An Observational Study of the Q Aspiration Catheter Used During Neurointervention for Acute Large Vessel Ischemic Stroke in Spain.
Conditions: Stroke, Ischemic
Sponsor: MIVI Neuroscience, Inc.

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An observational study of the Q Aspiration Catheter used 
during neurointervention for acute ischemic stroke in Spain 
 
The TAPAS Study 
 
 
 
Protocol #101347 
Rev B 
01 August 2019 
 
 
 
 
 
Sponsor: 
MIVI Neuroscience, Inc 
6545 City West Parkway 
Eden Prairie, Minnesota 55344 
USA 
 
 
 

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TABLE OF CONTENTS 
1 
PROTOCOL AGREEMENT ......................................................................................... 4 
2 
PROTOCOL SYNOPSIS & FLOW CHART ................................................................. 4 
3 
BACKGROUND ........................................................................................................... 5 
3.1 
OVERVIEW ......................................................................................................................................... 5 
3.2 
Q ASPIRATION CATHETER DESCRIPTION ............................................................................................. 6 
3.3 
INTENDED USE ................................................................................................................................... 7 
4 
STUDY DESIGN AND OBJECTIVES ......................................................................... 8 
4.1 
STUDY PURPOSE AND DESIGN ............................................................................................................. 8 
4.2 
PRIMARY ENDPOINTS ......................................................................................................................... 8 
4.3 
SECONDARY ENDPOINTS .................................................................................................................... 8 
5 
RISK / BENEFIT ANALYSIS ...................................................................................... 8 
5.1 
POTENTIAL RISKS............................................................................................................................... 8 
5.2 
POTENTIAL BENEFITS ......................................................................................................................... 8 
5.3 
MINIMIZATION OF FORESEEABLE RISKS .............................................................................................. 8 
6 
STUDY POPULATION ................................................................................................ 9 
6.1 
STUDY POPULATION ........................................................................................................................... 9 
6.2 
NUMBER OF SUBJECTS ........................................................................................................................ 9 
6.3 
INCLUSION CRITERIA .......................................................................................................................... 9 
6.4 
EXCLUSION CRITERIA......................................................................................................................... 9 
7 
ETHICS ........................................................................................................................ 9 
7.1 
ETHICS COMMITTEE (EC) AND ETHICAL CONDUCT OF THE STUDY ....................................................... 9 
7.2 
SUBJECT INFORMATION AND CONSENT ............................................................................................. 10 
8 
STUDY PROCEDURES ............................................................................................. 10 
8.1 
SCREENING AND ENROLLMENT ......................................................................................................... 10 
8.2 
BASELINE ........................................................................................................................................ 10 
8.3 
MECHANICAL THROMBECTOMY PROCEDURE .................................................................................... 10 
8.4 
HOSPITALIZATION ............................................................................................................................ 11 
8.5 
3 MONTH FOLLOW UP ...................................................................................................................... 11 
8.6 
SUBJECT WITHDRAWAL/STUDY COMPLETION ................................................................................... 12 
8.7 
PROTOCOL DEVIATIONS ................................................................................................................... 12 
9 
ADVERSE EVENTS .................................................................................................. 12 
9.1 
AE DEFINITIONS .............................................................................................................................. 12 
9.2 
ADVERSE EVENT REPORTING............................................................................................................ 13 
9.3 
DEVICE MALFUNCTION/FAILURE.................................................................................................... 13 
10 STATISTICAL DESIGN AND ANALYSIS PLAN .................................................... 13 
10.1 
STUDY DESIGN JUSTIFICATION ..................................................................................................... 13 
10.2 
STATISTICAL METHODS ............................................................................................................... 13 
10.3 
GENERAL STATISTICAL CONSIDERATIONS .................................................................................... 14 
11 STUDY MANAGEMENT .......................................................................................... 14 
11.1 
INVESTIGATOR/SITE SELECTION ................................................................................................... 14 
11.2 
SITE INITIATION AND TRAINING ................................................................................................... 14 
11.3 
Q ASPIRATION CATHETER DEVICES .............................................................................................. 14 
11.4 
CLINICAL STUDY MANAGEMENT RESPONSIBILITIES ...................................................................... 14 
11.5 
CASE REPORT FORMS (CRFS) ...................................................................................................... 15 
11.6 
STUDY MONITORING ................................................................................................................... 15 

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11.7 
CORE LABORATORIES .................................................................................................................. 15 
11.8 
TRIAL TERMINATION/INVESTIGATIONAL SITE TERMINATION ......................................................... 15 
11.9 
TRIAL REGISTRATION .................................................................................................................. 15 
12 RECORDS AND REPORTS ....................................................................................... 16 
12.1 
ESSENTIAL DOCUMENTS .............................................................................................................. 16 
12.2 
INVESTIGATOR RECORDS ............................................................................................................. 16 
12.3 
SPONSOR RECORDS ...................................................................................................................... 16 
13 PROTOCOL DEFINITIONS ....................................................................................... 16 
13.1 
ABBREVIATIONS .......................................................................................................................... 16 
13.2 
STUDY ENDPOINT DEFINITIONS .................................................................................................... 17 
13.3 
PROTOCOL-SPECIFIED AND OTHER DEFINITIONS ........................................................................... 17 
14 INVESTIGATIONAL PLAN HISTORY .................................................................... 18 
15 REFERENCES ............................................................................................................ 18 
 
