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NCT06340763

JETi Hong Kong Post Market Study (PMS)

Completed Results posted Last updated 16 December 2025
What this trial tests

trial testing JETi Hydrodynamic Thrombectomy System in Peripheral Venous Thrombosis in 12 participants. Completed in 15 February 2025.

Timeline
7 August 2024
Primary endpoint
12 February 2025
15 February 2025

Quick facts

Lead sponsorAbbott Medical Devices
StatusCompleted
Study typeOBSERVATIONAL
Enrollment12
Start date7 August 2024
Primary completion12 February 2025
Estimated completion15 February 2025
Sites4 locations across Hong Kong

Drugs / interventions tested

Conditions studied

Sponsor

Abbott Medical Devices — full company profile →

Who can join

18 and older, any sex, with Peripheral Venous Thrombosis or Peripheral Arterial Thrombosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Primary Effectiveness Endpoint - For Arterial and Arteriovenous Subjects: Clot Removal Grade for Each JETi-treated Vessel Primary · 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.

GroupValue95% CI
JETi Hydrodynamic Thrombectomy System2
JETi Hydrodynamic Thrombectomy System2
JETi Hydrodynamic Thrombectomy System5
Primary Safety Endpoint - For Arterial and Arteriovenous Subjects: Composite of JETi-related Major Adverse Events (MAEs) Primary · 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.

GroupValue95% CI
JETi Hydrodynamic Thrombectomy System0
Primary Effectiveness Endpoint - For Venous Subjects: Percent of Treated Vessel(s) With ≥ 75% Venous Thrombus Reduction Via Modified Marder Score (Limb Basis). Primary · 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.

GroupValue95% CI
JETi Hydrodynamic Thrombectomy System1
Primary Safety Endpoint - For Venous Subjects: Composite of JETi-related Major Adverse Events (MAEs) Primary · 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).

GroupValue95% CI
JETi Hydrodynamic Thrombectomy System0

Adverse events — posted to ClinicalTrials.gov

Time frame: From enrollment until end of follow-up, up to 30 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

JETi Hydrodynamic Thrombectomy System
Serious: 1/12 (8%)
Deaths: 0/12

Serious adverse events (1 terms)

ReactionSystemJETi Hydrodynamic Thrombec…
EndocarditisInfections and infestations

Most-reported serious reactions: Endocarditis.

Data from ClinicalTrials.gov NCT06340763 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other Abbott Medical Devices trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06340763.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing