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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04370691
Registration number
NCT04370691
Ethics application status
Date submitted
23/04/2020
Date registered
1/05/2020
Titles & IDs
Public title
JETi Peripheral Thrombectomy Registry
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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
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Universal Trial Number (UTN)
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Trial acronym
JETi
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Peripheral Artery Thrombosis
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Peripheral 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 Peripheral Thrombectomy System
JETi™ Hydrodynamic Thrombectomy System - Subjects who were treated with JETi™ Hydrodynamic Thrombectomy System will be included.
Treatment: Devices: JETi Peripheral Thrombectomy System
The JETi System is is a hydro-mechanical aspiration system, intended for the removal of intravascular thrombus. The system is comprised 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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For Arterial Subjects: Clot removal grade for each JETi-treated vessel
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Assessment method [1]
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Clot removal grade for each JETi-treated target vessel from pre-JETi angiogram to post-JETi angiogram (post-JETi thrombectomy and prior to any adjunctive therapies to treat underlying culprit lesions) per the grades. The independent imaging core laboratory will be responsible for assessing this endpoint.
The rate of clot removal grade for each JETi-treated target vessel will be measured as per the Grades below:
* Grade I: \< 50% reduction
* Grade II: 50- \<95% reduction
* Grade III: 95-100% reduction
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Timepoint [1]
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From pre-JETi angiogram/venogram to post-JETi angiogram/venogram (post-JETi thrombectomy and prior to any adjunctive therapies to treat underlying culprit lesions)
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Primary outcome [2]
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For Arterial Subjects: Composite of JETi-related major adverse events (MAEs)
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Assessment method [2]
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JETi-related events defined as device-related death, major amputation of the treated limb (arterial subjects only), or major bleeding up to 30 days post-index procedure and as adjudicated by a clinical events committee (CEC).
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Timepoint [2]
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Up to 30 days post-index procedure
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Primary outcome [3]
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For Venous Subjects: Percent of treated vessel(s) with = 75% venous thrombus reduction via modified Marder score
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Assessment method [3]
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Timepoint [3]
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From pre-JETi venogram to final venogram (post-JETi AND after any/all adjunctive therapies to treat underlying culprit lesions)
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Primary outcome [4]
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For Venous Subjects: Composite of JETi-related major adverse events (MAEs)
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Assessment method [4]
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JETi-related events defined as device-related death, symptomatic pulmonary embolism (PE), or major bleeding up to 30 days post-index procedure and as adjudicated by a clinical events committee (CEC).
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Timepoint [4]
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Up to 30 days post-index procedure
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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
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
280
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Accrual to date
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Final
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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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State/province [1]
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Arizona
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Arkansas
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California
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Colorado
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Delaware
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Indiana
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Iowa
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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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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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State/province [23]
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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, 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.
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Trial website
https://clinicaltrials.gov/study/NCT04370691
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Vinuta Rau, PhD
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Address
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Phone
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+1 408-845-0864
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04370691