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[Испытание устройства, которое не одобрено или не одобрено FDA США] (ARCH)

25 августа 2026 г. обновлено: C. R. Bard
The objective of the study is to assess the safety and effectiveness of the BD Liverty™ TIPS Stent Graft for the treatment of the complications of portal hypertension from cirrhosis. This includes recurrent or refractory ascites, hepatic hydrothorax, and/or variceal bleeding (esophageal and/or gastric).

Обзор исследования

Статус

Активный, не рекрутирующий

Условия

Вмешательство/лечение

Подробное описание

This is a prospective, multi-center, single-arm study designed to assess the safety and effectiveness of the BD Liverty™ TIPS Stent Graft for the treatment of the complications of portal hypertension. Safety and effectiveness measures for subjects receiving the BD Liverty™ TIPS Stent Graft will be compared to a Performance Goal (PG) derived from published literature.

Тип исследования

Интервенционный

Регистрация (Действительный)

177

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Германия
      • Berlin, Германия, 13353
        • Charité-Universitätsmedizin Berlin
      • Bonn, Германия, 53127
        • Universitatsklinikum Bonn
      • Dresden, Германия, 01307
        • Universitätsklinikum Carl Gustav Carus Dresden
      • Frankfurt, Германия, 60590
        • University Hospital Frankfurt
      • Hanover, Германия, 30625
        • Medizinische Hochschule Hannover
      • Münster, Германия, 48149
        • Westfälische Wilhelms-Universität
  • Соединенные Штаты
    • California
      • Palo Alto, California, Соединенные Штаты, 94305
        • Stanford University
    • District of Columbia
      • Washington D.C., District of Columbia, Соединенные Штаты, 20007
        • Georgetown University
    • Indiana
      • Indianapolis, Indiana, Соединенные Штаты, 46202
        • Trustees of Indiana University ("IU")/ Indiana University Health, Inc.
    • Kansas
      • Kansas City, Kansas, Соединенные Штаты, 66160
        • University of Kansas Medical Center Research Institute, Inc.
    • Massachusetts
      • Boston, Massachusetts, Соединенные Штаты, 02215
        • Beth Israel Deaconess Medical Center, Inc.
      • Boston, Massachusetts, Соединенные Штаты, 02114
        • The General Hospital Corporation d/b/a Massachusetts General Hospital
    • Missouri
      • St Louis, Missouri, Соединенные Штаты, 63110
        • Washington University - Mallinckrodt Institute of Radiology
    • New Jersey
      • Newark, New Jersey, Соединенные Штаты, 07103
        • Rutgers, The State University of New Jersey
    • New York
      • New York, New York, Соединенные Штаты, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, Соединенные Штаты, 10032
        • The Trustees of Columbia University in the City of New York
    • North Carolina
      • Charlotte, North Carolina, Соединенные Штаты, 28203
        • Charlotte Radiology
    • Ohio
      • Cleveland, Ohio, Соединенные Штаты, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Philadelphia, Pennsylvania, Соединенные Штаты, 19125
        • University of Pennsylvania
    • Texas
      • San Antonio, Texas, Соединенные Штаты, 78229
        • The University of Texas Health Science Center at San Antonio
    • Utah
      • Salt Lake City, Utah, Соединенные Штаты, 84112
        • University of Utah
    • Virginia
      • Charlottesville, Virginia, Соединенные Штаты, 22903
        • University of Virginia
    • Wisconsin
      • Milwaukee, Wisconsin, Соединенные Штаты, 53226
        • Medical College of Wisconsin / Froedtert Hospital
  • Франция
      • Chambray-lès-Tours, Франция, 37170
        • Centre Hospitalier Régional Universitaire de Tours
      • Dijon, Франция, 21079
        • CHU Dijon Bourgogne
      • Lyon, Франция, 69002
        • Hospices Civils de Lyon

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. The subject must voluntarily sign and date the approved Informed Consent Form (ICF) prior to the conduct of any study-specific procedures including any procedure required to determine subject eligibility (apart from those conducted as part of the subject's routine clinical management).
  2. The subject must be ≥18 years of age with a life expectancy of ≥12 months to allow for adequate completion of study procedures and collection of data.
  3. The subject must be willing and able to comply with protocol requirements, including all study visits and procedures.

