could not be retrieved 
• Duplicate or non-English articles language 
Of the included articles, all reported safety events were evaluated and neurological deficits 
that resulted in a sudden change in NIHSS of 4 or more (when reported) or as determined 
by a Codman neurosurgeon to cause a change in NIHHS of 4 or more were deemed to meet 
the primary safety endpoint. Based on this meta-analysis, a rate of 9.9% rounded to 10% 
(95% CI: 5.9% - 16.1%) for death due to neurological causes or major ipsilateral stroke 
was identified. A 5% margin of indifference for the primary safety endpoint is proposed, 
resulting in a Performance Goal (PG) of 15% for this endpoint.  
Figure 10.1.1A Forest Plot: Seven References with Usable Data to Estimate the 
Anticipated Primary Safety Endpoint at 12 Months 
 
Primary Safety Endpoint Hypotheses: 
Null Hypothesis H0: pMajor Stroke/Death ≥ 15%  
Alternative hypothesis HA: pMajor Stroke/Death < 15% 
Where pMajor Stroke/Death is the rate of Composite of Neurological Death or Major Ipsilateral 
Stroke (in downstream territory) up to 1 year post-procedure. 
Decision Criterion: The decision will be made to reject the null hypotheses and conclude 
the alternative hypothesis if the upper bound of a two-sided 95% normal approximation 
based confidence interval is < 15%. 
 

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Primary Effectiveness Endpoint Hypotheses: 
Null hypothesis H0: pCompleteOcclusion ≤ 46.34% 
Alternative hypothesis HA: pCompleteOcclusion > 46.3% 
Where pCompleteOcclusion is the rate of complete aneurysm occlusion without significant parent 
artery stenosis (> 50% stenosis) or prior retreatment at 1 year post-procedure. 
Decision Criterion: The decision will be made to reject the null hypotheses and conclude 
the alternative hypothesis if the lower bound of a two-sided 95% normal approximation 
based confidence interval is > 46.3%. 
 
Study Success: 
The study will be deemed to be a success if the primary safety and effectiveness endpoint 
null hypotheses are both rejected. 
10.1.2. 
Secondary Endpoints 
• Technical Success is defined as successful implantation of device— physician able to 
access target aneurysm, deploy PulseRider device at the neck of aneurysm and device 
was detached successfully. This endpoint will be reported by the investigator. The 
following hypothesis test of this endpoint will be performed if the primary safety and 
effectiveness endpoint null hypotheses are both rejected: 
• Null hypothesis H0: pTechnicalSuccess ≤ PG of 79% 
• Alternative hypothesis HA: pTechnicalSuccess > PG of 79% 
• Where pTechnicalSuccess is the rate of technical success 
• Decision Criterion: The decision will be made to reject the null hypotheses and 
conclude the alternative hypothesis if the lower bound of a two-sided 95% normal 
approximation based confidence interval is > PG of 79%. With 160 subjects, a rate 
for technical success of at least 85% is required to demonstrate success on this 
endpoint. 
• Ability to retain embolic coils within aneurysm immediately post-procedure (as 
evaluated by the core lab) 
• Complete aneurysm occlusion at 3 years and 5 years. Complete aneurysm occlusion is 
defined as Raymond I. Aneurysm occlusion grading will be evaluated by the 
independent core laboratory.   
• Adequate aneurysm occlusion (defined as Raymond I and II combined) at 1 year, 3 years 
and at 5 years. Aneurysm occlusion grading will be evaluated by the independent core 
laboratory. 
• The percentage of target aneurysms that are retreated through 1 year, 3 years and 5 years. 
Retreatment will be reported by the investigator. 

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• The percentage of subjects with significant stenosis defined as > 50% at implant site at 
1 year, 3 years and 5 years. This endpoint will be evaluated by the independent core 
laboratory 
• The percentage of subjects with mRS 0 – 2 at 1 year, 3 years and 5 years 
10.1.3. 
Additional Endpoints 
• The percentage of target aneurysm ruptures up to 1 year, 3 years and 5 years. This 
endpoint will be evaluated by the independent core laboratory. 
• No migration (defined as ≤ 2 mm) of the device at 1 year, 3 years and 5 years. This 
endpoint will be evaluated by the independent core laboratory. 
10.1.4. 
Adverse Events and Clinical Complications 
Adverse Events, SAEs, device- or procedure-related AEs, USADEs, UADEs, and deaths 
will be coded using the MedDRA system and summarized with frequencies. 
Study device malfunctions will also be summarized. 
In addition, a listing of adverse events will be provided for any subject that was consented 
and started the study procedure but did not undergo attempted treatment with the study 
device and therefore is not part of the modified Intent To Treat (mITT) population. 
10.1.5. 
Levels of Significance 
A 2-sided alpha of 0.05 will be used for statistical testing and confidence intervals unless 
otherwise noted. There will be no adjustment of significance levels or p-values for testing 
multiple hypotheses Both primary endpoints must be met for study success and the 
secondary effectiveness endpoint of technical success will only be tested if the primary 
endpoints are met.   
10.1.6. 
Analysis Datasets 
Modified Intent to Treat Analysis Set 
The mITT analysis set consists of all enrolled subjects in whom treatment with the 
PulseRider device is attempted as defined by advancement of any portion of the PulseRider 
device outside of the distal end of the microcatheter inside the subject. This includes 
subjects in which the PulseRider is not fully advanced outside of the microcatheter.  It is 
possible that the PulseRider device may not reach the target aneurysm, and as a result the 
treating physician does not advance the device outside of the distal end of the 
microcatheter.  In the rare event that this happens, the subject will not be considered part 
of the mITT population and will instead be followed for 30 days. 
Per Protocol (PP) Analysis Set   
The PP analysis set consists of all subjects who meet the following criteria: 
• there are no major deviations from the protocol eligibility criteria or DAPT requirements 
• the subject is successfully implanted with the PulseRider device 

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10.2. Sample Size Justification  
Meta-analysis 
As described above, a meta-analysis was executed to determine the safety Performance 
Goals for the proposed NAPA clinical study of the PulseRider using the R package ‘metaa' 
in a [R] environment, version 3.3-2.  To obtain an overall proportion from studies reporting 
a single proportion, a random-effects model was chosen over a fixed-effect model to 
acknowledge the variations in study design. Additional characteristics of the methodology 
are:   
• Inverse variance method used for weights 
• DerSimonian-Laird method used to estimate tau2 
• Logit transformation 
• Clopper-Pearson confidence interval for individual studies 
• Continuity correction of 0.5 in studies with zero cell frequencies 
Based on this meta-analysis, a rate of 9.9% rounded to 10% (95% CI: 5.9% - 16.1%) for 
death due to neurological causes or major ipsilateral stroke was calculated. A 5% margin 
of indifference for the primary safety endpoint is proposed, resulting in a PG of 15% for 
this endpoint. Based on the 1 year results of the ANSWER HDE Study, the anticipated rate 
for the primary safety endpoint is 7%. Results from a recently published meta-analysis 
[Fiorella 2017] of wide-neck bifurcation aneurysms indicate that the rate of complete 
occlusion at 1 year of wide-neck bifurcated aneurysms treated with conventional therapies 
is 46.3% (95% CI: 39.2% - 53.4%) whereas based on the ANSWER HDE Study the rate 
of complete occlusion is expected to be 58.8% with the PulseRider device. With Sponsor’s 
desire to seek superiority to a PG of 46.3% for the primary effectiveness endpoint and an 
expected attrition rate of   10%, one hundred sixty (160) subjects will provide 80% power 
for the primary safety endpoint and 85% power for the primary effectiveness endpoint.  
10.3. Analyses to be Conducted 
10.3.1. 
General Conventions 
Standard descriptive summaries for continuous data include the number of observations 
with data, number of observations with missing data, mean, standard deviation, median, 
minimum, and maximum values. For categorical data, the count and percent will be 
provided. Percentages will be based on the number of subjects without missing data. 
Analyses will take place using SAS statistical software version 9.4 or later in a server 
environment. 
 
                                                 
 
a Schwarzer G. Package ‘meta’. Meta-analysis with R, Version 4.7-0. 2015 

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10.3.2. 
Disposition of Study Subjects 
Subject disposition will be summarized in multiple ways: 
• With a summary of the number of subjects enrolled and treated by site/investigator 
• With a subject flow diagram which shows the number of enrolled, discontinued, lost to 
follow-up, withdrawn/early terminated, and completed subjects 
• With a subject accounting table 
10.3.3. 
Demographics, Baseline, and Procedural Characteristics 
All demographic characteristics, procedural, and immediate post-operative details will be 
summarized using the mITT analysis set, including but not limited to: age, sex, medical 
history, smoking status, prior treatment, aneurysm location, neck and diameter size, pre 
and post procedural DAPT, length of procedure, and length of hospital stay. 
10.3.4. 
Primary Endpoint Analyses 
Primary Safety Endpoint 
The primary safety endpoint analysis will be conducted on the mITT analysis set.  
If a subject experienced a death due to neurological causes or a major ipsilateral stroke in 
downstream territory within a year post-procedure then subject will be deemed a failure on 
the endpoint. If a subject completed the 1 year follow up and did not experience any such 
event then subject will be deemed a success on the endpoint. If a subject did not complete 
the 1 year follow up and did not experience such event then the subject will be imputed 
with a multiple imputation method that will make use of the similarities between the 
subject’s demographic, procedural, and aneurysm characteristics with those of the subjects 
with a non-missing endpoint (those who either experienced an event and those who 
completed the study without experiencing an event). The imputation method will also 
account for the length of time between the procedure and the last time the subject was seen. 
The longer that time period is, the less likely the subject will be imputed with an event. 
Subjects for whom implantation of the PulseRider was attempted but not successful will 
be followed up to a year. Any safety events which occur due to attempted implant or from 
retreatment, and which meet the primary safety endpoint definition will count as failures 
in the analysis. If such a subject is lost to follow-up then subject will be imputed with data 
based on other subjects for whom the implantation was not successful but who were not 
lost to follow-up. 
The multiple imputation method results in a large collection of imputed datasets. The 
proportion of primary endpoint events and its variance is computed for each dataset. Within 
and between imputation variances are then combined according to Rubin’s method [Rubin 
1996] in order to produce a single variance estimate for the proportion of events. 
The endpoint will be considered successful if the upper bound of the 2-sided 95% normal 
approximation based confidence interval for the rate of events is less than a performance 
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Primary Effectiveness Endpoint 
The primary effectiveness endpoint analysis will be conducted on the PP analysis set. 
Success on this endpoint is defined as complete aneurysm occlusion (Raymond I) without 
retreatment or significant parent artery stenosis (> 50% stenosis) at 1 year post-procedure. 
If the 1 year imaging is not available and if the subject did not experience a retreatment 
then the subject will be imputed using an  imputation method that will make use of the 
subject’s own past occlusion and stenosis evaluations if available and the similarities 
between the subject’s demographic, procedural, and aneurysm characteristics with those of 
the subjects with a non-missing endpoint. 
The multiple imputation method results in a large collection of imputed datasets. The 
proportion of complete aneurysm occlusion and its variance is computed for each dataset. 
Within and between imputation variances are then combined according to Rubin’s method 
in order to produce a single variance estimate for the proportion of complete aneurysm 
occlusion. 
The endpoint will be considered successful if the lower bound of the 2-sided 95% normal 
approximation based confidence interval for the rate is greater than a performance goal of 
46.3%. 
10.3.5. 
Secondary Endpoint Analyses 
The analysis of technical success which is reported by the investigator will be conducted 
on the mITT analysis set. The endpoint will be considered successful if the lower bound of 
the 2-sided 95% normal approximation based confidence interval for the rate is greater than 
a performance goal of 79%.  
The analyses of the remaining secondary effectiveness endpoints listed below will be 
conducted on the PP analysis set using the observed data. 
• The ability to retain embolic coils within aneurysm immediately post-procedure as 
reported by the independent core laboratory 
• Complete aneurysm occlusion at 3 years and 5 years as reported by the independent core 
laboratory 
• Adequate aneurysm occlusion at 1 year, at 3 years and 5 years as reported by the 
independent core laboratory 
• The percentage of target aneurysms that are retreated through the 1 year, 3 year and 5 
year as reported by the investigator  
• The percentage of subjects with significant stenosis defined as > 50% at implant site at 
1 year, 3 years and 5 years as reported by the independent core laboratory 
• The percentage of subjects with mRS 0-2 at 1 year, 3 years and 5 years 
10.3.6. 
Additional Endpoint Analyses  

