Venous Thrombosis
Conditions
Keywords
ABT - CIP -10433, Venous Thrombosis, Thrombectomy intervention
Brief 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.
Interventions
DEVICEJETi lower extremity venous thrombosis
The JETi System is a hydro-mechanical aspiration system, intended for the removal of intravascular thrombus. The system comprises of the JETi Catheter (6F or 8F), JETi Pump Set, JETi Saline Drive Unit (SDU), JETi Accessory Cart, JETi Suction tubing and JETi Non-Sterile Canister Set. The JETi System is designed to continuously aspirate thrombotic material into the catheter, where a high-pressure stream of saline within the catheter tip macerates the thrombus as it is aspirated.
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Subject or legally authorized representative must provide written informed consent. 3. Subject must be ≥ 18 years of age.
Exclusion criteria
1. 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. 2. Subject is currently participating in another drug or device clinical investigation. 3. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Effective Endpoint: Percent of Treated Vessel(s) With ≥ 75% Venous Thrombus Reduction in Modified Marder Score (From Pre-JETi to Final) | 30 days | The 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. Marder Score Reduction is calculated using the formula below: \[(Pre-JETi Marder Score - final Marder Score) / Pre-JETi Marder Score\] x 100. Modified Marder Score is a calculation based on summation of gradient thrombus burden at the following venous segments: iliac, common femoral, femoral and popliteal. Modified Marder score is based on total score of all imaged and assessed venous segments (including iliac, common femoral, femoral and popliteal) at that specific timepoint. Each limb can only have one modified Marder score. |
| The Primary Safety Endpoint: Composite of JETi-related Major Adverse Events (MAEs) up to 30 Days | 30 days | The composite of JETi-related MAEs (death, symptomatic pulmonary embolism (PE), major bleeding, or re-thrombosis of JETi-treated vessel(s) up to 30 days post-JETi procedure for subjects treated for lower extremity DVT and as adjudicated by a CEC |
Countries
Australia, Canada, Germany, United States
Participant flow
Recruitment details
A total of 116 lower extremity deep vein thrombosis (LE DVT) subjects were registered from a real-world all-comers population across 17 sites in the United States and Europe between August 3, 2020 and July 11, 2024.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 56.6 years STANDARD_DEVIATION 18.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 69 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 35 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 37 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) White | 59 Participants |
| Region of Enrollment Germany | 35 participants |
| Region of Enrollment United States | 81 participants |
| Sex: Female, Male Female | 58 Participants |
| Sex: Female, Male Male | 58 Participants |
| Source of Thrombus Embolic | 36 Participants |
| Source of Thrombus In Situ | 53 Participants |
| Source of Thrombus Unknown | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 116 |
| other Total, other adverse events | 16 / 116 |
| serious Total, serious adverse events | 53 / 116 |
Outcome results
None listed