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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07027878
Registration number
NCT07027878
Ethics application status
Date submitted
5/06/2025
Date registered
19/06/2025
Date last updated
19/06/2025
Titles & IDs
Public title
JETi Lower Extremity Venous Thrombosis
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Scientific title
JET Enhanced Thrombectomy Intervention Registry - JETi Registry
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Secondary ID [1]
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ABT-CIP-10433 Venous
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Universal Trial Number (UTN)
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Trial acronym
JETiRegistry
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Venous Thrombosis
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Cardiovascular
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Other cardiovascular diseases
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Blood
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Clotting disorders
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - JETi lower extremity venous thrombosis
JETi™ Hydrodynamic Thrombectomy System - Subjects who were treated with JETi™ Hydrodynamic Thrombectomy System were included.
Treatment: Devices: JETi 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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Composite of JETi-related major adverse events (MAEs)
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Assessment method [1]
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Composite of JETi-related MAEs up to 30 days post-JETi procedure, defined as the following JETi-related events adjudicated by a clinical event committee (CEC): 1. death, 2. symptomatic pulmonary embolism (PE), 3. major bleeding 4. re-thrombosis of JETi-treated vessel(s).
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Timepoint [1]
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Up to 30 days post-index procedure
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Primary outcome [2]
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Percent of treated vessel(s) with = 75% venous thrombus reduction via modified Marder score. The independent imaging core laboratory will be responsible for assessing this endpoint.
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Assessment method [2]
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Percent of treated vessel(s) with = 75% venous thrombus reduction via modified Marder from pre-JETi venogram to final venogram (post-JETi AND after any/all adjunctive therapies to treat underlying culprit lesions)
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Timepoint [2]
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Perioperative/Periprocedural
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/03/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
121
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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6000 - Perth
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Recruitment outside Australia
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United States of America
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Arizona
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Arkansas
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California
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Colorado
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Indiana
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Iowa
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Kentucky
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Massachusetts
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Michigan
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Missouri
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New York
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Ohio
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Oklahoma
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Texas
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Utah
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West Virginia
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Canada
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Quebec
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Germany
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Nordrhein Westfalen
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Germany
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Arnsberg
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Germany
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Berlin
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Germany
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Gießen
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Germany
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Köln
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Abbott Medical Devices
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT07027878
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/78/NCT07027878/Prot_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07027878
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