JET Enhanced Thrombectomy Intervention Hong Kong Post Market Study
Conditions: Peripheral Venous Thrombosis, Peripheral Arterial Thrombosis, Peripheral Arteriovenous Thrombosis
Sponsor: Abbott Medical Devices

 
 
 
 
JET Enhanced Thrombectomy Intervention Hong Kong Post Market Study 
Study Protocol including Statistical Analysis Plan (SAP) 
NCT06340763 
August 26, 2024 

 
 
Study Name: JETi Hong Kong PMS 
 
 
 
 
 
 
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SITE PRINCIPAL INVESTIGATOR SIGNATURE PAGE 
 
I have read and agree to adhere to the clinical investigation plan and all regulatory requirements 
applicable in conducting this clinical investigation. 
 
 
Site Principal Investigator 
 
Printed name: 
Signature: 
Date: 
 
 
 

 
 
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STUDY PRINCIPAL INVESTIGATOR  
SIGNATURE PAGE 
 
I have read and agree to adhere to the clinical investigation plan and all regulatory requirements 
applicable in conducting this clinical investigation. 
 
 
Study Principal Investigator 
 
Printed name: 
Signature: 
Date: 
 
 

 
 
Study Name: JETi Hong Kong PMS 
 
 
 
 
 
 
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TABLE OF CONTENTS 
 
1 
INTRODUCTION ................................................................................................................9 
2 
CLINICAL INVESTIGATION OVERVIEW ......................................................................... 10 
2.1 
Clinical Investigation Objective ................................................................................................ 10 
2.2 
Device Used in the Clinical Investigation.................................................................................. 10 
2.2.1 
JETi Hydrodynamic Thrombectomy System ................................................................... 10 
2.2.2 
Indication for Use ............................................................................................................ 10 
2.2.3 
Description of the Device ................................................................................................ 10 
3 
CLINICAL INVESTIGATION DESIGN .............................................................................. 10 
3.1 
Clinical Investigation Procedures and Follow-up Schedule ...................................................... 11 
3.2 
Measures Taken to Avoid and Minimize Bias ........................................................................... 14 
3.3 
Suspension or Early Termination of the Clinical Investigation .................................................. 14 
4 
ENDPOINTS ..................................................................................................................... 14 
4.1 
Primary Endpoints ................................................................................................................... 14 
4.1.1 
Arterial and Arteriovenous Subjects ................................................................................ 14 
4.1.2 
Venous Subjects ............................................................................................................. 15 
4.2 
Descriptive Endpoints .............................................................................................................. 16 
4.2.1 
All subjects ...................................................................................................................... 16 
4.2.2 
Arterial and Arteriovenous Subjects ................................................................................ 16 
4.2.3 
Venous Subjects ............................................................................................................. 17 
5 
SUBJECT SELECTION AND WITHDRAWAL .................................................................. 18 
5.1 
Subject Population ................................................................................................................... 18 
5.2 
Subject Recruitment/Screening and Informed Consent ............................................................ 19 
5.2.1 
Subject Recruitment and Screening ................................................................................ 19 
5.2.2 
Informed Consent ............................................................................................................ 19 
5.3 
Eligibility Criteria ...................................................................................................................... 21 
5.3.1 
General Eligibility Criteria ................................................................................................ 21 
5.3.2 
Inclusion Criteria ............................................................................................................. 21 
5.3.3 
Exclusion Criteria ............................................................................................................ 21 
5.4 
Subject Enrollment ................................................................................................................... 21 
5.5 
Subject Registration ................................................................................................................. 21 
5.6 
Subject Withdrawal and Discontinuation .................................................................................. 21 

 
 
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5.7 
Number of Subjects ................................................................................................................. 22 
5.8 
Total Expected Duration of the Clinical Investigation ............................................................... 23 
6 
TREATMENT AND EVALUATION OF ENDPOINTS ........................................................ 23 
6.1 
Arterial and Arteriovenous Subjects ......................................................................................... 23 
6.1.1 
Baseline .......................................................................................................................... 24 
6.1.2 
Index Procedure .............................................................................................................. 25 
6.1.3 
Discharge ........................................................................................................................ 26 
6.1.4 
30-day Follow-up (Office Visit) ........................................................................................ 27 
6.1.5 
Unscheduled Visit ........................................................................................................... 27 
6.1.6 
Schedule of Events ......................................................................................................... 27 
6.2 
Venous Subjects ...................................................................................................................... 29 
6.2.1 
Baseline .......................................................................................................................... 30 
6.2.2 
Index Procedure .............................................................................................................. 31 
6.2.3 
Discharge ........................................................................................................................ 32 
6.2.4 
30-day Follow-up (Office Visit) ........................................................................................ 32 
6.2.5 
Unscheduled Visit ........................................................................................................... 32 
6.2.6 
Schedule of Events ......................................................................................................... 32 
6.3 
Imaging Core Laboratories ...................................................................................................... 34 
7 
ADVERSE EVENTS ......................................................................................................... 34 
7.1 
Definition .................................................................................................................................. 34 
7.1.1 
Adverse Event ................................................................................................................. 34 
7.1.2 
Serious Adverse Event .................................................................................................... 34 
7.1.3 
Device Deficiency/Device Malfunction ............................................................................. 35 
7.2 
Device Relationship ................................................................................................................. 35 
7.3 
Adverse Event and Device Deficiency/Device Malfunction Reporting ...................................... 35 
7.3.1 
Adverse Event Reporting ................................................................................................ 35 
7.3.2 
Device Deficiency/Malfunction Reporting ........................................................................ 36 
7.3.3 
Adverse Event Reporting to Country Regulatory Authorities by the Sponsor .................. 37 
8 
STATISTICAL CONSIDERATIONS .................................................................................. 37 
8.1 
Analysis Populations ................................................................................................................ 37 
8.2 
Statistical Analyses .................................................................................................................. 37 
8.2.1 
Primary Endpoints Analyses ........................................................................................... 37 
8.3 
Sample Size Calculation .......................................................................................................... 38 

 
 
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8.4 
Timing of Analysis .................................................................................................................... 38 
8.5 
Subgroup Analysis ................................................................................................................. 38 
8.6 
Multiplicity ............................................................................................................................... 38 
8.7 
Pooling Strategy ...................................................................................................................... 39 
8.8 
Procedures for Accounting for Missing Data ............................................................................ 39 
9 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS .................................................... 40 
10 
QUALITY CONTROL AND QUALITY ASSURANCE ........................................................ 40 
10.1 
Selection of Clinical Sites and Investigators ............................................................................. 40 
10.2 
CIP Amendments ..................................................................................................................... 40 
10.3 
Training.................................................................................................................................... 40 
10.3.1 
Site Training .................................................................................................................... 40 
10.4 
Monitoring ................................................................................................................................ 40 
10.5 
Deviations from CIP ................................................................................................................. 41 
10.6 
Quality Assurance Audit ........................................................................................................... 42 
10.7 
Clinical Events Committee (CEC) ............................................................................................ 42 
11 
DATA HANDLING AND RECORD KEEPING ................................................................... 42 
11.1 
Protection of Personally Identifiable Information ...................................................................... 43 
11.2 
Data Management Plan ........................................................................................................... 43 
11.3 
Source Documentation ............................................................................................................ 43 
11.4 
Case Report Form Completion ................................................................................................ 44 
11.5 
Record Retention ..................................................................................................................... 44 
12 
ETHICAL CONSIDERATION ............................................................................................ 44 
12.1 
Institutional Review Board/Medical Ethics Committee Review and Approval ........................... 44 
13 
CLINICAL INVESTIGATION CONCLUSION .................................................................... 45 
14 
PUBLICATION POLICY .................................................................................................... 45 
15 
RISK ANALYSIS ............................................................................................................... 45 
15.1 
Anticipated Clinical Benefits ..................................................................................................... 45 
15.2 
Foreseeable Adverse Events and Anticipated Adverse Device Effects .................................... 46 
15.3 
Residual Risks Associated with the Device Under Investigation, as Identified in the Risk 
Management Report / Risk Analysis Report ....................................................................................... 46 
15.4 
Risks Associated with Participation in this Clinical Investigation .............................................. 46 
15.5 
Steps Taken to Control or Mitigate Risks ................................................................................. 46 
15.6 
Risk to Benefit Rationale .......................................................................................................... 47 

 
 
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APPENDIX I: ABBREVIATIONS AND ACRONYMS................................................................... 48 
APPENDIX II: DEFINITIONS ...................................................................................................... 49 
APPENDIX III: SITE CONTACT INFORMATION ....................................................................... 52 
APPENDIX IV: RATES OF FORESEEABLE ADVERSE EVENT ............................................... 53 
APPENDIX V: IFU AND LABELING ........................................................................................... 55 
APPENDIX VI: CASE REPORT FORMS .................................................................................... 56 
APPENDIX VII: INFORMED CONSENT FORM ......................................................................... 57 
APPENDIX VIII: MONITORING PLAN ........................................................................................ 58 
APPENDIX IX: ADDITIONAL DOCUMENTS .............................................................................. 59 
APPENDIX X: REVISION HISTORY .......................................................................................... 60 
APPENDIX XI: CIP SUMMARY .................................................................................................. 62 
 
 

 
 
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COMPLIANCE STATEMENT:  
 
This clinical investigation will be conducted in accordance with this Clinical Investigation Plan (CIP), the 
Declaration of Helsinki, applicable Good Clinical Practices (GCP) and regulations (ISO14155:2020) and 
the appropriate local legislation(s). The most stringent requirements, guidelines or regulations must 
always be followed. The conduct of the clinical investigation will be approved by the appropriate 
Institutional Review Board (IRB)/Ethics Committee (EC) of the respective investigational site and by the 
applicable regulatory authorities. 

 
 
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1 
INTRODUCTION 
The JET Enhanced Thrombectomy intervention (JETi) Hong Kong Post Market Study (PMS) is a post-
market study designed to collect real-world data on the safety, performance, and clinical benefits of the 
JETi™ Hydrodynamic Thrombectomy System (HTS) (will be refer to as JETi System throughout this 
document) for the treatment of acute/subacute thrombosis in the peripheral vasculature.  
 
The JETi System is a hydro-mechanical aspiration system manufactured by Abbott Medical, consisting 
of a catheter, pump set, and accessories. The system is intended to remove/aspirate fluid and break-up  
soft emboli and thrombus from the peripheral vasculature and to subselectively infuse/deliver 
diagnostics or therapeutics with or without vessel occlusion.  
 
Several published studies have shown that the JETi System is safe and effective in the peripheral 
vasculature. In a retrospective study1 of 18 consecutive patients with thrombus in the iliofemoral, 
axillosubclavian, and portal veins, mean thrombus reduction with JETi alone was 92%. Procedural 
success was 100%, and technical success with the JETi alone was 76%; 24% of procedures requiring 
subsequent catheter directed thrombolytics (CDT) overnight. One subsegmental pulmonary embolism 
(PE) event was reported. In another study, 30 patients with acute lower extremity deep vein thrombosis 
(DVT), including iliocaval, iliofemoral, and femoropopliteal) were treated with the JETi System.2 
Technical success was 93.3%, and mean thrombus removal was 74.0%. No major complications were 
observed. In a prospective pilot study conducted in 47 patients with thrombus in the iliocaval or 
iliofemoral veins treated in a single session with the JETi System, unobstructed flow was reestablished 
in 87% of patients with no major adverse events through 30 days.3 In addition to these studies reporting 
on venous thromboses, a recent presentation by Dandu et al.4 reported on a retrospective review of 27 
patients treated for acute lower extremity ischemia. The success rate of all interventions in which the 
JETi System was used was 85%.    
 
The JETi Hong Kong PMS is a single-arm, multi-center study registering approximately 20 subjects from 
up to 5 sites in Hong Kong. Both prospective and retrospective consent (if all assessments needed for 
primary endpoints are complete) are permitted. In cases of prospective consent, subject participation will 
be up to 30 days. If consent occurs after the procedure, duration of participation may vary given timing 
of consent but will not exceed 30 days.   
 
This study will collect data on how the JETi System performs in the treatment of patients undergoing a 
percutaneous thrombectomy procedure for peripheral thrombosis. Subjects treated for arterial, venous, 
or arteriovenous thromboses, and subject with diagnoses such as acute limb ischemia (ALI), chronic 
limb ischemia/chronic limb threatening ischemia (CLI/CTLI), peripheral artery disease (PAD), deep vein 
thrombosis (DVT), hemodialysis access thrombosis, and others may be included. The details of data to 
 
 
1 Cournoyer-Rodrigue J, Bui TB, Gilbert P, et al. Percutaneous Thrombectomy with the JETi8 Peripheral Thrombectomy System for the 
Treatment of Deep Vein Thrombosis. J Vasc Interv Radiol. 2020;31(3):444-453.e2. doi:10.1016/j.jvir.2019.10.022 
2 Khalsa B., Luu K., Gilbert B., et al. Single-session treatment of lower extremity venous thrombosis using a novel thrombectomy device: results 
of a pilot study. J Vasc Interv Radiol, 2020; 31(3):S83. doi:10.1016/j.jvir.2019.12.217 
3 Razavi C, Khalsa B, Openshaw L, Razavi MK. Single-Session Treatment of Patients with Symptomatic Iliocaval and Iliofemoral Deep Vein 
Thrombosis: Technical Results of a Prospective Pilot Study. J Vasc Interv Radiol. 2022;33(2):183-188. doi:10.1016/j.jvir.2021.10.011 
4 Dandu C, Natour A, Onofrey K, et al. Single-Center Experience with JETi Aspiration Thrombectomy for Acute and Subacute Lower Limb 
Ischemia. Presented at the Vascular Annual Meeting (VAM), June 2022. 

 
 
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3.2 Measures Taken to Avoid and Minimize Bias 
An independent core laboratory will be used for imaging data analysis to minimize bias. All angiograms 
and venograms (pre-JETi, post-JETi, and final) and duplex ultrasound (DUS) images will be sent to the 
core laboratory for analysis. See Section 6.3 for details. In addition, a Clinical Events Committee (CEC 
will be included for adjudication of safety events. 
3.3 Suspension or Early Termination of the Clinical Investigation 
The Sponsor reserves the right to discontinue the study at any stage or reduce the follow-up period with 
suitable written notice to the investigator. Should the Sponsor discontinue the study, sites will follow 
subjects per routine hospital practice with device-, and procedure-related AEs reported to the Sponsor 
as per vigilance/commercial reporting requirements. The investigator shall return all study materials to 
the Sponsor and provide a written statement to the IRB/ EC (if applicable). All applicable study 
documents shall be subject to the same retention policy as detailed in Section 11.5 of the CIP.  
 
If the Sponsor suspends or prematurely terminates the study or suspends or prematurely terminates at 
an individual site in the interest of safety, the Sponsor will inform all other Principal Investigators. If 
suspension or premature termination occurs, the Principal Investigator or authorized designee will 
promptly inform the registered subjects at his/her site. A Principal Investigator, IRB/EC, or regulatory 
authority may also suspend or prematurely terminate participation in the study at the investigational 
site(s) for which they are responsible. The investigators will follow the requirements specified in the 
Clinical Trial Agreement.  
4 
ENDPOINTS  
All endpoints are descriptive. There will be no hypothesis testing, and there are no statistical power 
considerations.  
4.1 Primary Endpoints 
4.1.1 Arterial and Arteriovenous Subjects  
For subjects treated for arterial thrombosis (may include diagnoses such as acute limb ischemia, chronic 
limb ischemia/chronic limb threatening ischemia, peripheral artery disease, etc.) or arteriovenous (AV 
graft, AV fistula) thrombosis, all endpoints are descriptive.  
For subjects treated for arterial or arteriovenous thrombosis, the primary endpoints are:   
  
• 
Clot removal grade for each JETi-treated target vessel from pre-JETi angiogram to post-JETi 
angiogram (post-JETi thrombectomy and prior to any adjunctive therapies to treat underlying 
culprit lesions) per the grades in Table 1 (vessel basis). The independent imaging core 
laboratory will be responsible for assessing this endpoint.  
• 
Composite of JETi-related major adverse events (MAEs) up to 30 days post-JETi procedure, 
defined as the following JETi-related events adjudicated by a clinical events committee (CEC) 
(subject basis) death, major amputation of the treated limb, or major bleeding. Refer to 
Appendix II for definitions of major adverse events.  

 
 
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The effectiveness outcome for subjects treated for venous thrombosis that is not lower extremity DVT as 
defined in Appendix II (e.g., upper extremity DVT) will be assessed by clot removal grade, as defined in 
Section 4.1.1. 
4.2 Descriptive Endpoints 
4.2.1 All subjects  
• 
Procedure-related death as adjudicated by a CEC. 
• 
JETi-related AEs collected during JETi procedure, at discharge, and 30-day follow-up, as 
adjudicated by a CEC.  
• 
Procedure-related access site complications such as hematoma, pseudoaneurysm (false 
aneurysm), perforation, as adjudicated by a CEC.  
• 
Treatment Used: The number and percentage of patients having each of the following 
treatments:  
o JETi mechanical thrombectomy (MT) only  
o JETi in combination with one or more of the following treatments:  
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
• 
Short-Form Health Survey-12 (SF-12) – score at baseline and 30-day visit. 
4.2.2 Arterial and Arteriovenous Subjects 
• 
Clot removal grade for each JETi-treated target vessel from pre-JETi angiogram to final 
angiogram (post-JETi thrombectomy and after any/all adjunctive therapies and prior to removal 
of the vascular sheath) per the grades in Table 1. 
• 
Components of the MAE, up to 30 days post-JETi procedure, including device-related death, 
major amputation of treated limb, and major bleeding up to 30 days as adjudicated by a CEC. 
• 
Ankle Brachial Index (ABI) of treated limb(s) at baseline and 30 days. Note this is applicable to 
lower extremity arterial subjects only. 

 
 
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• 
Rutherford classification of treated limb(s) at baseline and 30 days. Note this is applicable to 
lower extremity arterial subjects only. 
• 
Re-thrombosis of JETi-treated vessel at 30-day follow-up, as assessed by investigator/physician 
reported. 
• 
Patency as determined by duplex ultrasound at baseline and 30-day. Note that this endpoint will 
only apply to subjects treated for arteriovenous thrombus. 
• 
Vessel patency: assessed by the independent imaging core laboratory using the Modified 
Thrombolysis in Myocardial Infarction (TIMI) classification called TIPI (Thrombo-aspiration in 
Peripheral Ischemia)5 (Table 3) for each JETi-treated vessel, assessed using angiogram 
• 
At post-JETi timepoint (post-JETi thrombectomy and prior to any adjunctive therapies to 
treat underlying culprit lesions) 
• 
At final timepoint (post-JETi thrombectomy and after any/all adjunctive therapies and prior 
to removal of the vascular sheath) 
If no adjunctive therapies or devices are used after JETi, post-JETi TIPI score is also final TIPI 
score. 
 
Table 3. Thrombo-aspiration in Peripheral Ischemia (TIPI) 
Description 
TIPI score 
No recanalization of the thrombotic occlusion  
0 
Incomplete or partial recanalization of the thrombotic occlusion with no distal flow  
1 
Incomplete or partial recanalization of the thrombotic occlusion with any distal flow  
2 
Complete recanalization of the thrombotic occlusion with normal distal flow  
3 
• 
Acute success, as per 
 (Table 3):  
o Device success: Near complete or complete recanalization of occluded vessel, defined as 
post-JETi 
 
o Technical success: Near complete or complete recanalization of occluded vessel, defined 
as final 
 where 
evaluation occurs after JETi system and any other 
adjunctive device or procedures.  
o Procedural success: Technical success with no JETi-related MAEs within 5 days of 
registration or by discharge, whichever occurs first 
4.2.3 Venous Subjects 
• 
Percent of treated vessels (in lower extremity DVT) with ≥75% thrombus reduction from pre-JETi 
venogram to post-JETi venogram (post-JETi thrombectomy and before any adjunctive therapies 
to treat underlying culprit lesions) via modified Marder score. The independent imaging core 
laboratory will be responsible for assessing this endpoint. Note this is applicable to lower 
 
 
5 de Donato G, Pasqui E, Sponza M, et al. Safety and Efficacy of Vacuum Assisted Thrombo-Aspiration in Patients with Acute 
Lower Limb Ischaemia: The INDIAN Trial. Eur J Vasc Endovasc Surg. 2021;61(5):820-828. doi:10.1016/j.ejvs.2021.01.004 
 

 
 
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extremity DVT subjects only. The effectiveness outcome for subjects treated for venous 
thrombosis that is not lower extremity DVT as defined in Appendix II (e.g., upper extremity DVT) 
will be assessed by clot removal grade, as defined in Section 4.1.1. 
• 
Components of the MAE up to 30 days post-JETi procedure, including the following JETi-related 
events adjudicated by a CEC: device-related death, symptomatic pulmonary embolism (PE), 
major bleeding, and re-thrombosis of JETi treated vessel(s). 
• 
The Villalta Post Thrombotic Syndrome (PTS) severity scale at baseline, and 30-day follow-up. 
Note this is applicable to lower extremity DVT subjects only. 
• 
Edema component score from the Villalta Post Thrombotic Syndrome (PTS) severity 
scale at baseline, and 30-day follow-up.  
• 
A 7-point Likert Scale for leg pain at baseline, discharge, and 30-day follow-up. Note this is 
applicable to lower extremity DVT subjects only. 
• 
Venous patency and compressibility as determined by duplex ultrasound at baseline, and 30-day 
follow-up. The independent imaging core laboratory will be responsible for assessing this 
endpoint.  
• 
Acute success, 
, assessed by core laboratory:  
o Device success: post-JETi thrombus removal grade II-III 
 
o Technical success: Final thrombus removal grade II-III, 
 where 
final 
evaluation occurs after JETi system and any other adjunctive device or 
procedures. 
o Procedural success: Technical success with no JETi-related MAEs within 5 days of registration or by 
discharge, whichever occurs first. 
If no adjunctive therapies or devices are used after JETi, post-JETi 
score is also final 
 
score. 
 
 
 
 
 
  
 
 
 
5 
SUBJECT SELECTION AND WITHDRAWAL  
5.1 Subject Population 
This study will register subjects of all genders from the patient population undergoing percutaneous 
treatment of thrombosis in the peripheral vascular system.  

 
 
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5.2 Subject Recruitment/Screening and Informed Consent 
5.2.1 Subject Recruitment and Screening 
A member of the site’s study team previously trained to the CIP should evaluate patients for general 
study eligibility criteria. A patient who does not satisfy all general eligibility criteria prior to informed 
consent is considered a recruitment failure and should not be enrolled in the study. 
 
Sites will ask patients meeting general inclusion criteria and no general exclusion criteria to sign an 
Informed Consent Form (ICF) following the established Informed Consent process (described in Section 
5.2.2) if they wish to participate in the study.   
 
Enrolled (consented) subjects who do not have a JETi Catheter introduced into the intended vasculature 
are considered a screen failure and should be withdrawn from the study. The Principal Investigator or 
the delegated study personnel will record the screen failure in the hospital records and on a 
recruitment/screening log as required. 
 
5.2.2 Informed Consent 
The Investigator or his/her authorized designee (if applicable) will conduct the Informed Consent 
process, as required by applicable regulations and the center’s IRB/EC. This process will include a 
verbal discussion with the patient on all aspects of the study that are relevant to the patient’s decision to 
participate, such as details of study procedures, anticipated benefits, and potential risks of study 
participation. Sites must inform patients about their right to withdraw from the study at any time and for 
any reason without sanction, penalty, or loss of benefits to which the patient is otherwise entitled. 
Withdrawal from the study will not jeopardize their future medical care or relationship with the 
investigator.  
 
During the discussion, the Principal Investigator or his/her authorized designee will avoid any improper 
influence on the patient and will respect patient’s legal rights. Financial incentives will not be given to 
patients. Patients may be compensated for time and travel directly related to the participation in the 
study. The site shall provide the patient with the Informed Consent form written in a language that is 
understandable to the patient and that has been approved by the center’s IRB/EC. The patient shall 
have adequate time to review, ask questions, and consider participation. The Principal Investigator or 
his/her authorized designee will make efforts to ensure that the patient understands the information 
provided. If the patient agrees to participate, they must sign and date the Informed Consent form, along 
with the person obtaining the consent prior to any study-specific procedures. The site will file the signed 
original in the patient’s hospital or research charts and provide a copy to the patient. 
 
Sites should report any failure to obtain informed consent from a patient to the Sponsor within 5 working 
days and to the reviewing center’s IRB/EC according to the IRB’s/ EC’s reporting requirements. 
 
If, during the study, new information becomes available that can significantly affect a subject's future 
health and medical care, the Principal Investigator or his/her authorized designee (if applicable) will 
provide this information to the subject. If relevant, sites will ask the subject to confirm their continuing 
informed consent in writing. 

 
 
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5.2.2.1 Special Circumstances for Informed Consent  
Sites may enroll individuals who are unable to make the decision to participate in a study on their own.  
Sites will obtain informed consent from the patient’s legally authorized representative and will inform the 
patient about the study within his/her ability to understand. During the informed consent discussion, the 
Principal Investigator or his/her authorized designee will avoid any improper influence and make sure 
there is no manipulation of the patient and patient’s legal rights are respected. Enrollment of these 
patients is important as data of comparable validity cannot be obtained from clinical research involving 
persons able to give informed consent or by other research methods. - 
 
The legally authorized representative will represent the individual during the Informed Consent process, 
which will be performed according to the requirements in Section 5.2.2. Sites will respect the explicit 
wish of the individual to decline participation or withdraw from the study at any time. In addition, no 
incentives or financial inducements will be provided to these patients or their legally authorized 
representatives for their participation in the study. 
 
This study excludes individuals under the age of 18. 
 
Sites may enroll individuals unable to read or write in this study. Sites will obtain informed consent 
through a supervised oral process. An independent witness will be present throughout the Informed 
Consent process. A member of the site’s study team previously trained to the CIP will read the written 
Informed Consent form and any other information aloud and explain to the prospective subject or his/her 
legally acceptable representative and will sign and personally date the Informed Consent form. The 
witness will also sign and personally date the Informed Consent form attesting that the information was 
accurately explained, and that informed consent was freely given. In addition, no incentives or financial 
inducements will be provided to these patients or their legally authorized representatives for their 
participation in the study. 
 
Sites may enroll women who are pregnant or breastfeeding in this study. Informed consent must be 
obtained using the IRB/EC approved informed consent in accordance with IRB/EC requirements.  The 
study is expected to produce a direct benefit to the woman or her embryo, fetus, or child, outweighing 
the risks and burdens involved.  When breastfeeding women are included, care shall be taken to avoid 
any adverse impact to the health of the child. In addition, no incentives or financial inducements will be 
provided to these patients or their legally authorized representatives for their participation in the study. 
All other aspects of the Informed Consent process will follow Section 5.2.2. 
 
Sites may enroll individuals admitted to the emergency units in this study in cases where emergent 
removal of life- or limb-threatening thrombi in the peripheral vasculature is required. When prior informed 
consent of the individual is not possible because of the patient’s medical condition, sites will request the 
informed consent of the subject’s legally acceptable representative, if present. When it is not possible to 
obtain prior informed consent from the subject, and the subject’s legally acceptable representative is not 
available, sites will perform the informed consent process in accordance with Section 5.2.2 as soon as 
possible. In addition, patients are able to enroll in the study post-procedure. 
For live cases at congresses, the subject needs to sign a specific Live Case ICF, approved by the 
IRB/EC. The investigator must notify the Sponsor prior to performing a live case. 
 

 
 
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5.3 
Eligibility Criteria  
5.3.1 General Eligibility Criteria 
Assessment for general eligibility criteria is based on medical records of the site and interview with a 
candidate patient. Patients must meet ALL general inclusion criteria to participate in the study. If ANY 
general exclusion criteria are met, the patient is excluded from the study and cannot be enrolled 
(recruitment failure). 
5.3.2 Inclusion Criteria 
5.3.2.1 General Inclusion Criteria 
1. Subject was treated or is expected to be treated for acute/subacute thrombosis, as 
determined by investigator, in the peripheral vasculature with the JETi Hydrodynamic 
Thrombectomy System. 
2. Subject or legally authorized representative must provide written informed consent 
3. Subject must be ≥ 18 years of age and of Asian race. 
5.3.3 Exclusion Criteria 
5.3.3.1 General Exclusion Criteria 
1. Subject has previously been registered in the JETi Hong Kong PMS in the last 12 months 
unless treated in the contralateral limb/different anatomy; patients treated in the contralateral 
limb/different anatomy within the last 12 months may re-enroll in the study. 
2. Subject is currently participating in another drug or device clinical investigation. 
3. Subject has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading 
infectious agent within the past 20 days. 
5.4 Subject Enrollment  
A patient is considered enrolled in the study from the moment the patient provides written informed 
consent. 
5.5 Subject Registration 
An enrolled subject is considered registered in the study only after a JETi Catheter is introduced into the 
intended vasculature of the subject during the procedure (Day 0). Patients may be consented after the 
procedure if all assessments needed for the primary endpoints are complete. A subject who is enrolled 
but not registered in this study will be considered a screen failure. The sample size of the study is based 
on the number of registered subjects.  
5.6 Subject Withdrawal and Discontinuation 
Each registered subject shall remain in the study until completion of the required follow-up period; 
however, a subject’s participation in any study is voluntary, and the subject has the right to withdraw at 

 
 
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vessels will be assessed using the provided clot removal grades (Table 1). All angiograms are 
requested to be transmitted to the core lab for analysis. Guidance from the imaging core laboratory will 
be provided for reference.   
 
DUS will be collected at baseline and 30-Day Follow-Up for subjects with arteriovenous thrombosis. 
Refer to the DUS core laboratory guidelines for detailed information. All DUS completed are requested 
to be transmitted to the core lab for analysis. 
 
An ABI examination is required at Baseline and 30 Days. Rutherford classification is required at 
Baseline and 30 Days. Note: baseline ABI (within 3 months prior to procedure) and Rutherford 
assessment (within 4 days prior to procedure) can be obtained via a non-study physician, including a 
referring physician; this will not be considered a protocol deviation. Note these are applicable to lower 
extremity arterial subjects only.  
 
The Short Form (SF)-12 is a self-reported outcome quality of life measure. Its completion is requested at 
Baseline and at 30 days. For post-procedurally consented subjects, a baseline SF-12 will not be 
collected as the validity of this assessment is not supported when collected retrospectively.   
 
Anticoagulants, and antiplatelet medications will be collected for this study at Baseline (medications that 
the patient was taking within the 30 days prior to admission and upon admission), Index Procedure, 
Discharge, and 30-day follow-up timepoint. Thrombolytics used during the index procedure will be 
collected.  
 
AEs experienced by the patient during the study will be reported, starting as soon as the JETi catheter is 
introduced into the intended vasculature during the procedure. Please refer to AE reporting section 7.3.1 
for additional details of event reporting.  
 
The schedule of events for arterial subjects is located in Section 6.1.6  
 
Data collection at each timepoint is discussed in the sections below. 
6.1.1 Baseline 
Subject preparation will occur in accordance with standard hospital policy for the care of interventional 
endovascular procedures. Note that no data will be recorded until consent is obtained. The following 
baseline data will be collected:  
• 
Enrollment 
• 
Demographics – including age, sex 
• 
Medical history – subject medical history including general medical history, surgical history, 
vascular history, renal history, and thrombotic condition 
• 
Medications: anticoagulant, antiplatelet, and thrombolytic medications (if applicable) taken 
within the 30 days prior to admission  
• 
Laboratory assessments (within 14 days prior to the JETi procedure) such as:  
o eGFR 

 
 
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o Serum Creatinine (SCr) 
o Blood urea nitrogen (BUN) 
o Potassium (K) 
o Hemoglobin (Hgb) 
o Platelets (Plt) 
o International normalized ratio (INR) 
o Prothrombin time (PT) 
o Activated partial thromboplastin time (aPTT) 
• 
Clinical assessment (within 14 days prior to the JETi procedure) – clinical assessment 
information including height, weight, blood pressure, heart rate, temperature, and respiratory rate 
• 
Physical exam (within 14 days prior to the index procedure 
• 
Quality of life (QOL) questionnaire: SF-12 (not applicable for post-procedure consented 
subjects) 
• 
ABI  
• 
Rutherford classification * 
* Note: ABI (done within 3 months prior to procedure) and Rutherford assessment (done within 4 
days prior to procedure) can be obtained via a non-study physician, including a referring 
physician; this will not be considered a protocol deviation. ABI and Rutherford are applicable to 
lower extremity arterial subjects only. 
• 
Duplex ultrasound examination will be collected at Baseline (up to 14 days prior to the index 
procedure) for arteriovenous subjects. Guidance from the imaging core laboratory will be 
provided for reference. All DUS completed are requested to be transmitted to the core lab 
for analysis. 
 
6.1.2 Index Procedure  
The thrombectomy procedure with the JETi System should be conducted in accordance with standard of 
care practice and approved labelling. All consented subjects who have  the JETi Catheter introduced 
into the intended vasculature  will be considered registered subjects and will be entered into the study.  
 
The following procedural data will be collected: 
• Procedure information: Start and end dates/times, amount of contrast used during the entire 
procedure, total fluoroscopy time, access sites, obstruction location, and the number of 
sessions within the procedure (If multiple sessions were needed, the location of the subject in 
between the sessions is requested).  
• Treatment information: The treatments performed during the index procedure will be captured in 
the order of performance with specific details for each treatment. The treatment options will 
include the following: 
o JETi mechanical thrombectomy (MT) only  
o JETi in combination with one or more of the following treatments:  

 
 
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• 
Imaging Assessments:  
o Pre-JETi arteriogram: The pre-JETi arteriogram will be used to assess the initial degree 
of clot burden after catheter insertion into the vascular system and prior to JETi 
thrombectomy.  
o Post-JETi arteriogram: The post-JETi thrombectomy arteriogram will be used to assess 
the degree of clot removal after JETi thrombectomy and prior to any adjunctive therapies 
used to treat underlying culprit lesions.  
o Final arteriogram: The final angiogram will be completed to assess the degree of clot 
removal after JETi thrombectomy and any/all adjunctive therapies and prior to removal 
of the vascular sheath.  
All treated vessels will be assessed using the provided grades in Table 1, per core lab 
assessment. 
All treated arterial vessels will be assessed using the provided TIPI grades in Table 3, per core 
lab assessment. 
• 
Acute success, as per 
 (Table 3), per core lab assessment:  
o Device success: Near complete or complete recanalization of occluded vessel, defined as 
post-JETi 
 
o Technical success: Near complete or complete recanalization of occluded vessel, defined 
as 
 where
 evaluation occurs after JETi system and any other 
adjunctive device or procedures (final).  
o Procedural success: Technical success with no JETi-related MAEs within 5 days of 
registration or by discharge, whichever occurs first.  
• Adverse Events and Device Deficiency assessment 
• Medications: Anticoagulant, antiplatelet, and thrombolytic medications administered during 
the procedure; anticoagulant and antiplatelet treatments within the peri-operative period 
should follow recommended societal guidelines. 
6.1.3 Discharge 
Discharge is defined as the subject leaving the treating hospital. The following discharge data will be 
collected: 

 
 
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• 
Adverse events and device deficiency 
• 
Medications: Anticoagulant, and antiplatelet medications 
6.1.4 30-day Follow-up (Office Visit) 
A 7-day window is required for the 30-day follow-up visit (30 days ± 7 days). The following data will be 
collected at the follow-up visit: 
• 
Adverse events and device deficiency 
• 
Medications: Anticoagulant, and antiplatelet medications 
• 
ABI*  
• 
Rutherford classification*  
* Note: ABI and Rutherford assessment can be obtained via a non-study physician, including a 
referring physician; this will not be considered a protocol deviation. ABI and Rutherford are only 
applicable to lower limb arterial thrombosis.  
• 
QOL questionnaire (SF-12) 
• 
Duplex ultrasound examination will be collected at 30 days for arteriovenous subjects. 
Guidance from the imaging core laboratory will be provided for reference. All DUS 
completed are requested to be transmitted to the core lab for analysis. 
6.1.5 Unscheduled Visit  
Unscheduled visits may occur as clinically warranted, and data will be collected if the unscheduled visit 
is related to the JETi procedure and/or investigational device (as determined by the physician). Data on 
any imaging, clinical assessment, medication (anticoagulant, antiplatelet, and thrombolytic medications), 
AEs, DDs and SAEs will be collected if applicable.  
6.1.6 Schedule of Events 
The schedule of assessments for Arterial Subjects is listed in Table 4. 
 

 
 
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related to the procedure, then a determination of relatedness to the JETi System is required. All events 
determined by the physician to be related to the JETi System will need to be assessed as to whether the 
event caused serious injury or death, and will be collected. 
 
The schedule of events for venous subjects is located in Section 6.2.6. 
 
Data collection at each timepoint is discussed in the sections below. 
 
6.2.1 Baseline 
Subject preparation will occur in accordance with standard hospital policy for the care of interventional 
endovascular procedures. Note that no data will be recorded until consent is obtained. 
The following data will be collected:  
• 
Enrollment 
• 
Demographics – including age, sex 
• 
Medical history – subject medical history including general medical history, surgical history, 
vascular history, renal history, and thrombotic condition 
• 
Medications: anticoagulant, antiplatelet, and thrombolytic medications (if applicable) taken 
within the 30 days prior to admission  
• 
Laboratory assessments (within 14 days prior to the JETi procedure) such as:  
o eGFR 
o Serum Creatinine (SCr) 
o Blood urea nitrogen (BUN) 
o Potassium (K) 
o Hemoglobin (Hgb) 
o Platelets (Plt) 
o International normalized ratio (INR) 
o Prothrombin time (PT) 
o Activated partial thromboplastin time (aPTT) 
• 
Clinical assessment – clinical assessment information including height, weight, blood pressure, 
heart rate, temperature, and respiratory rate 
• 
Physical exam  
• 
Villalta PTS assessment (at baseline or within 4 days prior to the index procedure)*; note this is 
applicable to lower extremity DVT subjects only. 
* can be obtained via a non-study physician, including a referring physician; this will not be 
considered a protocol deviation  
• 
DUS (within 14 days prior to the index procedure)* 
* can be obtained via a non-study physician, including a referring physician; this will not be 
considered a protocol deviation  
• 
Quality of life (QOL) questionnaire: SF-12 (not applicable for post-procedure consented 
subjects) 

 
 
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• 
Leg pain assessment by 7-point Likert Scale; note this is applicable to lower extremity DVT subjects 
only. 
6.2.2 Index Procedure  
The thrombectomy procedure with the JETi System should be conducted in accordance with standard of 
care practice and approved labelling. All consented subjects who have  the JETi Catheter introduced into 
the intended vasculature  will be considered registered subjects and will be entered into the study.  
 
The procedural data to be collected is described below: 
• Procedure information: Start and end dates/times, amount of contrast used during the entire 
procedure, access sites, obstruction location, and the number of sessions within the procedure (If 
multiple sessions were needed, the location of the subject in between the sessions is requested).  
• Treatment information: The treatments performed during the index procedure will be captured 
in the order of performance with specific details for each treatment. The treatment options will 
include the following: 
o JETi mechanical thrombectomy (MT) only  
o JETi in combination with one or more of the following treatments:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
• Imaging Assessments 
o Pre-JETi venogram: The pre-JETi venogram will be used to assess the initial degree 
of clot burden after catheter insertion into the vascular system and prior to JETi 
thrombectomy.  
o Post-JETi venogram: The post-JETi thrombectomy venogram will be used to assess 
clot removal after JETi thrombectomy and prior to any adjunctive therapies used to treat 
underlying culprit lesions.  
o Final venogram: The final venogram will be completed to assess the degree of clot 
removal after JETi thrombectomy and any/all adjunctive therapies and prior to 
removal of the vascular sheath.  
All treated lower extremity venous vessels will be assessed using Marder score, per core laboratory 
assessment. Any other venous treated vessels (i.e., upper extremity) will be assessed by clot removal 
grade (per Section 4.1.1). 
• 
 Acute success, 
 core laboratory assessed:  
o Device success: Thrombus removal grade II-III 
 
  

 
 
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6.3 
Imaging Core Laboratories 
An independent core laboratory will be used in this study to assess the arteriograms/venograms, and 
DUS imaging submitted by the sites.  
7 
ADVERSE EVENTS  
To comply with worldwide standards and guidelines on clinical investigation adverse event reporting, the 
Sponsor has adopted uniform and worldwide applicable standard definitions and reporting timelines to be 
used and adhered to by the investigators.  
7.1 Definition 
7.1.1 Adverse Event 
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not 
related to the medical device under investigation. 
 
As part of ISO14155 Section 3.2, the Adverse Event definition has the following notes: 
 
Note 1: This definition includes events related to the medical device under investigation or the 
comparator. 
Note 2: This definition includes events related to the procedures involved. 
Note 3: For users or other persons, this definition is restricted to events related to medical devices under 
investigation. 
7.1.2 Serious Adverse Event 
If the AE meets any of the criteria below, it is regarded as a serious adverse event (SAE).  
 
o Led to a death, 
o Led to a serious deterioration in health of the subject, that either resulted in  
o a life-threatening illness or injury, or 
o a permanent impairment of a body structure or a body function, or 
o in-patient hospitalization or prolongation of existing hospitalization, or 
o medical or surgical intervention to prevent life threatening illness or injury or permanent 
impairment to a body structure or a body function. 
o chronic disease  
o Led to fetal distress, fetal death or a congenital abnormality or birth defect. 
 
Note: A planned hospitalization for a pre-existing condition, or a procedure required by the CIP without a 
serious deterioration in health, is not considered to be an SAE. 

 
 
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7.1.3 Device Deficiency/Device Malfunction  
Device deficiency is defined as an inadequacy of a medical device related to its identity, quality, 
durability, reliability, safety or performance, such as malfunction, misuse or use error and inadequate 
labeling. This includes the failure of the device to meet its performance specifications or otherwise 
perform as intended. Note: performance specifications include all claims made in the labeling of the 
device. 
 
A device malfunction is the failure of a device to meet its performance specifications or otherwise 
perform as intended, when used in accordance with the instructions for use or CIP. 
7.2 Device Relationship 
Determination of whether there is a reasonable possibility that the JETi System caused or contributed to 
an AE is to be determined by the Investigator and recorded on the appropriate case report (CRF) form. 
Determination should be based on the assessment of temporal relationships, evidence of alternative 
etiology, medical/biologic plausibility and patient condition (pre-existing condition). 
7.3 Adverse Event and Device Deficiency/Device Malfunction Reporting 
7.3.1 Adverse Event Reporting 
Safety surveillance and reporting starts as soon as the JETi catheter is introduced into the intended 
vasculature during the procedure. Safety surveillance and reporting will continue until sites perform the 
last follow-up visit, the subject is deceased, the subject concludes participation in the clinical 
investigation, or the subject withdraws from the clinical investigation.  Sites will collect all adverse event 
data, including deaths and device deficiency data (if applicable), throughout the period defined above.  
and will report these events to the Sponsor on a CRF. Sites should update additional information 
regarding an adverse event on the appropriate CRF.   
 