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The analyses of the percentage of target aneurysm ruptures up to 1 year, 3 years and 5 years 
post-procedure and of the percentage of no migration (defined as ≤ 2 mm) of the device at 
1 year, 3 years and 5 years post-procedure will be conducted on the PP population using 
the observed data. Both endpoints are evaluated by the independent core laboratory. 
10.3.7. 
Safety Analyses 
AE summaries (number of events and incidence) conducted on the mITT analysis set will 
be presented for: 
• All AEs 
• SAEs 
• UADEs  
• Deaths 
• Device and Procedure Related AEs 
• Neurologic AEs 
Study device malfunctions observed intra-operatively and overtime thereafter will be 
summarized using the mITT analysis set. 
AE and study device malfunction summaries will also be provided in the same fashion as 
above for T and Y shape devices separately. 
10.3.8. 
Plans for Interim Analyses 
There are no planned interim analyses.  
10.3.9. 
Handling of Missing Data 
Missing primary safety and effectiveness endpoint data will be imputed as per the multiple 
imputation method described in section 10.3.4. The secondary effectiveness endpoint is 
expected to have minimal to no missing data and analysis will not make use of any 
imputations.  
10.3.10. Sensitivity Analyses 
As a sensitivity analysis, the primary safety and effectiveness endpoints will be analyzed 
as described in section 10.5.4 but without imputing missing endpoint data using the 
Clopper-Pearson method. 
Other sensitivity analyses will analyze the primary endpoints as follows: 
• Consider all missing endpoints as successes, 
• Consider all missing endpoints as failures, 
• A Tipping point analysis which attempts to answer how many subjects with missing 
primary endpoint data need to change to either successes or failures for success on the 
endpoint to no longer hold. 

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10.3.11. Sub-Group Analyses 
Proportions of subjects and 95% confidence intervals of the primary safety and 
effectiveness endpoints will be presented for the mITT population set with only the 
observed data and of the primary effectiveness endpoint for the PP population set with only 
the observed data as appropriate, in the following subgroups:  
• sex. Males and Females will also be statistically compared at the 0.1 alpha level using a 
chi-square test based on a normal distribution. 
• race 
• ethnicity 
• age category (18-35, 36-50, 51-64, 65-75, and 76-80 years) 
• aneurysm location - basilar, carotid terminus, MCA and ACOM  
10.3.12. Assessment of Site Homogeneity  
Homogeneity of the primary safety and effectiveness endpoints across sites will be 
assessed with a chi-square test of proportions at an alpha level of 0.1 and will be conducted 
on the mITT population set for the safety endpoint and on the PP population set for the 
effectiveness endpoints using the observed data only for both. Sites with less than 5 
subjects will be pooled.  
10.4. Measures to Minimize Bias 
Pulsar Vascular, Inc. will be diligent in controlling for bias by utilizing proper study design 
and implementation of the approved study protocol.  IRB approval will be obtained at all 
clinical sites prior to study initiation.  Study agreements/contracts will be made with the 
hospitals/universities and all compensation for conduct of the study will be paid to the 
hospitals/universities and not to the investigators. Strict inclusion and exclusion criteria 
will be implemented to avoid selection bias.  
Investigators will assess potential subjects who are candidates for the study. In addition, an 
image of the subject’s aneurysm and branch arteries must be reviewed and approved by the 
Image Screening Committee. Candidates who meet the protocol inclusion/exclusion 
criteria with at least one bifurcation intracranial aneurysm that is acceptable for minimally 
invasive treatment and approved by the Image Screening Committee may be enrolled.  
A Clinical Events Committee (CEC) will review all reportable adverse events and 
adjudicate endpoints to determine whether they meet protocol-specified criteria.  The CEC 
will review all reportable adverse events to adjudicate the safety endpoint, in addition to 
AEs of interest specified in the CEC charter. CEC members will provide an impartial 
review and will not hold a financial interest in Pulsar Vascular, Inc.  An independent core 
laboratory will perform the angiographic assessments for the primary and secondary 
effectiveness endpoints. These evaluations will be performed by an independent reader 
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Clinical outcomes will be measured in a standardized manner using the National Institutes 
of Health Stroke Scale, a standardized, objective, clinical assessment tool used to quantify 
and document the neurological status of patients and to act as a predictor for clinical 
outcomes. It is used to determine stroke and the severity of stroke.  
Clinical outcomes will be measured in a standardized manner using the Modified Rankin 
Scale , a commonly utilized six-point scale measuring functional outcome and disability in 
patients with stroke. The mRS measures independence and dependence related to activities 
of daily living and can be used over time to determine recovery or regression. 
Study monitors will have clinical research experience and be proficient at study 
monitoring.  Study data will be source data verified (SDV) using the subject’s medical 
records, study source worksheets, clinic notes, and radiographic reports as applicable as 
source documentation. 
11. Ethics and Protection of Human Subjects 
11.1. Ethical Standard 
As the Sponsor of this study, Pulsar Vascular, Inc. has the overall responsibility for the 
conduct of the study, including assurance that the study is in accordance with the ethical 
principles that have their origin in the Declaration of Helsinki, as well as the regulatory 
requirements of the Food and Drug Administration and local government. The Sponsor 
will also maintain compliance with Good Clinical Practice (International Conference on 
Harmonization (ICH) version 4 du 1 May 1996), the European standard EN ISO 
14155:2011 (Clinical Investigation of Medical Devices for Human Subjects), Sponsor 
general responsibilities (21 CFR 812.40), selection of investigators (21 CFR 812.43), 
monitoring (21 CFR 812.46), supplemental applications (21 CFR 812.35 [a] and [b]), 
maintaining records (21 CFR 812.140 [b]), and submitting reports (21 CFR 812.150 [b)]), 
and to local regulations where required. 
• General Responsibilities   
Sponsor’s general duties consist of submitting the IDE application to FDA, assuring that 
sites have received IRB approvals prior to shipping the devices, selecting investigators, 
ensuring proper clinical site monitoring and ensuring subject informed consent is obtained.  
Any additional requirements imposed by an IRB or regulatory authority shall be followed, 
if appropriate. 
• Data Quality and Reporting 
Sponsor is responsible for providing quality data that satisfy federal regulations and 
informing proper authorities of unanticipated adverse effects and deviations from the 
protocol.   
• Selection of Investigators 
Sponsor will select qualified investigators, obtain a signed Investigator Agreement and 
provide the investigators with the information necessary to conduct the study. 

