JETi Peripheral Thrombectomy Registry (JETi)
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ClinicalTrials.gov Identifier: NCT04370691 |
Recruitment Status :
Recruiting
First Posted : May 1, 2020
Last Update Posted : January 12, 2023
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Condition or disease | Intervention/treatment |
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Peripheral Artery Thrombosis Venous Thrombosis | Device: JETi Peripheral Thrombectomy System |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 250 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 12 Months |
Official Title: | JET Enhanced Thrombectomy Intervention Registry - JETi Registry |
Actual Study Start Date : | March 6, 2020 |
Estimated Primary Completion Date : | April 2023 |
Estimated Study Completion Date : | March 2024 |
Group/Cohort | Intervention/treatment |
---|---|
JETi Peripheral Thrombectomy System
Subjects who were treated with JETi Peripheral Thrombectomy System will be included.
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Device: JETi Peripheral Thrombectomy System
The JETi Peripheral Thrombectomy System is comprised of the JETi Peripheral Catheter, JETi Pump Set, and JETi Peripheral Saline Drive Unit (SDU). The JETi Peripheral Thrombectomy System is designed to simultaneously deliver a stream of high-pressure saline via a displacement pump to the distal tip of the JETi Peripheral Catheter, while aspirating thrombotic material macerated by the saline stream |
- Percentage reduction in patient clot removal grade for each JETi-treated target vessel [ Time Frame: From pre-JETi angiogram/venogram to post-JETi angiogram/venogram (post-JETi thrombectomy and prior to any adjunctive therapies to treat underlying culprit lesions) ]
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: 50-99% reduction
- Grade III: 100% reduction
- Rate of JETi-related adverse events [ Time Frame: Up to 30 days post-index procedure ]Rate of JETi-related AEs such as (Amputation of treated limb, Bleeding - requiring transfusion, Blood loss - requiring transfusion etc.) will be assessed up to 30 days post-index procedure. Relationship to JETi will be investigator determined.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Subject is expected to be treated for acute/subacute thrombosis in the peripheral vasculature with the JETi Peripheral Thrombectomy System.
- Subject or legally authorized representative must provide written informed consent
- Subject must be ≥ 18 years of age
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04370691
Contact: Vinuta Rau, PhD | +1 408-845-0864 | vinuta.rau@abbott.com | |
Contact: Stacy Scribner | +1 651-756-5602 | stacy.scribner@abbott.com |
United States, Arizona | |
Honor Health | Recruiting |
Scottsdale, Arizona, United States, 85258 | |
Principal Investigator: Venkatesh Ramaiah, MD | |
United States, Arkansas | |
Arkansas Heart | Recruiting |
Little Rock, Arkansas, United States, 72211 | |
Principal Investigator: Vasili Lendel | |
United States, California | |
PIH Good Samaritan | Recruiting |
Los Angeles, California, United States, 90017 | |
Principal Investigator: Guy Mayeda | |
Stanford University Hospital and Clinics | Recruiting |
Palo Alto, California, United States, 94305 | |
Contact: Andrea Otte anotte@stanford.edu | |
Principal Investigator: William Kuo | |
United States, Colorado | |
University of Colorado | Recruiting |
Aurora, Colorado, United States, 80045 | |
Contact: Mahmood Kabeil mahmood.kabeil@cuanschutz.edu | |
Principal Investigator: Donald Jacobs | |
United States, Delaware | |
St Francis Hospital | Withdrawn |
Wilmington, Delaware, United States, 19805 | |
United States, Indiana | |
St. Mary Medical Center | Active, not recruiting |
Hobart, Indiana, United States, 46342 | |
United States, Iowa | |
Midwest Cardiovascular Research Foundation | Active, not recruiting |
Davenport, Iowa, United States, 52803 | |
United States, Kansas | |
University of Kansas Medical Center Research Institute | Withdrawn |
Kansas City, Kansas, United States, 66160 | |
United States, Massachusetts | |
Soutchoast Hospital | Recruiting |
New Bedford, Massachusetts, United States, 02740 | |
Contact: Richard Pin, MD | |
Principal Investigator: Richard Pin, MD | |
United States, Michigan | |
Henry Ford Detroit | Recruiting |
Detroit, Michigan, United States, 48202 | |
Contact: Loay Kabbani, MD | |
Principal Investigator: Loay Kabani, MD | |
United States, New York | |
Weill Cornell Medicine | Recruiting |
New York, New York, United States, 10021 | |
Contact: Rosa Chu roc2025@med.cornell.edu | |
Principal Investigator: Brian DeRubertis | |
Germany | |
University Hospital Aachen | Recruiting |
Aachen, Nordrhein Westfalen, Germany, 52074 | |
Principal Investigator: Houman Jalaie | |
Marien Hospital Herne | Active, not recruiting |
Herne, Nordrhein Westfalen, Germany, 44625 | |
Klinikum Hochsauerland | Recruiting |
Arnsberg, Germany, 59759 | |
Contact: Susanne Hochstein s.hochstein@klinikum-hochsauerland.de | |
Principal Investigator: Michael Lichtenberg | |
Sankt Gertrauden Krankenhaus | Recruiting |
Berlin, Germany, 10713 | |
Contact: Heike Bütow heike.buetow@sankt-gertrauden.de | |
Principal Investigator: Ralf Langhoff |
Responsible Party: | Abbott Medical Devices |
ClinicalTrials.gov Identifier: | NCT04370691 |
Other Study ID Numbers: |
ABT-CIP-10433 |
First Posted: | May 1, 2020 Key Record Dates |
Last Update Posted: | January 12, 2023 |
Last Verified: | October 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
ABT-CIP-10433 JETi Peripheral Thrombectomy System |
Thrombosis Venous Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |