A Prospective, Multicenter, Randomized Controlled, Non-inferiority Study to Investigate the Effectiveness and Safety of Intracranial Embolization Stents for Endovascular Treatment of Acute Ischemic Stroke
Phase: NA
Conditions: Ischemic Stroke, Acute, Brain Diseases, Cerebrovascular Disorders
Sponsor: Sinomed Neurovita Technology Inc.

 
<For the seal, refer to the source document> 
Protocol No.: SNSC202101 
 
Study on Effectiveness and Safety of Ghunter Revascularization 
Device for Endovascular Treatment of Acute Ischemic Stroke 
(A Prospective, Multicenter, Randomized Controlled, Non-inferiority Study) 
Clinical Trial Protocol of Medical Devices 
(NCT04973332) 
 
Name of investigational medical device: Ghunter Revascularization Device 
Models/Specifications: See the text 
Management category of investigational 
medical device: Class III medical device 
Class III medical device requiring clinical 
trial approval: Yes ☐ No  
Similar product in China: Yes  No ☐ 
Home-made similar product in China: Yes  No ☐ 
Protocol version No. and date: V3.0/February 9, 2022 
Study site: General Hospital of Eastern Theater 
Command, PLA 
Principal investigator (coordinating 
investigator): 
Professor Liu Xinfeng <signed> 
Sponsor: Sinomed Neurovita Technology Inc. 
Statistical analysis: 
Medical 
Statistics 
Office 
of 
Peking 
University First Hospital 
Professor Yao Chen 
Contract research organization: JetMed (Beijing) Co., Ltd. 
 
 
 
Statement of Confidentiality 
All information contained in this protocol is the proprietary information of Sinomed Neurovita Technology 
Inc. and is only available for review by the investigator, the coordinating investigator, Ethics Committee, 
supervisory and regulatory authorities and other relevant medical institutions. Without the written approval 
of the sponsor, any information cannot be disclosed to the third parities not associated with the study 
unless this disclosure is made to make the subjects who may participate in the study sign the informed 
consent form (ICF). 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
2 
Table of Contents 
Protocol Abstract ................................................................................................ 5 
1. Sponsor Information ..................................................................................... 9 
1.1. 
Name of Sponsor .................................................................................. 9 
1.2. 
Address of Sponsor ............................................................................... 9 
1.3. 
Contact Information of Sponsor ........................................................... 9 
1.4. 
Relevant Qualification Documents of Sponsor .................................... 9 
1.5. 
Name, Address, Contact Information and Relevant Qualification 
Documents of Agent ............................................................................. 9 
2. List of Study Sites and Investigators ........................................................... 9 
3. Purpose and Content of Clinical Trial ........................................................ 9 
3.1. 
Purpose .................................................................................................. 9 
3.2. 
Contents .............................................................................................. 10 
4. Background of Clinical Trial ..................................................................... 10 
5. Characteristics, Device Composition, Working Principle, Mechanism of 
Action and Study Scope of the Product .................................................... 13 
5.1. 
Product Characteristics ....................................................................... 13 
5.2. 
Device Composition, Operation Principle and Mechanism of Action
 ............................................................................................................. 13 
5.2.1. Device Composition .................................................................... 14 
5.2.2. Working Principle and Mechanism of Action ............................ 14 
5.3. 
Study Scope ........................................................................................ 14 
6. Overall Design ............................................................................................. 15 
6.1. 
Study Design ....................................................................................... 15 
6.1.1. Study Objective ........................................................................... 15 
6.1.2. Selection of Study Method and Justification .............................. 15 
6.1.3. Measures to Reduce and Avoid Bias .......................................... 15 
6.1.4. Investigational Medical Device and Control Device/Control 
Diagnostic and Therapeutic Method .......................................... 16 
6.1.5. Subject Enrollment ..................................................................... 17 
6.1.6. Effectiveness Evaluation Methods .............................................. 20 
6.1.7. Safety Evaluation Methods ......................................................... 22 
6.2. 
Study Process ...................................................................................... 23 
6.2.1. Study Process .............................................................................. 23 
6.2.2. Device Specifications (recommend the operation method, and the 
operator may make slight modification according to the actual 
situations) ................................................................................... 29 
6.3. 
Monitoring Plan .................................................................................. 34 
7. Statistical Analysis Method and Evaluation Method .............................. 34 
7.1. 
Statistical Design, Method and Analysis Procedure ........................... 34 
7.1.1. Statistical Design (Hypothesis Testing) ..................................... 34 
7.1.2. Statistical Analysis Methods ....................................................... 35 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
3 
7.2. 
Calculation of Sample Size ................................................................. 36 
7.2.1. Total Sample Size ........................................................................ 36 
7.2.2. Number of Subjects for Each Disease and Rationale for 
Determination ............................................................................. 37 
7.2.3. Minimum and Maximum Number of Subjects in Each Site and 
Justification................................................................................. 37 
8. Significance Level and Power of Clinical Study ...................................... 37 
8.1. 
Expected Drop-out Rate ..................................................................... 37 
8.2. 
Pass/Fail Criteria for Clinical Trial Results ........................................ 38 
8.3. 
Criteria for Termination of Trial Based on Statistics and Justification
 ............................................................................................................. 38 
8.4. 
Data Statistical Method, with the Handling Method of Missing, Unused 
and Wrong Data (Including Discontinuation and Withdrawal) and 
Unreasonable Data .............................................................................. 38 
8.5. 
Procedures for Reporting Deviation from Original Statistical Plan ... 38 
8.6. 
Selection Criteria for Subjects Included in the Analysis and 
Justification ......................................................................................... 38 
8.7. 
Exclusion of Special Data During Hypothesis Test and Justification (if 
applicable) ........................................................................................... 39 
9. Data Management ....................................................................................... 39 
9.1. 
Data Collection ................................................................................... 39 
9.2. 
Data Verification and Modification .................................................... 39 
9.3. 
External Data Management ................................................................ 40 
9.4. 
Database Locking ............................................................................... 40 
10. Feasibility Analysis ..................................................................................... 40 
10.1. Possibility Analysis on Success .......................................................... 40 
10.2. Possibility Analysis on Failure ........................................................... 41 
11. Quality Control of Clinical Trial ............................................................... 41 
11.1. Monitoring of Clinical Trial ............................................................... 41 
11.2. Filling of Case Report Form ............................................................... 42 
11.3. Retention of Raw Data ........................................................................ 42 
12. Ethical Issues and Informed Consent in Clinical Trial ........................... 42 
12.1. Ethical Considerations ........................................................................ 42 
12.2. Approval of Trial Protocol .................................................................. 42 
12.3. Informed Consent Process and Contents of Informed Consent Form 42 
13. Provisions for AE and Device Defect Reporting ...................................... 43 
13.1. AE ....................................................................................................... 43 
13.1.1. Definition of AE .......................................................................... 43 
13.1.2. Determination of AE Severity ..................................................... 43 
13.1.3. Recording of AE .......................................................................... 43 
13.2. Device Defect ..................................................................................... 43 
13.3. SAE  .................................................................................................... 44 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
4 
13.4. Reporting Procedures and Contact Information ................................. 44 
14. Deviation from Clinical Trial Protocol and Regulations for Protocol 
Amendment ................................................................................................. 45 
15. Direct Access to the Source Data and Documents ................................... 46 
16. Finance and Insurance ............................................................................... 46 
17. Contents to be Covered in Clinical Trial Report ..................................... 46 
18. Confidentiality Principle ............................................................................ 47 
19. Agreement on Publication of Trial Results .............................................. 47 
20. Responsibilities Assumed by All Parties ................................................... 48 
20.1. Responsibilities of the Sponsor: ......................................................... 48 
20.2. Responsibilities of Study Site and Investigator: ................................. 48 
References .......................................................................................................... 50 
Investigator's Statement ................................................................................... 51 
Appendix 1 List of Study Sites and Investigators .......................................... 52 
Appendix 2 ASPECTS Scale ............................................................................ 53 
Appendix 3 mTICI Image Grading Criteria:................................................. 54 
Appendix 4 mRS: .............................................................................................. 55 
Appendix 5 NIHSS: ........................................................................................... 56 
 
 
 
 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
5 
Protocol Abstract 
Protocol title 
Study on Effectiveness and Safety of Ghunter Revascularization Device for 
Endovascular Treatment of Acute Ischemic Stroke 
(A Prospective, Multicenter, Randomized Controlled, Non-inferiority Study) 
Protocol 
version No. and 
date 
V3.0/February 9, 2022 
Sponsor 
Sinomed Neurovita Technology Inc. 
Device name 
Ghunter Revascularization Device 
Device 
classification 
Class III medical device 
Study objective 
To verify the effectiveness and safety of Ghunter Revascularization Device for 
endovascular treatment of acute ischemic stroke 
Sample size 
220 subjects 
Number of 
study sites 
No less than 10 sites, competitive enrollment 
Indications for 
use 
Ghunter Revascularization Device is indicated for use in ischemic stroke patients 
whose symptom onset are within 24 h. 
Control setting 
Test group: Sinomed Neurovita Ghunter Revascularization Device 
Control group: Solitaire FR 
General 
inclusion 
criteria 
1) 
≥ 18 years old; 
2) 
NIHSS ≥ 6 at randomization; 
3) 
Pre-onset mRS < 2; 
4) 
Acute ischemic stroke was diagnosed; 
5) 
Within 24h from the stroke onset to the completion of femoral artery puncture 
(regardless of whether intravenous thrombolysis has been performed); the time 
point of stroke onset is defined as the time point at which the patient is last known 
to be normal; 
6) 
The subject (or his/her guardian) agrees to participate in this study and signs the 
informed consent form (ICF). 
Angiographic 
inclusion 
criteria 
1) 
Cerebral CT or MR should be performed when the time from the stroke onset to 
the completion of femoral artery puncture of a patient is ≤ 6h; 
2) 
Cerebral CT or MR should be performed when the time from the stroke onset to 
the completion of femoral artery puncture of a patient is 6 (exclusive)-24h 
(inclusive), and his/her ASPECTS score should be ≥ 6. (If immediate CT 
perfusion imaging or MR perfusion imaging is feasible, it is recommended to 
perform CTP or MRP simultaneously to assist in the assessment of the infarct 
core, and his/her ASPECTS score should also be ≥ 6); 
3) 
DSA angiography shows acute occlusion of large intracranial arteries, including 
intracranial internal carotid artery (C4-C7), middle cerebral artery (M1/M2), 
basilar artery and intracranial vertebral artery (V4). 
General 
exclusion 
criteria 
1) 
Those who could undergo neither MRI nor CT; 
2) 
Those with hemorrhagic stroke or major ischemic stroke within 6 months before 
enrollment; 
3) 
Those with severe persistent hypertension that could not be controlled by 
intravenous injection for blood pressure reduction, i.e. patients with sustained 
SBP > 185 mmHg or sustained DBP > 110 mmHg; 
4) 
Those with presumed septic emboli or suspected bacterial endocarditis; 
5) 
Renal failure, defined as creatinine > 3.0 mg/dL (264 µmol/L); 
6) 
Those with blood glucose < 2.78 mmol/L (50 mg/dL) or > 22.20 mmol/L (400 
mg/dL); 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
6 
7) 
Decreased platelet count (< 40 × 10 9/L); 
8) 
Those with known hemorrhage tendency, coagulation factor deficiency, are 
taking anticoagulants and with INR > 3.0; 
9) 
Pregnant or lactating women; 
10) Those with known severe allergy to contrast media or known allergy to nickel 
materials; 
11) Those with disorders possessing possibility of affecting neurological assessment 
(e.g., neurological and psychiatric disorders); 
12) Those who are unable to undergo interventional operations due to heart, lung, 
liver failure or other serious diseases; 
13) Participating in clinical trials of other drugs or devices; 
14) Life expectancy less than 6 months; 
15) Other conditions judged by the investigator to be not suitable for inclusion. 
Angiographic 
exclusion 
criteria 
1) 
There is evidence of intracranial hemorrhage on CT or MR or known 
hemorrhage tendency; 
2) 
CT/MR/DSA angiography suggests > 1 vascular occlusion (e.g., simultaneous 
occlusion of bilateral internal carotid artery vessels, or simultaneous occlusion 
of intracranial vessels in anterior and posterior circulation, or simultaneous 
occlusion of intracranial and extracranial internal carotid artery); 
3) 
Those with carotid artery dissection, occlusion of the initial segment of the 
carotid artery or arteritis; 
4) 
Those whose access vessels are severely tortuous, making the revascularization 
device difficult to reach the target location. 
Primary  
endpoint 
Success rate of instant recanalization 
Secondary 
endpoints 
Proportion of subjects with mRS scores of 0-2 on 90d postoperatively, time from 
femoral artery puncture to recanalization/the end time of operation for subjects whose 
recanalization failed, proportion of subjects with NIHSS score decrease > 4, and 
success rate of device operation 
Safety 
endpoints 
Incidence of symptomatic intracranial hemorrhage within 24h postoperatively, all-
cause mortality within 90d, incidence of SAE, incidence of AE, and incidence of device 
defects 
Clinical 
examination 
items 
 Vital signs: heart rate, blood pressure 
 Cerebral CT or MR 
 Blood routine: Red blood cell, hemoglobin, white blood cell count, and platelet 
count 
 Blood chemistry: Urea nitrogen (urea), serum creatinine, blood glucose 
 Coagulation: Prothrombin time, activated partial thromboplastin time and INR 
 Pregnancy testing (Only for women of childbearing potential who are planning to 
become pregnant) 
 Cerebral vascular DSA 
Expected 
duration of 
participation 
Screening/baseline period (-1 d ~ 0 d preoperatively), treatment period (day of 
operation/0d), observation period (24 ± 12 h postoperatively), follow-up period (7 ± 2 
d postoperatively (before discharge in case of premature discharge)), and follow-up 
period (90 ± 14 d postoperatively). The expected duration of participation of each 
subject is about 90 days. 
Statistical 
analysis 
Medical Statistics Office of Peking University First Hospital Professor Yao Chen 
Contract 
research 
organization 
JetMed (Beijing) Co., Ltd. 
Expected 
About 30 months 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
7 
duration of trial 
 
 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
8 
List of Abbreviations 
Abbreviation 
Terms and Definitions 
AE 
Adverse event 
SAE 
Serious adverse event 
FAS 
Full Analysis Set 
PPS 
Per Protocol Set 
SS 
Safety Analysis Set 
eCRF 
Electronic Case Report Form 
AIS 
Acute ischemic stroke 
rt-PA 
Recombinant tissue plasminogen activator 
sICH 
Symptomatic intracranial hemorrhage 
SAH 
Subarachnoid hemorrhage 
NIHSS 
National Institutes of Health Stroke Scale 
TIMI 
Thrombolysis in Myocardial Infarction 
mTICI 
Modified Thrombolysis in Cerebral Infarction 
mRS 
Modified Rankin Scale 
ASPECTS 
Alberta Stroke Program Early CT Score 
INR 
International Normalized Ratio 
RHV 
Rotating Hemostatic Valve 
 
 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
9 
1. Sponsor Information 
1.1. Name of Sponsor 
Sponsor: Sinomed Neurovita Technology Inc. 
1.2. Address of Sponsor 
Factory Building 3, Shicheng Sci.&Tech. Park, No.1566 Yinzhong South Road, 
Wuzhong Economic Development Zone, Suzhou 
1.3. Contact Information of Sponsor 
Contact person: Xia Ligang 
Tel.: 18612448465 
E-mail: xialigang@sinomed.com 
1.4. Relevant Qualification Documents of Sponsor 
Unified social credit code: 91320506MA2288DA27 
1.5. Name, Address, Contact Information and Relevant Qualification 
Documents of Agent 
N/A 
2. List of Study Sites and Investigators 
See Appendix 1 List of Study Sites and Investigators for details. 
During the clinical study, if the existing participating sites fail to obtain the 
approval of the clinical trial administrative department or the Ethics Committee, 
resulting in the progress of the study significantly slower than the expected 
schedule, the sponsor should fully communicate and discuss with the 
coordinating investigator, and then make adjustments to the participating sites 
(abandonment or addition), and may update the list of clinical study sites in the 
Appendix without amending the text of the protocol. The final list of participating 
sites should be submitted to the clinical trial administrative department and Ethics 
Committee of all participating sites for filling. 
3. Purpose and Content of Clinical Trial 
3.1. Purpose 
To verify that Ghunter Revascularization Device manufactured by Sinomed 
Neurovita Technology Inc. (hereinafter referred to as “Sinomed Neurovita”) is 
not inferior to Solitaire FR in success rate of instant recanalization for 
endovascular treatment of acute ischemic stroke, and to verify the effectiveness 
and safety of this product by clinical trial in accordance with the Good Clinical 
Practice for Medical Devices. 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
10 
3.2. Contents 
The study is a prospective, multicenter, randomized controlled, non-inferiority 
clinical trial, of which the investigational device is Sinomed Neurovita Ghunter 
Revascularization Device and the control device is Solitaire FR (hereinafter 
referred to as the control product under the trade name Solitaire FR) distributed 
by Covidien Healthcare International Trading (Shanghai) Co., Ltd.; the study is 
planned to be conducted in more than 10 sites and include 220 subjects. The 
subjects who meet the inclusion criteria will be randomized into the test group or 
control group in 1:1. The study is to collect and evaluate whether the success rate 
of instant recanalization is not inferior to Solitaire FR when Sinomed Neurovita 
Ghunter Revascularization Device is used for endovascular treatment of acute 
ischemic stroke, and to evaluate whether there is a statistically significant 
difference in the proportion of subjects with mRS score of 0 - 2 on 90d 
postoperatively, the time from femoral artery puncture to recanalization/the end 
time of operation for subjects whose recanalization failed, the proportion of 
subjects with NIHSS score decrease > 4, and the success rate of device operation 
as compared with Solitaire FR when Ghunter Revascularization Device is used 
for endovascular treatment of acute ischemic stroke. Also, whether there is 
statistical difference in incidence of symptomatic intracranial hemorrhage within 
24h postoperatively, all-cause mortality within 90d, incidence of SAE, incidence 
of AE, and incidence of device defects between Ghunter Revascularization 
Device and Solitaire FR for endovascular treatment of acute ischemic stroke will 
be evaluated. 
4. Background of Clinical Trial 
Stroke is one of the leading causes of disability and death in humans, and acute 
ischemic stroke (AIS) accounts for about 80% of all strokes. Recent studies have 
shown that the 1-month mortality rate of hospitalized acute ischemic stroke 
patients in China is 2.3%-3.2%; the 3-month mortality rate is 9%-9.6%, and the 
death/disability rate is 34.5%-37.1%; the 1-year mortality rate is 14.4%-15.4%, 
and the death/disability rate is 33.4%-33.8% [1]. The key to AIS treatment lies in 
early recanalization of obstructed vessels and saving the ischemic penumbra. 
Current treatment modalities mainly focus on intravenous thrombolysis and 
endovascular treatment, of which endovascular treatment mainly includes arterial 
thrombolysis, non-stented mechanical thrombectomy, and stented mechanical 
thrombectomy [2, 3]. 
At present, the proven effective treatment for early recanalization of AIS is 
intravenous recombinant tissue plasminogen activator (rt-PA) thrombolysis [4-6]. 
A pooled analysis of 9 randomized controlled studies of thrombolysis published 
in 2014 further confirmed the benefit of intravenous rt-PA thrombolysis within 
4/5h of ischemic stroke onset, and the earlier the time, the more the benefit [7]. 
However, because intravenous thrombolysis has strict time window restrictions, 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
11 
less than 3% of patients can benefit from it, and there is still a huge room for 
optimization of its therapeutic effect: compared with the control group, the 
mortality rate at 3-6 months after intravenous thrombolysis is not significantly 
reduced, still as high as 17.9%, and two-thirds of patients are still left with 
different degrees of disability, especially for patients with great vascular 
occlusion or severe disease, and its recanalization rate is low (13%~18%) [8]. 
Therefore, domestic and foreign scholars have been exploring the AIS 
endovascular treatment regime for patients with great vascular occlusion. Since 
September 2014, a series of studies have published more consistent findings: 
endovascular treatment based on mechanical thrombectomy can bring definite 
benefits [9-17]. 
Mechanical thrombectomy devices have gained much attention because of their 
many theoretical advantages: rapid recanalization, lower hemorrhage conversion 
rate, and prolonged stroke intervention time windows [15]. Merci Retrieval™ 
(2004) and Penumbra Stroke Systems™ (2008) were approved by the US Food 
and Drug Administration (FDA) as the first-generation mechanical 
thrombectomy devices. 
The invention of stent thrombectomy devices represents a great advance for 
endovascular treatment of stroke, and revascularization devices have the 
advantage of navigability and rapid recanalization without the risk of long-term 
complications. The stent thrombectomy device uses a temporary stent to capture 
the thrombus and to restore flow by moving the thrombus against the intracranial 
vessel wall; upon stent withdrawal, the thrombus is captured in the stent space 
and removed with the stent. Solitaire (Medtronic/ev3) and Trevo (Stryker) stent 
thrombectomy devices were approved by the US FDA in 2012 for treatment of 
great-vessel occlusive stroke. The Solitaire device versus Merci device for AIS 
treatment trial (SWIFT) [18] compared the Solitaire and Merci devices (non-
stented mechanical revascularization device) and terminated prematurely mid-
term due to a significant difference in effectiveness; in the primary endpoint, 
recanalization was defined as a TIMI grade of 2 or 3. More recanalization with 
the Solitaire device, more patients with mRS scores ≤ 2 after 3 months. The 
multicenter randomized clinical trial of AIS endovascular treatment (MRCLEAN) 
[10] was a prospective, multicenter, randomized controlled study and was the first 
to exhibit a significant benefit of endovascular treatment compared with the 
standard internal medicine treatment; the results demonstrated a higher rate of 
24h recanalization for endovascular treatment group, a smaller median infarct 
volume at 1 week, and a better 3-month mRS grade. The study, with endovascular 
mechanical thrombectomy as the primary endovascular treatment for AIS 
(SWIFT PRIME) [13] was conducted in 39 hospitals in the United States and 
Europe to compare the effectiveness of intravenous rt-PA thrombolysis with 
combined endovascular treatment (both using Solitaire), while it was terminated 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
12 
prematurely as the interim analysis suggested a significant benefit of 
endovascular treatment; the results demonstrated that patients in the 
thrombectomy group had a higher proportion in mRS scores of 0-2 on 90d and a 
tendency to reduce mortality. In the EXTEND-IA [11], a prospective, randomized 
controlled study to prolong the time from acute neurological deficit to intra-
arterial thrombolysis, subjects were randomized into the intravenous r-tPA 
thrombolysis group and intravenous r-tPA thrombolysis + Solitaire 
thrombectomy group; the results demonstrated that the early reperfusion rate of 
ischemic tissue at 24h after Solitaire thrombectomy, the early neurological 
improvement rate on 3d, and the proportion of patients with mRS scores of 0-2 
on 90d in patients with thrombectomy were significantly higher than those in the 
control group, showing a tendency to reduce mortality. In summary, there is clear 
evidence to support the use of stent thrombectomy devices for early or ultra-early 
thrombectomy [2]. 
DEFUSE-3 [19] was a multicenter, randomized, open-label, blinded evaluation 
outcome (PROBE) clinical study to determine whether patients with great 
vascular (ICA or M1) occlusion within 6 - 16 h from the last time being normal 
could benefit from thrombectomy. The results demonstrated that the 90-d mRS 
score of mechanical thrombectomy + drug treatment group was significantly 
better than that of the drug treatment group, and the 90-d mortality was 
significantly reduced. The incidences of symptomatic intracranial hemorrhage 
and 24h vascular patency rate were similar to those of the drug treatment group. 
DEFUSE-3 focused more on mismatch between perfused ischemic area and core 
infarct. DAWN [20] was a study of thrombectomy taking a treatment time window 
of 6 - 24 h in patients with sleep stroke and out-of-time window stroke with 
clinical image mismatch, and its evaluation endpoints were similar to DEFUSE-
3. In addition, 90-d mRS, 90-d mortality, 24-h infarct size increased, and 
symptomatic intracranial hemorrhage were also evaluated. The results 
demonstrated that the 90-d mRS was significantly improved in the thrombectomy 
group, and DAWN focused more on the mismatch between the patient’s clinical 
symptoms and infarct size. 
In the Chinese Guidelines for the Endovascular Treatment of Acute Ischemic 
Stroke (2018), mechanical thrombectomy for acute anterior circulation great-
vessel occlusive stroke within 6h of onset is classified into Class I 
recommendation (Level A evidence). According to the results of DEFUSE-3 and 
DAWN studies, patients with onset at 6 - 16 h and 16 - 24 h met the corresponding 
inclusion and exclusion criteria and were classified into Class I recommendation 
(Level A evidence) and Class IIa recommendation (Level B evidence), 
respectively. According to the 2018 AHA/ASA [4], mechanical thrombectomy is 
recommended as Class I recommendation (Level A evidence) for acute ischemic 
stroke patients within 6-16h from the last time being normal and target lesions in 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
13 
the anterior circulation great vessels if the enrollment meets the DOWM or 
DEFUSE-3 criteria. Mechanical thrombectomy is recommended as Class IIa 
recommendation (Level B evidence) in acute ischemic stroke patients within 6-
24h from the last time being normal and target lesions in the anterior circulation 
great vessels if the enrollment meets the DOWM or DEFUSE-3 criteria. 
At present, the self-expanding revascularization devices marketed in China 
include the ReVive SE (Self-Expanding) Thrombectomy Device (Trade Name: 
ReVive SE, NMPA (I) No. 2014 3773354), Solitaire FR Revascularization 
Device (Trade Name: Solitaire FR, NMPA (I) 2013 3774122) and Trevo ProVue 
(Trade Name: TrevoProVue, NMPA (I) 20153773927). Those products are all 
imported and are expensive. In view of this, on the premise of ensuring the safety 
and effectiveness, the localization and cost reduction of revascularization devices 
break the monopoly of foreign products, so that more stroke patients can receive 
advanced interventional therapy with mechanical thrombectomy, meeting the 
clinical and patient needs. 
As independently developed by Sinomed Neurovita, Ghunter Revascularization 
Device has passed the test of Tianjin Medical Device Quality Supervision and 
Testing Center, NMPA (Test Report No.: 2021-GJ-0081). The safety and 
effectiveness of the product were further verified through animal experiment and 
therefore the conditions for conducting a clinical trial are met. 
5. Characteristics, Device Composition, Working Principle, 
Mechanism of Action and Study Scope of the Product 
5.1. Product Characteristics 
The revascularization device is designed with open loop structure. When the 
diameter of the stent changes with the diameter of the vessel, the stent pattern 
remains unchanged, only the size of the overlapping region in the circumferential 
direction changes. This design allows the thrombectomy stent to overlap in the 
vessel, increases the contact area with the thrombus, and can better capture the 
thrombus; meanwhile, the stent has the greatest support force at the beginning of 
deployment, and rapidly reduces the support force at the later stage of deployment, 
thus reducing the damage to the vascular intima; in addition, when withdrawn, 
the stent can maintain the screening area and reduce the risk of thrombus shedding 
during cutting. This design has excellent stent wall apposition, and will not 
separate from the thrombus when the stent is withdrawn, reducing the risk of 
thrombus shedding. Meanwhile, several precious metal developing wires are 
embedded in the stent, so that the outline of the stent can be clearly displayed 
under DSA device, ensuring the effectiveness and safety of the product in clinical 
use. 
5.2. Device Composition, Operation Principle and Mechanism of 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
14 
Action 
5.2.1. Device Composition 
The Ghunter Revascularization Device is composed of a thrombectomy stent, a 
push rod and an introducer sheath. 
The thrombectomy stent is formed by laser engraving of nitinol material, with 
strong radial support force and excellent flexibility; the stent is connected distal 
to multiple radiopaque developing devices, so that the placement and deployment 
of the distal stent can be observed under DSA; multiple radiopaque wires are 
embedded on the main body of the stent, so that the deployment of the main body 
of the stent can be observed under DSA; the stent is also connected proximal to 
a radiopaque device, so that the relative position of the proximal stent and the 
distal microcatheter can be observed under DSA. 
The push rod is fabricated with a specially processed wire to ensure sufficient 
push force is provided. It is subjected to multi-step mechanical processing and 
heat treatment while being composited with multiple materials, so that its distal 
end has good over-bending capacity while providing pushing force, for adapting 
to the complex intracranial vascular path. 
The thrombectomy stent is retracted inside the introducer sheath during storage 
and transport, and during the operation, the introducer sheath is inserted into the 
proximal microcatheter, allowing the thrombectomy stent to be easily pushed into 
the inner lumen of the microcatheter and then into the target vessel. 
The structure of revascularization device is as shown in the figure below: 
 
5.2.2. Working Principle and Mechanism of Action 
The revascularization device, by means of interventional therapy, delivers a metal 
thrombectomy stent into the intracranial target vessel. After fully deployed, the 
stent has a strong capacity to capture the thrombus, and then the thrombus is 
withdrawn to the outside body with the revascularization device to achieve the 
purpose of recanalization. 
5.3. Study Scope 
The revascularization device is intended to remove the thrombus from large 
intracranial blood vessels of ischemic stroke patients within 24 hours after 
symptom onset, so as to restore blood flow. 
Deployment state 
Retraction state 
Thrombectomy stent 
Introducer sheath 
Push rod 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
15 
6. Overall Design 
6.1. Study Design 
6.1.1. Study Objective 
To verify that the success rate of instant recanalization of Ghunter 
Revascularization Device is not inferior to Solitaire FR for endovascular 
treatment of acute ischemic stroke. 
6.1.2. Selection of Study Method and Justification 
The therapeutic effect and prognosis of AIS patients are related to whether the 
infarcted vessels can be opened in time. Therefore, whether the vessels are 
successfully opened will be the primary endpoint of the thrombectomy effect. 
This trial assumes that the recanalization success rate of the investigational 
product is not inferior to that of the control product, and this hypothesis will be 
verified by a sufficient sample size. 
Study method: Prospective, multicenter, randomized controlled, non-inferiority 
test. 
1) Prospective: research method that start from the present and track into the 
future is used. 
2) Multicenter: More than 10 clinical sites are planned to be selected to conduct 
the clinical trial. 
3) Randomized control: Randomization is performed using the Interactive Web 
Response System (IWRS), with competitive block randomization and 
competitive enrollment by each site. After signing the ICF and passing the 
screening, the subjects are randomized into the test group and control group 
in 1:1, with 110 each in the test group and control group. Randomization 
numbers and groups are distributed by randomization personnel in the 
randomization system of each site to avoid selection bias. 
4) Non-inferiority test: to evaluate that the success rate of instant recanalization 
is not inferior to the control product when the investigational product is used 
for endovascular treatment of acute ischemic stroke. 
5) Blind reading: The thrombectomy procedure will be burned on a CD in 
DICOM format, and the target vessel will be blindly evaluated for 
recanalization by a central interpretation room independent of the trial. 
6.1.3. Measures to Reduce and Avoid Bias 
6.1.3.1. Multicenter: 
The samples from multi sites are more representative than those from a single site, 
and the latter may lead to bias of study results due to its systematic errors. 
Therefore, the conclusion obtained can be more reliable. In order to reduce 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
16 
differences in procedures between sites, trainings of study personnel in each site 
on the use of the same standards in the study should be performed. Clear 
evaluation criteria are adopted for effectiveness and safety indicators. 
6.1.3.2. Investigator Training: 
Before the start of the clinical trial, the CRA shall coordinate with the director of 
the study sites to train the investigators on the trial protocol so that the 
investigators can understand and be familiar with the test products, and shall also 
grasp all new information related to this product found during the trial. 
6.1.3.3. Monitoring of Clinical Trial: 
The monitoring plan is developed and the CRA appointed by the sponsor shall 
conduct regularly on-site monitoring visit to the hospitals conducting the clinical 
trial to ensure that all the contents in the trial protocol are strictly observed and 
the EDC is checked to ensure consistency with the raw data. 
6.1.3.4. Management of Clinical Trial: 
A clinical research coordinator (CRC) will assist the investigator in performing 
the specific non-medical judgment affairs of the clinical trial to ensure that all 
aspects of the trial protocol are strictly adhered to and that the EDC data is 
consistent with the raw data. 
6.1.4. Investigational Medical Device and Control Device/Control 
Diagnostic and Therapeutic Method 
6.1.4.1. Investigational Product: 
Product name: Ghunter Revascularization Device 
Models: ISR3-20, ISR3-25, ISR3-30, ISR4-20, ISR4-30, ISR4-40, ISR6-20, 
ISR6-30, ISR6-40 
The naming rule of Ghunter revascularization device is ISR XYY, and each letter 
represents the meaning as follows: 
 
According to the target vessel diameter and thrombus length, the 
revascularization device is divided into the following specifications: 
Effective length of thrombectomy stent 
Effective OD of thrombectomy stent 
Thrombectomy stent 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
17 
Model 
Recommended 
vessel diameter1 
Compatible 
microcatheter 
minimum ID 
Diameter × 
effective 
length2 
Total 
length 
of 
thrombe
ctomy 
stent 
Total 
length 
of 
revascul
arization 
device 
Distance 
from 
proximal 
marker to 
distal 
radiopaqu
e marker 
Quantity of 
radiopaque 
markers 
Minim
um 
(mm) 
Maximu
m (mm) 
(mm) 
(inch) (mm×mm) 
(mm) 
(cm) 
(cm) 
Distal Proxi
mal 
ISR3-20 
1.5 
3.0 
0.43 
0.017 
3×20 
31 
200 
<130 
3 
1 
ISR3-25 
1.5 
3.0 
0.43 
0.017 
3×30 
36 
200 
<130 
3 
1 
ISR3-30 
1.5 
3.0 
0.43 
0.017 
3×40 
41 
200 
<130 
3 
1 
ISR4-20 
2.0 
4.0 
0.53 
0.021 
4×20 
31 
200 
<130 
3 
1 
ISR4-30 
2.0 
4.0 
0.53 
0.021 
4×30 
41 
200 
<130 
3 
1 
ISR4-40 
2.0 
4.0 
0.53 
0.021 
4×40 
51 
200 
<130 
3 
1 
ISR6-20 
3.0 
5.5 
0.69 
0.027 
6×20 
31 
200 
<130 
4 
1 
ISR6-30 
3.0 
5.5 
0.69 
0.027 
6×30 
41 
200 
<130 
4 
1 
ISR6-40 
3.0 
5.5 
0.69 
0.027 
6×40 
51 
200 
<130 
4 
1 
1. 
XX revascularization device is selected based on the minimal diameter, listed in Table 1, of the 
thrombus-located vessel. 
2. 
The effective length of XX revascularization device should be no less than the thrombus length. 
 
