JETi Hong Kong Post Market Study (PMS)

JET Enhanced Thrombectomy Intervention Hong Kong Post Market Study

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Venous Thrombosis; Peripheral Arterial Thrombosis; Peripheral Arteriovenous Thrombosis
• Intervention / Treatment: Device: JETi Hydrodynamic Thrombectomy System

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.

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Prince of Wales Hospital
  • Hong Kong
    • Hong Kong, Hong Kong, Hong Kong
      • Princess Margaret Hospital
    • Hong Kong, Hong Kong, Hong Kong
      • Queen Elizabeth Hospital
    • Hong Kong, Hong Kong, Hong Kong
      • Queen Mary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Device: JETi 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During the procedure
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.	Up to 30 days post-index procedure
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.	During the procedure
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).	Up to 30 days post-index procedure

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2024
• Primary Completion (Actual): February 12, 2025
• Study Completion (Actual): February 15, 2025

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: March 29, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: ABT-CIP-10466; CRD_1058 (Other Identifier: Abbott)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes