Peripheral Arterial Thrombosis, Peripheral Arteriovenous Thrombosis, Peripheral Venous Thrombosis
Conditions
Brief summary
The JETi Hong Kong PMS is a single-arm, multicenter study to collect real-world data on the safety, performance, and clinical benefits of the JETi System for the treatment of acute and subacute thrombosis in the peripheral vasculature. This is a post-market study that will register approximately 20 subjects at approximately 5 centers in Hong Kong. Subjects participating in this study will be followed for up to 30 days (in cases of prospective consent) after Day 0. Day 0 is defined as the day when the JETi catheter is introduced into the intended vasculature of the subject.
Detailed description
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. 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. Both prospective and retrospective consent (if all assessments needed for the primary endpoints are complete) are permitted. After index procedure, subjects will be evaluated at discharge and 30 days in cases of prospective consent. In cases of retrospective consent, duration of participation will vary. If consent occurs after the procedure and prior to 30 days, the subject will be asked to return for a 30-day visit. If consent occurs after 30 days, the subject will not need to return for a study visit. Relevant data will be collected from the medical record.
Interventions
DEVICEJETi Hydrodynamic Thrombectomy System
The JETi Hydrodynamic Thrombectomy System is a hydro-mechanical aspiration system intended for the removal of intravascular thrombus. The system is comprised of the JETi Catheter, JETi Pump Set, and JETi Saline Drive Unit (SDU), accessory cart, suction tubing, and non-sterile canister set. The JETi System is designed to simultaneously deliver a stream of high-pressure saline via a displacement pump to the distal tip of the JETi Catheter, while aspirating thrombotic material macerated by the saline stream.
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint - For Arterial and Arteriovenous Subjects: Clot Removal Grade for Each JETi-treated Vessel | During the procedure | 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 (vessel basis). The independent imaging core laboratory will be responsible for assessing this endpoint. The rate of clot removal grade for each JETi-treated target vessel will be measured as per the Grades below: Grade I: \< 50% reduction; Grade II: 50- \<95% reduction; Grade III: 95-100% reduction. |
| Primary Safety Endpoint - For Arterial and Arteriovenous Subjects: Composite of JETi-related Major Adverse Events (MAEs) | Up to 30 days post-index procedure | JETi-related major adverse events (MAEs), 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. |
| Primary Effectiveness Endpoint - For Venous Subjects: Percent of Treated Vessel(s) With ≥ 75% Venous Thrombus Reduction Via Modified Marder Score (Limb Basis). | During the procedure | Percent of treated vessel(s) with ≥ 75% venous thrombus reduction from pre-JETi venogram to final venogram (post-JETi AND after any/all adjunctive therapies to treat underlying culprit lesions) via modified Marder score (limb basis). If no adjunctive therapies or devices are used after JETi, post-JETi score is also final score. |
| Primary Safety Endpoint - For Venous Subjects: Composite of JETi-related Major Adverse Events (MAEs) | Up to 30 days post-index procedure | JETi-related major adverse events (MAEs), 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). |
Countries
Hong Kong
Participant flow
Recruitment details
A total of 12 subjects were registered in the JETi Hong Kong PMS across 3 sites in Hong Kong between August 7, 2024 and January 24, 2025.
Participants by arm
| Arm | Count |
|---|---|
| JETi Hydrodynamic Thrombectomy System Subject was treated or is expected to be treated for acute/subacute thrombosis in the peripheral vasculature with the JETi Hydrodynamic Thrombectomy System. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | JETi Hydrodynamic Thrombectomy System |
|---|---|
| Age, Continuous | 68.9 Year STANDARD_DEVIATION 13.8 |
| Diagnosis Acute Limb Ischemia | 6 Participants |
| Diagnosis Deep Vein Thrombosis | 2 Participants |
| Diagnosis Hemodialysis Access: AV Fistula Thrombosis | 2 Participants |
| Diagnosis Hemodialysis Access: AV Graft Thrombosis | 1 Participants |
| Diagnosis Peripheral Artery Disease with Claudication (Rutherford 1-3) | 1 Participants |
| Intended Vasculature Arteriovenous | 3 Participants |
| Intended Vasculature Artery | 7 Participants |
| Intended Vasculature Vein | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 1 / 12 |
Outcome results
Primary
Primary Effectiveness Endpoint - For Arterial and Arteriovenous Subjects: Clot Removal Grade for Each JETi-treated Vessel
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 (vessel basis). The independent imaging core laboratory will be responsible for assessing this endpoint. The rate of clot removal grade for each JETi-treated target vessel will be measured as per the Grades below: Grade I: \< 50% reduction; Grade II: 50- \<95% reduction; Grade III: 95-100% reduction.
Time frame: During the procedure
Population: The number of participants analyzed includes arterial and arteriovenous subjects who had available data.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| JETi Hydrodynamic Thrombectomy System | Primary Effectiveness Endpoint - For Arterial and Arteriovenous Subjects: Clot Removal Grade for Each JETi-treated Vessel | Grade I | 2 Vessels |
| JETi Hydrodynamic Thrombectomy System | Primary Effectiveness Endpoint - For Arterial and Arteriovenous Subjects: Clot Removal Grade for Each JETi-treated Vessel | Grade II | 2 Vessels |
| JETi Hydrodynamic Thrombectomy System | Primary Effectiveness Endpoint - For Arterial and Arteriovenous Subjects: Clot Removal Grade for Each JETi-treated Vessel | Grade III | 5 Vessels |
Primary
Primary Effectiveness Endpoint - For Venous Subjects: Percent of Treated Vessel(s) With ≥ 75% Venous Thrombus Reduction Via Modified Marder Score (Limb Basis).
Percent of treated vessel(s) with ≥ 75% venous thrombus reduction from pre-JETi venogram to final venogram (post-JETi AND after any/all adjunctive therapies to treat underlying culprit lesions) via modified Marder score (limb basis). If no adjunctive therapies or devices are used after JETi, post-JETi score is also final score.
Time frame: During the procedure
Population: The number of participants analyzed includes venous subjects who had available data.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| JETi Hydrodynamic Thrombectomy System | Primary Effectiveness Endpoint - For Venous Subjects: Percent of Treated Vessel(s) With ≥ 75% Venous Thrombus Reduction Via Modified Marder Score (Limb Basis). | 1 Vessels |
Primary
Primary Safety Endpoint - For Arterial and Arteriovenous Subjects: Composite of JETi-related Major Adverse Events (MAEs)
JETi-related major adverse events (MAEs), 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.
Time frame: Up to 30 days post-index procedure
Population: The number of participants analyzed includes arterial and arteriovenous subjects who had available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JETi Hydrodynamic Thrombectomy System | Primary Safety Endpoint - For Arterial and Arteriovenous Subjects: Composite of JETi-related Major Adverse Events (MAEs) | 0 Participants |
Primary
Primary Safety Endpoint - For Venous Subjects: Composite of JETi-related Major Adverse Events (MAEs)
JETi-related major adverse events (MAEs), 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).
Time frame: Up to 30 days post-index procedure
Population: The number of participants analyzed includes venous subjects who had available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JETi Hydrodynamic Thrombectomy System | Primary Safety Endpoint - For Venous Subjects: Composite of JETi-related Major Adverse Events (MAEs) | 0 Participants |