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• Supplemental Applications—Protocol Amendments  
As appropriate, Sponsor will submit changes in the study protocol to the FDA and 
investigators to obtain IRB re-approval.  A justification for each amendment will be 
documented.   
• Maintaining Records  
Sponsor will maintain copies of correspondence, device shipment and disposition records, 
data, adverse device effects and other records related to the study. Sponsor will maintain 
records related to the signed Investigator Agreements and financial disclosure. 
• Submitting Reports  
Sponsor will submit any required regulatory reports identified in this section of the 
regulation.  This includes unanticipated adverse device effects, withdrawal of FDA 
approval, current investigators list, annual progress reports, recall information, final reports 
and device use without informed consent. 
11.2. Institutional Review Board 
The protocol, informed consent form, recruitment materials, and all participant materials 
will be submitted to the IRB for review and approval.  IRB approval of both the protocol 
and the consent form must be obtained before any participant is consented.  A stamped 
copy of the IRB approval letter and approved consent form must be submitted to Pulsar 
Vascular, Inc. certifying study approval prior to subject consent.   
Any amendment to the protocol will require review and approval by the IRB before the 
changes are implemented to the study.  Pulsar Vascular, Inc. and the IRB must approve in 
writing any changes to the protocol that affect the rights safety and/or welfare of the 
subjects or may adversely affect the validity of the study. All changes to the consent form 
will be IRB approved and a determination will be made regarding whether previously 
consented participants need to be re-consented. 
Investigators are responsible for submitting and obtaining initial and continuing review of 
the study by their IRB. 
11.3. Informed Consent Process 
11.3.1. 
Consent and Other Informational Documents Provided to Participants 
Patient’s informed consent must be obtained and documented according to the principles 
of informed consent in 21 CFR Part 50, the ethical principles that have their origin in the 
Declaration of Helsinki (Brazil, 2013), and ISO 14155:2011.  
The IRB must review and approve an informed consent form (ICF) specific to this study.  
Pulsar Vascular, Inc. will provide each study center with an example ICF.  The clinical 
center, to meet specific IRB requirements, may modify this example ICF; however, the 
ICF must contain all of the informed consent elements required by 21 CFR 50.25.  Each 
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and renewed approvals and consents as appropriate for the duration of the study.  The 
original, signed and dated ICF should be retained by the investigational site for monitoring, 
and a copy provided to the subject. 
11.3.2. 
Consent Procedures and Documentation 
Informed consent is a process that is initiated prior to an individual agreeing to participate 
in a study and continues throughout the individual’s study participation. Discussion of risks 
and possible benefits of participation will be discussed with the patients and their families 
as requested. The investigator, or designee, will explain the research study to the patient 
and answer any questions that may arise. All patients will receive verbal and written 
information in language at a level of complexity understandable to the patient about the 
purpose, procedures, and potential risks of the study and of their rights as research 
participants. Patients will have ample opportunity to review the written consent form and 
to ask questions prior to signing. The patients should be allowed additional time as desired 
to consider the study prior to agreeing to participate. Prior to participation in the study, the 
Patient Informed Consent Form will be signed and personally dated by the patient or his/her 
legal representative. The subjects may withdraw consent at any time throughout the course 
of the study. The rights and welfare of the participants will be protected and it will be 
emphasized to them that the quality of their medical care will not be adversely affected if 
they decline to participate in this study. A signed and dated copy of the Patient Informed 
Consent Form must be collected from each enrolled subject and kept in the study subject 
files.  Subjects will be notified in a timely manner of any significant new information that 
develops over the course of the study that may affect their willingness to participate. 
The informed consent will include an authorization for use and disclosure of the subject’s 
protected health information, in accordance with the Health Insurance Portability and 
Accountability Act (HIPAA) or as required per local regulations. Subject confidentiality 
will be maintained throughout the clinical study in a way that assures that individual subject 
data can be tracked back to the source data. For this purpose, a unique subject identification 
code will be used that allows identification of all data reported for each subject. Data 
relating to the study may be made available to third parties, provided the data are treated 
as confidential and that the subject’s privacy is guaranteed. 
It is not expected that the PulseRider device will be used emergently as eligibility 
confirmation includes a screening process, therefore, consent under emergency 
circumstances does not apply.  
11.4. Participant and Data Confidentiality 
During this clinical investigation, all representatives of the Sponsor will comply with all 
in-country privacy laws, including HIPAA and regulations regarding contact with subjects, 
their medical record information, copying of information, and protection of the subject 
identities. 
All information and data sent to Pulsar Vascular, Inc. concerning subjects or their 
participation in this clinical investigation will be considered confidential. Only authorized 

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Pulsar Vascular, Inc. personnel or representatives (including contracted service providers, 
i.e. Core Lab, Clinical Research Associate, etc.), representatives of the FDA will have 
access to these confidential files upon request (including, but not limited to, laboratory test 
result reports, admissions/discharge summaries for hospital admission occurring during a 
subject’s study participation and autopsy reports for deaths occurring during the clinical 
investigation).  All data used in the analysis and reporting of this evaluation will exclude 
identifiable reference to the subject. 
12. Quality Assurance and Quality Control 
Quality Control (QC) procedures will be implemented beginning with the data entry system 
and ongoing QC checks will be run on the database. Any missing data or data anomalies 
will be communicated to the site(s) for clarification/resolution.  
Following written (Standard Operating Procedures) SOPs, monitors will verify that the 
clinical study is conducted and data are generated, documented, and reported in compliance 
with the protocol, Good Clinical Practice (GCP), and the applicable regulatory 
requirements. If noncompliance is identified, Sponsor is required by regulation to 
implement measures to secure compliance.  
The investigational site will provide direct access to all study related information, source 
data/documents, and reports for the purpose of monitoring and auditing by the Sponsor, 
and inspection by local and regulatory authorities.  
13. Data Handling and Record Keeping 
13.1. Data Collection and Management Responsibility 
Data collection is the responsibility of the site clinical study staff under the supervision of 
the investigator.  The investigator is responsible for ensuring the accuracy, completeness, 
and timeliness of the data entered.  The Sponsor is responsible for all data management 
activities. These activities include the development of a database, utilizing validated 
database software, into which all study data will be entered by the clinical sites. The 
Sponsor will be responsible for ensuring the overall integrity of the database. 
13.1.1. 
Electronic Case Report Forms 
Electronic CRFs have been developed to capture the information outlined in this study 
protocol. Data on these eCRFs will be monitored, corrected if necessary, and entered into 
a validated database.  All changes made to the data will be tracked in the electronic audit 
trail, recording the current value, previous value, reason for change, date timestamp of data 
entry/change, and the name of the person who changed the data. The investigator will 
electronically sign all subject eCRFs as verification that the data have been reviewed and 
correctly reflects source documentation. Data from these eCRFs will be used to provide 
analysis of this study. 
13.1.2. 
Source Documentation 

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Data entered on to the eCRFs will be obtained from source documentation, such as hospital 
procedure reports, admission and discharge summaries, and other hospital or physician 
office/clinic documents. If no standard hospital or clinic document exists to capture 
information required specifically for this clinical investigation, a source worksheet may be 
developed to record this information. Any worksheets shall be signed by the investigator 
at the given site and will serve as the source document for those data parameters. These 
source documents will serve as the basis for monitoring subject specific information 
against the eCRFs. 
Electronic subject records will be considered source documents on the condition that the 
hospital’s database is a validated system. If this is not the case, electronic records will have 
to be printed and added to the subject’s paper file. A print-out of an eCRF cannot be used 
as source documentation. 
13.1.3. 
Study Records 
Regulations require that investigators maintain information in the subject’s medical 
records, which corroborate data collected on the eCRFs.  The Investigator is responsible 
for maintaining medical and study records for every subject participating in the clinical 
study (including information maintained electronically such as digital imaging).  The 
Investigator will also maintain original source documents from which study-related data 
are derived, which include, but are not limited to: 
• Clinic progress notes recording subject’s medical history and medications 
• Medical charts with operative reports and condition of subject upon discharge 
• Medical records regarding AEs, including treatment and clinical outcome  
• Results of diagnostic examinations 
• Imaging (such as x-rays, MRIs), as well as the report of the radiologist’s 
reading/interpretation of diagnostic imaging 
• Notes of phone calls and/or correspondence indicating investigational site’s attempts to 
follow study subjects at the required follow-up visits until subject’s participation in the 
study is complete or terminated 
• Records relating to subject death (e.g., death certificate, autopsy report) 
• Print-outs of source data generated by technical equipment (e.g., x-rays, MRIs) must be 
filed with the subject’s records.   
Only authorized Pulsar Vascular, Inc. personnel or representatives, authorized site 
personnel, local government authorities, or the FDA, acting in their official capacities, will 
have access to these confidential files. 
13.1.4. 
Health Economic Data 
The cost and frequency of health care utilization during hospitalization for the study index 
procedure and any additional hospitalizations during the study period will be collected.  

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This data will not be provided to the FDA as part of the IDE reporting because it does not 
support the safety and efficacy of the investigational device.   
The hospitalization health care data to be collected may include, but is not limited to, the 
subject’s admission date, discharge date, procedure date, ICD-10 and procedure codes, 
DRG assignment and total cost for the hospitalization will be extracted from the 
information. 
In addition, the Sponsor will collect health economic data associated with follow up care 
including any additional or necessary procedures/surgeries resulting from the index 
procedure, ER visits, and/or outpatient visits to address issues related to the target 
intracranial aneurysm. Data collected may include quality of life data, additional 
procedures data, any devices utilized, length of hospital stay, readmissions, procedure time, 
and hospital charges. 
13.1.5. 
Data Reporting 
The investigator, or designated individual, is responsible for timely completion of all data 
from the study via the eCRFs supplied by Pulsar Vascular, Inc. The investigator/delegated 
individual is required to electronically sign the eCRF on the appropriate pages to verify 
that he/she has reviewed, and attests to the correctness, of the recorded data. Completed 
eCRFs will be reviewed and monitored at the investigational site by Pulsar Vascular, Inc. 
personnel or designee at regular intervals throughout the study. To this end, the investigator 
and institution must permit inspection of the study files and subject eCRFs by such 
representatives and/or responsible government agencies.  
Investigators are required to prepare and submit accurate and timely reports on this study 
to the IRB and Pulsar Vascular, Inc., as applicable. 
13.1.6. 
Data Verification and Review 
Pulsar Vascular, Inc. will track the amount of missing data and contact sites as appropriate 
to instruct them on steps to minimize missing data and remain compliant with protocol 
required assessments. Missing or unclear data will be queried as necessary throughout the 
study.  Pulsar Vascular, Inc. will request further documentation such as physician and/or 
radiology reports when complications or malfunctions are observed and reported. Pulsar 
Vascular, Inc. will be responsible for auditing the database and confirming the overall 
integrity of the data. 
13.1.7. 
Final Data Analysis 
All exported datasets for analyses will undergo a final data review before final database 
lock. Once all critical data are monitored and locked, the final analyses of clinical 
investigation data will be performed. 
13.2. Study Record Retention and Archiving 
The investigator will maintain all essential study documents and source documentation that 
support the data collected on the study subjects in compliance with FDA guidelines per 21 

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CFR 812.140(d). Documents must be retained for a period of 2 years after the latter of the 
following two dates: The date on which the investigation is terminated or completed, or 
the date that the records are no longer required for purposes of supporting a premarket 
approval application. The investigator will take measures to ensure that these essential 
documents are not accidentally damaged or destroyed. If for any reason the investigator 
withdraws responsibility for maintaining these essential documents, custody must be 
transferred to an individual who will assume responsibility. Pulsar Vascular, Inc. must 
receive written notification of this custodial change. 
14. Protocol Deviations 
The investigator is responsible for ensuring that the clinical investigation is conducted in 
accordance with the procedures described in the protocol, FDA regulations and any 
conditions required by the reviewing IRB.  A protocol deviation is a failure to comply 
(intentionally or unintentionally) with the requirements of the clinical study as specified in 
the protocol.  Examples of protocol deviations include late visits, missed visits, required 
follow-up testing not completed, visit out of window, non-adherence to inclusion/exclusion 
criteria, etc. and shall be reported to the Sponsor through the eCRFs.   Deviations will be 
reviewed and assessed by the Sponsor.   
It is the responsibility of the site to use vigilance to identify and report deviations to the 
Sponsor and IRB per guidelines.  The study monitors shall verify that the conduct of the 
study is in compliance with the approved protocol and applicable regulations and shall 
identify deviations and any issues of noncompliance. Corrective and preventative actions 
will be implemented promptly as necessary and significant protocol deviations that raise 
subject safety concerns or indicate repeat noncompliance may be grounds for investigator 
disqualification. 
The investigator is not allowed to deviate from the protocol except under emergency 
circumstances to protect the rights, safety and well-being of study participants.  In such 
cases the emergency deviation shall be documented and reported to the Sponsor and IRB 
as soon as possible, and no later than 5 working days after the emergency occurred.  The 
Sponsor is required to report such deviation to the FDA within 5 working days after the 
Sponsor learns of the deviation.   
15. Data and Publication Policy 
Publications and/or presentation of the clinical investigational results will be coordinated 
between Pulsar Vascular, Inc. and the clinical investigation author(s).  Authorship will be 
determined prior to development of any manuscript.  All information concerning the study, 
PulseRider device, Sponsor operations, patent application, manufacturing processes, and 
basic scientific data supplied by the Sponsor to the investigator and not previously 
published, are considered confidential and remain the sole property of the Sponsor.   
16. Study Administration 
16.1. Study Leadership 

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The Pulsar Vascular, Inc. clinical leadership will conduct the clinical study in accordance 
with Good Clinical Practice Guidelines, including ISO 14155 and FDA regulations, 21 
CFR Parts 50, 54, 56, and 812.  Pulsar Vascular, Inc. will have certain direct responsibilities 
and will delegate other responsibilities to appropriate consultants.  Together, Pulsar 
Vascular, Inc. and consultants will ensure that the study is conducted according to all 
applicable regulations.   
16.2. Steering Committee 
A Steering Committee comprised of at least three physicians with experience in the areas 
of neurosurgery, neurology or interventional neuroradiology will be appointed for this 
study.  The responsibilities of the Steering Committee include: 
• Consultation on study design, protocol development, patient eligibility inquiries, data to 
be collected and investigator training 
• Review of evidence results (assist in data interpretation) 
• Support the Sponsor’s efforts in conducting meetings with the regulatory agencies, as 
appropriate. 
17. Conflict of Interest 
The term “conflict of interest” refers to situations in which financial or other personal 
considerations may compromise, or have the appearance of compromising a researcher's 
professional judgment in conducting or reporting research. Pulsar Vascular, Inc. will make 
every effort to safeguard against conflicts of interest to assure the integrity of the data, 
subject safety and investigator objectivity. 
Clinical investigators will complete financial disclosure forms prior to initiating the study 
and update them annually or when changes occur related to stock and stock options and 
income from salary, honorariums, and consulting fees. 
 
 
 

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