Clinical trial NCT04370691: JETi Lower Extremity Arterial Thrombosis
Official title: JET Enhanced Thrombectomy Intervention Registry - JETi Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Thrombosis
Keywords: ABT-CIP-10433
Arterial Thrombosis
Lower Extremity
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2020-05-01
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: 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

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.

Primary outcomes:
measure: Primary Effectiveness Endpoint - Clot Removal Grade From Pre-JETi to Post-JETi - Core Lab Assessed - Per Vessel Analysis
timeFrame: Baseline
measure: Primary Safety Endpoint - Composite Rate of JETi-related MAEs
timeFrame: Up to 30 days post-JETi procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Honor Health
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Heart
state: Arkansas
city: Los Angeles
country: United States
facility: PIH Good Samaritan
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford University Hospital and Clinics
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Thornton
country: United States
facility: ClinRé
state: Colorado
city: Hobart
country: United States
facility: St. Mary Medical Center
state: Indiana
city: Davenport
country: United States
facility: Midwest Cardiovascular Research Foundation
state: Iowa
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Fall River
country: United States
facility: Southoast Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Detroit
state: Michigan
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Bartlesville
country: United States
facility: Ascension St. John Jane Phillips
state: Oklahoma
city: Oklahoma City
country: United States
facility: Hightower Clinical
state: Oklahoma
city: Abilene
country: United States
facility: Hendrick Medical Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
city: Perth
country: Australia
facility: Royal Perth Hospital
city: Québec
country: Canada
facility: Hôpital Saint-François d'Assise
state: Quebec
city: Aachen
country: Germany
facility: University Hospital Aachen
state: Nordrhein Westfalen
city: Herne
country: Germany
facility: Marien Hospital Herne
state: Nordrhein Westfalen
city: Arnsberg
country: Germany
facility: Klinikum Hochsauerland
city: Berlin
country: Germany
facility: Evangelisches Krankenhaus Königin Elisabeth Herzberge
city: Berlin
country: Germany
facility: Sankt Gertrauden Krankenhaus
city: Gießen
country: Germany
facility: Universitätsklinikum Giessen
city: Köln
country: Germany
facility: Medizinische Einrichtungen der Universität zu Köln
Study officials:
References: