N/A
Completed N=12
JETi Hong Kong Post Market Study (PMS)
Peripheral Venous Thrombosis · Peripheral Arterial Thrombosis · Peripheral Arteriovenous Thrombosis
Source: ClinicalTrials.gov NCT06340763 ↗
Enrolled (actual)
12
Serious AEs
8.3%
Results posted
Dec 2025
Primary outcomePrimary: Primary Effectiveness Endpoint - For Arterial and Arteriovenous Subjects: Clot Removal Grade for Each JETi-treated Vessel — 2; 2; 5 Vessels
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Effectiveness Endpoint - For Arterial and Arteriovenous Subjects: Clot Removal Grade for Each JETi-treated Vessel |
2; 2; 5 | — |
| PRIMARY Primary Safety Endpoint - For Arterial and Arteriovenous Subjects: Composite of JETi-related Major Adverse Events (MAEs) |
— | — |
| PRIMARY Primary Effectiveness Endpoint - For Venous Subjects: Percent of Treated Vessel(s) With ≥ 75% Venous Thrombus Reduction Via Modified Marder Score (Limb Basis). |
1 | — |
| PRIMARY Primary Safety Endpoint - For Venous Subjects: Composite of JETi-related Major Adverse Events (MAEs) |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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.
- Subject or legally authorized representative must provide written informed consent
- Subject must be ≥ 18 years of age and of Asian race.
Exclusion Criteria
- 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.
- Subject is currently participating in another drug or device clinical investigation.
- Subject has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading infectious agent within the past 20 days.
Data sourced from ClinicalTrials.gov (NCT06340763). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.