Clinical trial NCT06340763: JETi Hong Kong Post Market Study (PMS)
Official title: JET Enhanced Thrombectomy Intervention Hong Kong Post Market Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Venous Thrombosis
Peripheral Arterial Thrombosis
Peripheral Arteriovenous Thrombosis
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2024-04-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects of all genders from the patient population undergoing percutaneous treatment of thrombosis in the peripheral vascular system will be enrolled in the study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: For Arterial and Arteriovenous Subjects: Clot removal grade for each JETi-treated vessel
timeFrame: During the procedure
measure: For Arterial and Arteriovenous Subjects: Composite of JETi-related major adverse events (MAEs)
timeFrame: Up to 30 days post-index procedure
measure: For Venous Subjects: Percent of treated vessel(s) with ≥ 75% venous thrombus reduction via modified Marder score (limb basis).
timeFrame: During the procedure
measure: For Venous Subjects: Composite of JETi-related major adverse events (MAEs)
timeFrame: Up to 30 days post-index procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Hong Kong
country: Hong Kong
facility: Princess Margaret Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Elizabeth Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
References: