Arterial ThrombosisJETiNCT04370691
JETi Lower Extremity Arterial Thrombosis
An observational study of Arterial Thrombosis, run by Abbott Medical Devices at 30 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Thrombosis
- What is being tested?
- JETi lower extremity arterial thrombosis
- Type of treatment
- Medical device
- How many people
- 129 participants
- Where
- 30 sitesin 4 countries
- Study dates
- 6 Mar 2020to 9 Oct 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects of all genders from the patient population undergoing percutaneous treatment of thrombosis in the peripheral vascular system will be enrolled in the study.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
30 sites in 4 countries.
30 sites in 4 countries
United States21 sites
Hendrick Medical Center
Abilene, Texas, 79601
University of Colorado
Aurora, Colorado, 80045
Ascension St. John Jane Phillips
Bartlesville, Oklahoma, 74006
Charleston Area Medical Center
Charleston, West Virginia, 25304
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44195
Midwest Cardiovascular Research Foundation
Davenport, Iowa, 52803
Henry Ford Detroit
Detroit, Michigan, 48202
Southoast Hospital
Fall River, Massachusetts, 02740
St. Mary Medical Center
Hobart, Indiana, 46342
St. Luke's Hospital
Kansas City, Missouri, 64111
Arkansas Heart
Little Rock, Arkansas, 72211
PIH Good Samaritan
Los Angeles, California, 90017
Cedars Sinai Medical Center
Los Angeles, California, 90095
University of Louisville
Louisville, Kentucky, 40202
Weill Cornell Medicine
New York, New York, 10021
Mount Sinai Hospital
New York, New York, 10029
Hightower Clinical
Oklahoma City, Oklahoma, 73102
Stanford University Hospital and Clinics
Palo Alto, California, 94305
University of Utah Hospital
Salt Lake City, Utah, 84132
Honor Health
Scottsdale, Arizona, 85258
ClinRé
Thornton, Colorado, 80023
Germany7 sites
University Hospital Aachen
Aachen, North Rhine-Westphalia, 52074
Klinikum Hochsauerland
Arnsberg, 59759
Evangelisches Krankenhaus Königin Elisabeth Herzberge
Berlin, 10365
Sankt Gertrauden Krankenhaus
Berlin, 10713
Medizinische Einrichtungen der Universität zu Köln
Cologne, 50937
Universitätsklinikum Giessen
Giessen, 35392
Marien Hospital Herne
Herne, North Rhine-Westphalia, 44625
About this study
Official title: JET Enhanced Thrombectomy Intervention Registry - JETi Registry
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.
- Conditions
- Arterial Thrombosis
- Being tested
- JETi lower extremity arterial thrombosis
- Keywords
- ABT-CIP-10433, Arterial Thrombosis, Lower Extremity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JETi lower extremity arterial thrombosisDevice
The JETi System is 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.
| Study group | Role | What they receive |
|---|---|---|
| JETi™ Hydrodynamic Thrombectomy System | Subjects who were treated with JETi™ Hydrodynamic Thrombectomy System were included. Receives: Device: JETi lower extremity arterial thrombosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint - Clot Removal Grade From Pre-JETi to Post-JETi - Core Lab Assessed - Per Vessel Analysis
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
Measured: Baseline
Primary Safety Endpoint - Composite Rate of JETi-related MAEs
JETi-related events defined as device-related death, major amputation of the treated limb, or major bleeding up to 30 days post-JETi procedure and as adjudicated by a clinical events committee (CEC).
Measured: Up to 30 days post-JETi procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start6 Mar 2020
- Primary completion16 Jan 2024
- Study completion9 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arterial ThrombosisStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 129 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370691
- Sponsor's protocol ID
- ABT-CIP-10433
- Acronym
- JETi
- Status last verified
- Jun 2025
- First submitted
- 23 Apr 2020
- Last updated
- 17 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JET Enhanced Thrombectomy Intervention Registry - JETi Registry
- ClinicalTrials.gov ID
- NCT04370691
- Acronym / sponsor ID
- JETi / ABT-CIP-10433
- Conditions
- Arterial Thrombosis
- Keywords
- ABT-CIP-10433, Arterial Thrombosis, Lower Extremity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 16 Jan 2024 (actual)
- Study completion
- 9 Oct 2024 (actual)
- First posted
- 1 May 2020 (actual)
- Results
- Posted 3 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JETi™ Hydrodynamic Thrombectomy System | – | Device: JETi lower extremity arterial thrombosisSubjects who were treated with JETi™ Hydrodynamic Thrombectomy System were included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects of all genders from the patient population undergoing percutaneous treatment of thrombosis in the peripheral vascular system will be enrolled in the study.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JETi lower extremity arterial thrombosisThe JETi System is 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. | Device | JETi™ Hydrodynamic Thrombectomy System |
Primary outcome
Primary Effectiveness Endpoint - Clot Removal Grade From Pre-JETi to Post-JETi - Core Lab Assessed - Per Vessel Analysis
Time frame: Baseline
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
Primary Safety Endpoint - Composite Rate of JETi-related MAEs
Time frame: Up to 30 days post-JETi procedure
JETi-related events defined as device-related death, major amputation of the treated limb, or major bleeding up to 30 days post-JETi procedure and as adjudicated by a clinical events committee (CEC).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Thrombosis, run by Abbott Medical Devices at 30 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Germany, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint - Clot Removal Grade From Pre-JETi to Post-JETi - Core Lab Assessed - Per Vessel Analysis (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.