The WEB® Intrasaccular Therapy Study (WEB-IT)
Phase: NA
Conditions: Wide Neck Bifurcation Intracranial Aneurysms, Intracranial Aneurysms
Sponsor: Microvention-Terumo, Inc.

CLINICAL PROTOCOL SYNOPSIS 
 
CP13-001 
12 August 2015                                                                                             Page 1 of 6                                                        C O N F I D E N T I A L  
The information contained in this document is proprietary to Sequent Medical, Inc. and may not be used, disclosed, or copied without written permission of Sequent Medical, Inc.    
 
 
 
 
 
 
 
Protocol Synopsis CP13-001 
The WEB® Intrasaccular Therapy Study 
(WEB-IT) 
 
 
 
Study Sponsor 
Sequent Medical, Inc. 
11 A Columbia 
Aliso Viejo, CA 92656 
USA 
 
 
 
 
DISCLOSURE STATEMENT 
This document contains information that is confidential and proprietary to Sequent Medical, Inc. (Sequent).  This 
information is being provided to you solely for the purpose of evaluating or conducting a clinical study for Sequent. 
You may disclose the contents of this document only to study personnel under your supervision who need to know the 
contents for this purpose and to your Institutional Review Board (IRB) or Ethics Committee (EC) otherwise; the 
contents of this document may not be disclosed without the prior authorization from Sequent. The foregoing shall not 
apply to disclosure required by governmental regulations or laws.  Any supplemental information that may be added 
to this document also is confidential and proprietary to Sequent and must be kept in confidence in the same manner as 
the contents of this document.

CLINICAL PROTOCOL SYNOPSIS 
 
CP13-001  
12 August 2015                                                                                                      Page 2 of 6                                                        C O N F I D E N T I A L  
The information contained in this document is proprietary to Sequent Medical, Inc. and may not be used, disclosed, or copied without written permission of Sequent Medical, Inc.    
 
 
 
 
 
The WEB® Intrasaccular Therapy Study (WEB-IT) 
1 
Study Summary 
 
Protocol: 
CP13-001 Rev.3.1 
Study Name: 
The WEB® Intrasaccular Therapy Study (WEB-IT) 
Study Purpose: 
To demonstrate the safety and effectiveness of the WEB Aneurysm 
Embolization System for the treatment of intracranial wide-neck bifurcation 
aneurysms  
Study Device:  
The WEB Aneurysm Embolization System 
Study Design: 
Prospective, single-arm, multicenter, international interventional cohort 
Sample Size 
Up to 150 treated subjects 
Study 
Population: 
Adults (18-75 years of age) with intracranial wide-neck aneurysms located at 
arterial bifurcations (see eligibility criteria)   
Study Duration: 
Each subject will participate for at least 5 years.  Total study duration will be 
approximately 6 years. 
Primary 
Endpoints: 
The study’s primary effectiveness endpoint is the proportion of subjects 
with complete aneurysm occlusion without retreatment, recurrent 
subarachnoid hemorrhage, without significant parent artery stenosis (>50% 
stenosis) at one year after treatment.  A subject will be considered an 
effectiveness success upon meeting all of the above criteria. 
 
The study’s primary safety endpoint is the proportion of subjects with death 
of any nonaccidental cause or any major stroke (defined as an ischemic or 
hemorrhagic stroke resulting in an increase of 4 points or more on the 
National Institutes of Health Stroke Scale) within the first 30 days after 
treatment or major ipsilateral stroke or death due to neurologic cause from day 
31 to the 1 year after treatment.  A subject will be considered a safety failure 
upon meeting any of the above criteria. All safety events will be adjudicated 
by an independent clinical events adjudicator. 
   
The study will be interpreted as a success if both of the primary effectiveness 
and primary safety endpoints are met.   
 

CLINICAL PROTOCOL SYNOPSIS 
 
CP13-001  
12 August 2015                                                                                                      Page 3 of 6                                                        C O N F I D E N T I A L  
The information contained in this document is proprietary to Sequent Medical, Inc. and may not be used, disclosed, or copied without written permission of Sequent Medical, Inc.    
 