Unchanged, chronic, non-worsening or pre-existing conditions are not AEs and should not be reported.  
 
The Sponsor will provide an offline form to allow the investigator to report SAEs in the event the entry 
cannot be made in the electronic data capture (EDC). This does not replace the EDC reporting system. 
Sites must still enter all information in the EDC system as soon as feasible. 
 
For the purposes of this study, the following adverse events will be reported for each subject through the 
30-day follow-up visit. 
• 
All device-and procedure-related AEs 
• 
All SAEs  
In addition, the following adverse events regardless of seriousness or relatedness will be collected: 
 
  
 
 
 
  
 
  

 
 
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SAE Reporting 
The investigator must report all SAEs to the Sponsor as soon as possible but no later than outlined 
below.  
 
Clinical Site 
Reporting timelines 
All Sites 
Sites must report SAEs to the Sponsor no later than 3 calendar days from the 
day the site personnel became aware of the event or as per the investigative 
site’s local requirements, if the requirement is more stringent than those outlined. 
 
Sites must record the date the site staff became aware that the event met the criteria of an SAE in the 
source document.  The Investigator will further report the SAE to the local IRB/EC according to the 
institution’s IRB/EC reporting requirements. 
7.3.2 Device Deficiency/Malfunction Reporting  
Sites should report all device deficiencies/malfunctions on the appropriate CRF form.  
 
The investigator must report all device deficiencies/malfunctions to the Sponsor as soon as possible but 
no later than outlined below.  
Clinical Sites 
Reporting timelines 
All Sites 
Sites must report device deficiencies/malfunctions to the Sponsor no later 
than 3 calendar days from the day the site personnel became aware of the 
event or as per the investigative site’s local requirements, if the requirement 
is more stringent than those outlined. 
 
Sites must report device deficiencies/malfunctions to the IRB/EC per the investigative site’s local 
requirements. 
 
Sites should return the device to the Sponsor, if possible.   
Sites will have access to an offline form to allow the investigator to report device 
deficiencies/malfunctions if sites cannot enter the information in the EDC system. This does not replace 
the EDC reporting system. Sites must still enter all information in the EDC system as soon as feasible.  
 
In case a device deficiency/malfunction occurred before the patient ID has been assigned, sites should 
report the device deficiency to the Sponsor via the offline reporting form.  This does not replace the EDC 
reporting system. Sites must still enter all information in the EDC system as soon as feasible. 
 

 
 
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7.3.3 Adverse Event Reporting to Country Regulatory Authorities by the Sponsor  
The Sponsor will report SAEs and reportable device deficiencies/malfunctions to the country regulatory 
authority, per local requirements.  
 
Note: Reportable device deficiencies/malfunctions include device deficiencies/malfunctions that might 
have led to an SAE if a) suitable action had not been taken or b) intervention had not been made or c) if 
circumstances had been less fortunate. These are handled under the SAE reporting system. 
8 
STATISTICAL CONSIDERATIONS 
8.1 Analysis Populations 
All registered subjects will be included in the analysis. 
8.2 Statistical Analyses  
The JETi Hong Kong PMS has not been powered to evaluate a hypothesis. Categorical variables 
will be summarized using frequency counts and percentages. Continuous variables will be 
summarized using means, standard deviation, median, min and max. Ninety-five percent 
confidence interval may be computed for exploratory purposes. 
  
8.2.1 Primary Endpoints Analyses 
The primary endpoints are:   
Arterial and Arteriovenous subjects  
For subjects treated for lower extremity arterial thrombosis, the primary endpoints are:  
• 
Clot removal grade for each JETi-treated target vessel from pre-JETi angiogram to post-JETi 
angiogram (post-JETi thrombectomy and prior to any adjunctive therapies to treat underlying 
culprit lesions) per the grades in Table 1 (vessel basis). The independent imaging core laboratory 
will be responsible for assessing this endpoint. 
• 
Composite of JETi-related major adverse events (MAEs), defined as the following JETi-related 
events: device-related death, major amputation of the treated limb (arterial subjects only), or 
major bleeding up to 30 days post registration and as adjudicated by a clinical events committee 
(CEC) (subject basis). Refer to Appendix II for definitions of major adverse events.  
 
Table 7.  Clot Removal Grade  
 Grade I 
< 50% reduction 
 Grade II 
50- <95% reduction 
 Grade III 
95 - 100% reduction 
 
Venous Subjects 
For this study, lower extremity deep vein thrombosis or deep venous thrombosis is defined as lower 
extremity venous thrombosis involving the femoral, common femoral, iliac, popliteal, or inferior vena cava 
(IVC) alone or in combination.  
For subjects treated for lower extremity DVT, the primary endpoints are:  

 
 
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8.7 
Pooling Strategy 
Analysis will be performed by pooling data 
 
 
8.8 
Procedures for Accounting for Missing Data 
Analysis will be based on available data with missing data excluded. Any unused or spurious data 
will be noted as appropriate in the final report. 

 
 
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9 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS 
The investigator/institution will permit direct access to source data/documents for performing study-
related monitoring, audits, IRB/EC review and regulatory inspections. 
 
Subjects providing informed consent agree to allow study monitors or regulatory authorities, including 
foreign countries, to review in confidence any records identifying the subjects in this study. This 
information may be shared with regulatory agencies; however, the Sponsor undertakes not to otherwise 
release the subject's personal and private information. 
10 QUALITY CONTROL AND QUALITY ASSURANCE 
10.1 Selection of Clinical Sites and Investigators 
The Sponsor will select investigators qualified by training and experience to participate in the study. Sites 
will be selected based upon review of a recent site assessment, if applicable, and the qualifications of the 
investigators who will participate in the study.  
10.2 CIP Amendments  
The Sponsor will provide approved CIP amendments to the Investigators prior to implementing the 
amendment. The Principal Investigator is responsible for notifying the IRB/EC or equivalent committee of 
the CIP amendment (administrative changes) or obtaining IRB’s/EC’s approval of the CIP amendment 
(changes in subject care or safety), according to the instructions provided by the Sponsor with the CIP 
amendment.   
 
Sites must document in writing acknowledgement/approval of the CIP amendment by the IRB/EC prior to 
implementation of the CIP amendment. Sites must also provide copies of this documentation to the 
Sponsor. 
10.3 Training 
10.3.1 Site Training 
All Investigators and study personnel are required to attend Sponsor training sessions, which may be 
conducted at an Investigator's meeting, a site initiation visit, or other appropriate training sessions. Over-
the-phone or self-training may take place as required. Training of Investigators and study personnel will 
include, but is not limited to, the CIP requirements, device usage, electronic case report form completion, 
and study personnel responsibilities. All Investigators and study personnel that are trained must sign a 
training log (or an equivalent) upon completion of the training.  
10.4 Monitoring  
Sponsor and/or designee will monitor the study over its duration according to the CIP-specific monitoring 
plan which will include the planned extent of source data verification.  
 

 
 
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Prior to initiating any procedure, the Sponsor monitor (or delegate) will ensure that the following criteria 
are met:  
 
• 
The investigator understands and accepts the obligation to conduct the study according to the 
CIP and applicable regulations and has signed the Investigator Agreement or the Clinical Trial 
Agreement.  
• 
The Investigator and his/her staff should have sufficient time and facilities to conduct the study 
and should have access to an adequate number of appropriate subjects to conduct the study.  
• 
Sites must have source documentation (including original medical records) to substantiate proper 
informed consent procedures, adherence to CIP procedures, adequate reporting and follow-up of 
adverse events, accuracy of data collected on case report forms, and device information.  
• 
The Investigator/site will permit access to such records and will maintain a monitoring visit sign-in 
log at the site. The Investigator will agree to dedicate an adequate amount of time to the 
monitoring process. The Investigator and/or research coordinator will be available for monitoring 
visits. It is expected that the Investigator will provide the monitor with a suitable working 
environment for review of study-related documents. 
10.5 Deviations from CIP 
The Investigator should not deviate from the CIP for any reason except in cases of medical emergencies 
when the deviation is necessary to protect the rights, safety, and well-being of the subject, or to eliminate 
an apparent immediate hazard to the subject. In that event, the Investigator will notify Sponsor 
immediately by phone or in writing.  
 
All deviations will be collected, with the following exception: 
• 
Baseline SF-12 in post-procedure consented subjects 
The following deviations will be considered major: 
• Late SAE, SADE, DD reporting 
• Lack of patient informed consent 
• Inclusion/exclusion criteria violations. 
 
The Sponsor will not grant any waivers for CIP deviations.  Sites must report all deviations to the 
Sponsor using the Deviation CRF. The Sponsor will monitor the occurrence of CIP for evaluation of 
investigator compliance to the CIP and regulatory requirements and handle according to written 
procedures. Investigators will inform their IRB/EC or equivalent committee of all CIP deviations in 
accordance with their specific IRB/EC or equivalent committee reporting policies and procedures.  
 
In the event of repeated non-compliance, as determined by the Sponsor, a Sponsor’s monitor or 
company representative will attempt to secure compliance by one or more of the following (and not 
limited to):  
• Visiting the investigator and/or delegate 
• Telephoning the investigator and/or delegate 

 
 
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• Corresponding with the investigator and/or delegate 
 
Repeated non-compliance with the signed agreement, the CIP, or any other conditions of the study may 
result in further escalation in accordance with the Sponsor’s written procedures, including securing 
compliance or, at its sole discretion, the Sponsor may terminate the investigator's participation in the 
study.  
10.6 Quality Assurance Audit 
A Sponsor representative or designee may request access to all study records, including source 
documentation, for inspection during a Quality Assurance audit.  
 
If an investigator is contacted by a Regulatory Agency in relation to this study, the Investigator will notify 
Sponsor immediately. The Investigator and Research Coordinator must be available to respond to 
reasonable requests and audit queries made during the audit process. The Investigator must provide the 
Sponsor with copies of all correspondence that may affect the review of the current study (e.g., Form 
Food and Drug Administration (FDA) 483, Inspectional Observations, Warning Letters, Inspection 
Reports, etc.). The Sponsor may provide any needed assistance in responding to regulatory audits. 
10.7 Clinical Events Committee (CEC) 
The Clinical Events Committee (CEC) is an independent adjudication body comprised of qualified 
physicians who are not participants in the clinical investigation. The CEC will review and adjudicate pre-
specified events reported by investigators or identified by Safety personnel for the clinical investigation 
as defined in the CEC charter and according to definitions provided in this CIP.   
11 DATA HANDLING AND RECORD KEEPING 
 
Sponsor and/or its affiliates will maintain documentation of the systems and procedures used in data 
collection for the duration of the study.  
 
CRF data collection will be performed through a secure web portal and only authorized personnel will 
access the EDC system using a unique username and password to enter, review or correct data. 
Passwords and electronic signatures will be strictly confidential.   
 
The data will be subjected to consistency and validation checks within the EDC system and 
supplemental review by the Sponsor.    
 
At the end of the study, completed CRF images with the date-and-time stamped electronic audit trail 
indicating the user, the data entered, and any reason for change (if applicable) will be provided to the 
investigational sites, if requested.  
 
For the duration of the study, the Investigator will maintain complete and accurate documentation 
including, but not limited to, medical records, study progress records, laboratory reports, CRFs, signed 
ICFs, correspondence with the IRB/EC, and study monitor/Sponsor, adverse event reports, and 
information regarding subject discontinuation or completion of the study. 

 
 
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11.1 Protection of Personally Identifiable Information 
The Sponsor respects and protects personally identifiable information collected or maintained for this 
study.  
 
The Sponsor implements technical and physical access controls to ensure that Personal Information is 
accessible only to and processed only on a ‘need to know’ basis, including periodic review of access 
rights, and revocation of access when an individual’s employment is terminated or the individual 
transitions to a role that does not require access to Personal Information, and appropriate restrictions on 
physical access to premises, facilities, equipment, and records containing Personal Information. 
 
The Sponsor requires the investigational sites to enter only pseudonymous Personal Information (key-
coded) necessary to conduct the study, such as the patient’s medical condition, treatment, dates of 
treatment, etc., into Sponsor’s data management systems. The Sponsor discloses as part of the study 
informed consent process that some Sponsor representatives still may see Personal Information at the 
participating sites for technical support of the participating physicians on the device implant or 
procedures, monitoring and quality control purposes. All parties will observe confidentiality of Personal 
Information always throughout the study. All reports and data publications will preserve the privacy of 
each subject and confidentiality of his/her information. 
 
The Sponsor data management systems and processes were designed, developed, and tested 
according to industry standards to appropriately safeguard Confidential Information (including any 
Personal Information) against unauthorized access and/or interference by third parties, intrusion, theft, 
destruction, loss or alteration. Study data are encrypted in transit and at rest.  
 
The Sponsor maintains a Privacy Incident procedure that complies in all respects with Applicable Law 
and industry best practices. 
11.2 Data Management Plan 
A Data Management Plan (DMP) will describe procedures used for data review, data cleaning, and 
issuing and resolving data discrepancies. If appropriate, the Sponsor may update the DMP throughout 
the duration of the study. The Sponsor will track and document control all revisions. 
11.3 Source Documentation  
Regulations and GCP require the Investigator to maintain information in the subject’s original medical 
records that corroborates data collected on the CRFs. To comply with these regulatory 
requirements/GCP, sites should include the following information in the subject record at a minimum and 
if applicable to the study: 
• 
Medical history/physical condition of the subject before involvement in the study sufficient to verify 
CIP entry criteria 
• 
Dated and signed notes on the day of entry into the study referencing the Sponsor, CIP number, 
subject ID number, and a statement that informed consent was obtained 
• 
Dated and signed notes from each subject visit (for specific results of procedures and exams) 

 
 
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• 
AEs reported and their resolution, including supporting documents, such as discharge 
summaries, catheterization laboratory reports, ECGs, and lab results including documentation of 
site awareness of SAEs and of investigator assessment of device relationship for SAEs. 
• 
CIP-required laboratory reports, reviewed and annotated for clinical significance of out of range 
results (if applicable).  
• 
Notes regarding CIP-required and prescription medications taken during the study (including start 
and stop dates) 
• 
Subject’s condition upon completion of or withdrawal from the study 
• 
Any other data required to substantiate data entered into the CRF 
• 
Patient reported outcome measures may be completed using CRF worksheets. This serves as 
source documentation. 
11.4 Case Report Form Completion  
Site research personnel trained on the CIP and CRF completion will perform the primary data collection 
clearly and accurately based on source-documented hospital and/or clinic chart reviews. The investigator 
will ensure accuracy, completeness, legibility, and timeliness of the data reported to the Sponsor on the 
CRFs and in all required reports. 
 
Sites will collect data on all subjects registered into the study. Only authorized site personnel will be 
permitted to enter the CRF data through the EDC system deployed by the Sponsor. The Sponsor will use 
an electronic audit trail to track any subsequent changes of the entered data. 
11.5 Record Retention 
The Sponsor and Investigator/Site will archive and retain all documents pertaining to the study as per the 
applicable regulatory record retention requirements. The Investigator must obtain permission from 
Sponsor in writing before destroying or transferring control of any study records. 
12 ETHICAL CONSIDERATION  
12.1 Institutional Review Board/Medical Ethics Committee Review and Approval 
The Principal Investigator at each investigational site will obtain IRB/EC approval for the CIP and 
ICF/other written information provided to the patient prior to consenting and enrolling patients in this 
study. The site must receive the approval letter prior to the start of this study and provide a copy to the 
Sponsor.  
 
Sites will submit any amendments to the CIP as well as associated ICF changes to the IRB/EC and 
written approval obtained prior to implementation, according to each institution’s IRB/EC requirements.  
 
No changes will be made to the CIP or ICF or other written information provided to the patient without 
appropriate approvals, including IRB/EC, the Sponsor, and the regulatory agencies (if applicable).  
 

 
 
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Until the study is completed, the Investigator will advise his/her IRB/EC of the progress of this study, per 
IRB/EC requirements. Written approval must be obtained from the IRB/EC yearly to continue the study, 
or according to each institution’s IRB/EC requirements.  
 
Sites will not perform any investigative procedures, other than those defined in this CIP, on the enrolled 
subjects without the written agreement of the IRB/EC and the Sponsor. 
13 CLINICAL INVESTIGATION CONCLUSION 
The study will be concluded when: 
• 
All sites are closed AND 
• 
The final report has been provided to investigators or the Sponsor has provided formal 
documentation of study closure. 
 
In addition, the Sponsor will submit the study report within one year of the end of the study to the 
investigational sites, competent authorities, and reviewing IRBs and ECs. 
14 PUBLICATION POLICY 
The data and results from the study are the sole property of the Sponsor. The Sponsor shall have the 
right to access and use all data and results generated during the study. The Investigators will not use this 
study-related data without the written consent of the Sponsor for any purpose other than for study 
completion or for generation of publication materials, as referenced in the Clinical Trial Agreement. 
Single-center results are not allowed to be published or presented before the multi-center results. The 
Sponsor must review and approve any proposals for publications or presentations by the investigators in 
a timely manner in compliance with the Sponsor’s publication policy set forth in the Clinical Trial 
Agreement. 
 
The Sponsor will be responsible for determining whether to register the study on www.clinicaltrials.gov or 
any other clinical trials, in accordance with the International Committee of Medical Journal Editors 
guidelines, or any other applicable guidelines. In the event the Sponsor determines that the study should 
be registered, the Sponsor shall be responsible for any such registration and results posting as required 
by the ClinicalTrials.gov website. Institution and/or Principal Investigator(s) shall not take any action to 
register the study. 
15 RISK ANALYSIS 
 
15.1 Anticipated Clinical Benefits 
JETi is similar in development and design to other mechanical thrombectomy devices that aspirate and 
remove thrombus in the peripheral vasculature. The JETi System functions by delivering a stream of 
high-pressure saline through a catheter to aspirate the thrombus and remove the material from the 
vessel. Use of the JETi System for mechanical thrombectomy may allow for thrombus removal without 
the use of thrombolytic drugs with an acceptable device-related serious adverse event rate. 

 
 
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APPENDIX I: ABBREVIATIONS AND ACRONYMS 
Acronym or 
Abbreviation 
Complete Phrase or Definition 
AE 
Adverse Event 
ABI 
Ankle Brachial Index  
BUN 
Blood Urea Nitrogen 
CDT 
Catheter-Directed Thrombolysis 
CFR 
Code of Federal Regulations 
CIP 
Clinical Investigation Plan 
CRF 
Case Report Form 
EC 
Ethics Committee 
EU 
European Union 
eGFR 
Estimated Glomerular Filtration Rate 
EDC 
Electronic Data Capture 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act Intersocietal Commission 
for the Accreditation of Vascular 
ICF 
Informed Consent Form 
IFU 
Information for Use 
INR 
International Normalized Ratio 
IRB 
Institutional Review Board 
IVC 
Inferior Vena Cava  
JETi 
JET Enhanced Thrombectomy intervention 
LMWH 
Low Molecular Weight Heparin 
PT 
Prothrombin Time 
PTS 
Post Thrombotic Syndrome 
aPTT 
Activated Partial Thromboplastin Time 
QOL 
Quality of Life 
SAE 
Serious Adverse Event 
SDU 
Saline Drive Unit 
SF-12 
Short Form-12 
 
 

 
 
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APPENDIX II: DEFINITIONS  
Amputation  
The removal of a body extremity by surgery.  For this study, the definition of amputation will only apply to 
amputations of the limb that was treated.   
Minor amputation: amputation below the ankle  
Major amputation: amputation above the ankle 
Ankle Brachial Index (ABI) 
The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the higher systolic blood 
pressure of the two arteries (Dorsalis pedis or Posterior tibial) at the ankle of the assessed leg by the higher 
of the two brachial systolic blood pressures.   
Calculation of the Ankle Brachial Index:  
ABI = Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure  
Death (per ARC 1) 
When possible, death will be classified according to underlying cause.  Death within 30 days of the study 
procedure will be classified as procedure related unless medical history or autopsy findings demonstrate 
otherwise.   
Cardiac death:  
Any death due to proximate cardiac cause (e.g., MI, low-output failure, fatal arrhythmia), unwitnessed 
death, or death of unknown cause. 
Vascular death: 
Death caused by noncoronary vascular causes, such as cerebrovascular disease, pulmonary 
embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular diseases. 
Non-cardiovascular death: 
Any death not covered by the above definitions, such as death caused by infection, malignancy, 
sepsis, pulmonary causes, accident, suicide, or trauma. 
Dissection  
National Heart, Lung, and Blood Institute (NHLBI) Dissection Classification System: 
A. Minor radiolucencies within the lumen during contrast injection with no persistence after dye 
clearance. 
B. Parallel tracts or double lumen separated by a radiolucent area during contrast injection with no 
persistence after dye clearance. 
C. Extraluminal cap with persistence of contrast after dye clearance from the lumen. 
D. Spiral luminal filling defects. 
E. New persistent filling defects. 
F. Non-A-E types that lead to impaired flow or total occlusion. 
Note:  Type E and F dissections may represent thrombus. 
Lower Extremity Deep Vein Thrombosis or Deep Venous Thrombosis (DVT) 
DVT occurs when a blood clot forms in a deep vein, usually in the lower leg, thigh, or pelvis, but it can also 
occur in the arm.  

 
 
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Episodes of DVT or PE can be symptomatic (the patient had symptoms and/or signs that prompted 
evaluation for DVT or PE) or asymptomatic (DVT or PE was detected on an imaging study in a patient 
without symptoms) 
 
Recurrent Deep Venous Thrombosis (DVT)  
Deep Vein Thrombosis that recurs in the treated limb. 
 

 
 
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APPENDIX III: SITE CONTACT INFORMATION 
Contact information for each participating clinical site is available under separate cover by contacting the 
Sponsor at: 
 
Contact Name 
Contact Address 
Contact Email 
Contact Phone  
 
 
 

 
 
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APPENDIX V: IFU AND LABELING 
Device IFU and labeling is available under separate cover.

 
 
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APPENDIX VI: CASE REPORT FORMS 
The Case Report Forms (CRF) will be provided under a separate cover. 
 
 

 
 
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APPENDIX VIII: MONITORING PLAN 
A copy of the Monitoring Plan can be obtained upon request from the Sponsor Clinical Project Manager 
for the study. 
 
 

 
 
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APPENDIX IX: ADDITIONAL DOCUMENTS 
 
The following documents will be provided separately: 
  
1. Quality of Life Survey (SF- 12) 
2. Villalta Score for PTS Assessment 
3. Core laboratory imaging guidelines  

 
 
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APPENDIX XI: CIP SUMMARY 
Clinical Investigation Name  
JETi Hong Kong Post Market Study  
Title 
JET Enhanced Thrombectomy intervention Hong Kong Post Market Study 
Objective 
To collect real-world data on the safety, performance, and clinical benefits of 
the JETi System for the treatment of thrombosis in the peripheral 
vasculature 
Device  
JETi™ Hydrodynamic Thrombectomy System 
Number of Subjects  
Approximately 20 subjects 
Clinical Investigation Design 
A single-arm, multi-center study 
Primary Endpoint(s) 
For subjects treated for arterial thrombosis:  
• 
Clot removal grade for each JETi-treated target vessel from pre-JETi 
angiogram/venogram to post-JETi angiogram/venogram (post-JETi 
thrombectomy and prior to any adjunctive therapies to treat underlying 
culprit lesions) per the grades in Table 1. The independent imaging core 
laboratory will be responsible for assessing this endpoint. 
• 
Composite of JETi-related major adverse events (MAEs) up to 30 days 
post-JETi procedure, defined as the following JETi-related events 
adjudicated by a CEC: death, major amputation of the treated limb 
(arterial subjects only), or major bleeding. Refer to Appendix II for 
definitions of major adverse events. 
For subjects treated for venous thrombosis: 
• 
Percent of treated vessel(s) with ≥ 75% venous thrombus reduction  
from pre-procedure venogram to final venogram (post-JETi AND after 
any/all adjunctive therapies to treat underlying culprit lesions) via modified 
Marder score.  
• 
Composite of JETi-related major adverse events (MAEs) up to 30 days 
post-JETi procedure, defined as the following JETi-related events 
adjudicated by a clinical events committee (CEC): death, symptomatic 
pulmonary embolism (PE), major bleeding, or re-thrombosis of JETi-
treated vessel(s). Refer to Appendix II for definitions of major adverse 
events. 
Subject Follow-up 
Office visits at 30 days after the start of JETi procedure (Day 0).  
Inclusion Criteria 
1. Subject was treated or is scheduled to be treated for 
acute/subacute thrombosis as determined by the investigator in 
the peripheral vasculature with any of the JETi System. 
2. Subject must provide written informed consent. 
3. Subject must be ≥ 18 years of age and of Asian race. 
Exclusion Criteria 
1. Subject has previously been registered in the JETi Hong Kong Study 
in the last 12 months unless treated in the contralateral limb/different 
anatomy; patients treated in the contralateral limb/different anatomy 
within the last 12 months may re-enroll in the study. 
2. Subject is currently participating in another drug or device clinical 
investigation. 

 
 
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3. Subject has active symptoms and/or a positive test result of COVID-19 
or other rapidly spreading infectious agent within the past 20 days.