Manufacturer: Sinomed Neurovita Technology Inc. 
6.1.4.2. Control Product: 
Product name: Solitaire FR 
Specification/model (mm × mm): 4 × 15, 4 × 20, 6 × 20, 6 × 30 
Manufacturer: Covidien Healthcare International Trading (Shanghai) Co., Ltd. 
6.1.5. Subject Enrollment 
6.1.5.1. Inclusion Criteria 
General inclusion criteria: 
1) ≥ 18 years old; 
2) NIHSS ≥ 6 at randomization; 
3) Pre-onset mRS < 2; 
4) Acute ischemic stroke was diagnosed; 
5) Within 24h from the stroke onset to the completion of femoral artery puncture 
(regardless of whether intravenous thrombolysis has been performed); the 
time point of stroke onset is defined as the time point at which the patient is 
last known to be normal; 
6) The subject (or his/her guardian) agrees to participate in this study and signs 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
18 
the informed consent form (ICF). 
Angiographic inclusion criteria: 
1) Cerebral CT or MR should be performed when the time from the stroke onset 
to the completion of femoral artery puncture of a patient is ≤ 6h; 
2) Cerebral CT or MR should be performed when the time from the stroke onset 
to the completion of femoral artery puncture of a patient is 6 (exclusive)-24h 
(inclusive), and his/her ASPECTS score should be ≥ 6. (If immediate CT 
perfusion imaging or MR perfusion imaging is feasible, it is recommended to 
perform CTP or MRP simultaneously to assist in the assessment of the infarct 
core, and his/her ASPECTS score should also be ≥ 6); 
3) DSA angiography shows acute occlusion of large intracranial arteries, 
including intracranial internal carotid artery (C4-C7), middle cerebral artery 
(M1/M2), basilar artery and intracranial vertebral artery (V4). 
6.1.5.2. Exclusion criteria 
General exclusion criteria: 
1) Those who could undergo neither MRI nor CT; 
2) Those with hemorrhagic stroke or major ischemic stroke within 6 months 
before enrollment; 
3) Those with severe persistent hypertension that could not be controlled by 
intravenous injection for blood pressure reduction, i.e. patients with sustained 
SBP > 185 mmHg or sustained DBP > 110 mmHg; 
4) Those with presumed septic emboli or suspected bacterial endocarditis; 
5) Renal failure, defined as creatinine > 3.0 mg/dL (264 µmol/L); 
6) Those with blood glucose < 2.78 mmol/L (50 mg/dL) or > 22.20 mmol/L (400 
mg/dL); 
7) Decreased platelet count (< 40 × 109/L); 
8) Those with known hemorrhage tendency, coagulation factor deficiency, are 
taking anticoagulants and with INR > 3.0; 
9) Pregnant or lactating women; 
10) Those with known severe allergy to contrast media or known allergy to nickel 
materials; 
11) Those with disorders possessing possibility of affecting neurological 
assessment (e.g., neurological and psychiatric disorders); 
12) Those with heart, lung, liver failure or other serious disorders leading to 
disablement of interventional operation; 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
19 
13) Participating in clinical trials of other drugs or devices; 
14) Life expectancy less than 6 months; 
15) Other conditions judged by the investigator to be not suitable for inclusion. 
Angiographic exclusion criteria: 
1) There is evidence of intracranial hemorrhage on CT or MR or known 
hemorrhage tendency; 
2) CT/MR/DSA angiography suggests > 1 vascular occlusion (e.g., 
simultaneous occlusion of bilateral internal carotid artery vessels, or 
simultaneous occlusion of intracranial vessels in anterior and posterior 
circulation, or simultaneous occlusion of intracranial and extracranial internal 
carotid artery); 
3) Those with carotid artery dissection, occlusion of the initial segment of the 
carotid artery or arteritis; 
4) Those whose access vessels are quite tortuous, making the revascularization 
device difficult to reach the target location. 
6.1.5.3. Criteria and Procedures for Withdrawal from/Discontinuation of 
Trial Treatment 
The subjects may withdraw from the study at any time during the course of the 
study without giving a reason: moreover, subjects may choose not to undergo any 
study procedures after signing the ICF, and if subjects choose not to undergo any 
study procedures after signing the ICF, the investigator must be informed. 
However, subjects have the right to continue receiving the standard of care 
regardless of the cases. 
Any subject may also be withdrawn from the study by the investigator based on 
medical judgement. 
Subject’s premature discontinuation or withdrawal from the study can be any of 
the following cases, but not limited to: 
1) The subject is unwilling to continue participating in this study for any reason; 
2) For medical or safety reasons, the investigator believes that the subject should 
be withdrawn from the study; 
3) Serious protocol violation (confirmed by the principal investigator); 
4) The investigator or the sponsor requests to terminate the study for any reason; 
or 
5) Death. 
For all subjects who terminate the study early, the investigator should make every 
effort to find out the reasons for withdrawal from the trial, for example: adverse 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
20 
events, failure of corrective treatment, the investigator’s decision or other reasons. 
The reasons for withdrawal should be recorded in the EDC. Subjects who 
withdraw early should be requested to complete an early withdrawal visit 
according to the visit schedule. 
Subjects who withdraw from the study will not be replaced, i.e. the randomization 
number will be uniquely related to each subject and cannot be reused. 
6.1.5.4. Expected Overall Duration of Clinical Trial and Its Rationale 
Overall duration: About 30 months. 
The overall duration of the clinical study includes the time of obtaining EC 
approval letters from all the study hospitals, time of signing the clinical study 
agreement, filling time, time of study initiation, enrollment and follow-up of 
subjects, time of collection and statistics of study data, and summary report 
writing, etc. The expectation is from March 2021 to September 2023. 
Rationale: The overall duration of this trial is predicted based on the number of 
the investigational devices used for the cases in each hospital to ensure adequate 
source of cases for the study, as well as the patient follow-up schedule and the 
process systems of each hospital. 
6.1.5.5. Expected Duration of Participation for Each Subject 
The duration of each subject participation is defined as a period from the time 
that the patient signs the ICF to the end time of the final follow-up. According to 
the study design, the visit time of each subject: screening/baseline period (-1 d~ 
0 d preoperatively), treatment period (day of operation/0d), observation period 
(24 ± 12 h postoperatively), follow-up period (7 ± 2 d postoperatively (before 
discharge in case of premature discharge)), and follow-up period (90 ± 14 d 
postoperatively). Therefore, the expected duration of participation of each subject 
is around 90 days. 
6.1.5.6. Number of Subjects for Confirmatory Clinic Trial 
220 subjects are enrolled into this clinical study in total. 
6.1.6. Effectiveness Evaluation Methods 
1) Description of effectiveness endpoints 
a) Primary effectiveness endpoint: success rate of instant recanalization 
b) Secondary effectiveness indicators: Proportion of subjects with mRS 
scores of 0-2 on 90d postoperatively, time from femoral artery puncture 
to recanalization/the end time of operation for subjects whose 
recanalization failed, proportion of subjects with NIHSS score decrease > 
4, and success rate of device operation 
2) Selection of Method and Time to Evaluate, Record and Analyze Effectiveness 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
21 
Indicators 
Primary endpoint: 
 Success rate of instant recanalization 
Recording time and method: During thrombectomy, cerebral vascular DSA 
examination will be performed to analyze whether the recanalization success is 
achieved. If the recanalization is affected due to in situ atherosclerotic stenosis, 
vascular dissection and vasospasm after thrombectomy, the investigator can 
handle it in an appropriate way and determine whether the target vessel is 
successfully revascularized according to the recanalization after treatment. 
* Recanalization success was evaluated separately by clinicians and a central 
interpretation room independent of the study, and when the evaluation results 
were inconsistent, the results of the blind evaluation by the central interpretation 
room prevailed. 
Formula: Success rate of instant recanalization = Number of subjects with instant 
recanalization success in this group/Number of subjects treated with 
revascularization devices in this group × 100%. 
Criteria for instant recanalization success: target vessel recanalization, with 
mTICl grade of 2b or 3. The mTICI grading is shown in Appendix 3. 
Secondary endpoint: 
 Proportion of mRS scores of 0-2 
Recording time and method: preoperatively and 90 ± 14 d postoperatively. 
Postoperative subjects’ degree of disability will be analyzed by 90-d mRS scores 
postoperatively. The mRS score is based on mRS scale (as shown in Appendix 
4). 
Proportion of subjects with mRS scores of 0-2 = Subjects with mRS scores of 0-
2 on 90d postoperatively/Number of subjects treated with intracranial 
thrombectomy device × 100%. 
 Time from femoral artery puncture to recanalization/the end time of 
operation for patients whose recanalization failed 
Evaluation time: Intraoperatively 
Evaluation site: target vessel 
Evaluation method: The recanalization time will be judged by intraoperative 
procedure and the vascular condition shown by imaging. 
Formula: Recanalization time = Recanalization success time - Femoral artery 
puncture time 
Precautions: The recanalization time is the time from the completion of femoral 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
22 
artery puncture to recanalization success. If the vessel is not revascularized, the 
end time point is recorded as the time point at the end of operation. Criterion for 
instant recanalization success: target vessel recanalization with mTICI grade of 
2b or 3 after thrombectomy with the investigational device. The investigator’s 
judgment intraoperatively shall prevail. 
 Proportion of subjects with NIHSS score decrease > 4 
Recording time and method: The preoperative and postoperative NIHSS scores 
are compared by three time points: pre-operation, 24 ± 12h postoperatively and 
7± 2d postoperatively (before discharge in case of premature discharge) to 
analyze the degree of impairment and improvement of neurological functions 
preoperatively and postoperatively. The NIHSS score is the total score based on 
NIHSS scale (as shown in Appendix 5). 
Proportion of subjects with NIHSS score decrease > 4 = Number of subjects with 
NIHSS score decrease > 4 postoperatively in this group/Number of subjects 
treated with thrombectomy through stents in this group × 100%. 
 Success rate of device operation 
Definition: The success rate of device operation is the proportion of device 
operation success. Device operation success is defined as successful delivery of 
the investigational device to the diseased vessel site to complete accurate 
deployment and withdrawal. 
Evaluation time: Intraoperatively (evaluation endpoint) 
Evaluation site: target vessel 
Evaluation method: The success rate of device operation is calculated by 
intraoperative evaluation of whether the delivery, deployment and withdrawal of 
the thrombectomy device are completed. 
Formula: Device operation success = Number of devices delivered, deployed and 
withdrawn/Number of all investigational devices used in this group × 100%. 
6.1.7. Safety Evaluation Methods 
6.1.7.1. Description of Safety Endpoints 
1) Safety Endpoints 
 Safety endpoints: Incidence of symptomatic intracranial hemorrhage within 
24 h postoperatively, mortality within 90d, incidence of SAE, incidence of 
AE, and incidence of device defects. 
2) Selection of Method and Time to Evaluate, Record and Analyze the 
Safety Endpoints 
 Incidence of symptomatic intracranial hemorrhage within 24h 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
23 
Recording time and method: Symptomatic intracranial hemorrhage within 24h, 
specifically refers to intracranial hemorrhage (parenchymal hematoma, 
subarachnoid hemorrhage, ventricular hemorrhage) accompanied by neurological 
deterioration (NIHSS score increases by ≥ 4 compared with that preoperatively). 
Incidence of symptomatic intracranial hemorrhage within 24 h = Number of 
subjects who develop symptomatic intracranial hemorrhage on CT or MR within 
24 h in this group/Number of subjects who receive revascularization device for 
thrombectomy in this group × 100%. 
* Subjects with symptomatic intracranial hemorrhage postoperatively who show 
additional hemorrhage on CT or MR within 24 h postoperatively will not be re-
evaluated. 
 All-cause mortality within 90 days 
Recording time and method: Throughout the clinical trial. All-cause mortality = 
Number of deaths in this group/Number of subjects who receive revascularization 
device for proximal thrombectomy in this group × 100%. 
 Incidence of device defects 
Recording time and method: During the thrombectomy. Incidence of device 
defects = Number of defective devices / Total number of devices × 100%. 
Note: The investigational device defects that occur during the clinical trial, such 
as device fracture and mislabeling. 
 Incidence of SAE 
Recording time and method: Throughout the clinical trial. Incidence of SAE = 
Number of subjects with SAE/Number of subjects treated with intracranial 
thrombectomy device for thrombectomy in total × 100%. 
 Incidence of AE 
Recording time and method: Throughout the clinical trial, incidence of AE = 
Number of subjects with AE/Number of subjects who receive intracranial 
thrombectomy device for thrombectomy × 100%. 
6.2. Study Process 
6.2.1. Study Process 
6.2.1.1. Enrollment 
The investigator will screen the subjects according to the inclusion and exclusion 
criteria after obtaining the ICF signed by the subjects (or their guardians). After 
the subjects pass the screening, at the end of cerebral DSA angiography and 
before using the revascularization device, the investigator will randomize the 
subjects into the test group and the control group in the randomization order, and 
the enrollment will be considered successful. 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
24 
6.2.1.2. Randomization 
Randomization will be performed via an electronic randomization system after 
screening for inclusion and exclusion criteria. The investigator will log into the 
randomization system, fill in the subject information and then submit, and the 
system will automatically give the randomization results. The investigator should 
select the corresponding test product to treat the subject according to the results 
given by the electronic randomization system. In Group A, Sinomed Neurovita 
Ghunter Revascularization Device will be used, and in Group B, Covidien 
Solitaire FR will be used. Once the subject information is entered into the 
electronic randomization system, no deletion will be allowed, and all operations 
will be automatically left on the system for verification. 
6.2.1.3. Visit Schedule 
1) Visit 1: Screening/baseline period (-1 d ~ 0 d) 
After all the subjects (or their guardians) sign the ICF, the investigator will screen 
the subjects according to the inclusion/exclusion criteria of the study. During this 
period, the following visit contents need to be completed: 
i. 
Signing of ICF; 
ii. 
Recording of basic information of the subject; 
iii. Present medical history: onset time and admission time; 
iv. Medical history: history of allergy, history of stroke, history of other 
significant diseases (e.g., presumed septic emboli or suspected bacterial 
endocarditis), history of neurological diseases; 
v. 
Vital signs (blood pressure, heart rate); 
vi. NIHSS score; 
vii. MRS score, ASPECTS score (required within 6 - 24 h of onset); 
Laboratory examination: 
viii. Pregnancy testing (Only for women of childbearing potential who are 
planning to become pregnant) 
ix. Administration of anticoagulant and antiplatelet drugs; 
x. 
Cerebral CT or MR will be performed, and the following information will 
be recorded: 
a) When the onset time is ≤ 6h, cerebral CT or MR is performed; 
b) Cerebral CT or MR is performed when the onset time is 6 (exclusive)-24h 
(inclusive) to determine whether ASPECTS score ≥ 6 is met; (if 
immediate CT perfusion imaging or MR perfusion imaging is feasible, 
CTP or MRP is recommended to assist in the assessment of the infarct 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
25 
core to determine whether ASPECTS score ≥ 6 is met). 
* For laboratory tests and imaging tests, the results after this admission 
and the results of external hospital examinations within 24h 
preoperatively are acceptable. 
c) Other significant abnormal conditions. 
2) Visit 2 (0 d): 
i. 
Recording of cerebral vascular DSA: 
a) Name of target vessel and lesion segment, proximal diameter of occluded 
vessel 
b) mTICI image grading postoperatively 
c) Does the patient suffer from carotid origin occlusion or carotid dissection 
or arteritis? 
d) Is the vessel access so tortuous that makes it difficult for the 
investigational/control device to reach the target location? 
ii. 
Recording of the operations: 
a) Date of operation, femoral artery puncture time, operation start and 
recanalization time (or end time) 
b) Intraoperative treatment method (Are implant stent, balloon dilatation and 
antithrombotic drugs used) 
c) Model of each revascularization device, the frequency of thrombectomy 
procedure, evaluation of success rate of device operation, whether the 
vessel is successfully revascularized, recanalization success time, and 
reason for failure 
iii. Administration of anticoagulant and antiplatelet drugs; 
iv. Recording of adverse events; 
v. 
Recording of device defects: 
Note: The frequency of thrombectomy procedure with the thrombectomy 
device will be determined by the investigator on a case-by-case basis. If 
recanalization fails, the investigator may use other diagnostic and 
therapeutic measures (including but not limited to dual-stent technique, stent 
implantation, and aspiration device) according to specific case 
characteristics. 
3) Visit 3: Observation period (V3: 24 ± 12 h postoperatively) 
The subjects undergo clinical follow-up 24 h ± 12 h postoperatively. All the visit 
information will be analyzed and recorded by investigators. In this visit, the 
following visit contents need to be completed: 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
26 
i. 
Vital signs; 
ii. 
NIHSS score; 
iii. Laboratory tests; 
iv. Cerebral CT or MR will be performed, and the following information will 
be recorded: 
a) Is there intracranial hemorrhage (parenchymal hematoma, subarachnoid 
hemorrhage, ventricular hemorrhage) 
b) Is there is a new cerebral infarction 
c) Other significant abnormal conditions 
v. 
Administration of anticoagulant and antiplatelet drugs; 
vi. Recording of adverse events; 
4) Visit 4: Follow-up period (V4: 7 ± 2 d postoperatively (before discharge in 
case of premature discharge)) 
The subjects undergo clinical follow-up 7 ± 2 d postoperatively. All the visit 
information will be analyzed and recorded by investigators. In this follow-up visit, 
the following visit contents need to be completed: 
i. 
Vital signs; 
ii. 
NIHSS score; 
iii. Laboratory tests (if laboratory test results had already been collected at Visit 
3, they might not be collected here); 
iv. Administration of anticoagulant and antiplatelet drugs; 
v. 
Recording of adverse events; 
5) Visit 5: Follow-up period (V5: 90 ± 14 d postoperatively) 
The subjects undergo outpatient/telephone follow-up 90 ± 14 d postoperatively. 
All the visit information will be analyzed and recorded by investigators. In this 
follow-up visit, the following visit contents need to be completed: 
i. 
mRS score; 
ii. 
Administration of anticoagulant and antiplatelet drugs; 
iii. Recording of adverse events; 
6) Premature termination of visit 
Subjects can withdraw from the study at any time, and once a subject withdraws 
prematurely from the study before the end of the follow-up period, an premature 
termination visit must be completed as soon as possible and the reason for 
termination will be recorded. Evaluations to be performed during this follow-up 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
27 
period is the same as Visit 5. All information will be analyzed and documented 
by the investigator. 
 
 
 
According to the medical history and clinical symptoms, the patient is likely 
to suffer from AIS as judged by the investigators 
Signing of ICF 
Is the patient eligible as indicated by the laboratory test and cerebral 
CT or MR assessment? 
Is the patient eligible as indicated by the 
cerebrovascular and internal carotid artery DSA? 
Log into the electronic system to 
obtain the grouping result 
Perform thrombectomy (with the 
investigational product) 
Hospital follow-up 24 (±12) h 
postoperatively 
Hospital follow-up 7 (± 2) d 
postoperatively 
Outpatient or telephone follow-up 90 
(± 14)d postoperatively 
Screening 
 
 
 
 
 
Fail 
Seriou
s 
advers
e 
events 
and 
device 
defect
s 
Rep
orti
ng 
Yes 
No 
Yes 
No 
Study Flowchart 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
28 
Data Collection: 
Visit time 
 
Visit 
contents 
Screening/Baseli
ne period 
Treatment 
period 
Observation 
period 
Follow-up period 
Preoperatively -1 
d ~ 0 d 
Day of 
operation/
0 d 
Postoperativel
y 24 h ± 12 h 
Postoperativel
y 7 d ± 2 d 
Postoperativel
y 90 d ± 14 d 
Signing of ICF 
× 
 
 
 
 
Medical 
history 
× 
 
 
 
 
Preoperative 
diagnosis 
× 
 
 
 
 
Vital signs1 
× 
 
× 
× 
 
NIHSS score2 
× 
 
× 
× 
 
mRS score3 
× 
 
 
 
× 
Laboratory 
test1 
× 
 
× 
 
Pregnancy 
test5 
× 
 
 
 
 
Cerebral CT or 
MR6,7 
× 
 
× 
 
 
Cerebrovascul
ar DSA7 
× 
 
 
 
 
Verification of 
eligibility 
criteria 
 
× 
 
 
 
Randomization 
 
× 
 
 
 
Operations 
 
× 
 
 
 
Antiplatelet 
and 
anticoagulant 
medication 
× 
× 
× 
× 
× 
Adverse event 
 
× 
× 
× 
× 
Device defect 
 
× 
 
 
 
Note: 
1) Vital signs include heart rate and blood pressure. 
2) NIHSS score: assessing the degree of neurological impairment of the subject. 
3) MRS score: assessing the degree of disability of the subject. 
4) Laboratory tests (The laboratory test results at 24 h preoperatively are 
accepted during the screening period, and one laboratory test within 9d 
postoperatively is sufficient): 
Blood routine: Red blood cell, hemoglobin, white blood cell count, and 
platelet count 
Blood chemistry: Urea nitrogen (urea), serum creatinine, blood glucose 
Coagulation: Prothrombin time, activated partial thromboplastin time and 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
29 
INR 
5) Only for women of childbearing potential who are planning to become 
pregnant, blood or urine pregnancy test result is acceptable. 
6) Cerebral CT or MR is performed when the onset time is ≤ 6h; cerebral CT or 
MR is performed when the onset time is 6 (exclusive)-24h (inclusive) to 
determine whether ASPECTS score ≥ 6 is met; (if immediate CT perfusion 
imaging or MR perfusion imaging is feasible, CTP or MRP is recommended 
to assist in the assessment of the infarct core to determine whether ASPECTS 
score ≥ 6 is met). 
7) CT or MRI images and DSA images during thrombectomy are burned on a 
CD in DICOM format and evaluated by a central interpretation room. 
8) Randomization: An electronic randomization system is logged into for 
randomization. 
* If any of the micro-guidewire and microcatheter does not pass through the 
thrombus segment of the target vessel during the operation, or if the 
thrombectomy device is not used for thrombectomy, this subject is 
statistically processed as having a blank randomization number; 
6.2.2. Device Specifications (recommend the operation method, and the 
operator may make slight modification according to the actual 
situations) 
6.2.2.1. Preparations 
1. Administer anticoagulant and antiplatelet drugs according to standard 
guidelines. 
2. With the aid of angiography, determine the location and size of the area for 
recanalization. 
3. Select a revascularization device based on the product specification/model. 
4. To achieve optimal use of the revascularization device and reduce the risk of 
thromboembolic complications, maintain continuous flushing of the 
following lumens: 
a) Between femoral sheath and guiding catheter; 
b) Between guiding catheter and microcatheter; 
c) Between microcatheter and push rod/revascularization device. 
Check all connections to ensure that no air enters the guiding catheter or 
microcatheter during continuous flushing. 
5. Deliver the appropriate guiding catheter as close as possible to the thrombus 
site by standard methods. If required in subsequent steps, the size of the 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
30 
guiding catheter should be appropriate for thrombus recovery. Connect the 
RHV to the guiding catheter and then connect an infusion line for continuous 
flushing. 
6. Based on the product specification/model, select the microcatheter suitable 
for delivering the revascularization device. 
7. Attach a second RHV to the microcatheter and then connect an infusion line 
for continuous flushing. 
8. Set the flushing speed according to standard guidelines. 
9. Deliver the microcatheter over the appropriate guidewire until the end of the 
microcatheter is distal to the thrombus so that the effective length portion of 
the revascularization device covers each side of the thrombus in the vessel 
when fully deployed. Tighten the RHV around the microcatheter. 
6.2.2.2. Delivering Revascularization Device 
10. Insert the distal portion of the introducer sheath into the RHV connected to 
the microcatheter. Tighten the RHV and verify that fluid exits the proximal 
end of the introducer sheath. 
11. Loosen the RHV and push the introducer sheath until its distal end is securely 
seated in the microcatheter hub. Tighten the RHV around the introducer 
sheath to prevent blood backflow, but the damage may occur to the device if 
tightened too tightly as the stent is pushed into the microcatheter. Verify that 
there are no air bubbles in the system. 
12. Push the push rod in a smooth continuous manner so that the thrombectomy 
stent is delivered into the microcatheter. Once the flexible portion of the push 
rod enters the microcatheter, loosen the RHV and remove the introducer 
sheath from the proximal end of the push rod. Upon completion, tighten the 
RHV around the push rod. Continued tight attachment of the introducer 
sheath to the inner lumen of the microcatheter will block normal flushing of 
the RHV and lead to backflow of blood into the microcatheter. 
13. After visually confirming that the flushing fluid input is normal, loosen the 
RHV and push the push rod. 
14. Once the proximal marker of the revascularization device enters the 
microcatheter, start the X-ray imaging system. With the aid of the x-ray 
imaging system, carefully deliver the stent until its distal marker is aligned 
with the distal microcatheter, and the stent remains in such a position that, 
when the device is completely deployed, its effective length portion covers 
each side of the thrombus in the vessel. 
 Warning: If excessive resistance encounters in the advancement of the 
stent, stop and identify the cause. Advancing the thrombectomy stent 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
31 
against heavy resistance may damage the device and/or injure the patient. 
6.2.2.3. Deploying Revascularization Device 
15. Loosen the RHV around the microcatheter. Fix the push rod so as to maintain 
the position of the thrombectomy device while carefully withdrawing the 
microcatheter to the proximal end. 
16. Withdraw the microcatheter until it approaches the proximal marker of the 
revascularization device. Tighten the RHV to prevent movement of the push 
rod. The effective length of the revascularization device should be greater 
than each side of the thrombus. 
17. Tighten the RHV around the microcatheter. Angiographically assess the 
target vessel for flow patency. 
18. Ancillary medical techniques (i.e. thrombolytics, etc.) may be used according 
to standard guidelines. 
6.2.2.4. Withdrawing the Device 
19. If using a balloon guiding catheter, inflate the balloon as directed on the 
balloon catheter label to occlude the vessel. 
20. Ensure that the proximal marker of the stent is inside the microcatheter and 
loosen the RHV around the microcatheter so that it moves but remains sealed. 
21. Slowly withdraw the microcatheter and the revascularization device as a 
whole to the end of the guiding catheter while aspirating the guiding catheter 
with a 60 cc syringe. Do not advance the stent deployed to the distal end. 
Caution: Ensure that the proximal marker of the revascularization device 
remains within the microcatheter. 
22. Perform vigorous aspiration of the guiding catheter with a syringe, while 
withdrawing the revascularization device and microcatheter into the guiding 
catheter. Continue aspiration of the guiding catheter until the thrombectomy 
stent and microcatheter are almost withdrawn from the guiding catheter. 
Note: If it is difficult to withdraw the guiding catheter, first deflate the balloon 
(if the balloon guiding catheter is used), and then withdraw the guiding 
catheter, microcatheter and revascularization device to the arterial sheath 
while maintaining aspiration, and withdraw together with the arterial sheath 
if necessary. 
 Warning: If excessive resistance encounters in the withdrawal of the 
revascularization device, discontinue thrombectomy and identify the 
cause. 
23. Open the RHV of the guiding catheter, and allow the microcatheter and 
revascularization device to be smoothly withdrawn. Take care of device 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
32 
interference and prevent air from entering the system. 
24. Continue aspiration of the guiding catheter and ensure there is no thrombus 
material in the guiding catheter. 
25. Deflate the balloon if the balloon guide catheter is used. 
26. If an additional attempt to restore flow is required, take the following steps: 
a) Use a new revascularization device, and then: 
i. Repeat the above steps from the "Preparations" section. 
b) Use the same revascularization device, and then: 
i. Clean the device with normal saline. 
Caution: Do not use other solvents or autoclaves. 
ii. Inspect the device for damage carefully. 
iii. In case of any damage, use a new device and follow the steps 
described above (starting with the "Preparations" section) for 
subsequent flow restoration attempt. 
iv. Use of a damaged device may result in further damage to the device 
and/or patient injury. 
6.2.2.5. Re-deploying Revascularization Device 
If the revascularization device should be re-deployed (e.g., repositioning), 
take the following steps: 
 Warning: When the device has been combined with thrombus, pushing 
the microcatheter may result in embolization fragments. No resistance 
encounters when advancing the microcatheter. 
1. 
Loosen the RHV around the microcatheter and around the push rod. With 
the help of radiographic monitoring, securely fix the push rod to prevent the 
revascularization device from moving. 
2. 
Carefully advance the microcatheter forward to the distal end of the 
revascularization device until the distal marker of the thrombectomy stent 
is aligned with the distal end of the microcatheter to complete re-sheathing. 
If great resistance encounters during one more sheathing, stop immediately. 
Proceed to the above "Withdrawing Revascularization Device" section. 
6.2.2.6. Precautions 
 Only physicians trained in neurointerventional techniques and ischemic 
stroke can use this device. 
 Inspect packaging and devices for damage in transit prior to use. Please do 
not use a bent or damaged device. 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
33 
 Use before the "Shelf-life" indicated on the label. 
6.2.2.7. Contraindications 
 Patients who are known to be allergic to nickel titanium alloy. 
 Patients with stenosis near the thrombus site and/or pre-existing stents, since 
safe withdrawal of a revascularization device may be hindered. 
 Patients with angiographic evidence of carotid artery dissection. 
6.2.2.8. Potential complications 
Potential complications include, but are not limited to, the following: 
 Hematoma and bleeding at the puncture site 
 Vascular injury (e.g., perforation) 
 Angiospasm 
 Confusion 
 Nervous system failure (including stroke and death) 
 Ischemia 
 Infection 
 Aeroembolism 
 Intracranial hemorrhage 
 Vascular embolization 
 Pseudoaneurysm formation 
 Postoperative bleeding 
 Distal embolization, including previously unaffected areas 
 Adverse reaction to antiplatelet/anticoagulation agents or contrast media  
 Device deformation, collapse, fracture or malfunction 
 Thrombosis (acute and subacute) 
 Arteriovenous fistula 
6.2.2.9. Warnings 
 Appropriate anti-platelet and anti-coagulation therapy should be used in 
accordance with standard guidelines. 
 No twisting of the revascularization device 
 For each new revascularization device, use a new microcatheter 
 Electrical detachment cannot be performed during thrombectomy 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
34 
 To prevent device detachment: 
a. Do not use oversized device. 
b. Do not withdraw the device if excessive resistance encounters. The 
device should be re-sheathed with a microcatheter and the entire system 
should be removed under aspiration. If resistance encounters during one 
more sheathing, stop entry and remove the entire system under aspiration. 
c. Do not treat patients with pre-existing stenosis proximal to the thrombus 
site. 
 The device is provided sterile and for single use. Do not re-use or re-sterilize. 
Reuse and re-sterilization increase the risks of patient infection and 
compromise device performance. 
6.3. Monitoring Plan 
The sponsor will entrust a contract research organization (CRO) for the 
monitoring of this trial, assign qualified CRA based on the complexity degree of 
this trial and the quantity of sites, and develop a corresponding monitoring plan, 
so as to ensure that the rights and interests of subjects are protected, data 
presented in trial records and reports is accurate and complete, and the trial is 
conducted in accordance with the approved protocol and relevant regulations. 
Monitoring before the trial mainly includes: investigational device, study 
documents, trial personnel and trial training; monitoring during the trial mainly 
includes: regular visits, documents to be submitted to the Ethics Committee 
during the trial, monitoring of adverse events; monitoring after end of (or before 
prematurely terminating) the trial mainly includes: recovery and destruction of 
investigational products, EDC data entry and data query, validation of trial 
document integrity, notification of Ethics Committee, site closure and clinical 
trial report. 
7. Statistical Analysis Method and Evaluation Method 
7.1. Statistical Design, Method and Analysis Procedure 
7.1.1. Statistical Design (Hypothesis Testing) 
This study is a prospective, multicenter and randomized controlled design, with 
comparison type of non-inferiority test. It is to demonstrate that the 
investigational device also meets the needs of clinical application through 
comparison with the similar products that have been marketed, with the primary 
evaluation endpoint set as success rate of recanalization; the corresponding 
statistical hypothesis test is: 
 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
35 
where, PT is the expected success rate of recanalization in the test group; PC is the 
expected success rate of recanalization in the control group; and △ is the non-
inferiority margin (taken as a positive value here). 
7.1.2. Statistical Analysis Methods 
7.1.2.1. General Principles 
Statistical description: The categorical data are described as frequency and 
proportion; while the continuous data are described as mean, standard deviation, 
maximum, minimum, median, 25th quantile, and 75th quantile. 
Statistical inference: For the comparison of general situation of the two groups, 
the quantitative indicators between groups are compared using group t test or 
Wilcoxon rank sum test according to the data distribution, classification 
indicators using chi-square test or accurate probability method (if the chi-square 
test is not applicable), and ordinal data using Wilcoxon rank sum test or CMH 
test. 
All statistical tests, if not specified, are two-sided and the difference is considered 
statistically significant when P value is <0.05 (two-sided). In addition to the 
statistical methods listed below, detailed and additional exploratory analyses may 
be required and confirmed in the Study Reports and Statistical Analysis Plan 
(SAP). 
7.1.2.2. Study Completion and Demographic Analysis 
The number of subjects enrolled and the completion status of enrollment of each 
site should be summarized, and the dropout cases should be listed. Different data 
set sizes in each group, case distribution of each site, total dropout rate 
comparison and reasons for discontinuation, should be tabulated in detail. The 
demographic characteristics (age and gender), the relevant medical history and 
the treatment history of the patients are described, and the comparison of age and 
gender, etc. between the two groups will be conducted to measure the 
comparability between the two groups. 
Demographic analysis is based on FAS. 
7.1.2.3. Primary Efficacy Indicator 
For the primary endpoint of recanalization success rate, at the level of α = 0.025 
(one-sided test) and β = 0.2, the success rate of target vessel recanalization in the 
study and control groups are compared, respectively. The 95% CI for their 
difference is calculated. If the lower limit of 95% CI for their difference is greater 
than -12.5%, it is considered that the test group is non-inferior to the control 
group. The inter-group comparison will be performed using the center effect-
modified CMH chi-squared analysis, and the Logistics regression model can be 
considered for the inter-group comparison as appropriate to correct for the effects 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
36 
of factors such as the center. 
7.1.2.4. Secondary Efficacy Indicators 
The secondary efficacy evaluation is based on Full Analysis Set (FAS) and Per-
Protocol Set (PPS). For the statistical description and inference of the data, the 
applicable descriptive indicators and hypothesis test methods are selected based 
on the characteristics of the data. 
7.1.2.5. Safety Indicator 
The number and proportion of cases with normal conditions before treatment and 
abnormal conditions after treatment will be described respectively by the test 
group and the control group. AEs are described by the number and the incidence 
of AEs, where the likelihood ratio X2 test or Fisher's exact probability test is used. 
Also, the manifestations and degree of AEs occurred in each group and their 
relationship to the investigational product will be described in detail. 
7.2. Calculation of Sample Size 
7.2.1. Total Sample Size 
The primary endpoint of the study is the success rate of recanalization, using non-
inferiority test. A total of 220 patients are planned to be enrolled and randomly 
assigned to the test or control group in a 1:1 ratio, with 110 subjects in each group. 
mTICI can reach 76% at 6-16h according to DEFUSE-3 and 84% at 6-24h 
according to DAWN. Within 6 h, mTICI is 86% in EXTEND-IA, 88% in SWIFT 
PRIME, and 87% in PISTE. 
According to the estimation combined with the existing clinical evidence and the 
experience of clinical experts, assuming that the recanalization success rate after 
treatment is 89% in both the test group and control group within 24h [10-19], the 
non-inferiority margin is set at 12.5% after discussion between the clinical 
investigator and the sponsor. When the significance level α of statistical test is set 
as one-sided 0.025 and the power 1-β is set as 80%, the sample size is calculated 
as 99 in each group. In consideration of the maximum possible dropout rate of 
10% in the study, the sample size in each group is 110. Therefore, 220 subjects 
are required in total It is calculated according to statistical principles that, 
the corresponding sample size formula is: 
 
where, nT and nC are the respective sample size of the test group and control 
group; Z1-a/2 and Z1-β are the percentiles in standard normal distribution; PT is the 
expected success rate of recanalization in the test group, Pc is the expected 
success rate of recanalization in the control group; |𝐷𝐷| is the absolute value of the 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
37 
difference between groups in the expected recanalization, |𝐷𝐷| = |𝑃𝑃𝑇𝑇−𝑃𝑃𝐶𝐶|; ∆ is 
the non-inferiority margin (taking the negative value). 
7.2.2. Number of Subjects for Each Disease and Rationale for 
Determination 
In this trial protocol, the inclusion/exclusion criteria for selected patients are 
strictly limited. It can be considered that the current study is only conducted for 
patients with a single indication. The above 220 patients have the same disease 
and are no longer further divided. 
7.2.3. Minimum and Maximum Number of Subjects in Each Site and 
Justification 
This trial will be carried out at the same time in multiple study sites. In principle, 
the number of subjects enrolled in each site will be distributed as evenly as 
possible to ensure adequate site representation. However, considering the 
feasibility and progress of the selection, the number of subjects enrolled in each 
participating site will be adjusted according to the actual situation, so as to ensure 
that the enrollment scale at each site is relatively balanced, and that the final 
enrollment scale for a specific site should not exceed 50% of the total number of 
cases. 
8. Significance Level and Power of Clinical Study 
8.1. Expected Drop-out Rate 
In determining the sample size, the highest possible drop-out rate during the study 
is expected to be 10%, including all conditions that make the subjects ultimately 
excluded from the primary analysis, often referring to major deviation of trial 
protocol (affecting the primary efficacy evaluation and/or safety evaluation) 
adjudicated by principal investigator. 
It may include the following conditions: 
a) Subjects who, for whatever reason, are unwilling or unable to continue the 
clinical trial, propose withdrawal from the clinical trial to the investigator and 
terminate the clinical trial; 
b) Subjects who are lost to follow-up despite not specifically proposing 
withdrawal from the clinical study but no longer receiving treatment and 
examination; 
c) Subjects, who experience SAE, should be withdrawn from the clinical study 
as judged by the investigator; 
d) Subjects, due to poor compliance, fail to complete follow-up for primary 
outcome; 
e) Lost to follow-up (The investigator cannot reach the subject to return to the 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
38 
clinic for visit assessment and examination via telephone or mail for two 
consecutive times). 
8.2. Pass/Fail Criteria for Clinical Trial Results 
If the lower limit of the 95% CI of the difference in recanalization success rate 
between the test group and control group is greater than -12.5% (the pre-specified 
non-inferiority margin), and there are no clinically unacceptable safety issues 
related to the investigational device, the study is qualified, otherwise it is 
unqualified. 
8.3. Criteria for Termination of Trial Based on Statistics and 
Justification 
The interim analysis and its corresponding early termination criteria are not pre-
established in this trial, so this section is not applicable. All statistical analyses 
are conducted after the completion of data collection, cleaning and final locking. 
8.4. Data Statistical Method, with the Handling Method of Missing, 
Unused and Wrong Data (Including Discontinuation and 
Withdrawal) and Unreasonable Data 
Missing data handling method: The missing data will be processed according 
to the division of the data set; primary efficacy data will be imputed with the use 
of the WOCF (Worst Observation Carry Forward). 
Wrong data handling method: In the process of data management, the quality 
management will be performed for the data in the database, wrong data found 
will be questioned in the form of Query to investigators, and the wrong data will 
be adjusted according to the written reply of investigators until all wrong data is 
corrected before locking the database. 
Unreasonable data handling method: In the process of data management, the 
data in the database will be checked logically, unreasonable data found will be 
questioned in the form of Query to investigators, and the unreasonable data will 
be adjusted according to the written reply of investigators until all unreasonable 
data is solved before locking the database. 
8.5. Procedures for Reporting Deviation from Original Statistical Plan 
The statistical analysis plan needs to be confirmed by the sponsor and the 
principal investigator and finalized before the database is locked. Prior to 
finalization, the initial analysis plan should be modified according to the actual 
conditions in the trial process. In principle, the main analysis principles, methods 
and analysis sets should not be modified, and all the modifications will be 
recorded. 
8.6. Selection Criteria for Subjects Included in the Analysis and 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
39 
Justification 
Statistical analysis will be carried out on the basis of the following analysis 
populations. The analysis populations will be clearly defined before the start of 
statistical analysis. And the analysis populations in this study include: 
Full Analysis Set (FAS): The set of subjects determined following the intent-to-
treat (ITT) principle refers to the data set constituted by all subjects who 
participate in the randomized study and receive the investigational product. For 
patients in whom the primary effectiveness endpoint is not observed, missing data 
are proposed to be carried forward using the WOCF (Worst Observation Carry 
Forward). 
Per-Protocol Set (PPS): refers to the subgroups of treatment population where the 
study has been completed with the major protocol violations excluded (which 
means that the subjects violate the inclusion criteria or exclusion criteria, etc.). 
Safety Set (SS): refers to the set of all subjects who receive the investigational 
device and complete safety evaluation at least once. 
8.7. Exclusion of Special Data During Hypothesis Test and Justification 
(if applicable) 
N/A 
9. Data Management 
The Electronic Data Capture (EDC) system is used to collect the trial data. The 
EDC system has been strictly tested and fully complies with the requirements of 
Good Clinical Practice for Medical Devices and Technical Guidance for Data 
Management in Clinical Trials. Before the system is formally launched, the 
relevant users need to be trained and assessed to ensure that the system meets the 
trial requirements. After the official launch, relevant personnel will be provided 
with the account and password. The account is bound with the role and authority 
of the user who is required to properly keep and not to disclose the account 
information to others or exercise corresponding rights on behalf of others. 
9.1. Data Collection 
The EDC directly transmits data from the client to the server through the Internet. 
Investigators can directly enter the source data into the EDC system to complete 
data collection. Investigators should be responsible for the quality of the entered 
data and ensure the authenticity and integrity of the data. The EDC system 
provides an interface printing function that allows the investigator to print the 
electronic case report form as required. 
9.2. Data Verification and Modification 
The EDC system provides on-line and off-line verification methods. When 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
40 
investigators have entered abnormal data, the EDC system will issue real-time 
warnings to remind them to check; and the data administrator performs logical 
check on the data stored in the server and issues the wrong data through EDC in 
the form of manual query. Investigators need to answer all published questions. 
The CRA needs to periodically remind and assist the investigators in answering 
queries to ensure that each query is handled correctly. The system will record all 
queries and answers thereto. 
9.3. External Data Management 
External data in the study, such as device parameters and review results of central 
interpretation room, require pre-defined transmission mode, format requirements, 
transmission frequency and encryption and must meet the requirements for later 
data management and statistical analysis. For data management, the 
completeness, consistency and accuracy of external data should be verified, and 
in case of any problematic data, the external data output party should explain or 
modify it to ensure that it can be combined with the ECRF database. 
9.4. Database Locking 
When all data entry is completed and submitted, and all queries are answered, the 
system enters a soft locking status. The statistician will generate a masked review 
report based on the database. If it is confirmed that the data would not be 
modified, the sponsor, the person in charge of data administration and the person 
in charge of statistics will sign the database locking form, and the data 
administrator would complete the database locking operation according to the 
form. The locked database cannot be modified again. If there is any wrong data 
that affects the primary effectiveness endpoint or safety indicators, the sponsor, 
the person in charge of data management and the person responsible for statistics 
will confirm the unlocking for modification and sign the database unlocking 
form, and the data administrator will modify the wrong data according to the 
unlocking reason and carry out quality control. The sponsor, the person in charge 
of data administration and the person in charge of statistics will sign the database 
locking form again once the error had been corrected. 
10. Feasibility Analysis 
10.1. Possibility Analysis on Success 
According to the clinical trial and clinical application of similar products, the 
application of mechanical revascularization device for treatment of acute 
ischemic stroke is safe and effective, because of its navigation and rapid 
recanalization advantages, and freedom from risk of long-term complications. In 
the Chinese Guidelines for the Endovascular Treatment of Acute Ischemic Stroke 
(2018), mechanical thrombectomy for acute anterior circulation great-vessel 
occlusive stroke within 6h of onset is classified into Class I recommendation 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
41 
(Level A evidence). According to the results of DEFUSE-3 and DAWN studies, 
patients with onset at 6-16h and 16-24h meet the corresponding inclusion and 
exclusion criteria and are classified into Class I recommendation (Level A 
evidence) and Class IIa recommendation (Level B evidence), respectively. 
According to the 2018 AHA/ASA, mechanical thrombectomy is recommended 
as Class I recommendation (Level A evidence) for acute ischemic stroke patients 
within 6-16h from the last time being normal and target lesions in the anterior 
circulation great vessels if the enrollment meets the DOWM or DEFUSE-3 
criteria. 
Mechanical 
thrombectomy 
is 
recommended 
as 
Class 
IIa 
recommendation (Level B evidence) in acute ischemic stroke patients within 6-
24h from the last time being normal and target lesions in the anterior circulation 
great vessels if the enrollment meets the DOWM or DEFUSE-3 criteria. 
The design of Ghunter Revascularization Device of Sinomed Neurovita 
Technology Inc. is optimized on the basis of similar products that have been 
marketed, and there is no difference in their main technical indicators. Before 
conducting the clinical trial, animal experiments have been performed to verify 
that Sinomed Neurovita Ghunter Revascularization Device is not inferior to the 
marketed product in terms of effectiveness and safety. 
The clinical sites participating in this study are equipped with complete 
instruments and equipment and are the hospitals with rich clinical experience; the 
physicians participating in this study have rich experience in using mechanical 
intracorporeal thrombectomy stents. 
10.2. Possibility Analysis on Failure 
The main reasons for failure or poor results may be related to the following 
factors: 1) The product is seen very special device defects. 2) Too many subjects 
dropped out due to the development of SAEs. 3) The training for the personnel 
of the study site is not in place, and the use of the device is not skilled, with the 
result that the effectiveness of the product fails to meet the requirements. 
In addition to the above reasons, there are other unpredictable risks that may exist 
in this study, leading to its failure. But the risk may be minimized by adherence 
to this protocol, treatment in the prescribed study sites, compliance with the 
inclusion/exclusion criteria of the subjects, and close monitoring of the physical 
condition of the subjects during the treatment or follow-up period. 
11. Quality Control of Clinical Trial 
11.1. Monitoring of Clinical Trial 
During the clinical trial, the CRA will conduct regular monitoring visits at the 
study site according to the monitoring plan, to ensure that all the contents in the 
study protocol are strictly observed, and will check the raw data to ensure that the 
filled contents of EDC are true, complete and correct. 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
42 
11.2. Filling of Case Report Form 
Permissible users perform data entry to ensure that the raw data are consistent 
with EDC data. 
11.3. Retention of Raw Data 
The raw data of this trial include the signed ICF, release records of test products, 
relevant laboratory test report, case records and other related records, which 
should be retained at the clinical study site of the hospital where the study site is 
located. All raw data and printed CRF should be retained for 10 years after the 
end of clinical trial. 
12. Ethical Issues and Informed Consent in Clinical Trial 
12.1. Ethical Considerations 
Before the clinical trial, the investigators need to submit the clinical trial protocol, 
ICF and other related documents to the Medical Ethics Committee of hospitals 
where the study sites are located. The clinical trial will be started only after 
obtaining the approval of the Ethics Committee. Any amendment to the study 
protocol must be approved by the Ethics Committee before it can be 
implemented. SAEs during the clinical trial shall be submitted to the Ethics 
Committee in writing timely. 
12.2. Approval of Trial Protocol 
The approval of the clinical trial protocol is performed by the Ethics Committee, 
and the clinical trial can be performed only after obtaining the final ethical 
approval. 
12.3. Informed Consent Process and Contents of Informed Consent 
Form 
The investigators must specify to the subjects or their guardians, prior to their 
enrollment, the details of this clinical trial, including the contents and purpose of 
the trial, intended efficacy, possible adverse events and countermeasures. The 
subjects can only be enrolled when they have fully understood this trial and 
signed the ICF. 
For incompetent subjects, if the Ethics Committee agrees in principle and the 
investigators believe that it is in their own interests for the subjects to participate 
in the clinical trial, they may also enter the clinical trial, but their guardians should 
sign and date before the trial. Although acute ischemic stroke patients may not be 
clinically comatose, their cognitive ability and hand function are affected, and 
such subjects should be signed and dated by their guardians before the trial. 
When the subjects or their guardians have no reading ability, a witness shall be 
present in the informed process. After the detailed explanation of the ICF, the 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
43 
witness's reading of the ICF shall be consistent with the oral informed content. 
After the subjects or their guardians show verbal consent, the witness shall sign 
and date the ICF and the signatures of the witness and the investigator shall be on 
the same day. 
13. Provisions for AE and Device Defect Reporting 
13.1. AE 
13.1.1. Definition of AE 
An AE is defined as any untoward medical occurrence after treatment with the 
investigational product, regardless of its relationship to the investigational 
medical device. This includes the events related to the followings: 
 
All events related to the investigational or control device. 
 
All events related to the study process (all processes in the clinical 
study plan). 
 
