Treatment With Intent to Generate Endovascular Reperfusion
Phase: NA
Conditions: Ischemic Stroke
Sponsor: Rapid Medical

 
 
 
 
 
 
TIGER STUDY 
 
Treatment with Intent to Generate Endovascular Reperfusion 
 
INVESTIGATIONAL PLAN 
 
IDE# G180004 
ClinicalTrials.gov ID: NCT03474549 
Protocol #: CLN-TI-001 
VERSION: 3.0 
DATE: Dec 12, 2019 
 
 
 
 
Study Sponsor: 
Rapid Medical 
P.O. Box 337 
Carmel Building 
Yokneam 2069205 
Israel 
 
 
 

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TIGER study, version 3.0 Dec 12, 2019 
 
 
CLINICAL INVESTIGATION PLAN (CIP) APPROVAL 
 
Study Title:  TIGER Study  
CIP Version: 3.0 
 
CIP Date: Dec 12, 2019 
 
 
Signatures: 
 
 
Dr. Walid Haddad 
VP Clinical Operations 
Rapid Medical 
Sponsor Representative 
 
 
 
Date 
Dr. Jeffrey L. Saver   
Geffen School of Medicine at UCLA   
Director, UCLA Comprehensive Stroke 
Center  710 Westwood Plaza   
Los Angeles, CA 90095 
 
Coordinating Principal Investigator 
 
 
 
 
 
Date 
Dr. Rishi Gupta 
WellStar Medical Group  
Neuroscience  
Atlanta, GA 
 
Co-Coordinating Principal Investigator 
 
 
Date 
 
 

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TIGER study, version 3.0 Dec 12, 2019 
 
CIP SIGNATURE PAGE 
 
Study Title:  TIGER Study 
 
CIP Version: 3.0 
CIP Date: Dec 12, 2019 
 
 
 
I have read the Investigational Plan and agree to adhere to the research plan contained herein.  
Deviations from the research plan will not be made prior to sponsor notification, except when 
necessary to protect the safety, rights, or welfare of study Subjects. 
I agree to conduct or supervise the conduct of the described investigation and ensure all 
participating investigators and research staff are appropriately trained regarding the study 
conduct prior to participating in any study related activities. 
I will ensure that the requirements relating to obtaining informed consent and Institutional 
Review Board (IRB) review and approval, as they pertain to 21 CFR Part 50, ICH E6 are met. 
I agree to maintain adequate and accurate records in accordance with 21 CFR 812.140 and to 
make those records available for inspection in accordance with 21 CFR 812.145 and ICH E6. 
I will ensure that the IRB complies with the requirements of 21 CFR Part 56 and ICH E6 and will 
be responsible for the initial and continuing review and approval of the clinical investigation.  I 
also agree to promptly report to the IRB any changes in research activity and all unanticipated 
problems involving risks to human Subjects or others.  Additionally, I will not make any changes 
in research without IRB approval, except where necessary to eliminate apparent immediate 
hazards to human Subjects. 
I agree to comply with all other clinical investigator obligations and pertinent requirements in 21 
CFR Part 812 and ICH E6. 
 
_______________________________ 
Site Principal Investigator (please print or use stamp) 
 
 
___________________________                           ________________________ 
Site Principal Investigator Signature  
 
Date 
 
 

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TIGER study, version 3.0 Dec 12, 2019 
LIST OF ABBREVIATIONS 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AIS 
Acute Ischemic Stroke 
AMC-LDS 
Academic Medical Center – Linear Disability Score 
A-P 
Anterior-Posterior 
ASPECTS 
Alberta Stroke Program Early Computed Tomography Score 
CDA 
Confidentiality Agreement 
CEC 
Clinical Events Committee 
CFR 
Code of Federal Regulations 
CMP 
Clinical Monitoring Plan 
CIP 
Clinical Investigation Plan 
CRO 
Contract Research Organization 
CTA 
Clinical Trial Agreement 
CT 
Computed Tomography 
CV 
Curriculum Vitae 
DSMB 
Data Safety Monitoring Board 
eCRF 
Electronic Case Report Form 
EDC   
Electronic Data Capture   
EVT 
Endovascular Treatment 
FDA   
Food and Drug Administration   
GCP   
Good Clinical Practice   
GFR 
Glomeruler Filtration Rate 
IA 
Intra-arterial 
ICF   
Informed Consent Form   
ICH   
Intracranial Hemorrhage   
ID 
Identification 
IDE 
Investigational Device Exemption 
IFU   
Instructions for Use   
INR 
International Normalized Ratio 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
ITT 
Intent To Treat 
IV   
Intravenous   
IV t-PA   
Intravenous tissue plasminogen activator   
LAR 
Legally Authorized Representative 
LVO 
Large Vessel Occlusion 
MDR 
Medical Device Reporting 
MRI   
Magnetic Resonance Imaging   

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TIGER study, version 3.0 Dec 12, 2019 
mRS   
Modified Rankin Score   
mTICI   
modified Thrombolysis in Cerebrovascular Infarction   
NIH   
National Institutes of Health   
NIHSS   
National Institutes of Health Stroke Score   
PG 
Performance Goal 
PI   
Principal Investigator   
PRO 
Patient Reported Outcome 
PT 
Prothrombin Time 
PTT 
Partial Thromboplastin Time 
RFA 
Rankin Focused Assessment 
RHV 
Rotating Hemostatic Valve 
rt-PA 
Recombinant Tissue Plasminogen Activator 
SAE   
Serious Adverse Event 
SADE   
Serious Adverse Device Effect   
sICH 
Symptomatic Intracranial Hemorrhage 
SOC 
Standard of Care 
TICI   
Thrombolysis in Cerebrovascular Infarction   
TIMI   
Thrombolysis in Myocardial Infarction   
UADE   
Unanticipated adverse device effect   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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PROTOCOL SUMMARY 
 
Title 
Treatment with Intent to Generate Endovascular Reperfusion 
Short title 
TIGER Study 
Sponsor 
Rapid Medical 
Coordinating 
Principal 
Investigators 
Dr. Jeffrey L. Saver 
Geffen School of Medicine at UCLA 
Director, UCLA Comprehensive Stroke Center 
710 Westwood Plaza 
Los Angeles, CA 90095, USA. 
 
Dr. Rishi Gupta 
WellStar Medical Group  
Neuroscience  
Atlanta, GA 
Investigational 
Product 
Tigertriever Mechanical Revascularization Device 
Objective 
The objective of the TIGER Study is to evaluate the safety and 
effectiveness of the Tigertriever device in restoring blood flow in the 
neurovasculature by removing thrombus in patients experiencing ischemic 
stroke due to a large vessel occlusion (LVO). This study is designed to 
support substantial equivalence to approved and marketed products such 
as the Solitaire or Trevo Retriever. 
Study Design 
This study is a US and EU, multicenter, single arm, prospective IDE study 
to evaluate the safety (defined as all cause mortality) and effectiveness of 
the Tigertriever Revascularization Device in Acute Ischemic Stroke (AIS) 
patients ineligible for IV t-PA treatment or who fail IV t-PA therapy. 
Device 
Description 
and Intended 
Use 
Tigertriever is a CE marked mechanical revascularization device. The 
Tigertriever Revascularization Device is indicated to restore blood flow by 
removing thrombus from a large intracranial vessel in patients experiencing 
ischemic stroke within 8 hours of symptom onset. Patients who are 
ineligible for IV t-PA or who fail IV t-PA therapy are candidates for 
treatment. 
Primary 
Endpoints 
Effectiveness: Successful reperfusion, defined as mTICI Score ≥ 2b at the 
end of the Tigertriever revascularization procedure. 
Safety: Composite of all-cause mortality at 90 (±14) days and symptomatic 
intracranial hemorrhage (sICH) within 24 (18-36) hours of the study procedure. 
Secondary 
Endpoints 
Effectiveness:  
 
Good Clinical Outcomes- Percentage of participants with a modified 
Rankin Scale (mRS) score of ≤2 at 90 (±14) days post treatment. 

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TIGER study, version 3.0 Dec 12, 2019 
 
Successful reperfusion (defined as mTICI 2b or better) at first pass.  
 
Health related quality of life (EQ-5D score) 
 
Degree of disability (Academic Medical Center – Linear Disability 
Scale score)  
Safety:  
 
Any asymptomatic intracranial hemorrhage within 24h (18h-36h) of 
the procedure 
 
Neurological deterioration (≥4-point increase in NIHSS score) at 24h 
(18h-36h) post-procedure. 
 
Embolization to previously uninvolved vascular territories, 
Number of Subjects: 
The maximum Sample size is 160, including 
up to 60 lead-in Subjects (up to 4 per site). 
Lead-in Subjects will be used for endpoint 
analysis. 
Number of Study Centers: 
Up to 25 centers total in the US and EU 
Population  
The TIGER Study will include male or female patients age 18-85 who 
present with acute ischemic stroke due to a large vessel occlusion 
confirmed by vessel imaging. 
Inclusion 
Criteria 
1.  New focal neurologic deficit consistent with being of acute 
cerebral ischemia origin. 
2. Age 18-85 years old (inclusive). 
3. Interventionalist estimates that treatment with the 
Tigertriever (first deployment in target vessel) can be 
achieved within 8 hours of symptom onset. 
4. Patient either: a) eligible for, and received, IV t-PA within 3 
hours of symptom onset, at the correct 0.9 mg/kg dose, or 
b) ineligible for IV t-PA.  
5.  NIH Stroke Scale score of 8-29. 
6.  No known significant pre-stroke disability (prestroke mRS 
0 or 1). 
7. Catheter angiographic confirmation of a large vessel 
occlusion in the intracranial internal carotid artery, the M1 
or M2 segments of the middle cerebral artery, the 
intracranial vertebral artery, or the basilar artery that is 
accessible to Tigertriever device. 
8. For strokes in the anterior circulation, the following 
imaging criteria should also be met:  
a. MRI criterion: volume of diffusion restriction visually 
assessed ≤50 mL, OR  
b. CT criterion: ASPECTS 6 to 10 on baseline NCCT or 
CTA-source images,  
 
9. For strokes in the posterior circulation, the following 

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TIGER study, version 3.0 Dec 12, 2019 
imaging criterion should also be met: pcASPECTS score 8 
to 10 on baseline NCCT, CTA-source images, or DWI 
MRI. 
10. 
Anticipated life expectancy of at least 6 months. 
11.  A signed informed consent by patient or a Legally 
Authorized Representative or independent physician in 
case of oral consent. 
 
Exclusion 
Criteria 
1. Subject already participating in another study of an 
investigational treatment device or treatment. 
2. Use of any other intra-arterial recanalization drug or 
device prior to the Tigertriever (Tigertriever not as first 
choice device).  
3. Angiographically evident excessive arterial tortuosity 
precluding device access to the thrombus.  
4. For all patients, severe sustained hypertension with SBP 
>220 and/or DBP >120; for patients treated with IV tPA, 
sustained hypertension despite treatment with SBP >185 
and/or DBP > 110.  
5. Glucose < 50 mg/dl (2.78 mmol/L)  or > 400 mg/dl (22.20 
mmol/L). 
6. Known hemorrhagic diathesis.  
7. Coagulation factor deficiency or oral anti-coagulant 
therapy with an international normalized ratio (INR) of 
more than 3.0.  
8. Treatment with heparin within 48 h with a partial 
thromboplastin time more than two times the laboratory 
normal.  
9. Patients who have received a direct thrombin inhibitor 
within the last 48 hours; must have a partial 
thromboplastin time (PTT) less than 1.5 times the normal 
to be eligible. 
10. Platelet count of less than 50,000/uL.  
11. History of severe allergy to contrast medium, nickel, or   
Nitinol. 
12. Intracranial hemorrhage. 
13. Significant mass effect with midline shift. 
14. Intracranial tumor (apart from small meningioma, ≤ 2 cm 
in diameter). 
15. Stenosis or any occlusion in the deployment site or in a 

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TIGER study, version 3.0 Dec 12, 2019 
proximal vessel requiring treatment or preventing device 
access to the thrombus (for example, stenosis or 
occlusion in the cervical internal carotid artery).  
16. Females who are pregnant or breastfeeding. 
17. Known current use of cocaine at time of treatment. 
18. Prior recent stroke in the past 3 months. 
19. Renal failure with serum creatinine >3.0 or Glomerular 
Filtration Rate (GFR) <30. 
20. Known cerebral vasculitis. 
21. Rapidly improving neurological status defined as 
improvement of greater than 8 points on the NIHSS or 
improvement to NIHSS of < 6 prior to procedure 
22. Clinical symptoms suggestive of bilateral stroke or stroke 
in multiple territories. 
23. Ongoing seizure due to stroke. 
24. Evidence of active systemic infection. 
25. Known cancer with metastases. 
26. Suspicion of aortic dissection, septic embolus, or 
bacterial endocarditis. 
27. Evidence of dissection in the extra or intracranial cerebral 
arteries. 
28. Occlusions in multiple vascular territories (e.g., bilateral 
anterior circulation, or anterior/posterior circulation). 
29. Aneurysm in target vessel. 
 
Study Duration  Enrolment: approximately 24 months 
Follow-up period: 3 months 
 
Statistical 
Analysis 
The primary efficacy endpoint, defined as successful reperfusion with the 
Tigertriever device, will be tested against a performance goal (PG) derived 
from adjudicated trial data for similar devices.   
 
The primary safety endpoint, defined as the composite of all-cause mortality 
at 90 days and symptomatic intracranial hemorrhage (sICH) at 24 hours, 
will be tested against a performance goal (PG) derived from the same set of 
trials. 
 
Secondary efficacy and safety endpoints will not be subject to hypothesis 
testing but will be examined using confidence intervals to characterize the 
relevant population parameter. 
 
 

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TIGER study, version 3.0 Dec 12, 2019 
Schedule of Events 
Elapsed 
time/Study 
procedures 
Baseline Procedure 24 hours 
(-6/+12) 
48 
hours 
(±12) 
Discharge 
or 4 days 
30 
(±7) 
days 
90 
(±14) 
days 
Informed Consent 
X 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
Medical History and 
Concomitant 
Medications 
X 
 
 
 
 
 
 
Time of Stroke 
Symptoms Onset 
X 
 
 
 
 
 
 
Brain CT Scan or MRI 
X 
 
X 
 
 
 
 
Vital Signs 
X 
X 
X 
 
X 
 
 
NIH Stroke Scale 
X 
 
X 
X 
X 
 
X 
Premorbid mRS score 
X 
 
 
 
 
 
 
mRS score 
 
 
 
 
X 
X 
X 
Clinical Laboratory 
X 
 
 
 
 
 
 
Time of groin puncture 
 
X 
 
 
 
 
 
Cath angiography and 
clot retrieval 
 
X 
 
 
 
 
 
mTICI Outcome 
 
X 
 
 
 
 
 
Functional activity 
questionnaire- Barthel 
Index 
 
 
 
 
 
X 
X 
Patient-Reported 
Outcomes (EQ-5D, 
AMC-LDS) 
 
 
 
 
 
 
X 
Prior/concomitant 
medications 
X 
X 
X 
X 
X 
X 
X 
AE (including 
hemorrhage other 
than sICH) 
 
X 
X 
X 
X 
X 
X 
 
 
 

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TIGER study, version 3.0 Dec 12, 2019 
Summary of Investigational Plan Changes 
 
Revision History 
Effective Date 
01 
01Jan2018 
02 
01Mar2018 
03 
 
 
Revision 02, 06Feb2018 
Section 
Change From 
Change To 
Rationale for Change 
3.1.2- 
Secondary 
Endpoint 
 
Added secondary 
effectiveness 
endpoint- 
- Health related quality 
of life (EQ-5D score)  
- Degree of disability 
(Academic Medical 
Center Linear 
Disability Scale score)  
 
 
Correction in response to 
conditions noted on FDA 
letter dated 04Feb2018 
3.2.1- 
Prinary 
Endpoint 
All- cause 
mortality at 90 
(±14) days 
Composite of all-cause 
mortality at 90 (±14) 
days and symptomatic 
intracranial 
hemorrhage (sICH) 
within 24 (18-36) 
hours of the study 
procedure 
Correction in response to 
conditions noted on FDA 
letter dated 04Feb2018 
3.2.2- 
Secondary 
Endpoint 
 
Added secondary 
safety endpoint- 
Embolization to 
previously uninvolved 
vascular territories 
 
Correction in response to 
conditions noted on FDA 
letter dated 04Feb2018 
5.4- Lead-in 
Phase 
 
Added- Subjects 
enrolled in the Lead-in 
phase will be 
consented, treated 
and followed 
according to the 
Correction in response to 
conditions noted on FDA 
letter dated 04Feb2018 

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TIGER study, version 3.0 Dec 12, 2019 
Section 
Change From 
Change To 
Rationale for Change 
clinical protocol, in the 
same manner as the 
regular study subjects. 
 
6.2.2-   Exc 
15 
Intracranial tumor 
(apart from small 
meningioma). 
Intracranial tumor 
(apart from small 
meningioma, ≤ 2 cm in 
diameter) 
Correction in response to 
conditions noted on FDA 
letter dated 04Feb2018 
6.2.1- 
Inc 8 
 
1. Added- Inclusion 
Criteria 8- For strokes 
in the anterior 
circulation, the 
following imaging 
criteria should also be 
met:  
a. MRI criterion: 
volume of diffusion 
restriction visually 
assessed ≤50 mL, OR  
b. CT criterion: 
ASPECTS 6 to 10 on 
baseline NCCT or 
CTA-source images. 
2. Added- Inclusion 
Criteria 9 – For strokes 
in the posterior 
circulation, the 
following imaging 
criterion should also 
be met: pcASPECTS 
score 8 to 10 on 
baseline NCCT, CTA-
source images, or DWI 
MRI. 
Deleted Exclusion 
criterion 12. 
Correction in response to 
conditions noted on FDA 
letter dated 04Feb2018 
7.2.4- 
Imaging 
 
Added- ASPECTS and 
pcASPECTS scores. 
 
 In response to conditions noted 
on FDA 
letter dated 04Feb2018 

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TIGER study, version 3.0 Dec 12, 2019 
Section 
Change From 
Change To 
Rationale for Change 
 
7.3.1- 
Angiography 
 
Added- The University 
of California at Los 
Angeles with the 
following address: 
Angiography and 
Noninvasive Imaging 
Core Lab 
David S Liebeskind, 
MD, FAAN, FAHA, 
FANA 
UCLA Department of 
Neurology 
Neuroscience 
Research Building 
635 Charles E Young 
Drive South, Suite 225 
Los Angeles, CA 
90095-7334 
 
Added Core Lab information 
7.3.2- 
Device 
preparation, 
delivery and 
positionong, 
7.3.3- 
Retrieval  
 
 
Precautions and clear 
instructions were added, in 
response to conditions noted on 
FDA 
letter dated 04Feb2018. The 
instructions are for determining 
whether there are an unseen 
stenosis or small caliber 
bifurcation in the deployment 
site, including angiographic 
confirmation.  
8- Statistical 
Analysis 
 
 
Statistical Analysis section was 
changed, according to FDA 
letter dated 04Feb2018. 
Performance goal was revised 
(8.2) and subgroup analysis was 
added (8.5). 
9.2- Main 
Potential 
Risks 
 
Added risk of ionizing 
radiation exposure 
Correction in response to 
conditions noted on FDA 
letter dated 04Feb2018 
11.6- Data 
and Safety 
 
Added- All AEs 
observed by the site 
Correction in response to 
conditions noted on FDA 

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TIGER study, version 3.0 Dec 12, 2019 
Section 
Change From 
Change To 
Rationale for Change 
Monitoring 
Board 
investigators will be 
reported to the DSMB 
for periodic review. 
letter dated 04Feb2018 
7.       Table 
4 
 
 
Minor corrections and 
clarifications 
 
Revision 03, 12Dec2019 
Section 
Change From 
Change To 
Rationale for Change 
Protocol 
Summary 
Sample size 185 plus up to 
60 lead-in Subjects.  Lead-in 
Subjects will not be used for 
endpoint analysis. 
 
Sample size 160, 
including up to 60 lead-
in subjects. Lead-in 
Subjects will be used 
for endpoint analysis. 
 
Sample size recalculation 
due to including the lead-in 
subjects in endpoint 
analysis and skipping the 
planned efficacy interim 
analysis. See explanations 
below. 
Protocol 
Summary 
Enrollment duration 18 
months 
Enrollment duration 24 
months 
Based on actual enrollment 
rate. 
5.1.1 
Enrollment 
and Informed 
Consent 
 
Added: Consent can be 
obtained electronically 
(Electronic Informed 
Consent) 
Allowing electronic informed 
consent (HIPPA Compliant 
and IRB approved) can 
avoid unnecessary waiting 
time for the legally 
authorized representative 
(LAR) of the subject to 
physically arrive and sign 
the consent. The electronic 
informed consent form will 
have the identical 
information as the paper 
form. 
5.4 Lead-in 
Phase 
Lead -in Subjects will be 
summarized separately and 
will not contribute to the 
study’s statistical evaluation 
of its primary endpoints. 
Lead -in Subjects will 
be included in the 
study’s statistical 
evaluation of its primary 
endpoints. 
Per FDA’s request, lead-in 
subjects will be included in 
the primary analysis. 
8.1 General 
Principles 
The primary analysis cohort 
will include all data collected 
for all enrolled Subjects 
(minus Lead-in) 
The primary analysis 
cohort will include all 
data collected for all 
enrolled Subjects 
Per FDA’s request, lead-in 
subjects will be included in 
the primary analysis. 
8.1 General 
Principles 
SAS software version 9.3 or 
higher, R version 3.2 or 
higher 
SAS software version 
9.4 or higher, R version 
3.3 or higher 
SAS and R have been 
updated to new versions. 

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TIGER study, version 3.0 Dec 12, 2019 
Section 
Change From 
Change To 
Rationale for Change 
8.2 Primary 
endpoint 
In the presence of the 
planned midway interim 
analysis, the actual alpha 
levels used to declare 
significance at each analysis 
will be as defined below. 
Deleted 
 
FDA requested that Lead in 
cases be included in the 
primary analysis sample.  
Since Lead in cases are 
now to be included, the 
company will now reach full 
enrollment necessary to test 
the hypothesis more quickly 
than originally anticipated.  
For this reason, the interim 
analysis is no longer 
necessary.  The study 
protocol and sample size 
will therefore be adjusted 
accordingly.  Elimination of 
the interim analysis results 
in a slight reduction in the 
required sample size, as 
described below.   
8.4 Sample 
size and 
Power 
With a hypothesized 
incidence rate of 75% for 
revascularization post-
procedure and desired 
power of 80%, and 
incorporating the planned 
midway interim analysis, the 
required evaluable sample 
size for primary efficacy is 
137, or a total of 169 after 
adjustment for potential 
missing data or 
misspecification of the 
hypothesized rate.  For 
primary safety, under a 
hypothesized incidence rate 
of 20% for the composite 
endpoint and desired power 
of 80%, the corresponding 
required evaluable sample 
size is 150, or 185 after 
adjustment.  As 185 is the 
larger of these two values, 
this will be the final required 
sample size after accounting 
for up to 10% attrition and an 
additional 10% as a 
safeguard against 
misidentification of the 
anticipated event rates. 
With a hypothesized 
incidence rate of 75% 
for revascularization 
post-procedure and 
desired power of 80%, 
and using an exact 
binomial test with a 
nominal 0.025 one-
sided significance level 
(equivalent to a two-
sided alpha=0.05), the 
required evaluable 
sample size for primary 
efficacy is 135.  For 
primary safety, under a 
hypothesized incidence 
rate of 20% for the 
composite endpoint 
and desired power of 
80%, the corresponding 
required evaluable 
sample size is 153.  As 
153 is the larger of 
these two values, this 
will be the required 
evaluable sample size 
to reach at least 80% 
power for both 
effectiveness and 
safety analyses.  
Since there would be no 
interim analysis, the type 1 
error adjustment to account 
multiplicity is no longer 
required.  In addition, based 
on the currently available 
patient follow-up data, very 
few losses to follow-up are 
expected.  Therefore, the 
Sponsor proposes to update 
the sample size calculation. 

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TIGER study, version 3.0 Dec 12, 2019 
Section 
Change From 
Change To 
Rationale for Change 
 
Table 7: Hypothesized 
reperfusion rate, 
safety event rate and 
sample size 
requirements. 
Hypothesized 
reperfusion 
rate 
Total 
sample 
size 
required 
73% 
257 
74% 
202 
75% 
169 
76% 
142 
77% 
122 
 
The above table expresses 
various sample sizes for 
efficacy under varying 
hypothesized reperfusion 
rates.  Similar variability 
applies to the safety 
objective.  As expected, 
substantial variance is 
present in sample size 
based on different 
reperfusion assumptions.  
While this risk is present in 
all study design, the 
presence of the planned 
interim analysis mitigates the 
risk of misidentifying 
reperfusion effectiveness, as 
partial results will be known 
prior to study completion.  
Under the hypothesized 
reperfusion rate of 75%, the 
sample size is 169 for 
efficacy as shown above, 
with total sample size set at 
185 as above to power for 
safety. 
Considering a 5% loss 
to follow-up rate, which 
is consistent with the 
observed follow-up rate 
to date, the Sponsor 
proposes to adjust the 
total sample size to 
160. 
 

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TIGER study, version 3.0 Dec 12, 2019 
Section 
Change From 
Change To 
Rationale for Change 
8.8 Interim 
and Final 
Analysis 
Interim and Final Analysis 
Indicated that there will 
not be an interim 
analysis 
See rationale for elimination 
interim analysis in the 
previous changes in this 
table 
11.6 DSMB 
Stated that DSMB will apply 
the pre-specified interim 
analysis 
Deleted 
There will be no interim 
analysis. 
12 Study 
Monitoring 
The TIGER Study contains a 
Lead-in cohort that will be 
monitored for safety only. 
Deleted 
As noted above, the lead-in 
subjects will be included in 
the primary analysis. 
 
 
 

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TIGER study, version 3.0 Dec 12, 2019 
Table of Contents 
1. 
INTRODUCTION AND BACKGROUND 
22 
1.1 
Clinical and Economic Impact of Stroke 
22 
1.2 
Current Stroke Treatments 
23 
1.2.1 
Thrombolytics 
23 
1.2.2 
Mechanical Thrombectomy 
24 
1.3 
Clinical Outcomes in Recent AIS Studies 
24 
1.4 
Ethical Consideration 
25 
2. 
DEVICE DESCRIPTION 
26 
2.1 
Investigational Device 
26 
2.1.1 
Device Intended Use 
27 
2.1.2 
Labeling 
27 
3. 
STUDY OBJECTIVES 
27 
3.1 
Effectiveness Endpoints 
27 
3.1.1 
Primary Endpoint 
27 
3.1.2 
Secondary Endpoints 
28 
3.2 
Safety Endpoints 
28 
3.2.1 
Primary Endpoint 
28 
3.2.2 
Secondary Endpoints 
28 
4. 
ENDPOINT JUSTIFICATION AND RATIONALE 
28 
5. 
SITES AND SUBJECTS 
29 
5.1 
Subjects 
29 
5.1.1 
Enrolment and Informed Consent 
29 
5.1.2 
Study Subject Numbering 
31 
5.1.3 
Subject Terminations 
31 
5.2 
Site Selection 
32 
5.3 
Site Training and Initiation 
32 
5.3.1 
Training 
32 
5.3.2 
Initiation 
33 
5.4 
Lead-in Phase 
33 
6. 
STUDY DESIGN 
33 

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TIGER study, version 3.0 Dec 12, 2019 
6.1 
Study Duration 
34 
6.2 
Subject Inclusion/Exclusion Criteria 
34 
6.2.1 
Inclusion Criteria 
34 
6.2.2 
Exclusion Criteria 
35 
7. 
STUDY PROCEDURES 
36 
7.1 
Study 
36 
7.2 
Screening and Baseline Visit 
38 
7.2.1 
General Medical Evaluation 
38 
7.2.2 
Laboratory Evaluation 
38 
7.2.3 
Neurologic Evaluation 
38 
7.2.4 
Imaging (Brain CT or MRI) 
38 
7.2.5 
Screen Failures 
39 
7.3 
Procedure 
39 
7.3.1 
Angiography 
39 
7.3.2 
Device Preparation, Delivery, & Positioning 
39 
7.3.3 
Retrieval 
41 
7.4 
24 Hour (-6/+12) Follow-up 
42 
7.5 
48 Hour (± 12h) Follow-up 
42 
7.6 
Day 4 or Discharge 
43 
7.7 
30 days (± 7 days), can be performed over the phone 
43 
7.8 
90 days (± 14 days) 
43 
7.9 
Unscheduled Visits 
43 
7.10 
Adverse Events 
43 
7.11 
Clinical Outcomes Assessment 
45 
8. 
STATISTICAL ANALYSIS 
45 
8.1 
General Principles 
45 
8.2 
Primary Endpoints 
45 
8.3 
Secondary Endpoints 
47 
8.4 
Sample Size and Power 
48 
8.5 
Subgroup Analysis 
48 
8.6 
Missing Data 
48 

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8.7 
Poolability Across Investigational Sites 
48 
8.8 
Interim  Analysis 
49 
8.9 
Deviations from the Statistical Plan 
49 
9. 
RISK/BENEFIT ANALYSIS 
49 
9.1 
Main Potential Benefits of the Tigertriever: 
49 
9.2 
Main Potential Risks: 
50 
9.2.1 
Minimization of Risk 
50 
10. DEVIATIONS FROM THE CLINICAL INVESTIGATION PLAN 
51 
10.1 
Protocol Deviations 
51 
10.2 
Major and Minor Protocol Deviations 
51 
11. SAFETY AND ADVERSE EVENTS 
52 
11.1 
Adverse Event Data Collection 
52 
11.2 
Definitions 
52 
11.2.1 
Adverse Events 
52 
11.2.2 Adverse Device Effect 
53 
11.2.3 Serious Adverse Events 
53 
11.2.4 Serious Adverse Device Effect 
53 
11.2.5 Anticipated Adverse Device Effect 
53 
11.2.6 Unanticipated Adverse Device Effect 
53 
11.2.7 Procedure-Related 
54 
11.2.8 Device-Related 
54 
11.3 
Determination of Event Severity and Relatedness 
55 
11.4 
Event Notification 
55 
11.5 
Clinical Events Committee 
55 
11.6 
Data and Safety Monitoring Board 
56 
12. STUDY MONITORING 
56 
12.1 
Source Documentation 
57 
12.2 
Access to Source Documents 
57 
13. DATA COLLECTION AND OWNERSHIP 
57 
13.1 
Protected Health Information and Confidentiality 
57 
13.2 
Data Management 
58 

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13.3 
Electronic Case Report Forms 
58 
13.4 
Record Retention and Storage 
58 
13.4.1 
Sponsor Record Retention 
58 
13.4.2 
Investigator Record Retention 
58 
13.5 
Publication Policy 
59 
14. AUDITS OR INSPECTIONS 
59 
15. REFERENCES 
59 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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TIGER study, version 3.0 Dec 12, 2019 
1. INTRODUCTION AND BACKGROUND 
 
Early recanalization of occluded vessels in acute ischemic stroke (AIS) either by intravenous 
(IV) thrombolysis or endovascular revascularization has been shown to be associated with 
improved clinical outcome and reduced mortality1. Initial works on endovascular treatment 
(EVT) of AIS were published in the 1980s. Since then, the endovascular techniques for AIS 
treatment have tremendously improved, advancing from intra-arterial (IA) administration of 
thrombolytic drugs to first-generation mechanical thrombectomy devices (Merci clot retriever 
and Penumbra clot aspiration) and more recently to second-generation mechanical 
thrombectomy devices (stent-retrievers). The introduction of more advanced tools and 
techniques for EVT for AIS has improved its efficacy and safety. 
1.1 Clinical and Economic Impact of Stroke 
 
Stroke is focal injury to the brain due to blockage or rupture of a blood vessel. Ischemic 
stroke is most common, and is caused by a clot blocking an artery supplying blood to a 
specific territory of the brain, preventing delivery of oxygen and nutrients. Hemorrhagic 
stroke is less common, and is caused by a burst blood vessel resulting in blood leak into 
or around the brain. In the United States, ischemic strokes account for 87 percent of all 
strokes, intracerebral hemorrhage for 10 percent, and subarachnoid hemorrhage for 3 
percent2. 
 
Stroke is the third most common cause of worldwide death, after myocardial infarction 
and cancer, the second leading cause of death for people above the age of 60, and the 
fifth leading cause in people aged 15 to 59. Stroke is also the single most common 
reason for permanent disability worldwide3. 
 
Stroke has reached epidemic proportions. One in 6 people worldwide will have a stroke 
in their lifetime. Fifteen million people worldwide suffer a stroke each year and 5.8 million 
people die from stroke. Many stroke survivors suffer from permanent disability. 
Furthermore, survivors of a first stroke are at high risk for a second attack. The burden of 
stroke is high in both human and economic terms, and action to curb the worldwide trend 
is clearly of high priority. In the United States alone, stroke afflicts approximately 
800,000 patients annually. Total stroke costs (direct and indirect) of treating stroke in the 
US is approximately $34 billion each year4. Given the medical and economic burdens 
associated with stroke, there is an imminent need to develop therapeutic options that 
manage and treat acute ischemic stroke in a timely, safe and effective manner. 
 
In AIS, the acute blockage of blood flow (ischemia) to brain cells leads to rapid neuronal 
injury and death.  
 
In patients experiencing a typical large vessel AIS, 1.9 million neurons are destroyed in 
each minute. Compared with the normal rate of neuron loss in brain aging, the ischemic 
brain ages 3.6 years each hour without treatment5. AIS leads to regions of brain tissue 

TIGER Study 
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TIGER study, version 3.0 Dec 12, 2019 
with no blood supply and at a risk of permanent tissue damage. However, this 
progressive tissue injury can be stopped if timely reperfusion is achieved. Thus, the 
fundamental goal of AIS treatment is to rapidly restore vascular perfusion in the brain by 
opening up (recanalizing) the occluded vessels. Early and effective recanalization leads 
to reperfusion of ischemic brain tissue thus preventing further tissue /loss6,7,8. Effective 
recanalization is also strongly associated with improved functional outcomes and 
reduced mortality9,10 ,11. Successful recanalization is associated with a 4 to 5-fold 
increase in the odds of good final functional outcome and a 4 to 5 fold reduction in the 
odds of death8. Because of the rapid ischemic cell death that AIS causes, earlier 
initiation of AIS treatment is crucial to maximize therapeutic benefit12,13,14. Immediate 
therapeutic intervention is critical because a delay in treatment significantly reduces the 
probability of good clinical outcomes for the patient10. 
 
Thus, the ideal therapeutic intervention is one that can be effectively used immediately 
after symptom onset, restores vascular perfusion and leads to good functional 
outcomes. 
1.2 Current Stroke Treatments 
1.2.1 
Thrombolytics 
 
Currently available treatment options for AIS focus on restoring cerebral perfusion to 
the affected area as quickly as possible, thereby reducing or preventing brain infarction 
and minimizing long-term disability and stroke-related mortality15. Recanalization is a 
powerful predictor of stroke outcome in patients with arterial occlusion treated with 
either IV recombinant tissue plasminogen activator (rt-PA) or an endovascular 
approach9. 
 
IV fibrinolysis within 3-4.5 hours after stroke onset is the reference therapy for acute 
ischemic stroke in the Western world. Many predictors of success or failure have been 
reported in relationship to this treatment16. IV-administered t-PA (IV t-PA) has been 
proven in clinical trials to be effective in improving clinical outcome and reducing 
subsequent disability. However, the percentage of patients with ischemic stroke who 
indeed are treated with thrombolytic therapy is exceedingly low, ranging from 2% to 
3% in the United States to 4% in Europe17, primarily because of the narrow time 
window required from symptom onset to drug administration and the potential for 
intracranial hemorrhage. Moreover, thrombi within large vessels, which account for 
35% of ischemic strokes18, are relatively resistant to plasminogen activators and IV 
thrombolysis alone often does not result in rapid recanalization19,20. These limitations 
have led to the exploration of alternative or complementary treatment approaches for 
AIS.  
 
 
 

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1.2.2 
Mechanical Thrombectomy 
 
Endovascular mechanical thrombectomy has developed over the past 15 years as a 
safe and effective intervention21,22,23,24. Rapid advancement in catheter-based and 
endovascular device technology has led to an increasing number of patients with AIS 
being treated when IV t-PA is ineffective or contraindicated25. 
 
Several types of devices and different techniques have been used for clot retrieval, 
including looped or corkscrew-like devices, snares or micro-forceps, suction devices, 
and columnar meshes or retrievable stents. With the aim of improving on the clinical 
outcomes achieved with the first-generation thrombus retriever devices, introduced in 
2004, stent-based retrievers have been developed more recently. Recent 
studies26,27,28,29,30 have reported significant superiority of stent-based retrievers 
compared with “non-stent” devices from both the clinical and technical aspects. 
Endovascular mechanical thrombectomy devices offer many potential advantages over 
pharmacologic thrombolysis, including more rapid achievement of recanalization, 
enhanced efficacy in treating large-vessel occlusions, and a potentially lower risk for 
hemorrhagic events31. Stent-based thrombus retrievers have been found to provide a 
safe and reliable treatment option for patients presenting with AIS17,32.  The concept of 
stent retrievers combines the advantages of intracranial stent deployment with 
immediate flow restoration and a thrombectomy device with definitive clot removal 
from the occluded artery. The complete removal of the device avoids the major 
disadvantages associated with permanent stent implantation, such as the need for 
double anti-platelet medication which potentially increases the risk of hemorrhagic 
complications33. 
1.3 Clinical Outcomes in Recent AIS Studies 
 
Data from recent clinical studies indicate that endovascular thrombectomy reduces 
disability for patients with large vessel AIS. Analysis shows that modern endovascular 
thrombectomy achieve faster and more complete reperfusion than older devices, leading 
to improved clinical outcomes compared with IV t-PA alone. Benefits are seen across a 
wide range of age and initial stroke severity. 
 
The combination of highly effective reperfusion with modern thrombectomy devices and 
earlier treatment, has transformed large vessel AIS patient outcomes30. 

TIGER Study 
25 
TIGER study, version 3.0 Dec 12, 2019 
T+B3:H14HERAPY  TYPE
Drug/Device
Merci 
Retriever
N
98
58
354
88
629
131
Baseline NIHSS
17
17.3 (4.5%)
18.1 
(6.6%)
18.3 (5.3%)
17.4 
(6.7%)
19
Functional independence (mRS 
≤2) at 90 days)
60%
37%
42%
34 (40%)
277 
(47.9%)
36%
Mortality Rate at 90 days
9%
17%
30%
29 (33%)
106 
(19.8%)
34%
Symptomatic ICH%
0%
2%
9.9%
6 (7%)
44 
(7.1%)
10%
No of Passes. Mean (SD) 
NA
1.7 (0.9)
1.9 (1.1)
2.4 (1.4)
1.9 (1.2)
NA
Solitaire FR
SWIFT 
PRIME Study
Multi MERCI 
trial
MECHANICAL THROMBECTOMY
Complete Successful 
Recanalization as defined per 
protocol
Outcome
SWIFT Study 
(Rand SFR)
Trevo 2 
Study
TRACK 
Registry
Trevo
NASA 
Registry
505 
(80.3%)
23%
88%
69%
256 
(72.5%)
60 (68%)
Table 1: Efficacy and safety outcomes from recent AIS studies34, 35, 28, 22, 11, 26 
 
1.4 Ethical Consideration 
 
The Tigertriever Revascularization Device and the legally marketed comparable devices 
are stent-based thrombus retrieval devices. The MERCI (Concentric Medical, 
Mountainview, CA) was the first stroke mechanical thrombectomy device cleared by the 
US Food and Drug Administration (FDA) in 2004. The MERCI is a flexible corkscrew-
shaped device constructed of nitinol memory wires, designed to remove blood clots form 
the brain in patient with ischemic stroke20. The two subsequent stent-based retrieval 
devices cleared by the FDA were: the Solitaire FR (EV3/Covidien, Irvine, California), 
cleared by FDA in March 2012; and the TREVO Provue (Stryker Neurovascular, 
Kalamazoo, MI), cleared by FDA in August 2012.  
 
The Tigertriever utilizes a design similar to the Solitaire FR and TREVO devices. The 
Tigertriever device has been CE marked in the European Union as of October 2015 and 
approved for use by the Israel Ministry of Health in July 2016. As of October 2016, more 
than 400 Tigertriever units had been sold and used across Europe.  

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TIGER study, version 3.0 Dec 12, 2019 
 
The Tigertriever device is only to be used in the US as part of the TIGER Investigational 
Device Exemption (IDE) Study.  The purpose of the TIGER IDE Study is to gather device 
performance and safety data to support an application for FDA clearance. 
 
2. 
DEVICE DESCRIPTION 
2.1 Investigational Device 
The Tigertriever device is available in two sizes: the Tigertriever and the Tigertriever 17.  
Any mention of the Tigertriever in the current protocol will be inclusive of both the 
Tigertriever and Tigertriever 17 as they are substantially equivalent. The Tigertriever 
Revascularization Device is a stent-based thrombus retrieval device. 
The Tigertriever (Figure 1) is comprised of a collapsible, fully retrievable, fine wire 
construction mounted on a wire shaft that expands to comply with the vessel diameter.  
A finger slide on the handle facilitates precise stent expansion to accommodate vessels 
of variable size. 
 
 
 
Figure 1. Tigertriever Revascularization Device with integrated handle slider (1). 
 
1 

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TIGER study, version 3.0 Dec 12, 2019 
 
 
Table 2:  Tigertriever Revascularization Device 
Specifications and Recommended Sizing Guidelines 
Model 
(Cat. 
Number) 
Recommended 
Vessel 
Diameter# [mm] 
Microcatheter 
Compatibility 
Net 
Length 
 
MC Inner 
Dameter 
MC Outer 
Diameter 
min 
max 
[inch] 
[French] 
[mm] 
Tigertriever 
(TRPP3155) 
1.5 
6.0 
Headway 21 
0.021 
OD 
Prox./Distal 
2.5/2  
32 
Tigertriever 
17 
(TRPP3166) 
0.5 
3.0 
Headway 17 
0.017 
OD 
Prox./Distal 
2.4/1.7  
23 
# Choice of Tigertriever Revascularization Device is based on the sizing 
recommendations listed in this table and diameter of smallest vessel at thrombus 
site. 
2.1.1 
Device Intended Use 
The Tigertriever Revascularization Device is indicated to restore blood flow by 
removing thrombus from a large intracranial vessel in patients experiencing ischemic 
stroke within 8 hours of symptom onset. Patients who are ineligible for IV t-PA or who 
fail IV t-PA therapy are candidates for treatment. 
2.1.2 
Labeling 
The Tigertriever device is considered investigational and is required to be used per the 
protocol and as specified in the Instructions for Use (IFU) document (attached as 
Appendix A).  The device is CE marked and currently available for purchase in Europe. 
With the exception of the indication statement, no other changes have been made to 
the device labeling. 
 
3. 
STUDY OBJECTIVES 
 
The TIGER Study primary objective is to evaluate the safety and effectiveness of the 
Tigertriever device in restoring blood flow by removing clots in patients who present with AIS 
due to a large vessel occlusion (LVO). 
3.1 Effectiveness Endpoints 
3.1.1 
Primary Endpoint 
 
Successful reperfusion, defined as mTICI Score ≥ 2b at the end of the 
Tigertriever procedure. 

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TIGER study, version 3.0 Dec 12, 2019 
3.1.2 
Secondary Endpoints 
 
Good Clinical Outcomes- Percentage of participants with a modified Rankin Scale 
(mRS) score of ≤2 at 90 (±14) days post treatment. 
 
Successful reperfusion (defined as mTICI 2b or better) at first pass.  
 
Health related quality of life (EQ-5D score) 
 
Degree of disability (Academic Medical Center – Linear Disability Scale score)  
3.2 Safety Endpoints 
3.2.1 
Primary Endpoint 
 
 
Composite of all-cause mortality at 90 (±14) days and symptomatic intracranial 
hemorrhage (sICH) within 24 (18-36) hours of the study procedure. Symptomatic 
intracranial hemorrhage (sICH) shall be defined as any parenchymal 
hematoma type 2, remote intracerebral hemorrhage, subarachnoid 
hemorrhage, or intraventricular hemorrhage that is the predominant cause of 
≥4 point NIHSS deterioration at 24 hours  
3.2.2 
Secondary Endpoints 
 
 
 
Any asymptomatic intracranial hemorrhage within 24h (18h-36h) of the 
procedure 
 
Neurological deterioration (≥4-point increase in NIHSS score) at 24h (18h-
36h) post-procedure 
 
Embolization to previously uninvolved vascular territories 
Additionally, for further evaluation of safety, all adverse events recorded during 
study conduct will be tabulated and reported, including classification by 
seriousness and device- and/or procedure-relatedness.  These endpoints will be 
summarized and reported to additionally characterize the clinical performance of 
the Tigertriever device.   
 
4. 
ENDPOINT JUSTIFICATION AND RATIONALE 
 
The study design and endpoint selection reflect the common standard in stroke trials 
evaluating IA therapy (Table 3). There are two major types of outcome measures for acute 
stroke studies: clinical outcome measures and radiographic measures. 
For the primary effectiveness endpoint, the trial will use the broadest and most clinically 
relevant reperfusion scale, the Thrombolysis in Cerebral Infarction Score. This reperfusion 
scale has been used in the great preponderance of recent endovascular trials, such as 
SWIFT, TREVO 2, SWIFT PRIME , NASA registry and Track Registry.  Extensive evidence 
on the validity, reliability and sensitivity of the TICI Score exists across the literature36. 

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TIGER study, version 3.0 Dec 12, 2019 
Additionally, for secondary clinical effectiveness, the study is using the modified Rankin 
Scale (mRS), a clinician-reported measure of global disability that has been widely applied 
for evaluating recovery from stroke and as a primary end-point in many clinical trials of 
emerging acute stroke treatments37. Extensive evidence on the validity, reliability and 
sensitivity of the mRS exists across the literature38. 
In clinical trials that are primarily concerned with recanalization strategies, the safety 
measures should reflect potential side effects of recanalization agents or strategies. The 
study uses safety outcome measures widely employed in acute stroke studies of 
recanalization: mortality and intracranial hemorrhage (ICH), particularly hemorrhage that 
causes clinical deterioration39. 
 
 
5. 
SITES AND SUBJECTS 
5.1 Subjects 
5.1.1 
Enrolment and Informed Consent 
Prior to admission to the study, a patient informed consent form (ICF) will be given to 
each prospective Subject or their Legally Authorized Representative [(LAR); as defined 
Table 3: IA stroke therapy study design and endpoint selection 
Study 
Goal/ Design 
Primary Endpoints 
NASA Registry35 
 
Retrospective, multi-center registry 
Recanalization, Clinical Outcomes 
(mRS 90 d) 
TREVO Study40 
 
Prospective, multi-center trial 
Recanalization, Clinical Outcomes 
(mRS 90 d) 
TREVO 2 Study26 
 
Prospective, Open-label randomized, 
controlled, multi-center trial 
Recanalization, Safety 
MERCI11 
 
Prospective, single-arm, multicenter trial 
Recanalization, Safety 
SWIFT PRIME22 
 
Multicenter, randomized, prospective, 
parallel-group trial 
Clinical Outcomes (mRS 90 d), 
Safety 
SWIFT28  
 
Multicenter, randomized, prospective, 
parallel-group trial 
Recanalization, Safety 
MR CLEAN21 
Multicenter, randomized, prospective, 
parallel-group trial, open-label with 
blinded outcome evaluation 
Clinical Outcomes (mRS 90 d) 
REVASCAT41 
multicenter, randomized, prospective, 
sequential, open-label with blinded 
outcome evaluation 
Clinical Outcomes (mRS 90 d) 
ESCAPE42 
multicenter, randomized, prospective, 
open-label, controlled trial with blinded 
outcome evaluation 
Clinical Outcomes (mRS 90 d) 

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TIGER study, version 3.0 Dec 12, 2019 
by the local Institutional Review Board (IRB) or Ethics Committee (EC)]. The ICF will 
include an explanation of the study, duration, explanation of medical record access and 
patient anonymity, and how their coded data may be transferred, used for publications 
or in submissions for reimbursement support. The ICF will contain language that is 
non-technical and understandable to the patient or his/her LAR. 
 
As the TIGER Study is a stroke treatment study, treatment will likely occur in an acute 
emergency situation.  For this reason, informed consent procedures may vary per site 
IRB/EC requirements. Consent can be obtained electoronically (Electronic Informed 
Consent). 
 
Each potential Subject will be provided with written and verbal information regarding 
the nature of the study in an understandable manner. Adequate time will be allowed 
for the Subject to consider participation in the clinical trial. Signed, written consent 
will be obtained for each Subject prior to data collection and entry into the study. 
Coercion or undue influence of potential Subjects to participate will be avoided, and 
the Subject’s legal rights should not be waived. The Investigator or an appropriately 
designated member of the study staff shall co-sign the consent form, indicating they 
believe the Subject or LAR understands the nature and risks of the study and scope 
of the consent. The Investigator must inform Subjects that they are in a controlled 
clinical trial, apprise them of their rights as set forth in the ICF, and make written 
documentation that such a discussion took place.   
If the Subject is not able to sign the ICF, but has given his/her oral consent to 
participate, a third party can sign the informed consent for the Subject if allowable per 
IRB/EC policy. The consenting process will be documented in the medical record and 
reason for Subject not signing the consent (in case of verbal confirmation). If the Subject 
is not able to give his/her informed consent to participate in the study, a LAR can sign 
the informed consent for the Subject if this is approved by the local IRB/EC.   
Short form informed consent may be utilized if approved by the IRB/EC. Each 
institution must follow their institutional IRB/EC policy for obtaining informed consent. If 
the short form informed consent is used, the summary must include all the basic 
elements of informed consent (21 CFR §50.25; ICH E6 4.8.10).   
The signed consent forms will be retained by the Investigator and made available (for 
review only) to the study monitor and auditor upon request.   
A template ICF is included as Appendix B. 
Subjects are considered enrolled once appropriate informed consent has been 
obtained and a Tigertriever device has first been introduced through the arterial 
sheath.   

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TIGER study, version 3.0 Dec 12, 2019 
5.1.2 
Study Subject Numbering 
 
Sites participating in the TIGER Study will each be assigned a site number prior to 
enrolling Subjects.  Each enrolled Subject will be assigned a Subject number.  Site 
study staff will use the electronic case report form (eCRF) assigned Subject number to 
complete documentation of the screening/enrolment log following appropriate 
consenting.  Subject study identification numbers will consist of the aggregate of site 
number followed by a sequential number, where “01” is the first enrolled Subject as the 
corresponding site. 
5.1.3 
Subject Terminations 
Subjects will be considered discontinued from the study if any of the following occur:   
 
1.  Subject voluntarily withdraws from the study.   Participation in the TIGER Study is 
voluntary.  Subjects may withdraw consent at any time by completing an informed 
withdrawal form.  Reasonable attempts will be made to determine the reason for 
withdrawal of consent.  Data obtained prior to withdrawal enrolled will be included in 
endpoint data analysis, but no data will be obtained subsequent to withdrawal.  
2.  Investigator withdraws Subject from the study due to safety concerns. If, during the 
conduct of research, an Investigator determines that participation in the study may 
increase the hazard to a subject that is not acceptable, an Investigator may withdraw 
the Subject from the study due to safety concerns.   
3.  Lost to Follow Up: In the event that a Subject fails to return for two consecutive  
follow-up visits and is unable to be reached at the Subject’s last know telephone 
number, a certified letter will be sent to the Subject’s last known mailing address to 
remind the Subject of study obligations.  Once all reasonable attempts to contact the 
Subject have been made, including contacting through the Subject’s general 
practitioner, the Subject is considered lost to follow-up.  Each attempt to contact a 
Subject will be documented.   
 
In this study, death is an endpoint event, not an early termination. If, during the 
conduct of the study, a Subject dies, all available information related to the event 
should be obtained.  Within 24 hours from study staff becoming aware of the event, an 
appointed Rapid Medical representative/study monitor should be notified by 
completing the appropriate study termination forms in the Subject’s eCRF.   
 
 
- If death occurs while the Subject is in the hospital, a copy of the death summary 
report should be submitted. If case of autopsy, a copy of the autopsy report 
should also be submitted.   

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TIGER study, version 3.0 Dec 12, 2019 
 
- If death occurs outside the hospital setting, effort should be made to obtain all 
information related to the death along with an Investigator’s summary of the events 
associated with the death.   
 
5.2 Site Selection 
 
The TIGER Study will recruit patients at up to 25 sites across the US and Europe.  At 
least 80% of the centers will be located in US whereas up to 20% of the centers will be 
located in Europe.  Sites will be selected based upon the following criteria: 
1.  Number of stroke procedures annually (min of 30 procedures) 
2.  Qualifications and experience of Investigators 
3.  Dedicated and experienced research team 
4.  Sufficient facilities to conduct stroke procedures 
5.  Previous experience in mechanical thrombectomy procedures and devices 
5.3 Site Training and Initiation 
5.3.1 
Training 
Investigators and Site Personnel will be trained on the Clinical Investigation 
Plan (CIP) prior to site initiation of enrollment.  Training will be documented on 
the Training Log and cover the following topics: 
1.   Study objectives 
2.   CIP review 
3.   Delegation of authority 
4.   Process for Informed Consent as well as IRB/EC requirements 
5.   Electronic case report form use and completion guidelines 
6.   Enrolment procedures 
7.   Protocol Deviation documentation 
8.   AE and SAE event reporting 
9.   Device malfunction reporting 
10.  Tigertriever Instructions for Use 
11.  Device training using a silicon model 
12.  Device accountability 
13.  Image collection and core lab submission 
14.  Investigator responsibilities and obligations 
15.  General Good Clinical Practice (GCP) guidelines 
16.  Regulatory requirements including essential documents 
 

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TIGER study, version 3.0 Dec 12, 2019 
Changes to existing TIGER Study staff responsibilities, as documented on the 
Delegation Log, or addition of new study personnel will require investigational 
plan training, as appropriate. 
5.3.2 
Initiation 
Rapid Medical, or a representative of Rapid Medical, will conduct study 
training as described in section 5.3.1. 
 
Prior to actively recruiting/enrolling Subjects, investigational sites must provide 
the following documentation to Rapid Medical: 
 
1. IRB/EC approval for the Investigational Plan 
2. IRB/EC and sponsor approved Informed Consent Form for the study 
3. Approval/notification from competent authority, as applicable 
4. Investigator(s’) curriculum vitae (CV) 
5. Financial Disclosure(s) for the PI and Sub-I(s) 
6. Signed Clinical Trial Agreement (CTA) including Confidentiality Agreement  
7. Training Log documentation to verify the appropriate study staff has been 
trained on the protocol, device, eCRFs and study conduct. 
Sites will be officially notified of site activation through receipt of an activation 
letter or email. 
5.4 Lead-in Phase 
All Investigators will be trained on use of the Tigertriever Revascularization Device prior 
to conduct of any procedures on Subjects.  A lead-in phase will precede enrolment of 
patients for primary endpoint analysis. During this phase, up to 4 patients per clinical site 
will be enrolled.  The Lead-in phase will be completed by the site either: 1)  achieving 
two successive successful reperfusions (mTICI 2b or higher), or 2) performing 4 cases, 
with case review and approval by the Central Neurointerventionalist Principal 
Investigator. Subjects enrolled in the Lead-in phase will be consented, treated and 
followed according to the clinical protocol, in the same manner as the regular study 
subjects. 
Lead -in Subjects will be included in the study’s statistical evaluation of its primary 
endpoints. 
 
6. 
STUDY DESIGN 
The TIGER Study is a multi-center, single arm, prospective IDE study.  The study will 
accumulate data in order to evaluate the safety and effectiveness of the Tigertriever 
mechanical revascularization device. 

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TIGER study, version 3.0 Dec 12, 2019 
The study will enroll patients experiencing AIS due to a LVO who are either refractory to or 
ineligible for IV t-PA treatment. Patients must meet all inclusion criteria and none of the 
exclusion criteria in order to be enrolled into the study. 
Device performance in this study will be compared with criteria performance goal derived 
from five recent studies of predicate stent-retriever devices, specifically TREVO 2, SWIFT, 
MR CLEAN, ESCAPE and REVASCAT. 
 
6.1 Study Duration 
 
All patients who are treated with the Tigertriever will be followed for 90 (±14) days 
post-procedure. 
6.2 Subject Inclusion/Exclusion Criteria 
Subjects are considered enrolled in the TIGER Study only after having met all 
inclusion/exclusion criteria, being properly consented, and having a Tigertriever device 
first introduced through the arterial sheath. 
6.2.1 
Inclusion Criteria 
Subjects must meet all of the following inclusion criteria: 
1.  New focal neurologic deficit consistent with being of acute cerebral ischemia 
origin. 
2. Age 18-85 years old (inclusive). 
3. Interventionalist estimates that treatment with the Tigertriever (first deployment 
in target vessel) can be achieved within 8 hours of symptom onset. 
4. Patient either: a) eligible for, and received, IV t-PA within 3 hours of symptom 
onset, at the correct 0.9 mg/kg dose, or b) ineligible for IV t-PA. 
5.  NIH Stroke Scale score of 8-29. 
6.  No known significant pre-stroke disability (prestroke mRS 0 or 1). 
7. Catheter angiographic confirmation of a large vessel occlusion in the 
intracranial internal carotid artery, the M1 or M2 segments of the middle 
cerebral artery, the intracranial vertebral artery, or the basilar artery that is 
accessible to Tigertriever device. 
8.For strokes in the anterior circulation, the following imaging criteria should also 
be met:  
a. MRI criterion: volume of diffusion restriction visually assessed ≤50 mL, OR  
b. CT criterion: ASPECTS 6 to 10 on baseline NCCT or CTA-source images,  
 
9. For strokes in the posterior circulation, the following imaging criterion should 
also be met: pcASPECTS score 8 to 10 on baseline NCCT, CTA-source 
images, or DWI MRI. 
 
10. 
Anticipated life expectancy of at least 6 months. 

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11. A signed informed consent by patient or a Legally Authorized Representative 
or independent physician in case of oral consent. 
6.2.2 
Exclusion Criteria 
 
1. Subject already participating in another study of an investigational treatment 
device or treatment. 
2. Use of any other intra-arterial recanalization drug or device prior to the 
Tigertriever (Tigertriever not as first choice device).  
3. Angiographically evident excessive arterial tortuosity precluding device access 
to the thrombus.  
4. For all patients, severe sustained hypertension with SBP >220 and/or DBP 
>120; for patients treated with IV tPA, sustained hypertension despite 
treatment with SBP >185 and/or DBP > 110.  
5. Glucose < 50 mg/dl (2.78 mmol/L)  or > 400 mg/dl (22.20 mmol/L). 
6. Known hemorrhagic diathesis.  
7. Coagulation factor deficiency or oral anti-coagulant therapy with an 
international normalized ratio (INR) of more than 3.0.  
8. Treatment with heparin within 48 h with a partial thromboplastin time more 
than two times the laboratory normal.  
9. Patients who have received a direct thrombin inhibitor within the last 48 hours; 
must have a partial thromboplastin time (PTT) less than 1.5 times the normal 
to be eligible. 
10. Platelet count of less than 50,000/uL.  
11. History of severe allergy to contrast medium, nickel, or Nitinol. 
 
12. Intracranial hemorrhage. 
13. Significant mass effect with midline shift. 
14. Intracranial tumor (apart from small meningioma, ≤ 2 cm in diameter)  
15. Stenosis or any occlusion in the deployment site or in a proximal vessel 
requiring treatment or preventing device access to the thrombus (for 
example, stenosis or occlusion in the cervical internal carotid artery. 
16. Females who are pregnant or breastfeeding. 
17. Known current use of cocaine at time of treatment. 
18. Prior recent stroke in the past 3 months. 
19. Renal failure with serum creatinine >3.0 or Glomerular Filtration Rate (GFR) 
<30. 
20. Known cerebral vasculitis. 
21. Rapidly improving neurological status defined as improvement of greater than 
8 points on the NIHSS or improvement to NIHSS of < 6 prior to procedure. 

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22. Clinical symptoms suggestive of bilateral stroke or stroke in multiple 
territories. 
23. Ongoing seizure due to stroke. 
24. Evidence of active systemic infection. 
25. Known cancer with metastases. 
26. Suspicion of aortic dissection, septic embolus, or bacterial endocarditis. 
27. Evidence of dissection in the extra or intracranial cerebral arteries. 
28. Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, 
or anterior/posterior circulation). 
29. Aneurysm in target vessel. 
 
 
 
7. 
STUDY PROCEDURES 
 
All non-investigational procedures will be according to the common practice at each site and 
determined by the treating physician. Procedures such as routine hospital examinations, 
brain CT scan or MRI will be performed according to each site’s standard management 
protocol and will be properly documented in the patient's medical records.  
7.1 Study   
Study flow of Subjects through the TIGER Study is illustrated in Figure 2. 
 
 
 

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7.2 Screening and Baseline Visit 
Screening against study inclusion/exclusion criteria will be completed to determine 
potential eligibility. Subject screening will be documented on the site specific Screening 
& Enrolment Log.  For patients/LARs who choose not to participate, the reason for non-
participation will also be documented. 
7.2.1 
General Medical Evaluation 
 
 
- Physical examination and medical history (including time last known well and 
time symptoms first observed) 
 
 
- Prior/Concomitant Medications 
 
 
- Vital signs (Blood pressure and pulse) 
7.2.2 
Laboratory Evaluation 
Blood and/or urine specimens for the following Clinical Laboratory tests: 
 
 
- Pregnancy (females of childbearing age) 
 
 
- Hemoglobin, platelet count per site standard of care (SOC) 
 
 
- Prothrombin time (PT)/International normalized ratio (INR) and partial   
thromboplastin time (PTT) per site SOC.   
 
 
- Creatinine or Glomerular Filtration Rate per site SOC 
 
 
- Serum glucose 
Note: Study informed consent not required for lab tests required as per the SOC in 
assessing acute ischemic stroke treatment. 
7.2.3 
Neurologic Evaluation 
National Institutes of Health Stroke Scale (NIHSS) recorded at screening along with 
pre-stroke mRS obtained from the Subject or their caretaker. NIHSS and mRS will be 
performed by certified Study personnel. 
7.2.4 
Imaging (Brain CT or MRI) 
CT or MRI will be used to confirm eligibility.  Patients with metal implants or other 
contraindications to MR will utilize CT exclusively.  Baseline imaging will be used to 
confirm: 
1. For anterior circulation strokes, baseline Alberta Stroke Program Early 
Computed Tomography Score (ASPECTS) of 6-10 on NCCT or CTA-source 
images, or DWI MR lesion volume ≤ 50 ml.  
2. For posterior circulation strokes, pcASPECTS 8-10, on CTA-source images 
or diffusion MRI  
3, No evidence of acute intracranial hemorrhage on presentation 
4. No evidence of significant mass effect with midline shift 
5. No evidence of intracranial tumor (apart from small meningioma, ≤ 2 cm in 
diameter) 

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6. No evidence of cerebral vasculitis 
7. No evidence of bilateral stroke or stroke in multiple territories (e.g. Bilateral 
anterior circulation, anterior/posterior circulation) 
8. No evidence of target vessel aneurysm 
 
Subjects who underwent a CT or MRI at a referring hospital and then were transferred to 
the study hospital for further treatment will need to undergo another CT or MRI at the 
study hospital to ensure continued absence of extended infarct or acute hemorrhage. 
7.2.5 
Screen Failures 
 
Subjects who do not satisfy all the inclusion/exclusion criteria prior to signing the 
ICF will be considered pre-screen failures.  If a Subject satisfies initial 
inclusion/exclusion criteria and has been consented but does not satisfy additional 
study inclusion/exclusion criteria at time of diagnostic angiography (such as 
excessive vessel tortuosity evident by angiography), the Subject will be 
considered a screen failure.  Screen fails will receive medical treatment per 
standard of care and will not enter into the trial population.  
7.3 Procedure 
7.3.1 
Angiography 
 
Diagnostic catheter angiography will be conducted prior to device deployment to 
confirm inclusion/exclusion criteria and to determine location of occlusion.  Diagnostic 
angiograms will also be obtained after each Tigertriever device pass (maximum of 3) 
and each pass of rescue therapy.  An angiogram will be considered for primary 
endpoint assessment where a rating of mTICI 2b or greater reperfusion is achieved 
(for 3 or less passes of the Tigertriever device) or after the third pass of the 
Tigertriever device.  A final post-procedure angiogram (full A-P lateral image) will be 
obtained once all treatments have concluded, including rescue therapy, if necessary. 
All images are to be de-identified and submitted to the core lab for review:  
 The University of California at Los Angeles with the following address: 
Angiography and Noninvasive Imaging Core Lab 
David S Liebeskind, MD, FAAN, FAHA, FANA 
UCLA Department of Neurology 
Neuroscience Research Building 
635 Charles E Young Drive South, Suite 225 
Los Angeles, CA 90095-7334 
7.3.2 
Device Preparation, Delivery, & Positioning 
 
 
 
1. 
Administer anti-coagulation and anti-platelet medications per SOC.   
 
  
2.     Introduce an 8FR or larger neurovascular balloon guiding catheter.   
3. 
Aided by angiographic fluoroscopy, determine the deployment location and its 
diameter.   

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Selectively access the occluded vessel using a microcatheter with a Rotating 
Hemostatic Valve (RHV) flushed with heparinized saline. With the aid of a 
guidewire  
3.a Advance the microcatheter until the end of the microcatheter is positioned 
distally to the thrombus, so that the usable length of the Tigertriever will extend past 
each side of the thrombus in the vessel. Verify the location of the distal side of the 
thrombus by injecting contrast media through the microcatheter.  
 3b. Stenosis identification: A suspected stenosis can be evidenced by difficulty 
crossing the lesion with a wire, poor expansion of the device, or calcium on a CT 
image. 
3c. Small caliber bifurcation identification: Carefully check whether the target 
occlusion crosses a small caliber bifurcation. For instance  opacification of the 
collateral vessels might indicate such bifurcation. If the clot occludes a bifurcation, 
prefer the larger division if possible (for example the inferior division of MCA). 
Perform a contrast injection through the microcatheter to evaluate the sizing of the 
branch where the device will be deployed. 
 
4. 
Remove the Tigertriever from the tray according to the Figure 2. 
Figure 2. Removal of the Tigertriever from the tray. 
 
5. 
Carefully advance the Tigertriever until the mesh completely extends from the 
loading tube.    
6. 
Slowly expand the device by sliding the Slider backwards. Do not over inflate. 
Make sure the device is not damaged.    
 
7. 
Soak the open mesh in heparinized saline.    
 8. 
Deflate the device carefully by advancing the Slider until the mesh reaches its 
minimal form (Figure 3). 
 Figure 3. Mesh in minimal form 
 
 
 

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9. 
Pull back until the tip is just inside the end of the loading tube (Figure 4). 
 
 
Figure 4. Tip at the end of the loading tube. 
 
10.   Insert the loading tube into the microcatheter’s RHV and lock it.   
11.  Slowly advance about 50cm of the Tigertriever through the loading tube into the 
microcatheter.    
12. Slide the loading device back towards the microcatheter’s RHV.   
13. Continue slowly advancing the device under fluoroscopic visual control until its tip 
extends out of the microcatheter. 
14.   Unsheathe the device slowly while following the tip of the device and distal and 
proximal markers for accurate deployment.    
 
Important: the proximal marker remains stationary during device expansion while 
the distal marker and tip move slightly backwards. As a result the proximal marker 
should be positioned proximally to the thrombus.    
15. Under fluoroscopic visual control slowly expand the device by sliding the Slider 
backwards.  
If stenosis or a small caliber bifurcation were idenified as described in steps 3b and 
3c above, use extra attention when expanding the Tigertriever, by slowly 
expansion and avoiding a maximal expansion.   
16. Wait 2 minutes to allow device expansion in the thrombus.   
17. Position the microcatheter until it is just proximal to the proximal marker of the 
device. Tighten the RHV to prevent relative movement between the 
microcatheter and the device.   
18. In cases where resistance during device expansion suggests the presence of 
atherosclerotic plaque at the site of clot, or that the clot and device are crossing a 
bifurcation and extending into a smaller caliber artery, care should be used not to 
apply excessively prolonged deployment expansion force to the device in these 
locations.  
7.3.3 
Retrieval 
 
1.   Inflate the guide catheter balloon to occluded vessel as specified in Balloon Guide 
Catheter labeling.   
2. Slowly withdraw the microcatheter and the Tigertriever device as a unit to   
the guide catheter tip while applying aspiration to the guide catheter with a 60cc 
syringe. If needed, adjust the size of the device under fluoroscopic visual control. 

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If excessive resistance is encountered during the retrieval partially deflate the 
device before continuing the retrieval. 
If stenosis or a small caliber bifurcation were identified as described in steps 3b and 
3c in the above, use extra attention when withdrawing the Tigertriever.   
3. Apply vigorous aspiration to the guide catheter using syringe and recover 
Tigertriever device and microcatheter inside the guide catheter. If needed, partially 
deflate the device prior to inserting it into the guide catheter. Continue aspirating 
guide catheter until the device and microcatheter are nearly withdrawn from the 
guide catheter.   
4. Open the guide catheter RHV to allow the microcatheter and device to exit without 
resistance. Use carefully to avoid interaction with the site of the intervention and to 
prevent air from entering the system.   
5. Aspirate the guide catheter to ensure the guide catheter is clean of any thrombus 
material.   
6. Deflate balloon guide catheter.   
7.  If additional flow restoration attempts are desired:   
-  Clot retrieval with Tigertriever devices may be attempted for up to a total of 3 
passes.    
-  Each Tigertriever device should only be used for a single pass.  
8.  If flow is not restored after 3 attempts with Tigertriever devices, a rescue device may 
be used per SOC.   
 
 
7.4 24 Hour (-6/+12) Follow-up 
 
-  Conduct visit at 24 hours (-6/+12 hours) from time of procedure 
-  Vital signs assessed 
-  Record concomitant medications 
-  Perform and record assessment of NIHSS  
-  Obtain MRI or CT, per standard of care, to assess intracranial hemorrhage 
Note: CT /MRI images will be sent as soon as possible to the Imaging Core Lab 
for evaluation. 
-  Record any Adverse Events (AEs), as necessary 
 
7.5 48 Hour (± 12h) Follow-up 
-  Record concomitant medications 
-  Perform and record assessment of NIHSS  
-  Record any Adverse Events (AEs), as necessary 
 
 

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7.6 Day 4 or Discharge  
 
-  Conduct visit at 4 days from time of procedure.  If Subject is discharged prior to 4 
days, conduct the follow up visit at time of discharge. 
-  Vital signs assessed 
-  Record concomitant medications 
-  Perform and record assessment of NIHSS 
-  Perform and record results of mRS using the Rankin Focused Assessment 
-  Record any AEs, as necessary 
 
NIH Stroke Scale and mRS should be performed by certified Study personnel. 
7.7 30 days (± 7 days), can be performed over the phone 
-  Conduct visit at 30 days (± 7 days) from time of procedure 
-  Record concomitant medications 
- Perform and record the Barthel Index 
-  Perform and record the mRS using the Rankin Focused Assessment 
-  Record any AEs, as necessary 
 
mRS should be performed by certified Study personnel. 
 
 
7.8 90 days (± 14 days) 
-  Conduct visit at 90 days (± 14 days) from time of procedure 
-  Record concomitant medications 
-  Perform and record assessment of NIHSS 
 
-  Perform and record results of mRS using the Rankin Focused Assessment 
-  Perform and record the Barthel Index 
-  Perform and record PRO assessments of health-related quality of life (EQ-5D) and 
degree of disability (AMC-Linear Disability Scale) -  Record any AEs, as necessary 
 
NIH Stroke Scale and mRS should be performed by certified Study personnel. 
 
 
7.9 Unscheduled Visits 
When clinically indicated, unscheduled assessments should be completed with 
corresponding data documented in the eCRF. 
7.10 Adverse Events 
Adverse events that occur during participation in the TIGER Study will be recorded.  
See section 11 for more information on AEs. 
 

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Table 4: Schedule of Events 
Schedule of Events 
Elapsed time/Study 
procedures 
Baseline 
Procedure 
24 
hours 
(-
6/+12) 
48 
hours 
(±12) 
Discharge 
or 4 days 
30 
(±7) 
daysiv 
90 
(±14) 
days 
Informed Consent 
X 
 
 
 
 
 
 
Demographics 
Xii 
 
 
 
 
 
 
Medical History and 
Concomitant 
Medications 
Xii 
 
 
 
 
 
 
Time of Stroke 
Symptoms Onset 
Xii 
 
 
 
 
 
 
Brain CT Scan or MRI 
Xii 
 
X 
 
 
 
 
Vital Signs 
Xii 
X 
X 
 
X 
 
 
NIH Stroke Scale 
Xii 
 
Xiii  
X 
X 
 
X 
Premorbid mRS score 
X 
 
 
 
 
 
 
mRS score 
 
 
 
 
X 
X 
X 
Clinical Laboratory 
Xii 
 
 
 
 
 
 
Time of groin puncture 
 
X 
 
 
 
 
 
Cath angiography and 
clot retirevali 
 
X 
 
 
 
 
 
mTICI Outcome 
 
X 
 
 
 
 
 
Functional activity 
questionnaire - Barthel 
Index 
 
 
 
 
 
X 
X 
Patient-Reported 
Outcomes (EQ-5D, 
AMC-LDS) 
 
 
 
 
 
 
X 
Prior/concomitant 
medications 
X 
X 
X 
X 
X 
X 
X 
AE (including 
hemorrhage other than 
sICH) 
 
X 
X 
X 
X 
X 
X 
i. Pre-procedure and post-procedure angiograms will be analyzed by an unbiased core laboratory to 
make a final determination about TICI Score. 
ii. Assessment may be completed during prescreening without obtaining informed consent if assessment 
at initial evaluation is be part of local standard of care. 
iii. NIHSS completed 24h and 48h post procedure. The 48 assessment should be performed at least 12 
hours after the 24h assessment. 
iv. possible to be performed over the phone 
 
 

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7.11 Clinical Outcomes Assessment 
 
Assessments to be performed as indicated in Table 4 are as follows: 
 
 
National Institutes of Health Stroke Scale (NIHSS):  Measures stroke-related 
neurological deficits through 15-item examination.  Must be performed by study 
personnel certified in NIHSS administration (nihstrokescale.org). 
 
Modified Rankin Scale (mRS):  Measures the global degree of disability or 
dependence of an individual on an ordinal scale. Must be performed by study 
personnel (who is not the treating physician) who are trained to conduct the mRS 
assessment using the  standardized Rankin Focused Assessment (RFA) 
 
Barthel Index:  Measures performance of activities of daily living on a 10-item, 0-
100 point scale. 
 
Patient Reported Outcome Assesment (PRO): 
o Academic Medical Center – Linear Disability Score (AMC-LDS):  Patient-
reported measure of disability status on a linear scale.  
o EQ-5D: Patient-reported measure of health-related quality of life, with 
brief patient-reported ratings along the 5 dimensions of mobility, self-care, 
usual activities, pain/discomfort, and affect. 
8. 
STATISTICAL ANALYSIS 
8.1 General Principles 
The primary analysis cohort will include all data collected for all enrolled Subjects, 
referred to in International Conference on Harmonization (ICH) document E9, “Statistical 
Principles for Clinical Trials,” as the full analysis set. 
Continuous variables will be summarized with standard statistics including the mean, 
standard deviation, median, interquartile range, and range.  Categorical variables will be 
summarized using frequency tables and cross-tabulations.  Statistical analysis will be 
performed using SAS software version 9.4 or higher (SAS Institute, Cary, NC, USA), R 
version 3.3 or higher (R Foundation for Statistical Computing, Vienna, Austria) or other 
validated statistical software. 
For the primary endpoint analysis, a P-value of less than 0.05 will be deemed statistically 
significant. For AE reporting, the primary analysis will be based on Subject counts, not 
event counts. Both Subject counts and event counts will be presented in tabular 
summaries of results. 
8.2 Primary Endpoints 
The primary effectiveness endpoint is successful reperfusion, defined as an mTICI score 
of 2b or better.  The performance goals (PG) for evaluating effectiveness is based on 
outcomes reported from six recent pivotal studies (TREVO 2, SWIFT, MR CLEAN, 
ESCAPE, REVASCAT and SWIFT PRIME) evaluating the Solitaire and Trevo stent-
retriever devices. 

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Table 5: Summary of criteria from prior studies used for generation of 
performance goal. 
Study 
Reperfusion using 
study-specific 
metric as reported 
Metric and threshold 
employed 
Converted to 
mTICI 2b/3 
TREVO 2 
68% 
Original TICI 2b/3 
78%* 
SWIFT 
69% 
TIMI 2/3 
76%** 
MR CLEAN 
59% 
Modified TICI 2b/3 
59% 
ESCAPE 
72.4% 
Modified TICI 2b/3 
73.8%*** 
REVASCAT 
65.7% 
Modified TICI 2b/3 
65.7% 
SWIFT PRIME 
88% 
Modified TICI 2b/3 
88% 
Pooled estimate 
 
 
73.4% 
 
 
* Adjustment for TREVO 2 is performed using Suh et al. (2013)43, in which 47% (69/146) of 
cases analyzed and classified as TICI 2a under the oTICI paradigm were found to be 
TICI 2b under the mTICI paradigm.  TREVO 2 results were then adjusted accordingly. 
 
** As reported in secondary publications versus original study endpoint of TIMI 2/344 
         *** As reported in secondary publication versus original study outcome of oTICI45 
The PG for the primary effectiveness endpoint of reperfusion post-procedure (mTICI 2b 
or better) is defined as the incidence in the five trials cited above minus a statistical 
margin of 10%, the same threshold as in the SWIFT pivotal trial (Saver, 2012, Lancet), 
therefore giving a PG of 73.4% - 10% = 63.4%. 
The resulting null and alternative statistical hypotheses are therefore as follows: 
 
 
H0: p ≤ PG 
 
HA: p > PG, 
 
where PG = 73.4% - 10% = 63.4% as above and p is the observed incidence of 
reperfusion post-procedure with the Tigertriever Revascularization Device.  The 
hypothesis test will be performed at an overall two-sided alpha level of 0.05 using exact 
binomial methods, in which the lower confidence bound on the observed incidence of 
reperfusion is compared to the PG.   
The primary safety endpoint is the composite of all-cause mortality at 90 (±14) days and 
symptomatic intracranial hemorrhage at 24 hours (18-36h).  The performance goal (PG) 
for evaluating safety is based on outcomes reported from the same six studies as for 
primary efficacy as employed above. 
 
 
 
 

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The performance goal (PG) for the composite primary safety endpoint of all-cause 
mortality and symptomatic intracranial hemorrhage is defined using the incidence of the 
individual endpoints in the six trials cited above.  For this purpose, the sum of the two 
pooled event rates is 18.2% + 4.2% = 22.4%; however, as sICH is known to be 
associated with mortality, this is likely an overestimate of the composite event rate.  For 
conservatism, therefore, only half of the sICH rate will be added to mortality as 
representing distinct subjects, resulting in a pooled event rate of 20.4%.  Adding to this a 
statistical margin of 10% gives a PG of 20.4% + 10.4% = 30.4%. 
 
The resulting null and alternative statistical hypotheses are therefore as follows: 
 
 
H0: p > PG 
 
HA: p ≤ PG, 
 
where PG = 20.4% + 10.4% = 30.4% as above and p is the observed incidence of 
revascularization post-procedure with the Tigertriever device.  The hypothesis test will 
be performed at an overall two-sided alpha level of 0.05 using exact binomial methods, 
in which the upper confidence bound on the observed incidence of revascularization is 
compared to the PG.  
 
The primary endpoint analysis will be performed using the intent to treat (ITT) 
population. The ITT population will consist of all enrolled subjects who had at least one 
Tigertriever device attempt/deployment irrespective of major protocol violation. The per 
protocol (PP) population is defined as ITT patients who do not have major protocol 
violations. A major protocol violation includes when a subject does not meet 
inclusion/exclusion criteria. All protocol violations will be reported. 
8.3 Secondary Endpoints 
 
The secondary study endpoints will be examined descriptively in both the ITT and PP 
populations.  
Table 6: All-cause mortality and sICH for comparable studies. 
Study 
All-cause mortality 
at 90 days 
sICH at 24 hours 
TREVO2 
33% 
7% 
SWIFT 
17.2% 
1.7% 
MR CLEAN 
21% 
7.7% 
ESCAPE 
10% 
3.6% 
REVASCAT 
18.4% 
4.9% 
SWIFT PRIME 
9% 
0% 
Pooled estimate 
18.2% 
4.2% 

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8.4 Sample Size and Power 
 
With a hypothesized incidence rate of 75% for revascularization post-procedure and 
desired power of 80%, and using an exact binomial test with a nominal 0.025 one-sided 
significance level (equivalent to a two-sided alpha=0.05), the required evaluable sample 
size for primary efficacy is 135.  For primary safety, under a hypothesized incidence rate 
of 20% for the composite endpoint and desired power of 80%, the corresponding 
required evaluable sample size is 153.  As 153 is the larger of these two values, this will 
be the required evaluable sample size to reach at least 80% power for both 
effectiveness and safety analyses.  Considering a 5% loss to follow-up rate, which is 
consistent with the observed follow-up rate to date, the Sponsor proposes to adjust the 
total sample size to 160.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.5  Subgroup Analysis 
Analysis of the primary endpoints will be conducted in subgroups of interest, including 
subgroups defined by device used (Tigertriever versus Tigertriever 17) and subgroups 
defined by subjects ineligible for IV-tPA administration versus those failing IV-tPA, 
subjects age 18-69 vs 70-85, and target occlusion location (ICA vs M1 vs M2 vs 
posterior circulation),   
 
8.6 Missing Data 
 
The number and proportion of Subjects eligible for and compliant with each follow-up 
examination will be presented. Subjects who withdraw from the study will be tabulated 
with reasons for withdrawal.  Since the primary efficacy endpoint is defined immediately 
post-procedure, the amount of missing data for this endpoint is anticipated to be very low 
and necessarily unrelated to subsequent losses to follow-up. 
 
8.7 Poolability Across Investigational Sites 
 
This is a multi-center clinical study, with standardization of Subject enrollment, data entry 
and adverse event reporting. All investigational sites will follow the requirements of a 
common protocol, data collection procedures and forms. To present the data from this 
clinical study in a summary form, a comparison of the primary endpoints across sites will 
be completed to determine if the generated data can be pooled. 
 

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The relevant statistical test for both primary efficacy and primary safety will be Pearson’s 
chi-square test across sites; a p-value less than 0.10 will be considered cause for 
investigation of non-poolability. 
 
8.8 Interim  Analysis 
 
No interim analysis is planned. 
8.9 Deviations from the Statistical Plan 
 
Any departure or deviation from these planned statistical methodologies will be 
documented and discussed in the Statistical Analysis Plan that will include the statistical 
rationale for change.   
 
 
9. 
RISK/BENEFIT ANALYSIS 
 
A risk analysis according to ISO 14971 (Application of Risk Management to Medical 
Devices) has been conducted as part of the CE Marking process. Risks have been 
minimized or eliminated through appropriate design control, and confirmed by pre-clinical 
bench, laboratory and animal testing. 
9.1 Main Potential Benefits of the Tigertriever: 
 
Vessel recanalization is one of the strongest predictors of improved functional outcomes 
and reduced mortality in ischemic stroke patients46. It has been further shown that if the 
vessels can be quickly recanalized, the correlation with good outcomes is even more 
powerful47.  
There are no guaranteed benefits from participation in this study; however, it is possible 
that treatment with the Tigertriever Device may improve blood flow through the treated 
artery. This may result in Subjects experiencing fewer or less severe long term ischemic 
stroke symptoms and less final disability. 
Information gained from the conduct of this study may be of benefit to other persons 
with the same medical condition and age rages. Study results will be analysed by 
subgroups based on age. 
 
The following features incorporated into the design of the device, enable the physician to 
have full control on the device and the process: 
 
Fully radiopaque, full visibility under fluoroscopy. 

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 
Ability of the physician to control the shape of the mesh and lock it in the required 
position. 
9.2 Main Potential Risks: 
  
The main possible complications that have been identified in  the risk management 
process for the Tigertriever are risks that are known for any catheterization and 
thrombectomy procedure, including, but not limited to: hematoma and hemorrhage at 
puncture site, infection, dissection, vessel perforation, emboli, thrombus, hemorrhage, 
ischemia, vasospasm, vascular occlusion, pseudo aneurysm formation, post procedure 
bleeding, distal thrombus formation, distal embolization including to a previously 
uninvolved territory, adverse allergic reaction to antiplatelet/anticoagulation agents or 
contrast media, device deformation/collapse/fracture/malfunction, arteriovenous fistula 
and neurological deficits, including stroke and death. Additional risks might include 
burning sensation, delay in procedure, (resulting to increase use of contrast, fluoroscopy 
and anesthesia), peripheral ischemia, incomplete treatment, (unable to treat or no 
improvement or major injury), organ impairment, fever, local or systemic inflammatory 
response, shock (traumatic, anaphylactic, hemorrhagic or septic), vassal stenosis or 
restenosis. General discomfort, tenderness or pain, standard risk of being under general 
anesthesia (nausea, vomiting), and ionizing radiation exposure. 
9.2.1 
Minimization of Risk 
 
The Tigertriever is intended to be used only by physicians who have received 
appropriate training in interventional neuro-endovascular techniques and neuro 
thrombectomy techniques. 
 
The design of the Tigertriever (material used, its visibility, the ability to control it, 
etc.) minimizes the potential risk to damage blood vessels and enables short and 
quick procedure.  
 
Detailed instructions for use that define the procedural steps, warnings of misuse, 
precautions and guidance for appropriate use of the device will be provided with the 
device.  
 
The Tigertriever will be deployed only in patients in whom an endovascular 
thrombectomy procedure has already been determined as clinically indicated by 
their clinical physicians. Accordingly, procedure-related risks, including risks of 
conscious sedation or general anesthesia, arterial puncture and sheath placement, 
exposure to ionizing radiation, and intra-procedural anticoagulation, are inherent to 
the patient’s clinical state and indicated course of therapy, and not the trial. Only 
device-specific risks, such as risks of device deformation/collapse/ 
fracture/malfunction are specific to the trial. 

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The estimated risks for all identified hazards all meet the defined criteria for risk 
acceptability. As a result the estimated risk for all identified hazards remains as low as 
possible. 
All of the above suggests that the advantages of mechanical revascularization using 
the Tigertriever in acute ischemic stroke outweigh its disadvantages and risks. 
 
 
10.  DEVIATIONS FROM THE CLINICAL INVESTIGATION PLAN 
10.1 Protocol Deviations 
 
A protocol deviation is defined as any change or alteration from the procedures stated in 
the clinical investigation plan, consent document, recruitment process, or study materials 
(e.g. questionnaires) that were originally approved by the IRB/EC where the change or 
alteration itself is not IRB/EC approved. Protocol deviations can be either major or minor.  
 
All protocol deviations must be reported to Rapid Medical or their authorized 
representatives ( study monitors) through the eCRF protocol deviation form.  All 
deviations, regardless of whether medically justifiable (Subject’s safety) or pre-
approved by Rapid Medical and/or the IRB/EC of record, shall be reported. In addition, 
the Investigator is required to adhere to IRB/EC of records’ procedures for reporting 
protocol deviations.   
Prior approval for deviation from the CIP shall be obtained by the Investigator from 
Rapid Medical, except in situations where necessary to protect the safety of a Subject 
(emergency) or for situations beyond the Investigator’s control such as Subjects missing 
scheduled follow-up visits. Approval for deviations shall be documented in writing and 
maintained in the Investigator and clinical study management files.  
Per 21 CFR §812.140 (a) (4), Investigators are required to maintain accurate, complete 
and current records, including documentation showing the dates of, and  reasons for, 
each deviation from the CIP.  Failure to comply with the CIP may result in Investigator 
termination of participation [21 CFR §812.46 (a)] in the TIGER study. 
10.2 Major and Minor Protocol Deviations 
 
A Major protocol deviation is defined as an event that resulted in an increased risk to a 
subject or others; affected the right, safety or welfare of a subject; or affected the 
integrity of the study. Major protocol deviations include, but are not limited to:  
• Failure to obtain informed consent prior to patient enrollment  
• Enrolled patient did not meet the inclusion/exclusion criteria  
• Source data permanently lost  

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• Introduction of rescue therapy prior to attempting revascularization with Tigertriever for 
three passes.  
 
Any other events that do not comply with the requirements of the protocol will be 
considered Minor protocol deviations. 
Examples of Minor protocol deviations are:  
• Incorrect version of the informed consent form used. 
• Patient did not attend follow-up visit or follow-up visit was outside the required window. 
 
 
11. SAFETY AND ADVERSE EVENTS 
 
Safety of study Subjects is of critical importance for the TIGER study.  Site Investigators are 
responsible for the safety of Subjects under his/her care.  In order to more clearly 
understand data and potential confounders, assessment of all Adverse Events observed by 
the site investigators will be recorded in the case report form and reported to the Data and 
Safety Monitoring Board for period review.  
11.1 Adverse Event Data Collection 
Recording of adverse events commence from time that a Subject is appropriately 
consented and culminate through the 90-day (± 14) follow up.  All available information 
related to the AE must be obtained by the Investigator so that proper determination of 
causality and outcome can be made and classification as a SAE can be made if 
warranted.  Adverse Events will be documented on the appropriate eCRF.  Data 
captured include the event description, onset, resolution status, seriousness, severity, 
causality (if known) and treatment, if done. The Investigator will follow all AEs until 
resolution or completion of the 90-day follow-up. 
 
11.2 Definitions 
11.2.1  Adverse Events 
Per ISO 14155:2011 section 3.2, an Adverse Event is any untoward medical occurrence, 
unintended disease or injury, or untoward clinical signs (including abnormal laboratory 
findings) in Subjects, users or other persons, whether or not related to the investigational 
medical device.  
In the event that a Subject participates in the TIGER Study with signs of prior disease 
and/or symptoms, these conditions would not be considered AEs unless the condition 
recurs after the Subject has recovered from the previously occurring condition or the 
condition worsens in intensity or frequency during participation in the TIGER Study. 

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11.2.2 Adverse Device Effect 
Per ISO 14155:2011 Section 3.1, an Adverse Device Effect (ADE) is any AE related 
to the use of an investigational medical device. 
 
11.2.3 Serious Adverse Events 
Per ISO 14155:2011 Section 3.37, an SAE is an AE that: 
 
1. Led to death, 
2. Led to serious deterioration in the health of the Subject, that resulted in: 
a.  a life-threatening illness or injury, or 
b.  a permanent impairment of a body structure or a body function, or 
c.  in-patient or prolonged hospitalization, or 
d.  medical or surgical intervention to prevent permanent life-threatening illness or 
injury or permanent impairment to a body structure or a body function. 
3. Led to fetal distress, fetal death or a congenital anomaly or birth defect 
 
11.2.4 Serious Adverse Device Effect 
Per ISO14155:2011 3.36, a Serious Adverse Device Effect (SADE) is an adverse 
device effect that has resulted in any of the consequences characteristic of a SAE. 
 
Examples of SADE for the TIGER Study include vessel dissections or perforations 
caused by the Tigertriever Revascularization Device. 
 
11.2.5 Anticipated Adverse Device Effect 
An anticipated adverse device effect (AADE) is an effect which by its nature, 
incidence, severity or outcome has been identified in the study protocol or application. 
 
11.2.6 Unanticipated Adverse Device Effect 
 
As described in 21 CFR §812.3 (s), an Unanticipated Adverse Device Effect (UADE) 
means any serious adverse effect on health or safety or any life-threatening problem 
or death caused by, or associated with, a device, if that effect, problem, or death was 
not previously identified in nature, severity, or degree of incidence in the study 
protocol or application (including a supplementary plan or application), or any other 
unanticipated serious problem associated with a device that relates to the rights, 
safety, or welfare of Subjects. 
 

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Rapid Medical will report the results of an evaluation of any UADE to the FDA/CA and all 
reviewing IRB/EC committees and Investigators within 10 working days from receiving 
notice of the UADE.   
 
11.2.7 Procedure-Related 
Definite Related: Must have all 3 of the following: 
1. Has a reasonable temporal relationship to the intervention procedure 
2. Could not possibly have been produced by the Subject’s clinical state or have 
been due to environmental or other interventions. 
3. Follows a known pattern of response to the intervention procedure. 
 
Possible Related: Must have at least 2 of the following 3 conditions: 
1. Has a reasonable temporal relationship to the intervention procedure 
2. Could not possibly have been produced by the Subject’s clinical state or have 
been due to environmental or other interventions. 
3. Follows a known pattern of response to intervention procedure. 
 
Unlikely Related: Has a reasonable or tenuous temporal relationship to intervention 
procedure, but also has BOTH of: 
1. Could readily have been produced by the subject’s clinical state, or 
environmental or other interventions. 
2. Does not follow known pattern of response to intervention procedure. 
 
Unrelated: The temporal relationship between intervention procedure and the 
adverse event is unreasonable or incompatible and/or adverse event is clearly due to 
extraneous causes (e.g., underlying disease, environment). 
 
11.2.8 Device-Related 
Definite Related: Must have all 3 of the following: 
1. Has a reasonable temporal relationship to the intervention device 
2. Could not possibly have been produced by the Subject’s clinical state or have 
been due to environmental or other interventions. 
3. Follows a known pattern of response to the intervention device. 
 
Possible Related: Must have at least 2 of the following 3 conditions: 
1. Has a reasonable temporal relationship to the intervention device 
2. Could not possibly have been produced by the Subject’s clinical state or have 
been due to environmental or other interventions. 
3. Follows a known pattern of response to intervention device. 
 
Unlikely Related: Has a reasonable or tenuous temporal relationship to intervention 
device, but also has BOTH of: 

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1. Could readily have been produced by the subject’s clinical state, or 
environmental or other interventions. 
2. Does not follow known pattern of response to intervention device. 
 
Unrelated: The temporal relationship between intervention device and the adverse 
event is unreasonable or incompatible and/or adverse event is clearly due to 
extraneous causes (e.g., underlying disease, environment). 
11.3 Determination of Event Severity and Relatedness  
 
Using all available information, Site Investigators will independently categorize event 
severity as Serious or Non-serious, using the above definitions.  
Using all available information, Site Investigators will categorize the relationship of non-
serious adverse events (NSAEs) and SAEs to study procedure and study device. In 
addition, a central Clinical Events Committee will independently adjudicate the 
relationship of all SAEs to study procedure and study device. 
11.4 Event Notification 
 
TIGER Study Investigators are required to report all UADEs/USADEs to Rapid Medical, 
or Sponsor representative, within 24 hours after first learning of the event.  In addition, 
the Investigator must follow the IRB/EC of record’s policies for SAE/UADE/USADE 
reporting.  Adverse Event reporting instructions will be included in the Safety 
Management Plan. 
All Medical Device Reporting (MDR) reportable events will conducted in accordance with 
21 CRF §803. 
 
11.5   Clinical Events Committee 
 
The Clinical Events Committee (CEC) will be an independent board consisting of stroke 
Neurologists and Neurointerventionalists who are not participating in the TIGER Study 
otherwise.  The CEC will adjudicate SAEs reported in the study. 
 
Major CEC responsibilities are as follows: 
 
1.  Adjudication of all intracranial hemorrhages, documented by the Independent Core 
Laboratory, as symptomatic or asymptomatic based on Subject neurological status. 
2. Adjudication of all dissections/perforations as to relationship to study device of 
study procedure. 

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3. Adjudicate of all SAEs as attributable to procedure or device or the natural history 
of the initial stroke and of patient’s other medical conditions.  
 
11.6   Data and Safety Monitoring Board 
 
The DSMB will consist of independent noninvasive Stroke Neurologists, 
Neurointerventionalists, and a Biostatistician.   
 
All AEs observed by the site investigators will be reported to the DSMB for periodic 
review.  
 
Major responsibilities of the DSMB are: 
 
1. Monitor the rates of all adverse events 
2. Recommend revisions to the TIGER Study CIP regarding safety of the study 
Subjects   
3. Periodically review and monitor aggregated and individual Subject data 
related to safety, data integrity, scientific validity and overall conduct of the 
study, to ensure the rights, safety, and welfare of the study participants   
4. Monitor Subject accrual and retention   
5. Consider factors external to the study when relevant information becomes 
available, such as scientific or therapeutic developments that may have an 
impact on the safety of the participants or on the ethical conduct of the study 
6. Ensure the confidentiality of trial data and the results of monitoring  
 
12. STUDY MONITORING 
 
The study will be monitored regularly by trained clinical trial monitors to ensure the 
protection of Subject rights and safety, as well as, data quality and integrity in compliance 
with 21 CFR §812 Subpart C.   
The monitor will verify information entered into the eCRFs against source documents and 
the Subject’s medical records to ensure validity of data. Source documents may be 
photocopied if required but will be anonymized prior to a monitor leaving the performance 
site.  The following on-site visits will occur: site initiation visit; first monitoring visit shortly 
after the first non-Lead-in Subject procedure is completed; additional monitoring visits 
determined by site enrollment rates.   
On the occasion that a monitor requests additional data or clarification of data for the eCRF, 
the request must be addressed appropriately prior to the next monitoring visit.  Once 
completed eCRF data are verified against source data, the study monitor will electronically sign off 

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to indicate that data has been monitored for correctness. The Investigator must sign all 
eCRFs prior to site close.  
In the event that a monitor discovers potential SAEs or SADEs which were not previously 
reported, Rapid Medical or the appointed representative/study monitor will inform the 
Investigator for their review and submission to the IRB/ethics committee, if applicable.   
There will be a site close out visit to ensure all documentation is in place and all outstanding 
items have been addressed.  Record retention policies will be reviewed and post-study 
Investigator responsibilities discussed.   
Device accountability will also be conducted by the study monitor at each monitoring visit.  
Unused, damaged, malfunctioning, or expired devices will be returned to Rapid Medical 
prior to or when enrollment closes. 
 
12.1 Source Documentation 
Investigators are required to record and maintain adequate and accurate case histories 
for all Subject observations, assessments, and data pertinent to TIGER Study conduct.  
 
12.2 Access to Source Documents 
 
The Investigator and Institution, as participants in the TIGER Study, will be responsible for 
providing direct access to source data to Rapid Medical, their designated 
representatives, and to appropriate authorities for the purposes of monitoring, audit, 
IRB/EC review or regulatory inspection.  Subjects will be notified of such access to study 
records as part of the consenting process.  
 
 
13. DATA COLLECTION AND OWNERSHIP 
 
13.1 Protected Health Information and Confidentiality 
 
The Investigator and members of the IRB/EC of record shall consider all data or findings 
generated during the conduct of the study, other than that information to be disclosed by 
law, as confidential.  Disclosure of such data or findings to any third party shall not occur 
without the prior written consent of Rapid Medical. 
All reports and communications relating to Subjects in the study will identify Subjects by 
their Subject ID number only.   

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13.2 Data Management 
 
Every effort will be taken to ensure the accuracy and reliability of data including the 
selection of qualified Investigators and appropriate study centers, review of protocol 
procedures with the Investigator and associated personnel before the study commences, 
and periodic onsite monitoring visits by the Sponsor, or their representatives, as deemed 
appropriate by the Sponsor. Guidance for eCRF completion will be provided and 
reviewed with the study personnel prior to the start of the study. The Sponsor will review 
eCRFs for accuracy and completeness and any discrepancies will be resolved with the 
Investigator or designee, as appropriate. 
13.3 Electronic Case Report Forms 
 
Study staff, as indicated in the Delegation log, who will use the EDC system will have 
adequate training in order to perform assigned tasks (21 CFR §11.10(i)).  Training will be 
conducted by Rapid Medical and/or their qualified designated appointee as part of the 
Site Initiation Visit or as needed. 
 
Data collected during the conduct of the TIGER Study will be entered into a 21CRF §11 
compliant eCRF database. Accuracy and data quality will be ensured through implementation 
of data edit checks.  Responses to requests for clarification of eCRF recorded data will be 
answered, dated, and electronically signed by the Investigator or designee.  Any required 
changes to the Sponsor’s eCRF/database will be followed by data review and validation 
procedures. 
 
Once the study is closed and all data has been monitored and signed by study 
Investigators, the database will be locked and analyzed for statistical evaluation and 
reporting. 
 
13.4 Record Retention and Storage 
13.4.1 Sponsor Record Retention 
 
Rapid Medical will retain all study documentation for a period of at least five (5) years 
or in accordance with GCP regulations in force in the Sponsor’s jurisdiction, whichever 
is greater, following formal discontinuation of the TIGER Study.  
13.4.2 Investigator Record Retention 
 
The Investigator shall retain all study documentation for a period of at least (3) years or 
in accordance with retention policies of the IRB/EC of record, whichever is longer.  

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13.5 Publication Policy 
 
As part of the TIGER Study, information related to the Tigertriever Revascularization 
Device (such as pre-clinical data and other device materials) may be supplied to TIGER 
Study Investigators.  Any information not previously published is considered confidential 
and shall remain the sole property of Rapid Medical. The Investigator agrees to use any 
such information as it pertains to study conduct and not use data generated from the study 
for other purposes without first obtaining the written consent of Rapid Medical.   
 
Every effort will be made to publish the results of this study regardless of whether the 
findings are in favor of the Tigertriever device. To achieve this goal, and to avoid 
publication bias, the TIGER study will be registered, prior to enrollment commencing, on 
the clinicaltrials.gov database. 
 
Rapid Medical will form a Publications Committee for the purpose of reviewing and 
publishing data from the study. This committee will include, at a minimum, the TIGER 
Study Principal Investigators (PIs) and a representative of Rapid Medical.  The 
Publications Committee will be tasked with creating a publication policy describing the 
authorship criteria. Abstracts and manuscripts will be written and/or reviewed by the 
Publication Committee prior to submission for journal or meeting acceptance.  
 
 
 
 
14. 
AUDITS OR INSPECTIONS 
 
Representatives of Rapid Medical or any regulatory body reviewing study results may 
visit study sites to conduct a TIGER Study audit in compliance with company policy and 
regulatory guidelines. Audits will require access to all study related documentation for 
inspection.  Investigators will immediately notify Rapid Medical upon learning of 
announced audits or inspections by regulatory agencies. 
   
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