 
Reference A:  Q Aspiration Catheter Instructions For Use 
Reference B:   TAPAS Core Lab Manual 
 

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1 
PROTOCOL AGREEMENT 
 
I, the undersigned Investigator(s), have read and understood the protocol.  I agree to 
perform and conduct the study as described herein and in accordance with the signed 
Investigator Agreement and all applicable laws. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Principal Investigator’s Signature 
 
 
 
Date 
 
 
2 
PROTOCOL SYNOPSIS & FLOW CHART 
Title 
An observational study of the Q Aspiration Catheter used during 
neurointervention for acute large vessel ischemic stroke in Spain. 
Description 
The TAPAS Study: Thrombectomy Aspiration Post market study in Acute 
Stroke 
Sponsor 
MIVI Neuroscience, Inc. 
Protocol No. 
101347 Rev B 
Study Device 
MIVI Q Aspiration Catheter (CE Marked) 
Primary Efficacy 
Endpoint 
Successful revascularization defined as final mTICI 2b-3 flow in the target 
vessel. 
Primary Safety 
Endpoint 
Symptomatic intracranial haemorrhage post- procedure as detected by CT 
scan/ MRI with an NIHSS change of > 4.  
Secondary 
Endpoints 
 
• 
Successful revascularization defined as mTICI 2b-3 flow in the target 
vessel post-treatment with the Q Catheter alone (first line therapy) 
• 
Embolization to a new neurovascular territory 
• 
Good functional outcome of Modified Rankin Score of 0-2 at 90 days  
• 
Mortality at 90 days 
Inclusion 
Criteria 
• 
Age 18 to 85 years 
• 
Diagnosis of acute ischemic stroke with mechanical thrombectomy 
procedure < 8 hours from onset of symptoms/ last well known well 
• 
Large Vessel Occlusion on CT scan or MRI in the Anterior Cerebral 
Vasculature up to A1, M1, M2, or Posterior Cerebral Vasculature 
• 
ASPECTS 6 – 10 or volume of diffusion restriction < 50 mL 
• 
Use of the Q Aspiration Catheter as the first line treatment according to 
the IFU 
• 
Signed informed consent form 
Exclusion 
Criteria 
• 
Occlusions in multiple vascular territories, extracranial or tandem 
occlusion 
• 
Evidence of dissection in the carotid or target artery for treatment 
• 
Evidence of recent/fresh haemorrhage on presentation  
●    Unwilling to agree to a 3 month follow up visit 

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Follow-up  
Subject will have one visit at about 3 months post-procedure. 
Scope 
This study will enroll a total of 50 subjects at up to 5 investigational sites in 
Spain. 
 
 
 
 
 
3 
BACKGROUND 
3.1 
Overview 
Stroke is the second single most common cause of death in Europe accounting for almost 1.1 
million deaths each year, based on data from WHO estimated the number of strokes in the year 
2000.  Furthermore, it has been predicted that stroke incidence will increase to 1.5 million per 
year by 2025, largely owing to the increasing proportion of elderly individuals.   
Ischemic strokes represent approximately 87% of all strokes while the remaining 13% are 
hemorrhagic.  The chief goal in treating acute ischemic stroke is to restore cerebral blood flow as 
rapidly and safely as possible.  Currently there are two approaches to treatment, intravenous (IV) 
delivery of Tissue Plasminogen Activator (tPA), a thrombolytic agent, and mechanical 
thrombectomy.  Combining IV tPA treatment with mechanical thrombectomy has recently been 
shown to demonstrate an advantage with good clinical results for patients.1,2,3  
Endovascular treatment using mechanical devices to recanalize the occlude vessel include the use 
of catheters to directly deliver a clot-disrupting or retrieval device to the thrombus, this includes 
aspiration catheters, stent-retrievers and other clot disrupting devices.  However, withdrawing the 
clot disrupting devices by mechanical force to perform thrombectomy may increase the risk of 
vascular intimal injury and the incidence of vasospasm.  Therefore, aspirating clot may be 
preferred to reduce vessel damage during recanalization.4  Mechanical revascularization using an 
aspiration catheter as the primary approach to clot removal is commonly performed and 
Procedure 
Q Catheter first line 
treatment as part of 
standard of care 
Patient Screening 
Screening for entrance 
criteria 
Hospitalization 
Including standard of care 
neuroimaging and neuro 
evaluation 
3 Months  
90 - 120 Days 
Study Exit 
Patient Consent 
Any time after confirmation 
of entrance criteria but prior 
to collecting 3 month data 

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sometimes referred to as the ADAPT technique.5 The ADAPT technique is favor by some 
physicians because of its potential to be less traumatic to the neurovasculature and improve on 
time to revascularization compared to stent retrievers.6,7 
The MIVI Neuroscience, Inc. CE Marked Q Aspiration Catheter is a family of short, extension 
catheters introduced through an 8F guide catheter/6F sheath.  Aspiration is performed from the 
short Q Catheter into the guide catheter/sheath.  The MIVI Neuroscience, Inc. Q Aspiration 
Catheter may offer an increased force of aspiration from the larger 8F guide lumen and the 
potential access to more distal clot with the small Q Catheter lumen. 
3.2 
Q Aspiration Catheter Description 
The MIVI Q Aspiration Catheter consists of a single lumen, variable stiffness shaft with 
radiopaque markers are included on the distal and proximal end of the catheter portion for 
angiographic visualization.   The catheter shaft has a hydrophilic coating to reduce friction 
during use.  The proximal portion of the catheter is a stainless-steel control wire. The Q 
Aspiration Catheter is designed to be used with an 8F guide/6F sheath for use in the removal of 
fresh, soft emboli and thrombi in the neurovascular system. 
 
FIGURE 1 
6F Q Catheter Illustration & Drawing 
                                                                                                                                                                                       
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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TABLE 1 
Q Dimensions and Configurations 
 
Device  
Total 
Length 
(cm) 
Catheter 
Section 
Length (cm) 
Proximal 
Catheter 
Section ID 
Proximal 
Catheter 
Section OD 
Distal 
Catheter 
Section ID 
Distal 
Catheter 
Section OD 
Q6 6F Catheter  
145 
25 
1.75 mm 
(0.069”) 
2.24 mm 
(0.088”) 
6.7F 
1.75 mm 
(0.069”) 
2.13 mm 
(0.084”) 
6.4F 
Q5 5F Catheter 
145 
25 
1.45 mm 
(0.057”) 
2.24 mm 
(0.088”) 
6.7F 
1.45 mm 
(0.057”) 
1.83 mm 
(0.072”) 
5.5F 
Q4 4F Catheter  
150 
30 
1.45 mm 
(0.057”) 
2.24 mm 
(0.088”) 
6.7F 
1.09 mm 
(0.043”) 
1.4 mm 
(0.055”) 
4.2F 
Q3 3F Catheter 
163 
43 
1.45 mm 
(0.057”) 
2.24 mm 
(0.088”) 
6.7F 
0.91 mm 
(0.036”) 
1.22 mm 
(0.048”) 
3.7F 
3.3 
 Intended Use 
The Q Aspiration Catheter is indicated for use in the removal of fresh, soft emboli and thrombi in 
the peripheral and neurovascular systems.  It may also be used as a diagnostic angiographic 
catheter. 
 
It is intended to be used by physicians skilled in the field(s) Interventional Radiology, 
Interventional Neuroradiology, Neurosurgery and/or Neurology who are skilled in endovascular 
interventional procedures for acute ischemic stroke. 
 
The Q Catheter is a family of short, extension catheters that is introduced through an 8F catheter.  
Aspiration is performed from the short Q and into the 8F catheter.  The Q is visible under 
fluoroscopy and must be hydrated for at least 1 minute in saline prior to use.  The Q is typically 
introduced over a guidewire and is advanced to the desired vessel in the neurovasculature under 
fluoroscopy.  Once in place, tubing attached to a vacuum pump and to the stopcock of an 8F 
catheter.  Thrombus is then aspirated through the Q and into the 8F catheter.  At the end of the 
procedure, all devices are carefully removed and discarded.  Device compatibility is in Table 2 
below. 
 
TABLE 2 
Q Compatibility 
 
Device 
Maximum 
Guidewire Size 
Maximum 
Microcatheter Size 
8F Guide Catheter / 
6F Sheath ID Range 
Q6 6F Catheter  
0.035” 
5.0F 
0.088” – 0.090” 
(2.2 – 2.3 mm) 
Q5 5F Catheter 
0.035” 
4.0F 
0.088” – 0.090” 
(2.2 – 2.3 mm) 
Q4 4F Catheter  
0.035” 
3.0F 
0.088” – 0.090” 
(2.2 – 2.3 mm) 
Q3 3F Catheter 
0.018” 
2.4F 
0.088” – 0.090” 
(2.2 – 2.3 mm) 
 
The MIVI Super 90 Guide Catheter or any other commercially available and compatible 8F 
catheter may be used with the Q Catheter.   
 
The Q Aspiration Catheter is a Class III medical device in the EU and obtained CE Mark in 
March 2018.   

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4 
STUDY DESIGN AND OBJECTIVES 
4.1 
Study Purpose and Design 
The purpose of this study is to demonstrate the safety and performance of the MIVI 
Neuroscience, Inc. Q Aspiration Catheter for use in the removal of fresh, soft emboli and 
thrombi in the neurovascular system during acute ischemic stroke.  The study is an observational 
study that will enroll a maximum of 50 subjects in Spain.   
 
Subjects will be followed through hospitalization and a visit 3 months post-procedure.  A 
maximum of 5 sites in Spain will be involved in this study.  Enrollment is expected to take 
approximately 6 months. 
4.2 
 Primary Endpoints 
The primary performance endpoint is successful revascularization defined as final mTICI 2b-3 
flow in the target vessel.  
 
The primary safety endpoint is symptomatic intracranial haemorrhage at 24 hours post-procedure 
as detected by CT scan/MRI with an NIHSS change of greater than or equal to 4. 
4.3 
 Secondary Endpoints 
• 
Successful revascularization defined as mTICI 2b-3 flow in the target vessel post-
treatment with the Q Catheter alone (first line therapy) 
• 
Embolization to a new neurovascular territory 
• 
Good functional outcome measured by Modified Rankin Score of 0-2 at 90 days  
• 
Mortality at 90 days 
5 
RISK / BENEFIT ANALYSIS 
5.1 
  Potential Risks 
The potential risks of mechanical aspiration thrombectomy for acute ischemic stroke treatment 
are well understood.  Patients were informed of procedural risk and consent to the procedure per 
the Hospital’s standard practice.  This is an observational study with patient consent after a 
“standard of care”, non-research mechanical thrombectomy procedure and hospitalization.  There 
is no additional risk of a 3 month visit. 
 
The potential risks of participation in this study are clearly identified in the subject informed 
consent form and are to be explained to the patient and/or their legal representative prior to 
participating in the study.  
5.2 
Potential Benefits 
There is no guarantee or certainty that the subjects will benefit from this study.  Data collected 
in this study may provide information for your doctor to treat future patients with a stroke. 
5.3 
Minimization of Foreseeable Risks 
The Aspiration Catheter has been tested during the development process, including mechanical 
testing, in vitro testing, and animal testing.  Standardized biomaterial safety testing has 
confirmed that the device is safe and comparable to legally marketed devices.  Currently there is 
no Clinical Investigation data.  

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The sites participating in the study must agree to conduct the study in compliance with the 
protocol, GCP, and applicable local and international regulatory requirement(s).   
 
6 
STUDY POPULATION 
6.1 
Study Population 
The observational study population is patients diagnosed with large vessel occlusion acute 
ischemic stroke within 8 hours of stroke onset treated with mechanical aspiration thrombectomy 
with the Q Aspiration Catheter as first line therapy.  The Q Aspiration Catheter must be used 
according to the IFU to be included in the study.  All study candidates (or legal representative) 
must be able to provide written informed consent and agree to be followed at 3 months post-
procedure. 
6.2 
Number of Subjects 
Up to 50 subjects may be enrolled at up to 5 investigational sites in Spain.  A center may enroll a 
maximum of twenty subjects. 
6.3 
Inclusion Criteria 
Subjects who meet the following criteria may be included in the study: 
1. Age 18 to 85 years; 
2. Diagnosis of acute ischemic stroke with mechanical thrombectomy procedure < 8 hours 
from onset of symptoms or last known well; 
3. Large Vessel Occlusion on CT scan or MRI in the Anterior Cerebral Vasculature up to 
A1, M1, M2, or Posterior Cerebral Vasculature; 
4. ASPECTS 6 – 10 or volume of diffusion restriction < 50 mL; 
5. Use of the Q Aspiration Catheter as the first line treatment according to the IFU;  
6. Signed informed consent by patient or legally authorized representative. 
6.4 
Exclusion Criteria 
Subjects who meet any one of these criteria will be excluded from the study: 
1. Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or 
anterior/posterior circulation) extracranial occlusion or tandem occlusion; 
2. Evidence of dissection in the carotid or target artery for treatment; 
3. Evidence of recent/fresh haemorrhage on presentation; 
4. Unwilling to agree to a 3-month follow up visit. 
 
 
7 
ETHICS 
7.1 
Ethics Committee (EC) and Ethical Conduct of the Study   
This study will be conducted in compliance Good Clinical Practice and the ethical principles of 
the Declaration of Helsinki. The study protocol and consent must be approved by the responsible 
EC for each investigational site.  Study activities (patient consent) must not commence prior to 
receipt of documentation of EC approval by the site and sponsor.  Copies of the Investigator’s 
reports and the EC continuance of approval must be sent to the sponsor.   The Investigator and 
study staff must comply with the requirements of their EC.   

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The Investigator must submit and, where necessary, obtain approval from the EC for all 
subsequent protocol amendments and changes to the Informed Consent Form. The Investigator 
must notify the EC of deviations from the protocol, SAEs, and SADEs occurring at the site in 
accordance with local procedures. 
7.2 
Subject Information and Consent 
Subjects must be informed about the study prior to enrollment.  Only those subject’s (or subject’s 
legal representative) who voluntarily provide written consent will be allowed to participate in the 
study.  The original signed consent form should be retained in the patient’s study records and a 
copy should be provided to the patient or legal representative.  If the patient is unable to provide 
informed consent or is deceased prior to consenting, a legally authorized representative may 
consent to use the patient’s medical record. 
 
A sample informed consent document suitable for use in this study will be provided.  Iterations 
of this document must be approved by the reviewing Ethics Committee and the sponsor or 
sponsor-designate.  Subjects must be presented with the most current EC approved version of the 
consent form for signature and study enrollment.  The consent form and consent discussion 
should be in a language the subject understands.  No study related data may be collected prior to 
patient consent.  Study subject’s must be consented prior to or at the study 3 month visit. 
 
Subjects may withdraw participation at any time during the investigation without sacrificing their 
rights as a patient or compromising their quality of medical care.   
 
8 
STUDY PROCEDURES 
8.1 
Screening and Enrollment  
All patients diagnosed with acute ischemic stroke who undergo mechanical thrombectomy with 
the Q Aspiration Catheter as first line therapy, without regard to gender, are eligible for 
screening to participate in the clinical study.  Patients will be screened based on the study 
inclusion and exclusion criteria after the procedure.   
 
A screening log should be kept of all subjects in whom the Q Aspiration Catheter was used to 
prevent bias in subject selection.  Death may be added to the screening log as reason for screen 
failure, if applicable. 
8.2 
Baseline 
Baseline data will only be collected after the subject has agreed to participate and signed an 
informed consent form.  Baseline data collected will include:  hospital transfer, age, sex, vital 
signs (height, weight, blood pressure, respirations, etc), pertinent medical history, pre-treatment 
NIHSS, pre-stroke Modified Rankin Score, neuroimaging results, and thrombolytic therapy. 
8.3 
Mechanical Thrombectomy Procedure  
To be eligible to participate, the procedure had to begin within 8 hours of stroke onset with 
planned first line therapy of the use of the Q Aspiration Catheter alone.  
Digital subtraction angiography should have been undertaken to verify vessel occlusion using 
diagnostic angiography and contrast agent.  Repeat diagnostic angiography should have been 
done on the treated region to assess recanalization grade per mTICI criteria after Q Catheter use 
and at the end of the procedure.   

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The Q Aspiration Catheter must be used per the Instructions for Use to be eligible for 
participation.  Per the IFU, the Q Aspiration Catheter may be used with three aspiration attempts.   
Procedural data collection will include: 
• 
General procedural data (anesthesia use, procedure start time, revascularization time 
and end time, thrombolytic therapy administered, ancillary device use) 
• 
Target vessel location  
• 
Pre-and post-procedure target vessel flow information 
• 
Q Aspiration Catheter use during the procedure 
• 
Rescue device use, if applicable 
• 
Treatment outcome 
• 
Embolization to a new territory 
• 
Procedure and device-related adverse events or any device related problems 
• 
De-identified procedural angiogram should be collected for the Core Lab (only after 
subject consent) (see Section 11.7) 
8.4 
Hospitalization   
Post procedural data collection will include: 
• 
Neurovascular imaging and NIHSS at day 1 post procedure results (0-36 hour 
window) 
• 
Serious Adverse Event monitoring including worsening symptoms/new symptoms 
 
Study Investigator should determine if there was an NIHSS increase greater than or equal to 4 
points along with neuroimaging (CT or MRI) results showing intracranial hemorrhage, if the 
subject experiences a symptomatic intracranial hemorrhage. 
If available, information on the subject’s discharge destination, days in intensive care unit and 
anticoagulation use will be collected along with any serious adverse event experience during 
hospitalization.   
8.5 
3 Month Follow Up 
The final and only study-specific visit will be the 3 month (90 - 120 days) office or telephone 
visit.  The Modified Rankin Scale (mRS) is administered, a review of the subject’s health and 
assessment for serious adverse events will be recorded. 
 
TABLE 3 
DATA COLLECTION 
Assessment 
Baseline 
Procedure 
Post 
Procedure 
Day 7 or Prior 
to Discharge  
3 Month 
Follow-up 
Visit Window 
< 8 hours 
from stroke 
onset 
< 8 hours 
from stroke 
onset 
0 - 36 hours 
post 
procedure 
1 day prior or 
day of 
discharge/ 
transfer or 
Day 7 
90 - 120 
days post- 
procedure 
Informed Consent 
 
 
X1 
X1 
X1 
Medical History 
X 
 
 
 
 
Vitals 
X 
 
 
 
 
Neuroimaging (CT/MRI) 
X 
 
X 
 
 
NIHSS 
X 
 
X 
 
 
mRS 
X 
 
 
 
X 

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1 Informed Consent may happen at any time after the procedure but must happen prior to the initiation of 
the 3 month visit (but may be signed at the beginning of the visit) 
8.6 
Subject Withdrawal/Study Completion 
Subjects will complete the study after the 3 month follow up visit.  For a subject who withdraws 
from the study, all data collected up to the point of withdrawal is retained.  A subject wishing to 
withdraw from the study should provide that request in writing to the site to document the 
decision.   
8.7 
Protocol Deviations 
A protocol deviation is defined as an event where the clinical investigator or site personnel did 
not conduct the study per the protocol or the Investigator/Trial Agreement.   
 
No protocol deviations will be made to the investigational plan.  The investigator is required to 
adhere to local EC procedures for reporting deviations.   
9 
ADVERSE EVENTS 
9.1 
AE Definitions 
Adverse Event (AE): 
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in 
subjects, whether or not related to the use of the study device or procedures. 
 
Serious Adverse Event (SAE): 
Any untoward medical occurrence that meets any of the following criteria: 
• 
Resulted in death 
• 
Resulted in inpatient hospitalization or prolonged an existing hospitalization  
• 
Resulted in a life-threatening illness or injury (patient in immediate danger of death) 
• 
Resulted in permanent impairment of a body function or permanent damage to a 
body structure 
• 
Necessitated medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment of a body function or body structure 
 
A life-threatening adverse event means any adverse event that places the patient, in the opinion 
of the Principal Investigator, at immediate risk of death from the reaction as it occurred, i.e., it 
does not include a reaction that, had it occurred in a more severe form, might have caused death. 
 
A planned hospitalization for a pre-existing condition, without a serious deterioration in health, is 
not considered a serious adverse event. 
 
Adverse Device Effect (ADE): 
An ADE is an adverse event related to the use of a medical device.  An event should be 
considered related to the device when it is the result of: insufficient or inadequate instructions for 
use or any malfunction of the device. 
 
An event should be considered not related to the device when it is the result of: a pre-existing 
medical condition, a new illness, injury or condition, or due to medication. 
Procedure and device use 
data 
 
X 
 
 
 
Serious Adverse Event 
Collection 
 
X 
X 
X 
X 

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Unanticipated Adverse Device Effect (UADE): 
An unanticipated adverse device effect is defined as “any serious adverse device effect which by 
nature, incidence, severity or outcome has not been identified in the current risk analysis.  Those 
known adverse events related to the device are listed in the IFU. 
 
9.2 
Adverse Event Reporting 
 
In the case of any serious adverse effects (SAE) or complications reported by patients or by the 
attending clinician attributable to the use of the device, the event will be reported to the EC and 
CA, as applicable, per standard post-market device monitoring. 
 
All serious adverse events, and/or device deficiencies that may have led to an ADE and is 
serious must be reported to the Sponsor within a reasonable time of the Principal 
Investigator becoming aware of the event and without an unjustified delay. 
 
The Sponsor can be contacted at the following:  
 
 
 
Email Address 
clinical@mivineuro.com 
Fax Number 
+1 952.944.3488 
Telephone Number 
+1 952.944.3834 
 
The Investigator shall assess adverse events according the definitions set out in this 
protocol and determine seriousness and relationship to the device.   
9.3 
Device Malfunction/Failure 
Device malfunctions or failures will be reported per post market device reporting 
requirements.  The following situations should be reported:  
• 
All situations where the device is physically defective, including out of the box 
failure; 
• 
All situations where the device physically deforms or breaks, even if caused by 
user error; 
• 
All situations where the device mechanically fails to perform as intended. 
10 STATISTICAL DESIGN AND ANALYSIS PLAN 
10.1   Study Design Justification 
This is a multi-center study involving up to 50 subjects at up to 5 investigational sites in Spain.  
The purpose of the study is to collect data on the safety and performance of the Q Aspiration 
Catheter used to remove thrombi and emboli from the neurovasculature during acute ischemic 
stroke.  The primary safety endpoint for this study symptomatic intracranial haemorrhage within 
24 hours post-procedure along with an NIHSS change of >4.  The primary performance 
endpoint is successful revascularization of the target artery defined as mTICI 2b-3 flow at the 
end of the procedure. 
10.2  Statistical Methods 
This study is a single arm, registry study with endpoints compared to well defined and published 
outcomes.  This study is designed for observational data to be collected and reported. There will 
be no formal statistical hypothesis testing conducted, and therefore sample size is not based on 
power calculations. 
 

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Data analysis will comprise of descriptive statistics (means, standard deviations, rates, 
correlations, etc.) on the variables detailed in the study endpoints and other data collected.   
 
The analyzed population will consist of all subjects who signed an informed consent form.  
10.3 General Statistical Considerations 
All endpoints will be analyzed descriptively. In general, continuous parameters will be 
summarized by number of evaluable observations, mean, standard deviation, median, minimum, 
and maximum.  Categorical data will be described by frequency counts and percentages. 
Every effort will be made to collect complete data.  Unless otherwise specified, imputation of 
missing data will not be performed.  Given the timing for evaluation, missing data is expected to 
be minimal to none for the primary safety and effectiveness endpoints.  The primary analysis for 
the primary endpoints will include all subjects in the analysis population. 
11 STUDY MANAGEMENT 
11.1  Investigator/Site Selection  
MIVI Neuroscience or its Contract Research Organization (CRO)/designee are responsible for 
conducting a Selection/Qualification Visit with potential investigational sites, if deemed 
necessary, to determine if the investigator and investigational site meets the criteria for 
conducting the clinical investigation.  The Selection/Qualification Visit may be in person, over 
the phone, based on previous experience with the site, or a combination thereof.  The site 
screening and qualification results will be documented, and a participation decision 
communicated to the potential site. 
11.2  Site Initiation and Training 
A Site Initiation Visit will be conducted and documented to train the study staff on study conduct 
prior to enrollment in the study.   Documentation of study specific training and study role will be 
documented.  Training will include the specifics of study conduct, device-specific information, 
and adverse event reporting.  A sponsor representative may be present at the procedure to 
provide additional training and support. 
 
Prior to enrolling patients at an investigational site, all required documentation must be 
completed.    
11.3   Q Aspiration Catheter Devices 
The Q Aspiration Catheter is a CE Marked device used according to the IFU, therefore device 
may be shelf stock.  A site may be supplied with devices for study.  If device is supplied to the 
site, the investigator or delegated personnel must maintain records of the product delivery to the 
site, the inventory at the site, the use, and the return to the sponsor.   
11.4  Clinical Study Management Responsibilities 
The sponsor’s clinical department personnel or a sponsor representative(s) will have overall 
study management responsibility including on-site consultation to assist with technical support, 
protocol adherence, assurance of the accuracy of case report forms, and compliance with 
applicable regulations.  The contact information for the study sponsor is: 
 
Attn: Clinical Department 

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MIVI Neuroscience, Inc. 
6545 City West Parkway 
Eden Prairie, MN  55344 USA 
Phone +1 (952) 944-3834 
Fax +1 (952) 944-3488 
11.5  Case Report Forms (CRFs) 
The sponsor or designee will provide case report forms for the study.  Case report forms must be 
completed to capture each enrolled subject’s study data either on paper or electronically.  The 
source data (paper or electronic) includes and is not limited to the information contained in 
original medical records and certified copies of results, test results and printouts, patient 
questionnaires, source worksheets, and electronic monitoring data.  Data queries will be 
routed to the investigational site to resolve any data discrepancies.  The site should respond to the 
query within 10 working days.  Investigators will be responsible for acknowledging the 
completeness and accuracy of the data by signing, either electronically or on paper, CRFs 
where indicated. 
11.6  Study Monitoring 
The investigational site will be monitored to ensure compliance with the study protocol, 
adherence to applicable regulations, and accuracy of study data.  MIVI Neuroscience and/or its 
CRO/designee will monitor the study by frequent communications with and visits to each clinical 
site to ensure the trial is conducted in accordance with this clinical protocol and the law.   
 
The study monitor(s) will be responsible to complete a review of regulatory documents, source 
documents, and case report forms for accuracy, completeness, and legibility.  Site monitoring 
visits will be documented in a written monitoring report to include the identification of any 
follow-up items or concerns.  Resolution of follow up items and concerns will also be 
documented in the monitoring report. 
 
The investigator will permit the sponsor and/or agent from the relevant regulatory 
authority or appointed member from the IEC, or equivalent, if requested, to inspect all case 
record forms and corresponding portions of the study patients' original office and/or 
hospital records. 
11.7 Core Laboratories 
An independent angiographic core laboratory will be utilized for this study to interpret 
all angiographic data gathered on all study subjects and determine mTICI scores.  The 
core lab data must be de-identified and labeled with subject number and date of 
procedure and then forwarded to the core lab.  Refer to Core Laboratory Manual for 
additional information. 
11.8 Trial Termination/Investigational Site Termination 
MIVI Neuroscience, Inc. may terminate this trial at any time.  MIVI Neuroscience also reserves 
the right to terminate an Investigational Site if that site fails to comply with the Clinical Trial 
Agreement, EU Regulations, submits falsified or unreliable data, or misuses the device. 
11.9 Trial Registration 
This study will be registered on www.clinicaltrials.gov. 

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12 RECORDS AND REPORTS 
12.1 Essential Documents 
Investigators are required to provide MIVI Neuroscience the following information prior to 
subject consent at the investigational site: 
• 
Copy of investigators’ curriculum vitae [principal investigator and co-investigator(s)] 
• 
Signed Clinical Trial Agreement 
• 
Copy of the EC approval letter and  
• 
EC approved informed consent document 
• 
Appropriate training documentation 
12.2 Investigator Records  
The investigator is responsible for the preparation, review, and retention of the records listed 
below: 
• 
All pertinent correspondence that pertains to the investigation 
• 
Signed and dated informed consent forms 
• 
Serious adverse event information 
• 
Medical history (medications etc.), medical records, progress notes, hospital charts, 
etc. 
• 
A record of each patient’s exposure to the investigational device (e.g. implant, 
follow up, etc.) 
• 
Documentation of any deviation from protocol 
• 
Signed Investigator’s Agreement and curriculum vitae 
• 
The protocol and any amendments 
 
Records are pertinent to regulatory authority’s inspection and must be retained for a minimum 
period of (2) years after the latter of two dates:  1) the date on which the investigation is 
terminated or completed, or 2) as long as local regulatory authorities in countries conducting the 
research study require retention. 
12.3  Sponsor Records  
MIVI Neuroscience or its designee will maintain the following records: 
• 
all pertinent correspondence which pertains to the investigation, 
• 
device shipment records and disposition logs (if applicable), 
• 
signed Clinical Trial Agreements and curriculum vitae for each Investigator, 
• 
adverse events and complaints, 
• 
all data forms, prepared and signed by the investigators, received source 
documentation and core lab reports, 
• 
investigational plan and report of prior investigations, 
• 
site monitoring reports, and 
• 
final reports. 
 
