Stryker Neurovascular Trevo® Retriever Registry
Conditions: Ischemic Stroke
Sponsor: Stryker Neurovascular

Trevo® Retriever Registry  
Investigator’s Signature Page 
 
STUDY TITLE: 
Trevo® Retriever Registry 
STUDY CENTER: 
 
 
(Print name of study center) 
 
We, the undersigned, have read and understand the protocol specified above and agree on its content. We 
agree to perform and conduct the study as described in the protocol. In addition, when applicable, we 
agree to enlist sub-investigators who also agree to perform and conduct the study as described in the 
protocol. 
 
Principal Investigator 
Print name:__________________________________________ 
 
Date 
DD/MMM/YYYY 
 
Co- Principal Investigator (if applicable) 
Print name: _________________________________________ 
 
 
Date 
DD/MMM/YYYY 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Trevo® Retriever Registry  
 
 
Trevo Retriever Registry Trial Investigator Agreement 
 
I have read this Investigational Plan and agree to adhere to the requirements of this current version of the 
protocol. 
 
I agree to personally conduct or supervise the research, and ensure all participating investigators and 
research staff are appropriately informed and trained prior to participating in any study related activities. 
 
I will ensure that the requirements relating to obtaining informed consent in 21 CFR Part 50, ICH E6 and 
institutional review board/Ethics Committee (IRB/EC) review and approval in 21 CFR Part 56  are met. I 
will ensure that the IRB/EC complies with the requirements of ICH E6 and 21 CFR Part 56 and will be 
responsible for the initial and continuing review and approval of the investigation.  I agree to promptly 
report to the IRB/EC and to the Sponsor all changes in the research activity and all unanticipated problems 
involving risks to human subjects or others.  I will not make any changes in research without IRB/EC 
approval, except where necessary to eliminate apparent immediate hazards to human subjects. 
 
I agree to comply with all other requirements regarding the obligations of clinical investigators and all other 
pertinent requirements in ICH E6, and/or the laws and regulatory requirements of the country in which the 
site is located. 
 
I agree to maintain adequate and accurate records and to make those records available for inspection in 
accordance with ICH E6. 
 
I agree to comply with all state and federal laws and regulations governing financial disclosure and to 
supply updated disclosure information, as it becomes known to me, during the course of the Trial and for 
one year following completion of the Trial, unless otherwise required by law or regulation. 
 
I have not been restricted from participating in clinical research, nor is any action pending that could result 
in such restriction.  If this occurs I shall provide immediate notification to the Sponsor.  
 
I have NOT been involved in an investigation or other research that was terminated:   
True□   False□ If False, please provide an explanation (including the circumstances that led to the 
termination): 
 
_____________________________________________________ 
 
_____________________________________________________________________________ 
Investigator Name (print) 
Signature 
DD/MMM/YYYY  
 
_____________________________________________________________________________ 
Co-Investigator Name (print)  N/A 
Signature 
DD/MMM/YYYY 
 
 
 
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Trevo® Retriever Registry 
Sponsor: 
Stryker Neurovascular 
47900 Bayside Parkway 
Fremont, CA 94538 
Study Responsibility: 
 Naina Mehta 
Senior CRA 
Stryker Neurovascular  
47900 Bayside Parkway 
Fremont, CA 94538 
Study PIs: 
Erol Veznedaroglu, MD, FAANS, FACS, FAHA 
Chairman, Department of Neurosurgery 
Director, Capital Institute for Neurosciences 
Capital Institute for Neurosciences 
750 Brunswick Avenue 
Trenton, New Jersey  08638 
Phone: 609-537-7137 
Fax:  609-815-7707 
eveznedaroglu@capitalhealth.org 
Ronald F. Budzik, Jr., MD 
Riverside Radiology and Interventional Associates 
Interventional Neuroradiology/Neurointerventional Surgery 
Chair, Neuroscience Clinical Operations Council 
Co-Director, Riverside Comprehensive Stroke Center 
Riverside Methodist Hospital 
3525 Olentangy River Road, Suite 5362 
Columbus, Ohio 43214 
Phone: 614-340-7741 
Fax: 614-341-7742 
rbudzik@riversiderad.com 
Study Centers: 
Up to 100 sites worldwide 
Date of Issue: 
16 JUL 2013 Protocol Number CDM10000023 Rev AA 
Date(s) of Amendment(s): 26 MAR 2015 Protocol Number CDM10000023 Rev AB 
24 MAR 2016 Protocol Number CDM10000023 Rev AC 
This protocol contains confidential information for use by the Investigators and their designated 
representatives participating in this clinical investigation. It should be held confidential and maintained in 
a secure location. 
Do not copy or distribute without written permission. 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE 
REPRODUCED, USED, OR DISCLOSED TO ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF STRYKER 
CORPORATION.                                                                                                                                                                   CDM 10000023 Rev. AC 
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Trevo® Retriever Registry  
Protocol Synopsis 
Study Objective 
Primary Objective 
To assess real world performance of the Trevo® Retriever which is intended to restore 
blood flow in the neurovasculature by removing thrombus in subjects experiencing 
ischemic stroke 
Primary Endpoint Revascularization status assessment at the end of the procedure using the modified 
TICI score 
Secondary 
Endpoints 
1. Day 90 mRS assessment 
2. Day 90 all cause mortality 
3. Neurological deterioration at 24 hours post procedure, defined as a four or more 
point increase in the NIHSS score from the baseline score 
4. Rates of device and procedure related serious adverse events (AEs) 
Other Key 
Assessments (Data 
points) 
1. Time points will be collected on the following: stroke symptom onset, admission 
to initial hospital/emergency department, if transferred, time of arrival to second 
hospital, diagnostic imaging, start of Intravenous tissue Plasminogen Activator 
(IV tPA), angio suite arrival, arterial puncture, time of each Trevo pass, clot 
integration, Trevo removal and end of procedure (defined as the time of the final 
cerebral angiogram) 
2. Data on the use of accessory products in conjunction with Trevo 
3. Health economics, costs of hospitalization, length of stay, discharge disposition 
4. Sub-study analysis of imaging (pre, angio, post) with an independent core lab 
measurement of ASPECTS, collaterals, modified TICI scores and core infarct volume. 
5. Compare Day 90 outcome with pre-stroke mRS, baseline imaging and symptom onset to 
time of treatment. 
Registry  Device 
Any approved Trevo Retriever approved for use by the local regulatory agency  
Control  
N/A 
Device Sizes 
All Trevo product sizes approved for use by the local regulatory agency 
Study Design  
Study Design 
Prospective, open-label, consecutive enrollment, multi-center, international registry 
Planned Number 
of Subjects 
Up to a maximum of 2000 subjects  
Planned Number 
of Sites / Countries 
Up to 100 sites worldwide 
 
Efficacy 
Parameters 
Post-procedural Modified TICI score  
Follow-Up 
Schedule 
a. Day 30 telephone contact 
b. Day 90 clinic visit 
Key Inclusion 
Criteria 
1. Subjects experiencing acute ischemic stroke who are eligible for restoration of 
blood flow using any approved Trevo Retriever in the neurovasculature to 
remove thrombus   
2. Trevo Retriever is the initial mechanical neuro-thrombectomy device used to 
remove the thrombus 
 
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Trevo® Retriever Registry  
3. Signed Informed Consent obtained 
4. Subject willing to comply with the protocol follow-up requirements  
5. Anticipated life expectancy of at least 3 months 
Key Exclusion 
Criteria 
The subject is participating in another mechanical neuro-thrombectomy device trial 
or any other clinical trial where the study procedure or treatment might confound 
the study end point. 
Statistical Methods 
Statistical Test 
Method 
There will be no sample size/or power estimation for this single-arm registry.  
 
Data analysis will be performed under guidance from the Study PIs, Steering 
Committee, and Sponsor. 
 
 
 
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PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE 
REPRODUCED, USED, OR DISCLOSED TO ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF STRYKER 
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Trevo® Retriever Registry  
TABLE OF CONTENTS 
 
1 
Introduction and Rationale ........................................................................................................... 9 
2 
Clinical Development Program for Trevo Retriever .................................................................. 9 
2.1 
TREVO Study ..................................................................................................................... 9 
Table 1. TREVO Study Primary and Secondary Endpoints [10] ..................................... 10 
Table 2. TREVO Adjudicated Safety Events [10] ............................................................. 10 
2.2 
TREVO 2 Study ................................................................................................................ 10 
Table 3. Primary Endpoint Results per the TREVO 2 (ITT population) [11] .................. 11 
Table 4. Secondary Endpoints in TREVO 2 (ITT population) [11] .................................. 12 
3 
Study Device Description ............................................................................................................ 12 
Figure 1a: Trevo Retrievers.............................................................................................. 13 
Figure 1b: Trevo Retrievers under fluoroscopy visualization .......................................... 14 
3.1 
Device Labeling ................................................................................................................ 15 
4 
Registry Objective ........................................................................................................................ 15 
4.1 
Primary Objective ............................................................................................................. 15 
5 
Registry Endpoints....................................................................................................................... 15 
5.1 
Primary Data point ............................................................................................................ 15 
5.2 
Secondary Data points ...................................................................................................... 15 
5.3 
Other Key Assessments (Data points) .............................................................................. 15 
6 
Justification for the Registry Design .......................................................................................... 16 
6.1 
Method of Enrollment ....................................................................................................... 16 
7 
Study Population .......................................................................................................................... 16 
7.1 
Selection Criteria .............................................................................................................. 16 
7.1.1 .... Inclusion Criteria: ............................................................................................... 16 
7.1.2 .... Exclusion Criteria: .............................................................................................. 17 
7.2 
Withdrawal and Replacement of Subjects ........................................................................ 17 
7.3 
Enrollment Controls .......................................................................................................... 17 
8 
Study Procedures ......................................................................................................................... 17 
8.1 
Written Informed Consent ................................................................................................ 17 
8.2 
Pre-procedure Assessment ................................................................................................ 17 
8.3 
Trevo Thrombectomy Procedure ...................................................................................... 18 
8.4 
24 hours (-6/+24) post procedure ...................................................................................... 19 
 
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Trevo® Retriever Registry  
8.5 
Discharge/Day 5-7 (whichever comes first) ..................................................................... 19 
8.6 
Post Discharge Follow-up ................................................................................................. 20 
8.6.1 .... Day 30 (+ 14) ...................................................................................................... 20 
8.6.2 .... Day 90 (± 14) ....................................................................................................... 20 
9 
Statistical Methods ....................................................................................................................... 21 
9.1 
Sample Size Estimate and Justification ............................................................................ 21 
9.2 
Analysis Populations ......................................................................................................... 21 
9.3 
Statistical Analysis ............................................................................................................ 21 
10 
Data Management ........................................................................................................................ 21 
10.1 
Data Collection and Processing ........................................................................................ 21 
11 
Monitoring .................................................................................................................................... 22 
12 
Auditing ........................................................................................................................................ 22 
13 
Device Accountability .................................................................................................................. 23 
14 
Adverse Events ............................................................................................................................. 23 
14.1 
Adverse Event Definitions and Classification .................................................................. 23 
14.2 
Relationship ...................................................................................................................... 24 
14.3 
Reporting Requirements ................................................................................................... 24 
14.4 
Device Failures, Malfunctions, and Product Nonconformities ......................................... 25 
14.5 
Reporting to Regulatory Authorities / IRBs / IECs / Investigators ................................... 25 
15 
Risk Benefit Analysis ................................................................................................................... 25 
15.1 
Risk Minimization ............................................................................................................ 25 
16 
Steering Committee ..................................................................................................................... 26 
17 
Ethical Considerations................................................................................................................. 26 
17.1 
Compliance with Good Clinical Practices (GCP) ............................................................. 26 
17.2 
Institutional Review Board/Independent Ethics Committee ............................................. 26 
17.3 
Protocol Adherence ........................................................................................................... 26 
18 
Study Administration .................................................................................................................. 27 
18.1 
Pre-Study Documentation Requirements .......................................................................... 27 
18.2 
Record Retention .............................................................................................................. 27 
18.3 
Criteria for Terminating Study.......................................................................................... 27 
18.4 
Criteria for Suspending/Terminating a Study Center ....................................................... 27 
19 
References ..................................................................................................................................... 28 
20 
Appendices .................................................................................................................................... 29 
 
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Trevo® Retriever Registry  
Appendix A. 
Abbreviations ....................................................................................................... 29 
Appendix B. 
Definitions ........................................................................................................... 31 
Appendix C. 
Study Informed Consent Form Template ............................................................ 33 
Appendix D. 
Time and  Events Schedule .................................................................................. 44 
Appendix E. 
Modified TICI Perfusion Categories ................................................................... 45 
Appendix F. 
Modified Rankin Scale (mRS) ............................................................................. 46 
Appendix G. 
National Institute of Health Stroke Scale (NIHSS) ............................................. 47 
 
 
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Trevo® Retriever Registry  
1 Introduction and Rationale 
Stroke is the fifth most common cause of death and the leading cause of adult disability in the United States. 
Each year stroke afflicts approximately 795,000 Americans causing over 130,000 deaths.  Stroke costs the 
nation $34 billion annually which includes the cost of medical care, medications and loss of productivity.[1]  
Around the world approximately 15 million people each year will endure a stroke resulting in an estimated 
5.5 million deaths. Of those patients who are alive at 90 days after their stroke, 50% have some type of 
disability with 26% dependent on others for daily living and 20% require institutional care. One in six 
people worldwide will experience a stroke in their lifetime.[2-4] Good clinical outcomes in ischemic stroke 
have been shown to be strongly linked to revascularization.[5] 
Intravenous tissue plasminogen activator (IV tPA) is the only FDA approved therapy for acute ischemic 
stroke and must be given within three (3) hours of ischemic stroke symptom onset. Unfortunately, only a 
small percentage of stroke patients receive IV tPA therapy, with estimates ranging from 2.4% to 9%. [6] 
Even so, the effect of IV tPA in patients in acute ischemic stroke has a short therapeutic time window [7-8] 
and is limited by the large thrombus burden that occurs in the setting of proximal arterial occlusion. One 
study reported that IV tPA has nearly no potential to recanalize occluded vessels with a thrombus length 
exceeding 8 mm. [9] When administered, IV tPA achieves early recanalization in only 30%–50% of subjects, 
with even lower recanalization rates in proximal large vessel occlusions (middle cerebral, basilar artery, 
and carotid terminus). Subjects who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates 
for treatment with the Trevo Retriever. The Trevo Retriever received CE mark on December 18, 2009 and 
was cleared by the FDA on August 13, 2012 to restore blood flow in the neurovasculature by removing 
thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset.  
2 Clinical Development Program for Trevo Retriever 
The principal goal in treating acute ischemic stroke is to restore cerebral blood flow as rapidly and safely 
as possible. Two clinical trials, the Thrombectomy REvascularization of large Vessel Occlusions (TREVO) 
in acute ischemic stroke and the TREVO 2 study, were conducted using the Trevo Retriever. Both clinical 
studies demonstrated that mechanical neurovascular thrombectomy can safely and effectively be performed 
up to eight (8) hours after onset of acute ischemic stroke symptoms. [10-11] 
2.1 TREVO Study  
The TREVO study was a post marketing prospective, multi-center, single arm study performed at seven 
sites in Europe designed to quantify the performance of the Trevo Retriever in providing 
revascularization and clinical benefit to subjects experiencing a large vessel occlusion within 8 hours of 
symptom onset. The devices used in the study were the Trevo 4 x 20 mm, Trevo Pro 4, and Trevo 3 x 
10 mm. 
Sixty (60) subjects were enrolled between February 2010 and August 2011. Revascularization and 
intracranial hemorrhage at 24 hours were independently assessed by a central core lab. A Clinical Events 
Committee (CEC) independently reviewed all protocol-defined safety endpoints to determine 
relationship to the device and the procedure, and the causes of all deaths.  
The primary endpoint in TREVO was defined as angiographic revascularization as measured by the 
independent core lab using the TICI scale. Success was defined as a final TICI score of 2a or better.  
Post procedure, successful revascularization was achieved in 91.7% of subjects. In the TREVO study, 
operators were not restricted from using intra-arterial (IA) lytic, but it was only used in 10% of cases.   
 
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Trevo® Retriever Registry  
The secondary endpoints in TREVO were 90-day good clinical outcomes (defined as mRS of 0-2), 90 
day mortality, device-related serious adverse events (DRSAEs) and symptomatic intracranial 
hemorrhage (SICH) at 24 hours (see Table 1).   
Coincidentally, the rate of DRSAEs and SICH endpoints were both 5% (3/60), however the rates are not 
cumulative. One of the three SICHs was a DRSAE, while the other two were procedure-related. As 
mentioned above, one of the DRSAEs resulted in SICH while the other two DRSAEs were associated 
with subarachnoid hemorrhage (SAH).  
Table 1. TREVO Study Primary and Secondary Endpoints [10] 
Primary Effectiveness Endpoint 
TREVO (N=60 subjects) 
Revascularization 
91.7% (55/60) 
Secondary Endpoints 
 
90-Day Good Outcome (mRS = 0-2) 
55.0% (33/60) 
90-Day Mortality 
20.0% (12/60) 
Device-Related SAEs (DRSAEs) 
5.0% (3/60) 
SICH at 24 Hours (SITS-MOST) 
5.0% (3/60) 
SICH (ECASS III definition) 
8.3% (5/60) 
 
The TREVO protocol pre-defined specific events that were captured to assess safety which included 
vessel dissection, vessel perforations, ICH (as identified by core lab) and all deaths.  Information for 
each of these events was collected and then independently adjudicated by the CEC.  The results of this 
review are presented in Table 2. Most of the SAEs were attributed to the 12 deaths that occurred in the 
study, but a minority of the SAEs were related to the procedure (8.3%, 5 cases) or Trevo Retriever (5%, 
3 cases).   
Table 2. TREVO Adjudicated Safety Events [10] 
Event 
TREVO (N=60 subjects) 
Serious Adverse Events (SAEs) 
21.7% (13/60) 
Procedure-Related SAEs 
8.3% (5/60) 
Device-Related SAEs 
5.0% (3/60) 
2.2 TREVO 2 Study  
The TREVO 2 study was an IDE trial designed to support a 510k application for FDA clearance in the 
U.S. The trial [8] enrolled 178 subjects between February 3, 2011 and December 1, 2011 at 26 sites in 
the United States and one site in Spain.  The subjects were randomized 1:1 to Trevo (N=88) or Merci 
(N=90) and were stratified by age and baseline NIHSS to ensure balance in the two arms.  The devices 
used in the study were the Trevo 4 x 20 mm in 10 subjects, and the Trevo Pro 4 in 78 subjects. The 
subjects treated with Merci® Retrievers were treated with commercially available product, at the 
discretion of the treating physician. 
 
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Trevo® Retriever Registry  
The results for the primary effectiveness and safety endpoints are shown in the Table 3, and the results 
of the secondary endpoints are shown in Table 4. 
Table 3. Primary Endpoint Results per the TREVO 2 (ITT population) [11] 
Endpoint 
Trevo 
(N=88) 
Merci 
(N=90) 
Difference  
[95% CI]a 
p-value 
Primary Effectiveness Endpoint: 
Post-Device Revascularization Success   
(TICI 2a+)* 
86.4% (76/88) 60.0% (54/90) 
26.4% 
[13.2%, 39.0%] 
< 0.0001b  
< 0.0001c 
Primary Safety Endpoint: 
Composite Events *** 
14.8% (13/88) 23.3% (21/90) 
-8.6% 
[-20.7%, 3.2%] 
0.1826d 
Vessel Perforation 
1.1% (1/88) 
10.0% (9/90) 
-8.9% 
[-17.0%, -2.2%] 
 
 
Intramural Arterial Dissection 
0.0% (0/88) 
1.1% (1/90) 
-1.1% 
[ -6.1%, 3.1%] 
 
Symptomatic ICH 
6.8% (6/88) 
8.9% (8/90) 
-2.1% 
[-10.7%, 6.4%] 
 
Embolization to Previously 
Uninvolved Territory 
6.8% (6/88) 
4.4% (4/90) 
2.4% 
[ -5.0%, 10.3%] 
 
Access Site Complication Requiring 
Surgical Repair or Blood Transfusion 
2.3% (2/88) 
1.1% (1/90) 
1.2% 
[ -4.0%, 6.9%] 
 
Mortality within 24 hours 
2.3% (2/88)** 
0.0% (0/90) 
2.3% 
[ -1.9%, 7.9%] 
 
In vivo Device Failure 
0.0% (0/88) 
0.0% (0/90) 
0.0% 
[ -4.1%, 4.2%] 
 
Other PR-SAE 
0.0% (0/88) 
0.0% (0/90) 
0.0% 
[ -4.1%, 4.2%] 
 
* Administration of IA t-PA was counted as a failure for post-device revascularization.   
** One death that occurred within 24 hours was related to the device, the other was attributed to the index stroke.   
***Patients who experienced more than one safety event are counted only once in the composite safety endpoint. 
 a: By normal approximation;  b: non-inferiority hypothesis using Blackwelder's method with non-inferiority margin of 10%; c: One-
sided Wald test of superiority; d: Fisher's exact test. 
 
 
 
 
 
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Trevo® Retriever Registry  
 
 
 
 
Table 4. Secondary Endpoints in TREVO 2 (ITT population) [11] 
Endpoint 
Trevo (N=88) 
Merci (N=90) 
Difference  
[95% CI]a 
p-value 
  Time to Revascularization (mins)b 
   Mean ± SD (N)  
   Median (min, max) 
47.8±44.2 (79) 
34.0 (6.0, 209.0) 
47.3±38.8 
(81)40.0 (4.0, 
207.0) 
0.5 
[11.4%]c 
< 0.0001d  
0.5326e 
 90-Day Good Outcome (Modified  
Rankin Score 0-2)  
40.0% (34/85) 
21.8% (19/87) 
18.2% 
[ 4.2%, 31.7%] 
0.0130f 
  90-Day Mortality  
33.0% (29/88) 
23.6% (21/89) 
9.4% 
[ -4.2%, 22.7%] 
0.1845f 
  Asymptomatic ICH at 24 hours  
40.9% (36/88) 
53.3% (48/90) 
-12.4% 
[-27.1%, 2.5%] 
0.1017f 
  Neurological Deterioration at 24 
hoursg 
15.9% (14/88) 
22.2% (20/90) 
-6.3% 
[-18.4%, 5.5%] 
0.3418f 
a: By normal approximation; b: Time to Revascularization was defined as the time from the start of the embolectomy procedure to 
achieving durable TICI 2a or better or to the end of the procedure if TICI 2a was not achieved.  Subjects who had a baseline TICI score of 
2a or did not have a study device used are excluded from this analysis (7 cases in Trevo arm, 8 cases in Merci arm);  c: Per hypothesis 
testing setup, one-sided 95% upper confidence interval is used;  d: One-sided Student's t-test of non-inferiority test with non-inferiority 
margin of 0.5 hours;  e: One-sided Student's t-test of superiority test;  f: Fisher's exact test;  g: Defined as a four or more point increase in 
the NIHSS at 24 hours as compared to the baseline.  
 
Overall the results of the TREVO and TREVO 2 trials demonstrate revascularization efficacy and safety 
of the Trevo Retriever. 
3 Study Device Description 
The Trevo Retriever is manufactured by Concentric Medical, a division of Stryker Neurovascular.  The 
Trevo Retrievers consist of a self-expanding, laser cut, nitinol stent-like device permanently attached to a flexible, 
pusher wire. The retrievers have platinum markers at the distal end and platinum wires incorporated in the stent-like 
section to allow fluoroscopic visualization.  (Figure 1a and 1b). The packaged Retriever is pre-loaded into the 
Insertion Tool. The device has a hydrophilic coating to reduce friction during use and a shaft marker to 
indicate proximity of the Trevo tip relative to Microcatheter tip.  
 
 
 
 
 
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Trevo® Retriever Registry  
 
Figure 1a: Trevo Retrievers 
 
 
 
 
 
 
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Trevo® Retriever Registry  
Figure 1b: Trevo Retrievers under fluoroscopy visualization 
 
 
 
During the procedure, the Trevo ProVue Retriever is delivered to the thrombus using a microcatheter. The 
microcatheter is then retracted to deploy the shaped section of the Retriever. The shaped section engages 
and traps the clot. The Retriever and microcatheter are pulled back to dislodge the thrombus. The Retriever, 
the thrombus, and the microcatheter are then removed from the body.   
 
The Trevo Retriever has been designed and tested to perform multiple retrieval attempts in a single subject. 
Per the Instructions for Use (IFU), each Trevo Retriever may be used for up to three (3) retrieval attempts. 
After each deployment of the device it should be thoroughly cleaned and inspected before reloading. No 
more than six (6) retrieval attempts should be performed in the same vessel using any combination of 
retrieval devices. Refer to the IFU for detailed instructions on how to use the device.  The Trevo Retriever 
should not be re-sterilized and reused.  
There are no specific contraindications for the use of the Trevo Retriever apart from the inclusion and 
exclusion criteria of this Investigational Plan.  Refer to the IFU for a listing of warnings and precautions. 
All Trevo Retriever models (e.g. Trevo® ProVue™, Trevo® XP ProVue™) and device sizes will be allowed 
in the Trevo Registry upon receipt of local regulatory agency approval. 
 
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Trevo® Retriever Registry  
 
Refer to the package (IFU) for further details and current information 
3.1 Device Labeling 
A copy of the device Instructions for Use (IFU) is included in each device package. The Trevo labels 
and labeling contain the following information:  
• 
Device Dimensions 
• 
Lot Number 
• 
Expiration (use before) date 
• 
Microcatheter Compatibility 
4 Registry Objective 
4.1 Primary Objective 
To assess real world performance of the FDA cleared/CE marked Trevo Retriever intended to restore 
blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. 
5 Registry Endpoints 
Clinical data will be evaluated in all subjects where the Trevo Retriever is used as the initial thrombectomy 
device to remove thrombus from the neurovasculature in the setting of acute ischemic stroke.  
5.1 Primary Data point 
Revascularization status at the end of the procedure using the modified TICI score.  
5.2 Secondary Data points 
a. Day 90 mRS (good clinical outcomes defined as mRS of 0-2) 
b. Day 90 mortality 
c. Neurological deterioration at 24 hours, defined as a four or more point increase in the NIHSS 
score from the baseline score 
d. Rates of device and procedure related serious AEs 
5.3 Other Key Assessments (Data points) 
The following time points will be collected on the electronic Case Report Forms (eCRFs): stroke 
symptom onset, admission to initial hospital/emergency department, if transferred, time of arrival to 
second hospital, diagnostic imaging, start of IV tPA, angio suite arrival, arterial puncture, time of each 
Trevo pass, clot integration, Trevo removal and end of procedure (defined as the time of the final cerebral 
angiogram).  
Data on the use of accessory products during Trevo thrombectomy such as the balloon guide catheter 
(BGC) and intermediate catheters such as the distal access catheter (DAC) will be collected. 
 
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Trevo® Retriever Registry  
De-identified images may be sent to a core lab for adjudication (e.g. CT/MRI scans and angiographies). 
Information will be collected on factors influencing health economics in the treatment of stroke such as 
costs of hospitalization, length of hospital stay and discharge disposition. The data collected will consist 
of hospital charges for cases involving real world use of the Trevo Retriever. . The UB-04 form will be 
collected within the United States while in other countries a CRF containing similar information will be 
completed. Collection of health economic information shall be disclosed to the subject in the Informed 
Consent Form (ICF).  
6 Justification for the Registry Design 
The data results from the TREVO and TREVO 2 trials demonstrate revascularization efficacy and safety 
of the Trevo Retriever. The Trevo Retriever Registry is a prospective, open-label, consecutive enrollment, 
multi-center, international trial. The purpose of the Trevo Registry is to assess the performance of the Trevo 
retriever in real world practice to increase knowledge on the performance of the device, monitor safety 
outcomes, detect rare complications, and to obtain information for potential improvements for next 
generation devices. 
6.1 Method of Enrollment 
Clinical data points will be evaluated in all subjects who meet the inclusion/exclusion criteria and where 
Trevo Retriever is used as the initial mechanical thrombectomy device to remove thrombus from the 
neurovasculature in the setting of acute ischemic stroke.  For purposes of this registry, enrollment occurs 
when the Trevo Retriever is deployed through the compatible Microcatheter into the neurovasculature 
as the first mechanical neuro-thrombectomy device used to remove the thrombus.  
A Screening and Enrollment Log will be maintained by each site to document basic information such as 
date screened and reason for screen failures for subjects who fail to meet the study eligibility criteria.  In 
order to avoid bias, if a center chooses to participate in the Trevo Registry, every effort should be made 
to include all Trevo cases performed over a given duration of time in the registry. No site will be allowed 
to enroll more than 15% (300 subjects) of the entire maximum study population unless first approved 
by Stryker.  
  
7 Study Population 
7.1 Selection Criteria 
7.1.1 Inclusion Criteria: 
1. Subjects experiencing acute ischemic stroke who are eligible for restoration of blood flow using a 
Trevo Retriever in the neurovasculature to remove thrombus   
2. Trevo Retriever is the initial mechanical neuro-thrombectomy device used to remove the thrombus 
3. Signed Informed Consent obtained 
4. Subject willing to comply with the protocol follow-up requirements 
5. Anticipated life expectancy of at least 3 months 
 
 
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Trevo® Retriever Registry  
7.1.2 Exclusion Criteria: 
The subject is participating in another mechanical neuro-thrombectomy device trial or any other clinical 
trial where the study procedure or treatment might confound the study end point. 
7.2 Withdrawal and Replacement of Subjects 
While study withdrawal is discouraged, subjects may withdraw from the study at any time, with or 
without reason and without prejudice to further treatment. Withdrawn subjects will not undergo any 
additional follow-up, nor will they be replaced. If a subject chooses to withdraw from the registry, the 
reason(s) for withdrawal will be recorded on the appropriate eCRF and in the medical record.   
7.3 Enrollment Controls 
Enrollment will be monitored to ensure that no more than the specified number of subjects is enrolled. 
An electronic data capture (EDC) system will be used and the system will be monitored to ensure 
maximum enrollment is contained. All sites will be notified when enrollment is near the target (within 
15 subjects to maximum enrollment). The electronic database will display a message announcing that 
target enrollment is reached. 
8 Study Procedures 
 
8.1 Written Informed Consent  
A sample ICF is provided in Appendix C for the Investigator to prepare for use at the site. The written 
Informed Consent documents must be prepared in the language(s) of the potential subject population.  
The ICF must be approved by the study Institutional Review Board (IRB)/Ethics Committee (EC) and 
a copy provided to Stryker Neurovascular. Modifications to the form must be approved by Stryker 
Neurovascular prior to implementation. The document version must be identified on the ICF to maintain 
version control. 
Written Informed Consent must be obtained for all subjects prior to data entry into the Trevo Retriever 
Registry electronic database. The subject or the subject’s legally authorized representative (LAR) will 
be asked to sign the ICF. Consent should be obtained pre-procedure but depending on subject’s acuity 
the consent may be obtained up to seven days post-procedure. No data may be entered into the database 
until written consent has been obtained.  In the absence of informed consent, an IRB/EC approved waiver 
of consent and executed data use agreement must be in place.   
Study personnel should document the consent process in the subject’s medical record per Good Clinical 
Practice (GCP). The subject or LAR is to be provided a copy of the signed ICF. 
 
8.2 Pre-procedure Assessment 
The following pre-procedure data will be collected: 
• 
Confirmation that the subject meets the Inclusion/Exclusion criteria 
 
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Trevo® Retriever Registry  
• 
Demographics and medical history, including blood pressure and pre-stroke mRS  
• 
Baseline Labs (PT, PTT, platelets, INR, glucose, pregnancy test if applicable) 
• 
Baseline Medications 
• 
Neurological examination including mRS and NIHSS assessments    
• 
Determination of intracranial lesion location and if clot location is amenable for treatment utilizing 
the Trevo Retriever 
 
8.3 Trevo Thrombectomy Procedure 
Physicians should follow the most current IFU at all times with regards to the device compatibility, 
preparation and the recommended retrieval procedure. The Trevo thrombectomy procedure should be 
performed per the following general steps: 
• 
Gain arterial access with 6F (or larger) Guide Catheter or BGC 
• 
Place the appropriate Trevo Microcatheter distal to the clot 
• 
Use of intermediate DAC for added support is optional 
• 
Load the Trevo Retriever into the compatible Trevo Microcatheter using the insertion tool and 
advance to site of occlusion 
• 
Pull back on the Trevo Microcatheter to unsheathe the Trevo Retriever within the clot 
• 
After deploying the Retriever within the clot, visualize strut expansion and allow sufficient time 
for clot integration into the Retriever (approximately 5 minutes) 
• 
If using a BGC, inflate the balloon to arrest flow 
• 
Slowly pull the Trevo Retriever and Trevo Microcatheter back as a unit 
• 
As the Trevo Retriever and microcatheter are being removed, begin vigorous aspiration through 
the guide catheter until the Trevo Retriever is removed from the subject 
NOTE: Do not perform more than six (6) retrieval attempts in the same vessel. This total number applies 
for any combination of retrieval devices.  
Immediately after each retrieval attempt with the Trevo Retriever, perform biplane angiography in order 
to assess the vessel patency in the neurovascular tree that is being treated. The same angiogram 
orientation should be used before and after the Trevo Thrombectomy procedure to assess the reperfusion 
status of the vessel(s). 
• 
If reperfusion has been successful with the Trevo Retriever (recommended modified TICI score in 
the territory treated is ≥2b) the Trevo thrombectomy procedure should be stopped and no further 
interventions performed. 
• 
If reperfusion has not been successful (recommended modified TICI score in the territory treated 
is ≥2b) with the Trevo Retriever continue with additional retrieval attempts (up to the maximum 
allowed per the IFU). At any time during the procedure, adjunctive treatment (rescue therapy) may 
be initiated if deemed appropriate by the treating physician. 
 
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Trevo® Retriever Registry  
If adjunctive treatment (rescue therapy) is used AFTER the Trevo Retriever, biplane angiography should 
be performed immediately afterwards in order to reassess vessel patency and determine the effect of the 
adjunctive rescue treatment. The last angiogram prior to the use of rescue therapy will be considered 
when rating post-Trevo Retriever reperfusion.  
NOTE: The Trevo thrombectomy procedure should be terminated if any of the following occur:  
• 
Neurological deterioration or alteration in function is detected leading to the suspicion of an 
intracranial hemorrhage. 
• 
Evidence of intracranial hemorrhage on imaging is noted. 
• 
The occlusion is refractory to six retrieval attempts in a single vessel.  
Neurological deterioration or alteration in function leading to the suspicion of an intracranial hemorrhage 
will necessitate an emergent head CT or MRI scan.  At the discretion of the treating physician, this 
evaluation may also include angiography or other diagnostic tests to determine the etiology of the clinical 
alteration.  Management of an intracranial hemorrhage will be performed according to each institution’s 
usual practice. 
 
8.4 24 hours (-6/+24) post procedure 
The following data will be collected at 24 hours (-6/+24) post procedure: 
• 
NIHSS (see appendix G) 
• 
SAEs related to the device or procedure.   
• 
For all subjects who expire prior to the 24 hours (-6/+24) assessment, available information 
regarding the primary cause of death and date/time of death will be recorded, as well as, whether 
the subject was made “do not resuscitate” (DNR) or “comfort care only” prior to expiration.  
Any death or SAE must be reported to Stryker Neurovascular within 24 hours of becoming aware by 
eCRF completion. 
8.5 Discharge/Day 5-7 (whichever comes first) 
A subject may be discharged from the hospital when clinically stable, at the Investigator’s discretion. 
The following data will be collected at between Day 5-7 (if patient remains in the hospital) or at 
Discharge, whichever occurs first: 
• 
NIHSS (see appendix G)  
• 
mRS (see appendix F) 
• 
SAEs related to the device or procedure  
• 
Subject disposition at time of discharge  
• 
For all subjects who expire prior to the Day 5-7/Discharge assessment, available information 
regarding the primary cause of death and date/time of death will be recorded, as well as, whether 
the subject was made DNR or “comfort care only” prior to expiration.  
 
 
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Trevo® Retriever Registry  
Any death or SAE must be reported to Stryker Neurovascular within 24 hours of becoming aware by 
eCRF completion 
8.6 Post Discharge Follow-up 
The designated staff at the clinical site will review the study requirements with the subject to maximize 
compliance with the follow-up schedule. The staff will instruct subjects to return for follow-up 
assessments according to the study Time and Events Schedule in Appendix D. Study staff should 
establish a date for the follow-up visits with the subject and if possible, schedule the visits at the time of 
hospital discharge. 
The study will be considered complete after all subjects have completed the Day 90 ± 14 follow-up 
assessments. Requirements of each follow-up evaluation are detailed below. 
8.6.1 Day 30 (+ 14)  
At Day 30 (+14 days) the following study assessments should be performed:  
• 
mRS (see Appendix F) - A telephone assessment is conducted 
• 
SAEs related to the device or procedure  
• 
For all subjects who expire prior to the Day 30 assessment, available information 
regarding the primary cause of death and date/time of death will be recorded, as well as 
whether the subject was made DNR or “comfort care only” prior to expiration.  
 
Any deaths or SAE must be reported to Stryker Neurovascular within 24 hours of becoming aware 
by eCRF completion. 
8.6.2 Day 90 (± 14)  
At Day 90 (± 14 days) the following study assessments should be performed:  
• 
mRS score (see Appendix F) - If subject is unable to return to the clinic for the Day 90 
visit, a telephone mRS assessment is preferable to no assessment 
• 
SAEs related to the device or procedure  
• 
De-identify copies of heath economic forms such as completed UB-04 Claims Forms, 
or equivalent claims forms per Country will be provided to Stryker with the registry 
subject number of the forms 
• 
For all subjects who expire prior to the Day 90 assessment, available information 
regarding the primary cause of death and date/time of death will be recorded, as well as 
whether the subject was made DNR or “comfort care only” prior to expiration.  
 
Any death or SAE must be reported to Stryker Neurovascular within 24 hours of becoming aware 
by eCRF completion.  
 
 
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Trevo® Retriever Registry  
9 Statistical Methods 
9.1 Sample Size Estimate and Justification 
There will be no sample size/or power estimation for this single-arm registry.  
In order to conduct sub-group analyses and detect rare complications, of real world data a sample size of 
2000 will provide more data for the further subgroup analysis. With total 2000 subjects, additional analysis 
of comparing TICI scores or 90 days mRS among the different locations could be carried out.  Since recent 
positive data released from MR CLEAN and three other stent retriever randomized trials, there are more 
research questions to be answered such as how the time to treat will affect the patient outcome and how 
image screening may contribute to  patient selection. Data analysis will be performed under guidance from 
the Study PIs, Steering Committee, and Sponsor. 
 
9.2 Analysis Populations 
The Intent-to-treat principle will be followed to define the analysis population. All of the subjects who 
signed the informed consent and in whom Trevo Retriever was deployed through the microcatheter are 
considered enrolled and will be included in the analyses.  
 
Sub-group analyses for the Registry will be performed under guidance from the Study PIs, Steering 
Committee, and Sponsor. 
 
Day 90 outcomes will be compared to pre-stroke mRS status, baseline imaging and time of symptom 
onset to treatment.  The first interim analysis will be performed after 300 subjects are enrolled and the 
results will be reported. Additional interim analyses and data reporting will occur throughout the study 
enrollment period. 
 
9.3 Statistical Analysis 
All statistical analyses will be performed using SAS version 9.2 or above. (Copyright © 2002-2008 by 
SAS Institute Inc., Cary, North Carolina, USA, All rights reserved)  
10 Data Management 
10.1 Data Collection and Processing 
Data will be collected in a secure, password protected electronic data capture (EDC) system, which is 
accessible via the Internet.  All pertinent data will be entered by trained study center personnel into the 
electronic Case Report Forms (eCRFs).  A unique subject ID number will be assigned to each 
subject.  Every reasonable effort should be made to complete data entry within one week of data 
collection. Any data discrepancies may be queried during ongoing review of data by the sponsor or may 
be identified and queried during routine remote monitoring process.  Remote monitoring may be 
performed to verify data accuracy and ensure queries are resolved. The Principal Investigator or Sub-
investigator must ensure the accuracy and completeness of the recorded data and provide his/her 
electronic signature on the appropriate eCRF. 
 
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Trevo® Retriever Registry  
If images are sent to a Core Lab the results may also be entered into the EDC system and may be 
electronically signed by the reviewer responsible for entering this data. Ongoing data review will be 
performed to identify possible data discrepancies. Manual and/or automatic queries will be created in 
the EDC system and will be issued to Core Lab for appropriate resolution.   
11 Monitoring 
Data will be monitored remotely for completeness and logical consistency. De-identified procedure 
summary, anesthesia record, Trevo Registry worksheets and UB-04 forms or equivalent claims forms per 
country must have the Trevo Registry subject identification number recorded on any forms sent to Stryker 
Neurovascular. The de-identified procedure documents may be compared against the eCRFs to ensure 
consistency for each subject enrolled.  
Stryker Neurovascular will conduct an assessment of each participating site to assure that the investigators 
understand the investigational plan, as well as, their obligations to conduct the registry in accordance with 
applicable Regulations, GCP’s and the registry protocol. The monitor will also confirm that the investigator 
has an adequate subject population, facilities, personnel and time to conduct the registry properly.  Periodic 
monitoring visits may be made to confirm that the site remains compliant with the protocol, applicable 
Regulations, GCP and that all agreed-upon activities are carried out by the investigator and other specified 
staff members.   
It is important that the Investigator and relevant study site personnel are available during monitoring visits 
and that sufficient time is devoted to the process. In order to perform her or his role well, the monitor must 
be given access to primary subject medical records which support the registry eCRFs. This access must be 
disclosed to the subject via the informed consent. 
The investigator agrees to complete all registry requirements within three months of written notice of 
enrollment completion.  Continuation of the registry beyond this time must be mutually agreed upon in 
writing by both the investigator and Stryker Neurovascular.    
Stryker Neurovascular will conduct a registry closeout meeting with each Trevo Registry site after the final 
data query is generated and data requests are addressed. The purpose of the closeout meeting is to confirm 
that all registry-related activities are complete and site personnel are aware of the regulatory obligations 
following study closure activities. The closeout meeting may transpire remotely e.g.  teleconference or at 
an on-site monitoring visit. The closeout activities include but are not limited to the following: 
• 
Final regulatory document review and collection of any outstanding documents including a copy 
of the investigator notification letter sent to the IRB/EC regarding completion of the Trevo 
Retriever Registry  
• 
Address and close any open action items 
• 
Discuss record retention requirements 
• 
Review publication guidelines 
12 Auditing  
Sites may be subject to a quality assurance audit by Stryker Neurovascular or its designees, or other 
regulatory authorities. 
 
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Trevo® Retriever Registry  
It is important that the Investigator and relevant study personnel are available during any audits and that 
sufficient time is devoted to the process. 
13 Device Accountability 
There will be no device accountability or tracking as the Trevo Retriever has regulatory authorization to 
market the device. 
14 Adverse Events 
The following adverse events will be reported:  
• 
all adverse events that occur during the procedure  
• 
all SAEs related to the device or the procedure through Day 90  
• 
all adverse events that result in death through Day 90 
14.1 Adverse Event Definitions and Classification 
Term 
Definition 
Reference 
Adverse Event 
(AE) 
Any untoward medical occurrence in a subject. This definition 
does not imply that there is a relationship between the adverse 
event and the device under investigation. 
ISO 14155-1 
Adverse 
Device Effect 
(ADE)  
Any untoward and unintended response to a medical device.  
Note 1: This definition includes any event resulting from 
insufficiencies or inadequacies in the instructions for use or the 
deployment of the device.  
Note 2: This definition includes any event that is a result of a user 
error.  
ISO 14155-1 
Serious adverse 
event (SAE) 
An adverse event that:  
• led to death 
• resulted in a life-threatening illness or injury 
• resulted in a permanent impairment of a body structure or a 
body function 
• required in-subject hospitalization or prolongation of existing 
hospitalization 
• resulted in medical or surgical intervention to prevent 
permanent impairment to body structure or a body function 
• led to fetal distress, fetal death or a congenital abnormality or 
birth defect 
ISO 14155-1 
 
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Trevo® Retriever Registry  
Term 
Definition 
Reference 
Serious 
Adverse 
Device Effect 
(SADE) 
An adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event or that 
might have led to any of these consequences if suitable action had 
not been taken or if circumstances had been less fortunate.  
ISO 14155-1 
Unanticipated 
Adverse 
Device Effect 
(UADE)  
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 
ISO 14155-1 
 
Underlying diseases are not reported as AEs unless there is an increase in severity or frequency during the 
course of the registry. Death should not be recorded as an AE, but should be reflected as an outcome to a 
specific AE.  
14.2 Relationship 
The Investigator must assess the relationship of the AE to the study device using the following criteria 
categories and definitions: 
Unrelated - The AE is due to a concurrent illness or effect of another device/drug and is not related 
to the study device. 
Related - The AE is due to the study device (possible, probable, or highly probable).  
Unknown - The temporal relationship between the AE and study device cannot be clearly 
determined. 
 
The Investigator must assess the relationship of the AE to the index procedure using the following 
categories and definitions: 
Unrelated - The AE is due to a concurrent illness or effect of a drug and is not related to the index 
procedure. 
Related - The AE is due to the index procedure (possible, probable, or highly probable).  
Unknown - The temporal relationship between the AE and index procedure cannot be clearly 
determined. 
14.3 Reporting Requirements 
All required AEs (i.e. all AEs resulting in deaths and device and procedure related AE) will be recorded 
in the appropriate eCRFs.  
All required SAEs and UADEs shall be reported within 24 hours of becoming aware to Stryker 
Neurovascular via data entry into the eCRFs.  If access to eCRFs is not available then the information 
can be faxed to the Stryker Neurovascular Safety Department personnel listed in current Study Contacts 
List provided in the study binder. 
 
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Trevo® Retriever Registry  
14.4 Device Failures, Malfunctions, and Product Nonconformities 
All Trevo Retriever failures, malfunctions, and product nonconformities will be documented on the 
appropriate eCRF and the involved device(s) should be returned to Stryker Neurovascular for analysis 
if possible. Instructions for returning the study device(s) will be provided to the sites in their study 
binder. Device failures and malfunctions should also be documented in the subject’s medical record. 
All Trevo Retriever failures, malfunctions, and product nonconformities shall be reported within 24 
hours of becoming aware to Stryker Neurovascular via data entry into the eCRFs. If access to eCRFs is 
not available then the information can be faxed to the Stryker Neurovascular Safety Department 
personnel listed in the current Study Contacts List provided in the study binder. 
NOTE: Trevo Retriever failures, malfunctions, and product nonconformities should be reported as soon 
as possible after becoming aware of them and are not to be reported as adverse events. However, if there 
is an adverse event that results from a device failure or malfunction, that specific event would be 
recorded on the appropriate eCRF. Trevo Retriever failures, malfunctions, product nonconformities and 
resulting AEs are reported to the Stryker Neurovascular complaint reporting system. 
All Stryker Neurovascular non-study device malfunctions and nonconformities related to ancillary 
devices used in the procedure should be reported to the local Stryker Neurovascular customer service 
center. The customer service listing is provided in the study binder. 
14.5 Reporting to Regulatory Authorities / IRBs / IECs / Investigators 
Stryker Neurovascular is responsible for reporting adverse event information to all participating 
investigators and regulatory authorities, as applicable. 
The Site PI is responsible for informing the IRB/ Independent Ethics Committee (IEC) of UADEs and 
SAEs as required by local procedure. A copy of this report should be sent to Stryker Neurovascular. 
15 Risk Benefit Analysis  
The risks associated with this study are limited to a possibility that confidential patient information may 
be disclosed.  It is possible that subjects enrolled into the Trevo Registry will receive no direct benefit 
from participation.  Possible benefits of the registry include providing information regarding the use of 
the Trevo Retriever that  may benefit future patients.  
15.1 Risk Minimization  
In order to minimize risks, Stryker Neurovascular will carefully select study sites and investigators who 
have experience with neuro-interventional procedures.  Thorough training on the protocol, IFU and 
registry requirements will be conducted and Stryker Neurovascular will be available to address any 
registry specific issues or questions. Reasonable measures will be taken to minimize any risk of loss of 
confidentiality including the use of subject ID numbers for data entry and de-identification of any images 
or records sent to the core-lab or Stryker. A Steering Committee will assist in oversight of the Trevo 
Registry and Safety monitoring of the data will be continuous throughout the registry.   
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE 
REPRODUCED, USED, OR DISCLOSED TO ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF STRYKER 
CORPORATION.                                                                                                                                                                   CDM 10000023 Rev. AC 
 
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Trevo® Retriever Registry  
16 Steering Committee 
The Trevo Retriever Registry will include a Steering Committee of up to 5 members or more of which 
one member may assume the Trevo Registry PI role. The Steering Committee will assist in oversight of 
the Trevo Registry with regard to protocol review and study progress. The Steering Committee will 
oversee dissemination of any study results through appropriate scientific sessions and publications. One 
of the Steering Committee members will Chair the publication committee. The Steering Committee will 
prepare a manuscript for publication of the interim analyses that will begin after 300 subjects have been 
enrolled. Subsequent interim analyses may be conducted and published throughout the study enrollment 
period. The Steering Committee may select study investigators to participate on the publication 
committee. These additional publication committee members are chosen based on enrollment, adherence 
to the protocol and protocol deviation rates.  The Steering/ Publication Committee will participate in the 
review and approval of all requests for data analyses, abstract and manuscript preparation and 
submission.  
17 Ethical Considerations 
17.1 Compliance with Good Clinical Practices (GCP) 
The Investigator will ensure that this study is conducted in accordance with the ethical principles that 
have their origins in the Declaration of Helsinki and that are consistent with GCP and applicable 
regulatory (local) requirements; whichever affords the greater protection to the subject. 
17.2 Institutional Review Board/Independent Ethics Committee 
A copy of the protocol, proposed ICF, other written subject information, and any proposed advertising 
material must be submitted to the IRB/IEC for written approval. A copy of the written IRB/IEC approval 
of the protocol and ICF must be received by Stryker Neurovascular before recruitment of subjects into 
the Trevo Registry. The Investigator must submit and, where necessary, obtain approval from the 
IRB/IEC for all subsequent protocol amendments and changes to the ICF. The Investigator must notify 
the IRB/IEC of SAEs per IRB/IEC procedures, UADEs occurring at the site and other SAE/UADE 
reports received from Stryker Neurovascular in accordance with local procedures and regulations. 
The Investigator is responsible for obtaining initial IRB/IEC approval and renewal throughout the 
duration of the registry. Copies of the Investigator’s reports and the IRB/IEC continuance of approval 
must be sent to Stryker Neurovascular.  
17.3 Protocol Adherence 
Prior to beginning the study, the Investigator must sign the Investigator Agreement and Signature page 
documenting his/her agreement to conduct the study in accordance with the protocol. An Investigator 
must not make any changes or deviate from this protocol, except to protect the life and physical well-
being of a subject in an emergency. Each deviation from the protocol must be documented with the date 
and reason for the deviation and reported to the Stryker Neurovascular as soon as possible, and to the 
IRB/EC per local guidelines and government regulations. Major and minor protocol deviations are 
defined within Appendix B.  
Stryker Neurovascular will ensure that this study is conducted in compliance with GCPs and all 
applicable regulatory requirements.  
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE 
REPRODUCED, USED, OR DISCLOSED TO ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF STRYKER 
CORPORATION.                                                                                                                                                                   CDM 10000023 Rev. AC 
 
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Trevo® Retriever Registry  
18 Study Administration 
18.1 Pre-Study Documentation Requirements 
Prior to enrolling any subjects into the registry the site must complete all pre-study essential documents, 
and these must be confirmed to be on file with the Stryker Neurovascular, including but not limited to: 
CV, medical license, W-9 or W-8, and signed clinical trial agreement; IRB/EC approval of the study and 
the Informed Consent; and all required study training. A site initiation visit will be conducted prior to 
authorization to enroll. No site may begin enrolling subjects until they receive written approval from the 
Stryker Neurovascular.  
18.2 Record Retention 
The Investigator will maintain all essential registry documents and source documentation, in original 
format, that support the data collected on the study subjects in compliance with the ICH/GCP guidelines. 
Documents must be retained for 2 years or longer per local governing Regulatory guidelines after a) the 
last approval of marketing application or b) formal discontinuation of the clinical investigation of the 
product. These documents will be retained for a longer period of time by agreement with Stryker 
Neurovascular or in compliance with other regulatory requirements. When these documents no longer 
need to be maintained, it is Stryker Neurovascular’s responsibility to inform the Investigator. 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. Stryker 
Neurovascular must receive written notification of this custodial change.  
18.3 Criteria for Terminating Study 
Stryker Neurovascular reserves the right to terminate the study but intends only to exercise this right for 
valid scientific or administrative reasons and reasons related to protection of subjects. Investigators and 
associated IRB/EC will be notified in writing in the event of termination. 
18.4 Criteria for Suspending/Terminating a Study Center 
Stryker Neurovascular reserves the right to stop or suspend a study center at any time after the study 
initiation visit if no subjects have been enrolled, or if the center has multiple or severe protocol violations 
without justification or fails to follow remedial actions. 
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE 
REPRODUCED, USED, OR DISCLOSED TO ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF STRYKER 
CORPORATION.                                                                                                                                                                   CDM 10000023 Rev. AC 
 
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Trevo® Retriever Registry  
19 References 
1. 
Centers for Disease Control and Prevention, National Center for Health Statistics. Underlying Cause 
of Death Database released 2015. Data are from the Multiple Cause of Death Files, 1999-2013, as 
compiled from data provided by the 57 vital statistics jurisdictions through the Vital Statistics 
Cooperative Program: http://wonder.cdc.gov/ucd-icd10.html. Accessed on Feb 3, 2015. 
2. 
Stroke Statistics: Stroke Association. stroke.org.uk  January 2013 
3. 
Sabaté, E and Wimalaratna, S, Acute Stroke: Priority Medicines for Europe and the World "A Public 
Health Approach to Innovation” World Health Organization, 2004, Chapter 6. 
4. 
Seshadri S, et al., The lifetime risk of stroke: estimates from the Framingham Study. Stroke, 2006. 37: 
p. 345-50. 
5. 
Rha, J.H. and J.L. Saver, The impact of recanalization on ischemic stroke outcome: a meta-analysis. 
Stroke, 2007. 38(3): p. 967-73. 
6. 
Mullen, T.M., Joint Commission Primary Stroke Centers Utilize More rtPA in the Nationwide 
Inpatient Sample, J Am Heart Assoc, 2013. 
7. 
Hacke, W.K., et al., Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. NEJM, 
2008. 359: p. 1317–29. 
8. 
Lees, K.R., et al., Time to treatment with intravenous alteplase and outcome in stroke: an updated 
pooled analysis of ECASS, ATLANTIS, NINDS, and EPITHET trials. Lancet, 2010. 375 (9727): p. 
1695-1703. 
9. 
Riedel, C.H., Zimmermann, P., Jensen-Kondering, U., Stingele, R., Deuschl, G., Jansen, O., The 
importance of size: successful recanalization by intravenous thrombolysis in acute anterior stroke 
depends on thrombus length. Stroke, 2011. 42: p.1775-1777. 
10. Wahlgren, N., Macho, J. Killer M., Liebeskind D., Jansen, O. Final Results from the Trevo Study 
(Thrombectomy Revascularization of large Vessel Occlusions in acute ischemic stroke). International 
Stroke Conference, 2012. 
11. Nogueira, R.G., Lutsep, H.L., Gupta, R., et al., Trevo versus Merci retrievers for thrombectomy 
revascularization of large vessel occlusions in acute ischaemic stroke (TREVO 2): a randomised trial. 
Lancet, 2012. 280: p.1231-40 
12. English, J.D., Yavagal D.R., Gupta R., Janardhan V., Zaidat, O.O., Xavier, A.R., Nogueira, R.G., 
Kirmani, J.F., Jovin, T.G. Mechanical Thrombectomry-Ready Comprehensive Stroke Center 
Requirements and Endovascular Stroke Systems of Care: Recommendations from the Endovascular 
Stroke Standards Committee of the Society of Vascular and Interventional Neurology (SVIN). Intervent 
Neurol 2015:4:138-150. 
13. Powers W.J., et al on behalf of the American Heart Association Stroke Council. 2015 American Heart 
Association/American Stroke Association Focused Update of the 2013 Guidelines forthe Early 
Management of Patients With Acute Ischemic Stroke Regarding Endovascular Treatment A Guideline 
for Healthcare Professionals From the American Heart Association/American Stroke Association; 
Stroke. 2015;46:3020–3035. 
 
 
 
 
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE 
REPRODUCED, USED, OR DISCLOSED TO ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF STRYKER 
CORPORATION.                                                                                                                                                                   CDM 10000023 Rev. AC 
 
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Trevo® Retriever Registry  
20 Appendices 
Appendix A. Abbreviations  
Abbreviation/ Acronym 
Full Term 
AE 
Adverse Event 
AHA 
American Heart Association 
Carotid T 
Distal terminus of the carotid artery 
CRA 
Clinical Research Associate 
CRF 
Case Report Form 
CSA 
Clinical Study Agreement 
CT 
Computed Tomography 
CTA 
Computed Tomography Angiography 
DRSAE 
Device-related SAE 
eCRF 
electronic Case Report Form 
GCP 
Good Clinical Practices  
IA 
Intra-Arterial 
ICH 
Intracranial Hemorrhage 
ID 
Identification 
IFU 
Instructions For Use 
IV 
Intravenous 
IV tPA 
Intravenous tissue Plasminogen Activator 
LAR 
Legally Authorized Representative 
MR 
Magnetic Resonance  
MRI 
Magnetic Resonance Imaging 
mRS 
Modified Rankin Scale 
PI 
Principal Investigator  
SAE 
Serious Adverse Event 
SADE 
Serious Adverse Device Effect  
SAH 
Subarachnoid Hemorrhage 
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE 
REPRODUCED, USED, OR DISCLOSED TO ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF STRYKER 
CORPORATION.                                                                                                                                                                   CDM 10000023 Rev. AC 
 
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Trevo® Retriever Registry  
SBP 
Systolic Blood Pressure 
SICH 
Symptomatic Intracranial Hemorrhage 
TICI 
(modified) Thrombolysis in Cerebral Infarction  
t-PA 
Tissue Plasminogen Activator 
UADE 
Unanticipated Adverse Device Effect 
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE 
REPRODUCED, USED, OR DISCLOSED TO ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF STRYKER 
CORPORATION.                                                                                                                                                                   CDM 10000023 Rev. AC 
 
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Trevo® Retriever Registry  
Appendix B. Definitions 
Adverse Event (AE): 
Any unintended disease or injury or untoward clinical sign in a 
research subject.  NOTE - This definition does not imply that there 
is a relationship between the adverse event and the device under 
investigation. 
Device Malfunction/Nonconformity: 
The failure of a device to meet its performance specifications or 
otherwise perform as intended. Performance specifications include 
all claims made in the labeling for the device. The intended 
performance of a device refers to the intended use for which the 
device is labeled or marketed.  
Device-Related Serious Adverse Event 
(DRSAE): 
Trevo device related vascular perforation or intramural arterial 
dissection, symptomatic ICH, embolization to a new territory, 
intra-procedural death, or device failure (in vivo breakage). 
Distal Embolization (DE): 
Any downstream occlusion distal to the target artery lesion, into 
the target ischemic territory, is considered DE unless complete 
angiogram or pre procedure non-invasive imaging demonstrated 
patency of these distal branches. 
Embolization to New Territory: 
Embolization into a previously uninvolved area of the brain, e.g. 
ACA embolization during MCA-M1 thrombectomy procedure.  
Good Clinical Outcome: 
A measure of neurologic functional outcome with a score of 0–2 on 
the modified Rankin Scale (mRS), usually assessed 90 days after 
treatment. 
Irreversible Neurological Deterioration:   
Neurological deterioration that is more than transitory, and is not 
related only to sedation.  The neurological deterioration persists 
even after removal of sedation. 
Modified Rankin Scale (mRS): 
Scale for measuring the degree of disability or dependence in the 
daily activities of people who have suffered a stroke or other 
causes of neurological disability. 
NIHSS Scale: 
An assessment to objectively quantify the impairment caused by a 
stroke. It is composed of 11 items, each of which scores a specific 
ability between a 0 and 4. For each item, a score of 0 typically 
indicates normal function in that specific ability, while a higher 
score is indicative of some level of impairment. The individual 
scores from each item are summed in order to calculate a subject’s 
total NIHSS score. The maximum possible score is 42, with the 
minimum score being a 0. 
Pre-stroke disability: 
Obtained at baseline, is representative of the subject’s status before 
the index stroke, assessed by mRS on medical history obtained 
from subject, medical chart, or family members. 
Procedure-Related Serious Adverse 
Event (PRSAE): 
Procedure-related  events that include, but are not limited to 
vascular perforation or intramural arterial dissection, symptomatic 
ICH, embolization to a new territory, or access site complication 
requiring surgical repair or blood transfusion, intra-procedural 
death, or device failure (e.g. in vivo breakage). 
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE 
REPRODUCED, USED, OR DISCLOSED TO ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF STRYKER 
CORPORATION.                                                                                                                                                                   CDM 10000023 Rev. AC 
 
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Trevo® Retriever Registry  
Protocol Deviation:   
This protocol does not require specific  interventions,  therefore the 
term deviation will only be used to describe the following situation: 
Failure to obtain informed consent per Good Clinical Practices 
(GCP). 
Serious Adverse Device Effect (SADE):   
An adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event or that might 
have led to any of these consequences if suitable action had not 
been taken or if circumstances had been less fortunate. 
Serious Adverse Event (SAE): 
An adverse event in a research subject that led to a death, or led to 
a serious deterioration in the health of the subject that resulted in a 
life-threatening illness or injury, or resulted in a permanent 
impairment of a body structure or a body function, or required in-
subject hospitalization or prolongation of existing hospitalization, 
or resulted in medical or surgical intervention to prevent permanent 
impairment to body structure or a body function. SAEs are a subset 
of AEs.  
Subarachnoid Hemorrhage (SAH):   
Bleeding into the subarachnoid space - the area between the 
arachnoid membrane and the pia mater surrounding the brain.  
Symptomatic ICH (SICH):   
The primary protocol definition is adapted from ECASS III as any 
apparently extravascular blood in the brain or within the cranium 
that is associated with clinical deterioration as defined by an 
increase of four points or more in the NIHSS or that led to death 
and was judged to be the predominant cause of a neurologic 
deterioration.  SITS-MOST definition is any PH-2, defined as 
dense hematoma > 30% total of the infarcted area with substantial 
space-occupying effect or any hemorrhage area outside the 
infracted area. 
Unanticipated Adverse Device Effect 
(UADE): 
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. 
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE 
REPRODUCED, USED, OR DISCLOSED TO ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF STRYKER 
CORPORATION.                                                                                                                                                                   CDM 10000023 Rev. AC 
 
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Informed Consent Form & HIPAA Authorization Form for Participation in the  
Trevo® Retriever Registry 
<Insert Name of Hospital> 
<Insert Name of Investigator> 
 
Appendix C. Study Informed Consent Form Template  
You may be eligible to take part in a data collection study called the Trevo® Retriever Registry. This form 
will give you important information about why the research registry is being done, what will happen during 
the registry, and the risks and possible benefits.  Please read it carefully. This consent form may contain 
words that are new to you. If you read any words that are not clear, please ask the person who gave you this 
form to explain them to you. You may also want to talk to family, friends, your primary care doctor, or 
other health care provider about joining this study.  If you decide that you would like to take part in the 
study, you will be asked to sign and date this form and you will be given a copy of the signed form to keep. 
Investigator/ 
Hospital 
Insert name and Hospital 
Sponsor 
Stryker Neurovascular 
Introduction and Purpose 
The purpose of this Trevo Registry is to collect information (data) on a medical device called the Trevo 
Retriever.  The registry will also collect data on other standard of care treatments and increase our 
understanding that the treatment has on stroke patients. You have been asked to participate in the registry 
being conducted by <Dr’s name> at <site name> because you had a stroke.  
The type of stroke that you had occurs when there is a blood clot that stops the flow of blood to an artery 
in your brain. This type of stroke can be treated in many ways, including the use of drugs to try to dissolve 
the blockage, the use of devices (like the Trevo Retriever) to remove the  blood clot, and the use of 
therapeutic treatments that prevent stroke from happening or help you get better after having a stroke. This 
registry will collect data on the usage of the Trevo Retriever which is a type of stent (a small metal mesh 
tube) that is made to be put into your brain to grab the clot and pull it out to unblock the blood vessel. The 
Trevo Retriever does not stay in your body. The Trevo Retriever is not investigational or experimental and 
has received approval to sell and be used in the USA, Europe, and other countries. 
You were chosen as a possible participant in the Trevo Retriever Registry because your doctor may use or 
may have used the Trevo Retriever to treat your stroke.  
The Trevo Registry is expected to include about 2000 patients from approximately 100 hospitals around 
the world.  
The Trevo Registry will collect data from your medical records starting from the time you are admitted to 
the hospital through your 90 day checkup visit with your doctor. Information about your health history, 
demographics, blood tests, brain imaging exams, treatment, and cost of your treatment and hospital stay 
will be collected. The brain image testing conducted during your hospitalization may be reviewed by a core 
lab that will provide an independent central assessment of the images. After you leave the hospital, the 
registry staff will ask you, or a family member, for a health check on your ability to do daily activities at 
30 and 90 days after your treatment. 
Whether or not you participate in this data collection registry, you will be given the same standard of care 
as all stroke patients at this hospital.  Currently, standard care for stroke patients may include, but is not 
limited to the following: 
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Informed Consent Form & HIPAA Authorization Form for Participation in the  
Trevo® Retriever Registry 
<Insert Name of Hospital> 
<Insert Name of Investigator> 
 
o Physical exam and medical history 
o Neurological and functional tests 
o Routine blood tests 
o Neurological imaging studies such as a CT (computed tomography) or MRI (magnetic 
resonance imaging) 
o Treatment using a “clot busting” drug to break up the clot such as tissue plasminogen activator 
(t-PA) 
o Cerebral angiogram 
o Interventional radiology procedure(s) to treat a blocked artery using a device like the Trevo 
Retriever 
o Other routine supportive therapies 
You need to tell your doctor your medical history, especially if you are pregnant, have drug allergies, or 
have allergies to any metals or plastics, and if you are taking any medications. You and your doctor will 
determine which treatment choices are best for you.  
Potential Benefits of Participating 
The data collected on your treatment will be used to better understand how stroke diagnosis, treatment, and 
outcomes are related. Additionally the data will further direct the development of future stroke research 
studies. Your participation may help decide the best treatment to reduce health care costs related to stroke 
care while improving outcomes. We cannot and do not guarantee or promise you will receive any benefit 
from the registry. 
Potential Risks by Your Participation 
There are no risks involved with data collection in this registry. However, there may be a risk of loss of 
confidentiality. All efforts will be made to ensure that your health information remains confidential. The 
research staff will take every measure possible to protect your confidentiality.  Please refer to the section 
titled “Confidentiality” and the “HIPAA Authorization Form” attached to this consent for more information 
about your personal health information.  There are no other known risks to you for allowing the study doctor 
to collect information about you and the treatment you receive for your acute ischemic stroke. 
Trevo Retriever Examinations 
You may be enrolled in the research registry if you meet the enrollment criteria. Before any procedure is 
done, the doctor will obtain your medical history, perform a physical examination, and review your blood 
tests. Neurological exams including a test that measures the degree of disability or dependence on patients 
who have had a stroke [modified Rankin Score (mRS)] and a neurological examination to accurately and 
consistently assess the patient [National Institute of Health Stroke Scale (NIHSS)] will be done. Your 
physician will explain the Trevo Retriever procedure and the benefits and risks associated with this type 
of treatment and alternative treatments available to you. 
 
Your participation in the registry includes data collection of the following assessments after the procedure: 
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Informed Consent Form & HIPAA Authorization Form for Participation in the  
Trevo® Retriever Registry 
<Insert Name of Hospital> 
<Insert Name of Investigator> 
 
24 (-6/+24) hours after the procedure the hospital staff with test how well you can move your arms and 
legs, talk, understand speech, and see in all directions.   
At 5-7days after the procedure or when you are discharged, (whichever occurs first), you will again have 
a test to see how well you can move your arms and legs, talk, understand speech, and see in all directions. 
You will also be tested for how well you are able to perform your daily activities (i.e. bathing, dressing, 
and walking).  A copy of your hospital bills may also be collected so that the costs of different treatments 
can be compared. 
30 days (one month) after the procedure, you may return to see the  doctor or you may receive a telephone 
call to see how you are doing and answer a few questions regarding your daily activities. 
90 days (three months) after the procedure, you will be scheduled for a return visit with the doctor who 
will test how well you are able to perform daily activities and evaluate your progress. Your participation 
in the registry will be finished after this follow-up visit. 
Alternative Procedures 
Several devices have been cleared for revascularization of blocked intracranial arteries in patients with 
acute ischemic stroke within 8 hours of stroke onset. The alternative to participating in this data collection 
study is to receive routine treatment without providing access to your medical records and allowing 
collection of your medical information.  
Voluntary Participation in the Trevo Registry 
Your participation in this registry is completely voluntary.  You may refuse to take part or you may 
withdraw from the registry at any time without penalty or loss of benefits to which you are normally entitled. 
The registry may be stopped by a regulatory authority or Stryker Neurovascular.  Additionally, your doctor 
may decide to stop your participation in the registry, with or without your consent, for medical reasons. 
He/she will tell you in writing if they have decided to stop your participation in this registry.  Your doctor 
will be available if you have any questions, at any time, regarding your participation in this registry. 
At any time, you may withdraw your participation from the registry. After you withdraw your authorization, 
no further health information will be used or disclosed to the registry. Your physician, designated medical 
staff, the Stryker Neurovascular representative, or governmental regulatory body (e.g. FDA) will continue 
to have access to the data collected during your participation in the registry as well as to your future medical 
records and/or vital status information that may be related to the safety of the product being studied in this 
trial, with the stipulation that your identity and data be kept confidential and that this access would end at 
the closure of the registry. Contact your doctor for instructions on how to withdraw yourself from the 
registry.  
Responsibilities 
As a participant in the Trevo Registry, your responsibilities are: 
o Follow the instructions of your doctor 
o Take prescribed medications as instructed.  
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Informed Consent Form & HIPAA Authorization Form for Participation in the  
Trevo® Retriever Registry 
<Insert Name of Hospital> 
<Insert Name of Investigator> 
 
o Keep your Day 30 and Day 90 follow-up appointments.  If it is necessary to miss an appointment, 
please contact the doctor or research staff to reschedule as soon as you know you will miss the 
appointment. 
o Tell the doctor or research staff about any side effects, medications, doctor visits, or admissions to 
a hospital that you may have. 
o Ask questions as you think of them. 
o Tell the doctor or research staff if you change your mind about staying in the study. 
Confidentiality 
Your privacy is important.  All information gathered in the Trevo Registry will be kept private.  Your 
identity as a participant in this registry will remain strictly confidential.   
If you consent to participate in this registry, you will be asked to sign a form that permits <Institution’s 
Name> to use and disclose your personal information for purposes of the registry. For example, the form 
will permit <Institution’s Name> to share your information with the registry staff, with the institutional 
review board and study oversight staff, and with any other people who will need access to your personal 
information in order to conduct the registry. The form will also permit <Institution’s Name> to share your 
personal information with Stryker Neurovascular and with those who help the registry sponsor manage the 
registry.  
Your personal information will usually be shared on study forms without your name, except when your 
name is necessary to make sure that the information on the study forms is accurate. Your name will not be 
reported in any publication. Only the data obtained as a result of your participation in this registry will be 
made public.  
Because this registry involves devices and medications that are regulated by the US FDA and other 
regulatory agencies, these regulatory agencies may inspect records identifying you as a subject in this 
registry.  
In addition, if your participation in this registry is for treatment or evaluation purposes, the hospital in which 
you are treated may ask you to sign a separate informed consent document for specific procedures or 
treatment, and that informed consent form may be included in the medical record of that facility. The 
medical record is maintained by your treating physician or hospital, as applicable, and will be subject to 
state and federal laws and regulations concerning confidentiality of medical records. 
Duration of Participation 
This research registry is expected to last up to 90 days after your procedure date. After your procedure, the 
research staff will ask you, or a family member, for a health check test of your daily activities at 30 and 90 
days post procedure.  
Compensation and Costs 
You will not be paid to provide medical information for this registry.  There is no cost to you for 
participating in this registry.  
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Informed Consent Form & HIPAA Authorization Form for Participation in the  
Trevo® Retriever Registry 
<Insert Name of Hospital> 
<Insert Name of Investigator> 
 
Treatment and Compensation for Injuries 
Neither Stryker Neurovascular nor your doctor will provide financial assistance for illness, medical and/or 
other injury-related costs. Doctor <name> can provide you with information about the general liability 
policies of this institution to determine if compensation may be available from that source. 
Additional Information 
You or your legal representative will be notified in a timely manner of any new information that develops 
over the course of this study that may affect your willingness to participate in this study.  
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. 
Law. This Web site will not include information that can identify you. At most, the Web site will include a 
summary of the results. You can search this Web site at any time. 
For Further Information 
If you would wish to obtain more information regarding this registry or its risks, advantages, or medical 
alternatives, please contact the study doctor (investigator). You should also inform the study doctor if you 
have been injured or hospitalized for any reason during the registry. 
Contact Information: 
Investigator:  
 
Study Coordinator:  
Telephone:  
 
Telephone: 
 
For more information about your rights as a study subject contact: 
 
 
 
 
 
 
By signing this Consent Form, you are agreeing to share your health information as it relates to your 
diagnosis and treatment of your stroke. This may include your medical exams, blood tests, x-ray and brain 
imaging exams prescribed by your physician. Your records may be looked at by representatives of the 
Stryker Neurovascular (Sponsor) and by Regulatory Agencies as required by law, such as the Food and 
Drug Administration (FDA). As a study participant, your brain images may be reviewed by a Core Lab 
who will provide an independent central assessment of your brain images. These images would only include 
your study ID number as a reference. Your physical exam and medical history information will be collected 
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Informed Consent Form & HIPAA Authorization Form for Participation in the  
Trevo® Retriever Registry 
<Insert Name of Hospital> 
<Insert Name of Investigator> 
 
and entered into a database. The results of specific tests and procedures you undergo to assess and/or treat 
your stroke will be entered into a database.  
My signature below means that:  
o I have read and understand this consent form.  
o I have been informed of the purpose of the registry and was able to ask questions. 
o All my questions were answered to my satisfaction. 
o I have been given information on the procedure and have been informed of the potential benefits 
and risks involved. I have been provided with alternative treatment options available to me. 
o I agree to voluntarily participate in the research registry based on the information provided. 
o I agree to comply with the research registry follow-up requirements.  
o A copy of this form and the HIPAA Authorization Form has been given to me. 
 
 
 
 
 
 
Patient’s Name (print) 
 
Patient’s Signature 
 
Date Signed 
Time Signed 
 
 
 
 
 
 
Doctor’s Name (print) 
 
Doctor’s Signature 
 
Date Signed 
Time Signed 
 
 
 
 
 
 
Witness’ Name (print) 
 
Witness’ Signature 
 
Date Signed 
Time Signed 
 
 
 
 
 
 
If the patient is unable to consent complete the following, 
Print Patient’s name 
here:                                   
is not able to consent 
because: 
 
 Health status 
 Minor less than 18 years of age 
 
 
 
 
 
 
 
 
Legally Authorized Representative 
Name (print) 
 
Signature 
 
Date Signed 
Time Signed 
Legally Authorized Representative Relationship to 
Patient: 
 
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Informed Consent Form & HIPAA Authorization Form for Participation in the  
Trevo® Retriever Registry 
<Insert Name of Hospital> 
<Insert Name of Investigator> 
 
Interpreter and Translation Services Statement 
If the language of this document is not my first language,  
an interpreter and or translation services were offered and provided to me: 
 YES         
 NO       
 NOT APPLICABLE 
 
If yes (an interpreter was used), 
 
 
 
 
 
 
Printed Name 
 
Signature 
 
Date 
Time 
 
 
THE SUBJECT OR HIS OR HER PERSONAL REPRESENTATIVE MUST BE PROVIDED A COPY 
OF THIS FORM IN ITS ENTIRETY AFTER IT HAS BEEN SIGNED. 
 
 
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Informed Consent Form & HIPAA Authorization Form for Participation in the  
Trevo® Retriever Registry 
<Insert Name of Hospital> 
<Insert Name of Investigator> 
 
HIPAA Authorization for Participation in a Medical Device Study: Trevo 
Registry 
<Institution Name> 
We understand that information about you and your health is personal, and we are committed to protecting 
the privacy of that information.  Because of this commitment, we must obtain your special authorization 
before we may use or disclose your protected health information (PHI) for the research purposes described 
in the Informed Consent Form for this study. This form provides that authorization and helps us make sure 
that you are properly informed of how this information will be used or disclosed.  Please read the 
information below carefully before signing this form. 
USE AND DISCLOSURE COVERED BY THIS AUTHORIZATION 
Who will disclose, receive, and/or use your information?   
The following person(s), class(es) of persons, and/or organization(s) may disclose, use, and/or receive your 
protected health information, but they may only use and disclose the information to the other parties on this 
list, to you or your personal representative, or as otherwise permitted or required by law: 
 Stryker Neurovascular Corporation and its affiliated corporations and their respective 
employees, contractors and other agents (“Sponsor”) 
 Every research site for this study, including this Institution, and including each site’s research 
staff and medical staff 
 Every health care provider who provides services to you in connection with this study 
 Any laboratories and other individuals and organizations that analyze your health information 
in connection with this study in accordance with the study’s protocol 
 The United States Food and Drug Administration, Medicare, Medicaid, Notified Bodies, 
Competent Authorities and other regulatory agencies 
 The members and staff of the Institution’s affiliated Institutional Review Board, Ethics 
Committee(s), Privacy Board, and all other institutional review boards or persons who watch over 
how the research is performed and/or monitor the safety and success of the research, including the 
Institution that approves this study 
   Principal Investigator 
   Study Coordinator 
   Members of the Research Team, including core lab review of brain imaging tests  
   Members of the Institution’s administrative staff responsible for administering clinical trials and 
other research activities 
  
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Informed Consent Form & HIPAA Authorization Form for Participation in the  
Trevo® Retriever Registry 
<Insert Name of Hospital> 
<Insert Name of Investigator> 
 
What information will be used or disclosed? 
The entire research record and any medical records held by the Institution and any health care provider 
authorized to disclose, use, or receive the information may be used and disclosed.   
What could happen if you agree to this use or disclosure of your health information? 
• 
There is the possibility that information disclosed under this authorization for the use of your 
personal health information may be re-disclosed and that the Federal privacy laws (laws that 
protect the privacy to your personal health information) may no longer protect it from being given 
to another person, class of persons, and/or company.   
• 
Once information that could be used to identify you has been removed and your information is 
no longer identifiable (connected to your identity), the information that remains is no longer 
protected by this Authorization (agreement) and may be used and given by the Researchers and 
Sponsor to others, including for other research reasons. 
• 
The Researchers and Sponsor have agreed that no publication or presentation of the research will 
reveal your identity without your separate specific written permission and authorization 
(agreement) [even if you revoke (take back) this Authorization (agreement)]. 
What rights do you have? 
• 
You have a right to refuse to sign this authorization.  While your health care outside the study, 
the payment for your health care, and your health care benefits will not be affected if you do not 
sign this form, you will not be able to participate in the research described in the informed consent 
form and will not receive treatment as a study participant if you do not sign this form. 
• 
You may change your mind and cancel this agreement at any time.  To cancel this agreement, 
you must write to:  <insert name of Study Coordinator, Principal Investigator, or other 
responsible person or department, with full Institution Name and Address>.   However, if you 
cancel this agreement, you may no longer be allowed to participate in the research study and may 
no longer receive research-related treatment.  Also, even if you cancel this agreement, the 
information already obtained may remain a part of the research as necessary to preserve the 
integrity of the research study. 
• 
You will be given a copy of this agreement after you have signed it. 
When does this Authorization expire? 
This authorization will never expire unless and until you revoke it. 
Please use this alternative language for California:  
“This Authorization has no expiration date, but shall expire at the end of the research study identified 
above”. 
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Informed Consent Form & HIPAA Authorization Form for Participation in the  
Trevo® Retriever Registry 
<Insert Name of Hospital> 
<Insert Name of Investigator> 
 
 
SPECIFIC UNDERSTANDINGS 
By signing this research authorization form, you authorize the use and/or disclosure of your protected health 
information (PHI) described above.  The purpose for the uses and disclosures you are authorizing is to 
conduct the research project explained to you during the informed consent process and to ensure that the 
information relating to that research is available to all parties who may need it for research purposes.  Your 
information may also be used as necessary for your research-related treatment, to collect payment for your 
research-related treatment (when applicable), and to run the normal business operations of the Institution 
or other providers providing services in connection with this study. 
 
SIGNATURE 
By signing below I represent and warrant that I have authority to sign this document and authorize the use 
or disclosure of protected health information (PHI) and that there are no restrictions that would prevent me 
from authorizing the use or disclosure of this Protected Health Information (PHI). 
 
I have read this form and all of my questions about this form have been answered. 
 
 
 
 
 
 
Printed Name 
 
Signature 
 
Date 
Time Signed 
If the patient is unable to consent complete the following, 
 
Print Patient’s 
name:                          
is not able to consent 
because: 
 Health status 
 Minor less than 18 years of age 
 
 
 
 
 
 
 
Legally Authorized 
Representative Name (print) 
 
Signature 
 
Date Signed 
Time Signed 
Legally Authorized Representative Relationship 
to Patient: 
 
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Informed Consent Form & HIPAA Authorization Form for Participation in the  
Trevo® Retriever Registry 
<Insert Name of Hospital> 
<Insert Name of Investigator> 
 
Address: 
 
Telephone: 
 
(daytime) 
 
 
 
(evening) 
 
Email: 
 
 
 
THE SUBJECT OR HIS/HER LEGALLY AUTHORIZED REPRESENTATIVE 
MUST BE PROVIDED WITH A COPY OF THIS FORM AFTER IT HAS BEEN SIGNED 
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Trevo® Retriever Registry  
Appendix D. Time and  Events Schedule  
Time and Events Schedule 
Assessments: 
Pre-
procedure 
(Screening 
/Baseline) 
Procedure 
24 (-6/+24) 
hrs post 
procedure 
Discharge (or 
Day 5-7 
whichever 
comes first) 
Day 30 +14 
days 
Day 90*** 
±14 days 
Inclusion/Exclusion 
Criteria 
 
 
 
 
 
 
Informed Consent* 
 
 
 
 
 
 
Demographics and 
Medical History 
 
 
 
 
 
 
Baseline Medications 
 
 
 
 
 
 
Baseline Labs (PT, PTT 
platelets, INR, glucose). 
Pregnancy test, if 
applicable 
 
 
 
 
 
 
mRS** 
 
 
 
 
 
 
NIHSS assessment 
 
 
 
 
 
 
Stroke onset/etiology 
 
 
 
 
 
 
CT/MRﻻ  
 
 
 
 
 
 
Angiogram Procedure 
Information ‡*** ﻻ 
 
 
 
 
 
 
Hospital Stay/Discharge 
Disposition 
 
 
 
 
 
 
Post Discharge Follow-
up**** 
 
 
 
 
 
 
Adverse Events‡ 
 
 
 
 
 
 
Utilization/Economic 
measures‡‡ 
 
 
 
 
 
 
Study Completion 
 
 
 
 
 
 
*Written IC must be obtained prior to any data entry.  
**Telephone mRS assessment is acceptable if subject not able to return to the clinic in person.  
***See study binder for worksheets listing items to record during the procedure.  
****Study Staff should review the study requirements with the subject and arrange all follow-up visits at discharge. 
‡ All AE during procedure and only DR and PR SAE, death post procedure. 
‡ ‡De-identify forms and enter subject ID # prior to sending to Stryker 
ﻻ CT/MR and Angiographic images will be de-identified with subject ID# if submitted to SNV or the core lab. 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE 
REPRODUCED, USED, OR DISCLOSED TO ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF STRYKER 
CORPORATION.                                                                                                                                                                              CDM 10000023 Rev. AC 
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Trevo® Retriever Registry  
Appendix E. Modified TICI Perfusion Categories 
Grade 0: No Perfusion. No antegrade flow beyond the point of occlusion. 
Grade 1: Penetration with Minimal Perfusion. The contrast material passes beyond the area of obstruction 
but fails to opacify the entire cerebral bed distal to the obstruction for the duration of the angiographic run. 
Grade 2: Partial Perfusion. The contrast material passes beyond the obstruction and opacifies the arterial 
bed distal to the obstruction. However, the rate of entry of contrast into the vessel distal to the obstruction 
and/or its rate of clearance from the distal bed are perceptibly slower than its entry into and/or clearance 
from comparable areas not perfused by the previously occluded vessel, e.g. the opposite cerebral artery or 
the arterial bed proximal to the obstruction. 
Grade 2a: Partial filling with <50% of the entire vascular territory is visualized. 
Grade 2b: Partial filling with ≥50% of the entire vascular territory is visualized. If complete filling of all of 
the expected vascular territory is visualized, the filling is slower than normal. 
Grade 3: Complete Perfusion. Antegrade flow into the bed distal to the obstruction occurs as promptly as 
into the obstruction and clearance of contrast material from the involved bed is as rapid as from an 
uninvolved other bed of the same vessel or the opposite cerebral artery. 
 
Reference 
Higashida RT, Furlan AJ, Roberts H, et al., Trial design and reporting standards for intra-arterial cerebral 
thrombolysis for acute ischemic stroke. Stroke, 2003. 34:e109–137 
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE 
REPRODUCED, USED, OR DISCLOSED TO ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF STRYKER 
CORPORATION.                                                                                                                                                                              CDM 10000023 Rev. AC 
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Trevo® Retriever Registry  
Appendix F. Modified Rankin Scale (mRS) 
0 - No symptoms at all 
1 - No significant disability despite symptoms; able to carry out all usual duties and activities 
2 - Slight disability; unable to carry out all previous activities, but able to look after   
     own affairs without assistance 
 
3 - Moderate disability; requiring some help, but able to walk without assistance 
4 - Moderately severe disability; unable to walk without assistance and unable to  
     attend to own bodily needs without assistance 
5 - Severe disability; bedridden, incontinent and requiring constant nursing care and attention 
6 - Dead 
 
Reference 
 
Bonita R, Beaglehole R. Modification of Rankin Scale: Recovery of motor function after stroke. Stroke. 
1988. 19 (12): p. 1497-1500 
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE 
REPRODUCED, USED, OR DISCLOSED TO ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF STRYKER 
CORPORATION.                                                                                                                                                                              CDM 10000023 Rev. AC 
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Trevo® Retriever Registry  
Appendix G. National Institute of Health Stroke Scale (NIHSS) 
 
[See Study Binder for NIHSS Worksheet] 
 
Reference 
National Institute of Health, National Institute of Neurological Disorders and Stroke Scale. 
http://www.ninds.nih.gov/doctors/NIH_Stroke_Scale.pdf 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE 
REPRODUCED, USED, OR DISCLOSED TO ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF STRYKER 
CORPORATION.                                                                                                                                                                              CDM 10000023 Rev. AC 
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