N/A
N=129
JETi Lower Extremity Arterial Thrombosis
Arterial Thrombosis
Bottom Line
View on ClinicalTrials.gov: NCT04370691 ↗Enrolled (actual)
129
Serious AEs
21.7%
Results posted
Mar 2025
Primary outcome: Primary: Primary Effectiveness Endpoint - Clot Removal Grade From Pre-JETi to Post-JETi - Core Lab Assessed - Per Vessel Analysis — 36; 41; 52; 93 Vessels
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- JETi lower extremity arterial thrombosis (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Effectiveness Endpoint - Clot Removal Grade From Pre-JETi to Post-JETi - Core Lab Assessed - Per Vessel Analysis |
36; 41; 52; 93 | — |
| PRIMARY Primary Safety Endpoint - Composite Rate of JETi-related MAEs |
— | — |
Summary
The JETi Registry is a prospective, single-arm, multi-center study to collect real-world data on the safety, performance, and clinical benefits of the JETi™ Hydrodynamic Thrombectomy System (JETi System) for the treatment of acute/subacute thrombosis in the peripheral vasculature. This post-market study 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 (NCT04370691). 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.