13 PROTOCOL DEFINITIONS 
13.1 Abbreviations 
ADE 
Adverse device effect; also UADE (unanticipated adverse device 
effect) 
AE 
Adverse Event; also SAE (serious adverse event) 

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ASPECTs 
Alberta Stroke Program Early CT score 
BP 
Blood Pressure 
CA 
Competent Authority 
CEC 
Clinical Events Committee 
CRF/eCRF Case Report Form/electronic Case Report Form 
CT/CTA 
Computerized Tomography / CT Angiography 
CV 
Curriculum Vitae 
EC 
Ethics Committee 
ENT 
Embolization to a new territory 
ICF 
Informed Consent Form 
(s) ICH 
(Symptomatic) intracranial hemorrhage 
ICH GCP 
International Conference on Harmonization E6 Guidelines for Good 
Clinical Practice  
IFU 
Instructions For Use 
LR/LAR 
Legal Representative/ Legally authorized representative 
MRI/ A 
Magnetic Resonance Imaging/ Angiogram 
mRS 
modified Rankin Score 
NIHSS 
National Institutes of Health Stroke Scale 
SAE 
Serious Adverse Event 
mTICI 
Modified Thrombolysis in Cerebral Infarction (Scale)  
tPA 
Tissue Plasminogen Activation 
UADE 
Unanticipated Adverse Device Effect   
13.2 Study Endpoint Definitions 
Primary Performance Endpoint of successful revascularization defined as mTICI flow 2b-3 in 
the target vessel at the end of the procedure as determined by in independent 
Angiographic Core Laboratory. 
Primary Safety Endpoint of Symptomatic Intracranial Hemorrhage (SICH) –  
 
Defined according to ECASS II definition of any apparently extravascular blood in the 
brain or within the cranium associated with clinical deterioration, as defined by an 
increase of 4 points or more in the score on the National Institutes of Health Stroke Scale 
(NIHSS), or that leads to death and is identified as the predominant cause of the 
neurologic deterioration.  This endpoint is assessed from data obtained within 24 hours 
post procedure (0-36 hrs).  
 
Secondary Endpoints 
• 
Successful revascularization defined as mTICI 2b-3 with the Q Aspiration Catheter as 
determined by an independent Angiographic Core Lab. 
• 
Embolization to a new neurovascular territory during the procedure as determined by 
the Core Lab 
• 
Good functional outcome measured by Modified Rankin Score of 0-2 at 90 days  
• 
All-cause mortality at 90 days 
13.3 Protocol-specified and Other Definitions 
Device Failure 
The device is used in accordance with the IFU but does not perform according to IFU and 
negatively impacts the treatment. 
 
Device Malfunction 
An unexpected change to the device that is contradictory to the IFU and may or may not affect 
device performance. 

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Rescue therapy 
The use of another mechanical thrombectomy device, mechanical pump aspiration, intracranial 
[stenting, or initiation of intra-arterial tPA during the procedure after a failure to recanalize with 
the study device. 
 
Modified TICI Flow 
Thrombolysis In Cerebral Infarction scale (classification of cerebral artery flow) -  
0       No perfusion or anterograde flow beyond site of occlusion 
1       Penetration but not perfusion. Contrast penetration exists past the initial obstruction 
but with minimal filling of the normal territory 
2       Incomplete perfusion wherein the contrast passes the occlusion and opacifies the 
distal arterial bed but rate of entry or clearance from the bed is slower or 
incomplete when compared to non-involved territories 
2A Some perfusion with distal branch filling of <50% of territory visualized 
2B 
Substantial perfusion with distal branch filling of ≥ 50% of territory 
visualized 
2C 
Near complete perfusion except for slow flow in a few distal cortical vessels, 
or presence of small distal cortical emboli 
3 
Complete perfusion with normal filling of all distal branches 
 
14 INVESTIGATIONAL PLAN HISTORY 
 
Revision Date 
Change(s) 
DRAFT 
OCT2018 
Changed study type from a prospective, single arm study to an 
observational study.   
A 
14MAR2019 
Initial Release 
B 
01AUG2019 
Changed the FU visit from office to either office or telephone visit, 
deleted NIHSS at FU visit, minor edits for clarity, and added 
mTICI 2C definition. 
15 REFERENCES 
1. Badhiwala JH, et al.  JAMA 2015; 314 (17): 1832-1843. 
2. Elgendy IY, et at.  JACC 2015; 66 (22): 2498-505.  
3. Goyal M, et al.  Lancet 2016; 387: 1723-31. 
4. Peschillo S, et al.  J Neuro Intervent Surg 2017;9 (8):743-749. 
5. Turk AS, et al. J Neurointerv Surg 2014 Apr 1;6 (3):231-7. 
6. Phan K, et al.  Neurosurgery 2017 Jul; 0 (0): 1-10.  
7. Wei D, et al.  Am J Neuroradiol 2017 Oct; 38 (10): 1978-83.