Other adverse events. 
13.1.2. Determination of AE Severity 
The process, degree, handling and outcome of the adverse events should be 
observed in detail and be filled in the Adverse Event Report Form. According to 
the following criteria, the severity of adverse events can be divided into mild 
(inquired), moderate (active narration, but able to endure) and severe (objective 
manifestation, unendurable). 
13.1.3. Recording of AE 
AEs after treatment with the investigational product must be recorded truthfully 
in the Adverse Event Form. Record the duration of adverse events (that is, from 
start to end), severity, and correlation with the clinical study of adverse events as 
well as the corresponding treatment and other management measures. Follow-up 
shall be made to the end of the trial or the outcome of adverse events. 
13.2. Device Defect 
The device defect refers to the unreasonable risk that may endanger the human 
health and life safety in the normal use of the medical device during the clinical 
trial, such as label errors, quality problems and failures. 
The investigators should record the device defects occurred or found during the 
clinical trial and analyze the cause of the event together with the sponsor, form a 
written analysis report, propose the opinions on continuing, suspending or 
terminating the trial and report to the Ethics Committee through the 
administrative department for medical device clinical trials of the clinical trial 
institution for review. 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
44 
The investigators and subjects can make complaints against the investigational 
device at any phase of this clinical study. 
13.3. SAE 
The SAE refers to the event that causes death or serious deterioration of health in 
the process of clinical trial, including: 
 
Fatal disease or injury; 
 
Permanent impairment of a body structure or a body function; 
 
Requiring in-patient hospitalization or prolongation of existing 
hospitalization; 
 
Requiring medical treatment or surgical intervention so as to avoid 
permanent impairment of the body structure or body function; 
 
Leading to a fetal distress, fetal death or a congenital abnormality; 
 
Congenital defect, etc. 
Hospitalization or prolongation of hospitalization cannot be considered an 
SAE if at least one of the following exceptions is met: 
1) 
Pre-planned hospitalizations (e.g., scheduled elective or scheduled 
operations or examinations prior to study start) 
2) 
Hospitalization not related to an AE (e.g., community hospitalization 
for short-term or long-term care purposes) 
3) 
Measures such as tracheal intubation or tracheotomy to help stroke 
patients breathe better with sputum 
4) 
Not symptomatic intracranial hemorrhage as judged by the 
investigators 
Note: Symptomatic intracranial hemorrhage refers to intracranial 
hemorrhage 
(parenchymal 
hematoma, 
subarachnoid 
hemorrhage, 
ventricular hemorrhage) accompanied by neurological deterioration 
(NIHSS score increases by ≥ 4 compared with that preoperatively) 
However, any interventional therapy performed during hospitalization may 
meet the criteria for a "significant medical event" and may be reported as a 
SAE based on clinical judgment. In addition, if local regulatory authorities 
specifically require stricter definitions, local regulations shall prevail. 
13.4. Reporting Procedures and Contact Information 
In case of any SAE during the clinical trial, whether related to the investigational 
device or not, the investigators should immediately take appropriate therapeutic 
measures for subjects and report the event in writing to the administrative 
department for medical device clinical trials of the clinical trial institution, and 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
45 
then the clinical trial institution reports the same to the Sponsor in writing. The 
administrative department for medical device clinical trials should send written 
reports to corresponding Ethics Committee, the food and drug administrative 
authorities, the competent authority of health and family planning in local 
province, autonomous region and municipality within 24 h. Regarding any death 
event, the clinical trial institutions and investigators should provide all required 
data to corresponding Ethics Committees and sponsor; 
The sponsor should promptly investigate the SAE with the investigator and take 
necessary measures to ensure the safety and rights and interests of the subjects. 
Any SAE or device defect that may cause serious adverse events should be 
reported to the food and drug administrative authorities and the competent 
department of health and family planning at the same level where the device is 
filed within 5 working days after being informed. Meanwhile, other clinical trial 
institutions and investigators that participate in the trial should also be informed, 
and the Ethics Committee of such clinical trial institution should also be timely 
informed through its administrative department for medical device clinical trials. 
If it is determined to be a test device-related SAE, the sponsor shall bear the cost 
of rescuing the subject and the corresponding economic compensation. 
14. Deviation from Clinical Trial Protocol and Regulations for 
Protocol Amendment 
Before the start of the clinical verification, the trial protocol is discussed, revised, 
finalized and signed by the investigators and the sponsor, and then reported to the 
Ethics Committee for approval before the trial can be initiated. 
If this protocol has problems in clinical verification and actual implementation 
that need to be revised, the investigators should be informed of. After the 
multicenter discussion, the protocol shall be revised by the leading site and 
submitted to the investigators and the study sites in writing for signature and 
approval, and then reported to the Ethics Committee for approval before 
implementation. 
During the clinical study, if the existing participating sites fail to obtain the 
approval of the clinical trial administrative department or the Ethics Committee, 
resulting in the progress of the study significantly slower than the expected 
schedule, the sponsor should fully communicate and discuss with the 
coordinating investigator, and then make adjustments to the participating sites 
(abandonment or addition), and may update the list of clinical study sites in the 
Appendix without amending the text of the protocol. The final list of participating 
sites should be submitted to the clinical trial administrative department and Ethics 
Committee of all participating sites for filling. 
If the important new information regarding the investigational device becomes 
available, the informed consent form must be revised in writing and re-approved 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
46 
by the Ethics Committee before obtaining consent from subjects once again. 
In the event of deviation from the protocol during the course of the trial, the 
investigators should promptly notify the sponsor and the ethics committee. 
15. Direct Access to the Source Data and Documents 
In this clinical study, the principal investigator and authorized investigators 
thereof can access and generate out-patient medical records, ICF (ICF) of 
subjects, EDC and original medical records in HIS system. 
The laboratory inspection personnel and investigators can access and generate the 
inspection result report issued by them. The data administrator can access and 
generate the data of data management; the statistical analyst can access and 
generate the statistical analysis data. 
The access and editing permissions of the remaining source data, in accordance 
with the requirement of the relevant laws and regulations and technical 
specifications in China, shall be specified in detail by SOP of the corresponding 
department. 
16. Finance and Insurance 
In this clinical study, the sponsor shall sign a written agreement with clinical trial 
institutions, with the financial situation and payment methods for this clinical trial 
specified in detail in the agreement. The specific content is detailed in the signed 
agreement. 
In case of any injury or death related to the clinical trial, the sponsor should 
assume corresponding compensation, which should be fully in accordance with 
relevant laws and regulations and GCP requirements. 
17. Contents to be Covered in Clinical Trial Report 
Each participating institution should complete the clinical trial summary of each 
sub-site, and the medical statistics office should complete the statistical analysis 
report. The leading site of this clinical trial should complete the clinical trial 
summary report according to the contents of statistical analysis report, which 
should include the clinical trial summary of each sub-site. 
The clinical trial summary of each sub-site should include at least the clinical trial 
overview, general clinical data, description on investigational medical devices, 
safety and effectiveness data set, incidence and treatment of adverse events, 
description of protocol deviation, etc., with CRFs attached. 
According to the requirements of the Good Clinical Practice for Medical Device 
(CFDA Order No. 25) issued by the China Food and Drug Administration 
(CFDA) and National Health and Family Planning Commission of China 
(NHFPC), the clinical trial report should be consistent with the clinical trial 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
47 
protocol and should cove: 
(I) 
General information: 
(II) 
Abstract; 
(III) 
Brief introduction; 
(IV) 
Objective of clinical trial; 
(V) 
Method of clinical trial; 
(VI) Contents of clinical trial; 
(VII) General clinical data; 
(VIII) Investigational medical device and control device or control 
diagnostic and therapeutic method; 
(IX) 
Statistical analysis methods and evaluation methods adopted; 
(X) 
Clinical evaluation criteria; 
(XI) Organizational structure of clinical trial; 
(XII) Description of ethics; 
(XIII) Clinical trial results; 
(XIV) AEs observed in the clinical trial and their treatment; 
(XV) Analysis and discussion of clinical trial results, especially the 
indications, intended use, contraindications and precautions; 
 
(XVI) Conclusion of clinical trial; 
(XVII) Existing problems and suggestions for improvement; 
(XVIII) List of personnel involved in the trial; 
(XIX) Other conditions that need to be described. 
18. Confidentiality Principle 
This agreement and the contents of this clinical trial and all the attached data are 
confidential and proprietary information of the sponsor, and the investigators 
shall be held responsible for confidentiality, including the patent application, 
manufacturing process and unpublished data available to the investigators 
provided by the sponsor, which shall not be disclosed to any third party unless 
the consent of the sponsor is obtained and the obligation of confidentiality shall 
survive the termination or end of this trial. 
19. Agreement on Publication of Trial Results 
The investigators have the right to prepare sub-site papers, reports, etc., but the 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
48 
investigators should notify the sponsor in writing before publishing to the public, 
and shall not violate the confidentiality obligations agreed in this protocol. 
20. Responsibilities Assumed by All Parties 
All parties shall strictly implement the relevant provisions in accordance with the 
Good Clinical Practice for Medical Devices (Order No. 25). 
20.1. Responsibilities of the Sponsor: 
(1) Provide the medical institutions with test devices, trial protocol, EDC and 
ICF free of charge; 
(2) Provide relevant training for clinical investigators before trial; 
(3) Bear the costs related to the trial; 
(4) Before terminating a medical device clinical trial, the sponsor should issue a 
notice to the medical institution, Ethics Committee and municipal medical 
products regulatory authority and National Medical Products Administration 
that have accepted the application for the registration of this medical device, 
and describe the reasons; 
(5) Any SAE once occurred should be investigated with the investigators 
promptly, necessary measures should be taken to ensure the safety and 
interests of subjects, and the SAE should be reported to the medical products 
regulatory authorities and health administrative authorities in a timely 
manner; 
(6) The sponsor should bear the treatment cost and relevant economic 
compensation for the clinical trial-related injury or death of subjects, with 
the exception of damage due to the fault of medical institution and medical 
staff in the diagnosis and treatment. 
20.2. Responsibilities of Study Site and Investigator: 
(1) The study site should properly keep the records and basic documents of 
clinical trial according to the agreement with the sponsor; 
(2) Fulfill the clinical trial protocol, report any deviation from the clinical trial 
protocol to the sponsor, and reach an agreement with the sponsor; 
(3) Use devices according to the clinical trial protocol. Whether it is for devices 
or for the clinical trial protocol, any change must be reported to the sponsor; 
(4) Ensure that personnel and facilities can carry out the clinical trial safely and 
effectively; 
(5) Clinical trial personnel always have an appropriate number of subjects; 
(6) Obtain the ICF; 
(7) According to the national laws and regulations, the CRF should be recorded 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
49 
in a timely manner, and its data should be consistent with the recorded data 
of the subjects; 
(8) Record and report AEs and device defects to the sponsor according to 
procedures; 
(9) Keep records of withdrawal of subjects, non-compliance with the physician's 
orders and any termination of clinical trial; 
(10) Provide the clinical trial report to the sponsor in a timely manner together 
with the clinical study site, and bear legal responsibility for the correctness, 
clarity and reliability of the report after the completion of device use. 
 
 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
50 
References 
[1] Chinese Society of Neurology, Chinese Stroke Society. Chinese guidelines for diagnosis and treatment 
of acute ischemic stroke 2018 [J]. Chin J Neuro,2018,51 (9):666-682. 
[2] Gao F，Xu AD. Chinese guidelines for endovascular treatment of acute ischemic stroke 2015 [J]. Chin 
J Stroke,2015.10(7):590-606. 
[3] Cheng YM. Current status of thrombolytic therapy for acute ischemic stroke (review) [J]. Chinese 
journal of urban and rural enterprise hygiene,2012(6):25-28. 
[4] Powers W J, Rabinstein A A, Ackerson T, et al. 2018 Guidelines for the Early Management of Patients 
With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart 
Association/American Stroke Association [J]. Stroke,2018,49(3):158. 
[5] An-Ding X, Yong-Jun W, Wang D Z. Consensus statement on the use of intravenous recombinant 
tissue plasminogen activator to treat acute ischemic stroke by the Chinese Stroke Therapy Expert Panel 
[J]. Cns Neuroscience & Therapeutics,2013,19(8):543-548. 
[6] Levy E I, Siddiqui A H, Annemarie C, et al. First Food and Drug Administration-approved prospective 
trial of primary intracranial stenting for acute stroke: SARIS (stent-assisted recanalization in acute 
ischemic stroke) [J], Stroke; a journal of cerebral circulation,2009,40(11):3552. 
[7] Jonathan E, Lees K R, Patrick L, el al. Effect of treatment delay, age, and stroke severity on the effects 
of intravenous thrombolysis with alteplase for acute ischaemic stroke: a meta-analysis of individual 
patient data from randomised trials[J]. Lancet,2014,384(9958): 1929-1935. 
[8] Asadi H, Dowling R, Yan B, el al. Advances in endovascular treatment of acute ischaemic stroke[J]. 
Internal Medicine Journal,2015,45(8):798-805. 
[9] Zaidat O O. North American Solitaire Stent Retriever Acute Stroke registry: post-marketing 
revascularization 
and 
clinical 
outcome 
results. 
[J]. 
Journal 
of 
Neurointerventional 
Surgery,2014,6(8):584-588. 
[10] Berkhemer O A, Fransen P S, Beumer D, et al. A randomized trial of intraarterial treatment for acute 
ischemic stroke [J], N Engl J Med,2015,372(1):11 -20. 
[11] Campbell B C V, Mitchell P J, Kleinig T J, et al. Endovascular therapy for ischemic stroke with 
perfusion-imaging selection[J], N Engl J Med,2015,372(11): 1009-1018. 
[12] Alakeson N, Flettt T, Hunti V, et al. Randomized Assessment of Rapid Endovascular Treatment of 
Ischemic Stroke[J]. N Engl J Med,2015,49(2): 1019-1030. 
[13] Saver J L, Goyal M, Bonafe A, et al. Stent-Retriever Thrombectomy after Intravenous t-PA vs. t-PA 
Alone in Stroke[J]. N Engl J Med,2015,372(24):2285-2295. 
[14] Jovin T G, Angel C, Erik C, et al. Thrombectomy within 8 hours after symptom onset in ischemic 
stroke[J]. New England Journal of Medicine,2015,372(24):2296-2306. 
[15] Ferrell A S, Britz G W. Developments on the horizon in the treatment of neurovascular problems[J]. 
Surgical Neurology International,2013,4:S31-S37. 
[16] Saver J L, Jahan R, Levy E I, el al. Solitaire flow restoration device versus the Merci Retriever in 
patients with acute ischaemic stroke (SWIFT): a randomized, parallel-group, non-inferiority trial [J]. 
Lancet,2012,380(9849): 1241- 1249. 
[17] Goyal M, Menon B K, Zwam W H V, et al. Endovascular thrombectomy after large-vessel ischaemic 
stroke: 
A 
meta-analysis 
of 
individual 
patient 
data 
from 
five 
randomised 
trials[J]. 
Lancet,2016,387(10029): 1723-1731. 
[18] Albers G W, Mp M, S K, et al. Thrombectomy for Stroke at 6 to 16 Hours with Selection by Perfusion 
Imaging [J]. N Engl J Med,2018,378(8):708. 
[19] Nogueira R G, Jadhav A P, Haussen D C, et al. Thrombectomy 6 to 24 Hours after Stroke with a 
Mismatch between Deficit and Infarct[J]. N Engl J Med,2017,378(I):a 1706442. 
 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
51 
Investigator's Statement 
I hereby agree that: 
1. I will carry out this clinical trial in strict compliance with the Declaration of 
Helsinki, current regulations of China and the requirements of this trial 
protocol. 
2. I undertake that the EDC data will be true, valid and complete, and the 
electronic data signature will be completed on time. 
3. I will make sure that the investigational medical device will be used only for 
the purpose of this clinical trial; and will completely and accurately record 
the receipt and use of the investigational medical device, with such records 
retained throughout the clinical trial. 
4. I will accept monitoring, verification and inspection of the CRA and auditor 
authorized by the sponsor as well as regulatory authorities on the clinical trial. 
5. I will strictly implement the terms in the clinical trial contract/agreement 
signed among parties. 
 
