Peripheral Artery Thrombosis Clinical Trial
— JETiOfficial title:
JET Enhanced Thrombectomy Intervention Registry - JETi Registry
| NCT number | NCT04370691 |
| Other study ID # | ABT-CIP-10433 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 6, 2020 |
| Est. completion date | March 2025 |
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® Peripheral 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 in the US and Europe. Subjects participating in this registry will be followed through their 12-month follow up visit.
| Status | Recruiting |
| Enrollment | 280 |
| Est. completion date | March 2025 |
| Est. primary completion date | April 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Germany | University Hospital Aachen | Aachen | Nordrhein Westfalen |
| Germany | Klinikum Hochsauerland | Arnsberg | |
| Germany | Evangelisches Krankenhaus Königin Elisabeth Herzberge | Berlin | |
| Germany | Sankt Gertrauden Krankenhaus | Berlin | |
| Germany | Universitätsklinikum Giessen | Gießen | |
| Germany | Marien Hospital Herne | Herne | Nordrhein Westfalen |
| Germany | Medizinische Einrichtungen der Universität zu Köln | Köln | |
| United States | Hendrick Medical Center | Abilene | Texas |
| United States | University of Colorado | Aurora | Colorado |
| United States | Ascension St. John Jane Phillips | Bartlesville | Oklahoma |
| United States | Charleston Area Medical Center | Charleston | West Virginia |
| United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
| United States | Midwest Cardiovascular Research Foundation | Davenport | Iowa |
| United States | Henry Ford Detroit | Detroit | Michigan |
| United States | St. Mary Medical Center | Hobart | Indiana |
| United States | St. Luke's Hospital | Kansas City | Missouri |
| United States | University of Kansas Medical Center Research Institute | Kansas City | Kansas |
| United States | Arkansas Heart | Little Rock | Arkansas |
| United States | Cedars Sinai Medical Center | Los Angeles | California |
| United States | PIH Good Samaritan | Los Angeles | California |
| United States | University of Louisville | Louisville | Kentucky |
| United States | Soutchoast Hospital | New Bedford | Massachusetts |
| United States | Mount Sinai Hospital | New York | New York |
| United States | Weill Cornell Medicine | New York | New York |
| United States | Stanford University Hospital and Clinics | Palo Alto | California |
| United States | University of Utah Hospital | Salt Lake City | Utah |
| United States | Honor Health | Scottsdale | Arizona |
| United States | St Francis Hospital | Wilmington | Delaware |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott Medical Devices |
United States, Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | For Arterial Subjects: Clot removal grade for each JETi-treated vessel | 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 |
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 | For Arterial Subjects: Composite of JETi-related major adverse events (MAEs) | JETi-related events such 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). | Up to 30 days post-index procedure | |
| Primary | For Venous Subjects: Percent of treated vessel(s) with = 75% venous thrombus reduction via modified Marder score | From pre-JETi venogram to final venogram (post-JETi AND after any/all adjunctive therapies to treat underlying culprit lesions) | ||
| Primary | For Venous Subjects: Composite of JETi-related major adverse events (MAEs) | JETi-related events such 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). | Up to 30 days post-index procedure |