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 VesselPrimary· 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.
Group
Value
95% CI
JETi Hydrodynamic Thrombectomy System
2
JETi Hydrodynamic Thrombectomy System
2
JETi Hydrodynamic Thrombectomy System
5
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.
Group
Value
95% CI
JETi Hydrodynamic Thrombectomy System
0
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.
Group
Value
95% CI
JETi Hydrodynamic Thrombectomy System
1
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).
Group
Value
95% CI
JETi Hydrodynamic Thrombectomy System
0
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.
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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Sponsor: as reported to ClinicalTrials.gov by Abbott Medical Devices
Last refreshed: 16 December 2025
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.