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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
Scientific title
JET Enhanced Thrombectomy Intervention Registry - JETi Registry
Secondary ID [1] 0 0
ABT-CIP-10433
Universal Trial Number (UTN)
Trial acronym
JETi
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Artery Thrombosis 0 0
Peripheral Venous Thrombosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
For Arterial Subjects: Clot removal grade for each JETi-treated vessel
Timepoint [1] 0 0
From pre-JETi angiogram/venogram to post-JETi angiogram/venogram (post-JETi thrombectomy and prior to any adjunctive therapies to treat underlying culprit lesions)
Primary outcome [2] 0 0
For Arterial Subjects: Composite of JETi-related major adverse events (MAEs)
Timepoint [2] 0 0
Up to 30 days post-index procedure
Primary outcome [3] 0 0
For Venous Subjects: Percent of treated vessel(s) with = 75% venous thrombus reduction via modified Marder score
Timepoint [3] 0 0
From pre-JETi venogram to final venogram (post-JETi AND after any/all adjunctive therapies to treat underlying culprit lesions)
Primary outcome [4] 0 0
For Venous Subjects: Composite of JETi-related major adverse events (MAEs)
Timepoint [4] 0 0
Up to 30 days post-index procedure

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/03/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
Accrual to date
Final
260
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Delaware
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Utah
Country [18] 0 0
United States of America
State/province [18] 0 0
West Virginia
Country [19] 0 0
Germany
State/province [19] 0 0
Nordrhein Westfalen
Country [20] 0 0
Germany
State/province [20] 0 0
Arnsberg
Country [21] 0 0
Germany
State/province [21] 0 0
Berlin
Country [22] 0 0
Germany
State/province [22] 0 0
Gießen
Country [23] 0 0
Germany
State/province [23] 0 0
Köln

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Vinuta Rau, PhD
Address 0 0
Country 0 0
Phone 0 0
+1 408-845-0864
Fax 0 0
Email 0 0
vinuta.rau@abbott.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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