I have already read the clinical trial protocol entirely, including the above 
statement and I fully agree with all the above contents. 
 
Comments of the investigator 
 
Approved 
<signed> 
 
 
Signature: 
February 17, 2022 
 
Comments of the sponsor 
 
Approved 
<stamped> 
 
 
Signature (stamp): 
February 10, 2022 
 
Comments of the medical device study sites 
 
Approved 
<stamped> 
 
 
Signature (stamp): 
February 25, 2022 
 
 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
52 
Appendix 1 List of Study Sites and Investigators 
Clinical Study on Safety and Effectiveness of Ghunter 
Revascularization Device for Endovascular Treatment of Acute 
Ischemic Stroke 
List of Study Sites and Investigators 
Site # 
Name of site 
Investigator 
01 
General Hospital of Eastern Theater Command, PLA 
Liu Xinfeng 
02 
The First Affiliated Hospital of USTC (Anhui 
Provincial Hospital) 
Hu Wei 
03 
The Second Affiliated Hospital of Soochow University 
Xiao Guodong 
05 
The First Affiliated Hospital of Nanchang University 
Fang Pu 
07 
The First Affiliated Hospital of Wannan Medical 
College (Yijishan Hospital) 
Zhou Zhiming 
13 
Ganzhou People's Hospital 
Zeng Guoyong 
15 
Taiyuan Central Hospital 
Wen Chao 
17 
Zhuhai People's Hospital 
Cheng 
Guangsen 
18 
Jiangmen Wuyi Hospital of Traditional Chinese 
Medicine 
Shi Qing 
19 
Central Hospital of Xiang Tan city 
Yuan 
Guangxiong 
20 
Meizhou People's Hospital 
Wei Tongguo 
21 
General Hospital of Northern Theater Command, PLA 
Chen 
Huisheng 
22 
Jinan Central Hospital 
Zhao Yanxin 
23 
Qingdao Center Hospital 
Yuan 
Haicheng 
24 
Ganzhou Municipal Hospital 
Liu Hanwen 
25 
Xinxiang Central Hospital 
He Wenlong 
26 
Handan Central Hospital 
Ma Wenqun 
 
 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
53 
Appendix 2 ASPECTS Scale 
Alberta Stroke Program Early CT Score (ASPECTS) 
 
Subcortical 
structural area: 
(1) Caudate nucleus 
(C) 
(2) Lenticular 
nucleus (L) 
(3) Internal capsule (IC) 
 
 
 
Middle 
cerebral 
artery cortex: 
(4) Anterior cortical area of middle 
cerebral artery (M1) 
(5) Insular cortex (I) 
(6) Lateral cortical area of middle 
cerebral artery insular (M2) 
(7) Posterior cortical area of middle 
cerebral artery (M3) 
(8) Middle cerebral cortex above M1 
(M4) 
(9) Middle cerebral cortex above M2 
(M5) 
(10) Middle cerebral cortex above M3 
(M6) 
 
 
 
 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
54 
Appendix 3 mTICI Image Grading Criteria: 
mTICI image grading criteria 
Classific
ation 
Criteria 
Grade 0 
No perfusion 
Grade 1 
Trace flow through occluded segment with minimal or no perfusion 
Grade 2a 
Partial antegrade perfusion of less than 50% downstream ischemic area 
Grade 2b 
Partial antegrade perfusion of more than 50% downstream ischemic area 
Grade 3 
Complete antegrade perfusion of downstream ischemic area 
Note: Perfusion is defined as capillary visualization or parenchymal staining 
 
 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
55 
Appendix 4 mRS: 
mRS 
Score 
Description 
0 
No symptoms at all 
1 
No significant disability; able to carry out all usual duties and activities, despite 
some symptoms 
2 
Slight disability; able to look after own affairs without assistance, but unable to 
carry out all previous activities 
3 
Moderate disability; requires some help, but able to walk unassisted 
4 
Moderately severe disability; unable to attend to own bodily needs without 
assistance, and unable to walk unassisted 
5 
Severe disability; requires constant nursing care and attention, bedridden, 
incontinent 
6 
Death 
 
 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
56 
Appendix 5 NIHSS: 
The National Institutes of Health Stroke Scale (NIH Stroke Scale, NIHSS) 
Item 
Scoring criteria 
1a. Level of consciousness: 
The investigator must choose a response if a 
full evaluation is prevented by such obstacles as 
an 
endotracheal 
tube, 
language 
barrier, 
orotracheal trauma/bandages. A 3 is scored 
only if the patient makes no movement (other 
than reflexive posturing) in response to noxious 
stimulation. 
0  Alert; keenly responsive 
1  Somnolence, but arousable by minor stimulation to 
obey, answer, or respond 
2  Lethargic or slow in response, requires repeated 
stimulation to attend, or requires strong or painful 
stimulation to make movements (not stereotyped) 
3  Stuporous; responds only with reflex motor or 
autonomic effects or totally unresponsive, flaccid, 
and areflexia 
1b. Level of consciousness questions: 
The patient is asked the month and his/her age. 
It is important that only the initial answer be 
graded. Aphasic and stuporous patients who do 
not comprehend the questions will score 2. 
Patients 
unable 
to 
speak 
because 
of 
endotracheal intubation, orotracheal trauma, 
severe dysarthria from any cause, language 
barrier, or any other problem not secondary to 
aphasia are given a 1. Written responses will be 
available. 
0  Answers both questions correctly. 
1  Answers one question correctly. 
2  Answers neither question correctly. 
1c. Level of consciousness commands: 
The patient is asked to open and close the eyes 
and then to grip and release the non-paretic 
hand. Only the first attempt is scored. Credit is 
given if an unequivocal attempt is made but not 
completed due to weakness. If the patient does 
not respond to command, the task should be 
demonstrated to him or her (pantomime), and 
the result scored. Patients with trauma, 
amputation, or other physical impediments 
should be given suitable one-step commands. 
0  Performs both tasks correctly. 
1  Performs one task correctly. 
2  Performs neither task correctly. 
2. Gaze: 
Only horizontal eye movements will be tested. 
Voluntary or reflexive (oculocephalic) eye 
movements will be scored. If the patient has a 
conjugate deviation of the eyes that can be 
overcome by voluntary or reflexive activity, the 
score will be 1. If a patient has an isolated 
peripheral nerve paresis, score a 1. Gaze is 
testable in all aphasic patients. Patients with 
ocular 
trauma, 
bandages, 
pre-existing 
blindness, or other disorder of visual acuity or 
fields 
should 
be 
tested 
with 
reflexive 
movements, and a choice made by the 
investigator. Establishing eye contact and then 
moving about the patient from side to side will 
occasionally clarify the presence of a partial 
gaze palsy. 
0  Normal 
1  Partial gaze palsy gaze is abnormal in one or both 
eyes, but forced deviation or total gaze paresis is not 
present). 
2  Forced deviation, or total gaze paresis is not 
overcome by the oculocephalic maneuver. 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
57 
3. Visual: 
If the patient can see the finger on the side, 
record it as normal. If there is unilateral 
blindness or enucleation, visual fields in the 
remaining eye are scored. Score 1 only if a 
clear-cut 
asymmetry, 
including 
quadrantanopia, is found. If patient is blind 
from any cause, score 3. If there is extinction, 
patient receives a 1, and the results are used to 
respond to item 11. 
0  No visual loss 
1  Partial hemianopia 
2  Complete hemianopia 
3  Bilateral hemianopia (blind including cortical 
blindness) 
4. Facial palsy 
0  Normal 
1  Minor 
paralysis 
(flattened 
nasolabial 
fold, 
asymmetry on smiling). 
2  Partial paralysis (total or near-total paralysis of 
lower face) 
3  Complete paralysis of one or both sides (absence of 
facial movement in the upper and lower face). 
5 and 6.  Motor arm and motor leg: 
The limb is placed in the appropriate position: 
extend the arms (palms down) 90 degrees (if 
sitting) or 45 degrees (if supine); hold the leg at 
30 degrees (always tested supine). Score 1~4 if 
the arm falls before 10 seconds and the leg falls 
before 5 seconds. The aphasic patient is 
encouraged using urgency in the voice and 
pantomime, but not noxious stimulation. Each 
limb is tested in turn, beginning with the non-
paretic arm. 
Arm: 
0  No drift; limb holds 90 (or 45) degrees for full 10 
seconds. 
1  Limb holds 90 (or 45) degrees, but drifts down 
before full 10 seconds; does not hit bed or other 
support. 
2  Some effort against gravity; limb cannot get to or 
maintain 90 (or 45) degrees. 
3  No effort against gravity; limb falls rapidly. 
4  No movement. 
9  Amputation or joint fusion, explain: 
5a Left arm; 5b Right arm 
Leg: 
0  No drift; leg holds for full 5 seconds. 
1  Leg falls by the end of the 5 second period but does 
not hit the bed. 
2  Leg falls to bed by 5 seconds but has some effort 
against gravity. 
3  No effort against gravity; leg falls to bed 
immediately. 
4  No movement. 
9  Amputation or joint fusion, explain: 
6a Left leg; 6b Right leg 
7. Limb Ataxia: 
This item is aimed at finding evidence of a 
unilateral cerebellar lesion. Test with eyes 
open. In case of visual defect, ensure testing is 
done in intact visual field. The finger-nose-
finger and heel-shin tests are performed on both 
sides, and ataxia is scored only if present out of 
proportion to weakness. Ataxia is absent in the 
patient who cannot understand or is paralyzed. 
In case of blindness, test by having the patient 
touch nose from extended arm position. Only in 
the case of amputation or joint fusion, score 9 
and explain. 
0  Absent 
1  Present in one limb. 
2  Present in two limbs, ataxia in: 
Right arm 1 = yes, 2 = no 
9  Amputation or joint fusion, explain: 
Left arm 1 = yes, 2 = no 
9  Amputation or joint fusion, explain: 
Right arm 1 = yes, 2 = no 
9  Amputation or joint fusion, explain: 
Left leg 1 = yes, 2 = no 
9  Amputation or joint fusion, explain: 
Right leg 1 = yes, 2 = no 

Ghunter Revascularization Device Clinical Trial Protocol V3.0/February 9, 2022 
 
58 
8. Sensory: 
Sensation or grimace to pinprick when tested, 
or withdrawal from noxious stimulus in the 
obtunded or aphasic patient. Only sensory loss 
attributed to stroke is scored as abnormal and 
the examiner should test as many body areas 
[arms (not hands), legs, trunk, face] as needed 
to accurately check for hemisensory loss. A 
score of 2 is given when a severe or total loss of 
sensation 
can 
be 
clearly 
demonstrated. 
Stuporous and aphasic patients will, therefore, 
probably score 1 or 0. The patient with 
brainstem stroke who has bilateral loss of 
sensation is scored 2. If the patient does not 
respond and is quadriplegic, score 2. Patients in 
a coma (1a = 3) are scored 2. 
0  Normal 
1  Mild-to-moderate sensory loss; patient feels 
pinprick is less sharp or is dull; or there is a loss of 
pinprick, but patient is aware of being touched. 
2  Severe to total sensory loss; patient is not aware of 
being touched in the face, arm, and leg. 
9. Language: 
Naming and reading tests. If visual loss 
interferes with the tests, ask the patient to 
identify objects placed in the hand, repeat, and 
produce speech. The intubated patient should 
be asked to write. The patient in a coma will 
automatically score 3 on this item. The 
examiner must choose a score for the patient 
with stupor or limited cooperation, but a score 
of 3 should be used only if the patient is mute 
and follows no one-step commands. 
0  Normal 
1  Mild-to-moderate aphasia; some obvious loss of 
fluency or facility of comprehension, without 
significant limitation on ideas expressed or form of 
expression. 
2  Severe aphasia; all communication is through 
fragmentary expression; great need for inference, 
questioning, and guessing by the listener. Range of 
information that can be exchanged is limited. 
3  Mute, global aphasia; no usable speech or auditory 
comprehension. 
10. Dysarthria: 
Read or repeat words from the attached list. If 
the patient has severe aphasia, the clarity of 
articulation of spontaneous speech can be rated. 
Only if the patient is intubated or has other 
physical barriers to producing speech, the 
examiner should record the score as 9 and 
clearly write the explanation for this choice. Do 
not tell the patient why he or she is being tested. 
0  Normal 
1  Mild-to-moderate dysarthria; patient slurs at least 
some words and, at worst, can be understood with 
some difficulty. 
2  Patient's speech is so slurred as to be unintelligible 
in the absence of or out of proportion to any 
dysphasia, or is mute/anarthric. 
9  Intubated or other physical barrier, explain: 
11. Neglect: 
If the patient has a severe visual loss preventing 
visual double simultaneous stimulation, and the 
cutaneous stimuli are normal, the score is 
normal. If the patient has aphasia but does 
appear to attend to both sides, the score is 
normal. The presence of visual spatial neglect 
or anosagnosia may also be taken as evidence 
of abnormality. 
0  Normal 
1  Visual, tactile, auditory, spatial, or personal 
inattention or extinction to bilateral simultaneous 
stimulation in one of the sensory modalities. 
2  Profound hemi-inattention or extinction to more 
than one modality; does not recognize own hand; or 
orients to only one side of space.