N/A
N=116
JETi Lower Extremity Venous Thrombosis
Venous Thrombosis
Bottom Line
View on ClinicalTrials.gov: NCT07027878 ↗Enrolled (actual)
116
Serious AEs
45.7%
Results posted
Apr 2026
Primary outcome: Primary: The Primary Effective Endpoint: Percent of Treated Vessel(s) With ≥ 75% Venous Thrombus Reduction in Modified Marder Score (From Pre-JETi to Final) — 84.5 percentage of limbs
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- JETi lower extremity venous thrombosis (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Effective Endpoint: Percent of Treated Vessel(s) With ≥ 75% Venous Thrombus Reduction in Modified Marder Score (From Pre-JETi to Final) |
84.5 | — |
| PRIMARY The Primary Safety Endpoint: Composite of JETi-related Major Adverse Events (MAEs) up to 30 Days |
1.7 | — |
Summary
The JETi Registry is a prospective, 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 280 subjects at approximately 30 centers globally. Subjects participating in this registry will be followed through their 12-month follow up visit.
Eligibility Criteria
Inclusion Criteria
- Subject was treated or is expected to be treated for acute/subacute thrombosis, as determined by the 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.
Exclusion Criteria
- Subject has previously been registered in the JETi Registry 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 novel infectious agent within the past 20 days.
Data sourced from ClinicalTrials.gov (NCT07027878). 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.