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O estudo clínico NCT07027878 (JETiRegistry) para Trombose Venosa está ativo, não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
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JETi Lower Extremity Venous Thrombosis (JETiRegistry) 121 Dados de vida real

Ativo, não recrutando
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07027878 (JETiRegistry) é um estudo observacional para Trombose Venosa. Seu status atual é: ativo, não recrutando. O estudo começou em 6 de março de 2020 e pretende incluir 121 participantes. Coordenado por Abbott e deve ser concluído em 1 de agosto de 2025. Essas informações foram atualizadas no ClinicalTrials.gov em 19 de junho de 2025.
Resumo
The JETi Registry is a prospective, single-arm, multicenter study to collect real-world data on the safety, performance, and clinical benefits of the JETi System for the treatment of acute and subacute thrombosis in the peripheral vasculature. This is a post-market study that will register approximately 280 subjects at approximately 30 centers globally. Subjects participating in this registry will be followed through...Mostrar mais
Título oficial

JET Enhanced Thrombectomy Intervention Registry - JETi Registry

Condições médicas
Trombose Venosa
Outros IDs do estudo
  • JETiRegistry
  • ABT-CIP-10433 Venous
Número NCT
NCT07027878
Data de início (real)
2020-03-06
Última atualização postada
2025-06-19
Data de conclusão (estimada)
2025-08
Inscrição (estimada)
121
Tipo de estudo
Observacional
Status
Ativo, não recrutando
Palavras-chave
ABT - CIP -10433
Venous Thrombosis
Thrombectomy intervention
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
JETi™ Hydrodynamic Thrombectomy System
Subjects who were treated with JETi™ Hydrodynamic Thrombectomy System were included.
JETi lower extremity venous thrombosis
The JETi System 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 withi...Mostrar mais
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
Composite of JETi-related major adverse events (MAEs)
Composite of JETi-related MAEs up to 30 days post-JETi procedure, defined as the following JETi-related events adjudicated by a clinical event committee (CEC): 1. death, 2. symptomatic pulmonary embolism (PE), 3. major bleeding 4. re-thrombosis of JETi-treated vessel(s).
Up to 30 days post-index procedure
Percent of treated vessel(s) with ≥ 75% venous thrombus reduction via modified Marder score. The independent imaging core laboratory will be responsible for assessing this endpoint.
Percent of treated vessel(s) with ≥ 75% venous thrombus reduction via modified Marder from pre-JETi venogram to final venogram (post-JETi AND after any/all adjunctive therapies to treat underlying culprit lesions)
Perioperative/Periprocedural
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
  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.

  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.
Abbott Medical Devices logoAbbott
Sem dados de contato.
30 Locais do estudo em 4 países

Arizona

HonorHealth, Scottsdale, Arizona, 85258, United States

Arkansas

Arkansas Heart Hospital, Little Rock, Arkansas, 72211, United States

California

PIH Good Samaritan, Los Angeles, California, 90017, United States
Cedars Sinai Medical Center, Los Angeles, California, 90095, United States
Stanford University Hospital and Clinics, Palo Alto, California, 94305, United States

Colorado

University of Colorado, Aurora, Colorado, 80045, United States
ClinRé, Thornton, Colorado, 80023, United States

Indiana

St. Mary Medical Center, Hobart, Indiana, 46342, United States

Iowa

Midwest Cardiovascular Research Foundation, Davenport, Iowa, 52803, United States

Kentucky

University of Louisville, Louisville, Kentucky, 40202, United States

Massachusetts

Southoast Hospital, Fall River, Massachusetts, 02740, United States

Michigan

Henry Ford Detroit, Detroit, Michigan, 48202, United States

Missouri

St. Luke's Hospital, Kansas City, Missouri, 64111, United States

New York

Weill Cornell Medicine, New York, New York, 10021, United States
Mount Sinai Hospital, New York, New York, 10029, United States

Ohio

University Hospitals Cleveland Medical Center, Cleveland, Ohio, 44195, United States

Oklahoma

Ascension St. John Jane Phillips, Bartlesville, Oklahoma, 74006, United States
Hightower Clinical, Oklahoma City, Oklahoma, 73102, United States

Texas

Hendrick Medical Center, Abilene, Texas, 79601, United States

Utah

University of Utah Hospital, Salt Lake City, Utah, 84132, United States

West Virginia

Charleston Area Medical Center, Charleston, West Virginia, 25304, United States
Royal Perth Hospital, Perth, 6000, Australia

Quebec

Hôpital Saint-François d'Assise, Québec, Quebec, G1L 3L5, Canada

North Rhine-Westphalia

University Hospital Aachen, Aachen, North Rhine-Westphalia, 52074, Germany
Marien Hospital Herne, Herne, North Rhine-Westphalia, 44625, Germany
Klinikum Hochsauerland, Arnsberg, 59759, Germany
Evangelisches Krankenhaus Königin Elisabeth Herzberge, Berlin, 10365, Germany
Sankt Gertrauden Krankenhaus, Berlin, 10713, Germany
Medizinische Einrichtungen der Universität zu Köln, Cologne, 50937, Germany
Universitätsklinikum Giessen, Giessen, 35392, Germany