 
 
 
Secondary 
Endpoint: 
The study’s secondary endpoint is the proportion of subjects with 
angiographic aneurysmal recurrence defined as aneurysm growth or 
recanalization at one year after treatment.   
Other 
Endpoints: 
Secondary analyses include: 
• 
Technical success 
• 
 IA occlusion status at other time points (6 mo, 2, 5 yrs) 
• 
Change in mRS (for unruptured subjects only) 
• 
% Aneurysm occlusion 
• 
Proportion of IAs with each occlusion category at all angiographic 
follow-up time points. 
• 
Durability of occlusion – defined as “Same”, “Better”, “Worse” when 
comparing the 1 year angiographic result with the 6 month 
angiographic result 
Inclusion 
Criteria 
1. Patient must be 18-75 years of age at the time of screening. 
2. Patient must have a single ruptured or unruptured IA requiring 
treatment.  If the subject has an additional IA requiring treatment, the 
additional IA must not require treatment within 60 days of the index 
procedure. 
 
Definition: For the purposes of this study a ruptured IA patient is defined as 
a patient with computed tomography (CT), magnetic resonance imaging 
(MRI), or lumbar puncture (LP) evidence of subarachnoid hemorrhage 
attributed to the index aneurysm within the last 60 days. 
3. The index IA to be treated must have the following characteristics: 
a. Saccular in shape 
b. Located in basilar apex (BA), middle cerebral artery (MCA) 
bifurcation, internal carotid artery terminus (ICAt), anterior 
communicating artery complex (ACom) 
c. Dome-to-Neck (DN) ratio ≥1   
d. Diameter of the IA is appropriate for treatment with the WEB 
Aneurysm Embolization System per device Instructions for Use 
e. Wide-neck IA with neck size ≥ 4mm or Dome-to-Neck (DN)  < 2; 
 
4. Patient has an IA that is appropriate for treatment with WEB without 
the use of additional implanted devices; 
5. If the IA previously ruptured, patient must be neurologically stable 
with Hunt & Hess Score of I or II. 
6. Patient must be able to comply with all aspects of the screening, 
evaluation, treatment, and the postprocedure follow-up schedule. 
Patient must sign and date an IRB/EC-approved written informed 
consent prior to initiation of any study procedures.  
7. Patient must sign and date an IRB/EC-approved written informed 
consent prior to initiation of any study procedures. 

CLINICAL PROTOCOL SYNOPSIS 
 
CP13-001  
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The information contained in this document is proprietary to Sequent Medical, Inc. and may not be used, disclosed, or copied without written permission of Sequent Medical, Inc.    
 
 
 
 
Exclusion 
Criteria 
1. Patient has an IA with characteristics unsuitable for endovascular 
treatment; 
2. Microcatheter could not reach patient’s index aneurysm to allow 
necessary access to treat with study device. 
3. Patient has vessel characteristics, tortuosity or morphology which 
could preclude safe access and support during treatment with 
study device; 
4. Patient has vascular disease or other vascular anomaly so as to 
preclude the necessary access to the aneurysm for use of the study 
device. 
5. Patient has clinical, angiographic or CT evidence of vasospasm, 
vasculitis, or intracranial tumor (except small meningioma) or any 
other intracranial vascular malformations on presentation; 
6. Patient has conditions placing them at high risk for ischemic stroke  or 
has exhibited ischemic symptoms such as transient ischemic attacks, 
minor strokes, or stroke-in-evolution within the prior 60 days; 
7. Patient has any circulatory, neurovascular, cardiovascular, or 
neurologic conditions that have resulted in unstable neurological 
symptoms  
8. Patient has mRS ≥ 2 prior to presentation or rupture (as applicable); 
9. Patient has had an SAH from a nonindex IA or any other intracranial 
hemorrhage within 90 days; 
10. Patient has physical, neurologic or psychiatric conditions which 
preclude his/her ability to comply with all aspects of the screening, 
evaluation, treatment, and the postprocedure follow-up schedule; 
11. Patient’s index IA was previously treated; 
12. Patient is taking anticoagulants or has a known blood dyscrasia, 
coagulopathy, or hemoglobinopathy; 
13. Patient is pregnant; 
14. Patient has known hypersensitivity, which cannot be medically 
treated, to any component of the study device, procedural materials, or 
medications commonly used during the procedure; 
15. Patient is concurrently involved in another investigational study or a 
postmarket study that could affect the safety and effectiveness of IA 
treatment with the study device or with the study’s follow-up 
schedule; 
16. Patient has an acute life-threatening illness other than the neurological 
disease to be treated in this trial; 
17. Patient has a life expectancy of less than 5 years due to other illness or 
condition (in addition to an intracranial aneurysm). 
 
Study 
Procedures: 
Subjects will be screened for study eligibility after giving informed 
consent.  The WEB embolization procedure will be performed in the digital 
angiographic suite using standard angiographic techniques. 
Schedule of 
Examinations: 
Screening (Day -30 to Day 0) 
Procedure 

CLINICAL PROTOCOL SYNOPSIS 
 
CP13-001  
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Discharge 
30-day follow-up (mRS per office or telephone update) 
Six month follow-up (office visit and angiographic follow-up) 
One year follow-up (office visit and angiographic follow-up) 
Two year and four year follow-up (office visit per standard of care or 
telephone update) 
Three year and five year follow-up (office visit and imaging follow-up per 
standard of care) 
Figure 1. Diagram of Study Flow. 
 
 
 
 

CLINICAL PROTOCOL SYNOPSIS 
 
CP13-001  
12 August 2015                                                                                                      Page 6 of 6                                                        C O N F I D E N T I A L  
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Table 1. Schedule of Assessments. 
Parameter 
Screening 
Procedure 
Discharge 
30-Day Follow-Up  
6-Month Follow-Up 
1-Year Follow-Up 
2- and 4-Year Follow-
Up 
3- and 5-year Follow-
Up 
Health history 
X 
 
 
 
 
 
 
 
Physical examination 
X 
X 
X 
 
X 
X 
 
X 
Neurological examination  
X 
 
 
 
X 
X 
 
X 
Site and subject information 
X 
 
 
 
 
 
 
 
Aneurysm information (size, location, etc.) 
X 
X 
 
 
 
 
 
 
Rupture status  
X 
 
 
 
 
 
 
 
Hunt and Hess Grade (ruptured aneurysms only) 
X 
 
 
 
 
 
 
 
Microcatheter(s) used 
 
X 
 
 
 
 
 
 
Ancillary devices used (eg, stent, balloon used) 
 
X 
 
 
 
 
 
 
Medications used 
X 
X 
X 
 
X 
X 
 
X 
Size and lot number of WEB device(s) used 
 
X 
 
 
 
 
 
 
WEB procedure fluoroscopy time 
 
X 
 
 
 
 
 
 
Total procedure fluoroscopy time 
 
X 
 
 
 
 
 
 
3D angiographic imaging 
X 
X 
 
 
X 
X 
Optional 
X* 
Additional imaging per standard of care 
 
 
 
 
 
 
X 
X 
Occlusion assessments (Core Lab) 
 
 
X 
 
X 
X 
Optional 
X* 
Modified Rankin Scale score 
X 
 
X 
X 
X 
X 
 
 
NIHSS score  
X 
As required 
QOL Assessment (EQ-5D) 
 
 
 
 
X 
 
 
 
Additional scales as appropriate 
 
X 
 
 
X 
X 
Optional 
Optional 
Technical events 
 
X 
 
 
 
 
 
 
Adverse events 
 
X 
X 
X 
X 
X 
X 
X 
Retreatments /Additional Procedures 
 
 
 
X 
X 
X 
X 
X 
Rebleed (if ruptured)/New bleed 
 
 
X 
X 
X 
X 
X 
X 
Comments 
X 
X 
X 
X 
X 
X 
X 
X 
*  Per local Standard of Care