  4. The subject must have a diagnosis of portal hypertension from cirrhosis with at least one of the following indications for de novo TIPS creation including:

    1. Recurrent, or Refractory Ascites (defined as ascites that cannot be mobilized or recurs after large volume paracentesis despite dietary sodium restriction and diuretic therapy)
    2. Hepatic Hydrothorax
    3. Esophageal Variceal Bleeding that is Endoscopically, Medically, or Balloon Tamponade-Controlled Esophageal Variceal Bleeding, or Recurrent Esophageal Variceal Bleeding
    4. Gastric Variceal Bleeding that is Endoscopically, Medically, or Balloon Tamponade-Controlled Gastric Variceal Bleeding, or Recurrent Gastric Variceal Bleeding
  5. The subject must have adequate functional hepatic reserve with a Model for End-Stage Liver Disease (MELD) Score of ≤18 or Child-Pugh Score of ≤12.
  6. The subject must have a platelet count of ≥50,000/microliter (with correction, if needed), as determined by the most recent pre-treatment laboratory tests performed within 7 days prior to treatment (Index Procedure).

Note: If multiple lab tests are performed within 7 days prior to the date of Index Procedure, the most recent results must demonstrate eligibility.

Exclusion Criteria:

Subjects are excluded from the study if any of the following criteria apply:

  1. The subject is pregnant. Subjects of child-bearing potential must have a negative pregnancy test (urine or serum).
  2. The subject has undergone prior transcatheter procedures for the treatment of complications from portal hypertension (e.g., TIPS, surgical shunt creation, peritoneovenous shunt, retrograde transvenous obliteration (-RTO)). Note: Subjects with variceal bleeding that have undergone -RTO at least 8 weeks prior to the planned Index Procedure may be enrolled.
  3. The subject has undergone prior stent or stent graft placement in the hepatic vein, portal vein and/or inferior vena cava (IVC).
  4. The subject is hemodynamically unstable with uncontrolled bleeding.
  5. The subject has hepatic and/or portal vein thrombosis (PVT). Note: Subjects with partial non-flow-limiting, non-malignant PVT may be enrolled.
  6. The subject has undergone prior liver transplant or is a current transplant candidate that is likely to undergo liver transplant within 6 months of enrollment.
  7. The subject has extrahepatic or hepatic malignancy or a history of previous hepatic malignancy, unless treated curatively ≥5 years prior to enrollment.
  8. The subject has overt (West Haven Criteria Grade ≥2), controlled or uncontrolled hepatic encephalopathy.

  9. The subject has any of the following medical conditions contraindicated to placement of TIPS:

    1. Congestive Heart Failure or Pulmonary Edema
    2. Severe Tricuspid Regurgitation
    3. Elevated Right or Left Heart Pressures
    4. Polycystic Liver Disease
    5. Moderate or Severe Pulmonary Hypertension or Severe Hepatopulmonary Syndrome
    6. Uncontrolled Systemic Infection or Sepsis
    7. Unrelieved Biliary Obstruction
    8. Acute Kidney Injury, Renal Failure, or Dialysis
    9. Uncontrolled Blood Coagulation/Bleeding Disorder
  10. The subject has a known allergy, intolerance, or condition (e.g., allergy to contrast media/narcotics/sedatives, bleeding diathesis, or severe peripheral arterial disease) that cannot be adequately pre-treated and would preclude angiography or selective catheterization.
  11. The subject has a known allergy or hypersensitivity to any of the device materials including nickel-titanium (nitinol) or tantalum.
  12. The subject is taking a medication or has another medical condition, which, in the opinion of the Investigator, would preclude safe treatment with the BD Liverty™ TIPS Stent Graft, may cause the subject to be non-compliant with the protocol, or may confound the data interpretation.
  13. The subject is currently participating in an investigational drug or another device study that has not completed the study treatment or that clinically interferes with the study endpoints. Note: Studies requiring extended follow-up visits for products that were investigational, but have since become commercially available, are not considered investigational studies.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Н/Д
  • Интервенционная модель: Одногрупповое задание
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Subjects
Subjects that are treated with the BD Liverty™ TIPS Stent Graft
Устройство: BD Liverty™ TIPS Stent Graft
Treatment of portal hypertension complications with placement of the BD Liverty™ TIPS Stent Graft after creation of a Transjugular Intrahepatic Portosystemic Shunt.
Другие имена:
  • ПОДСКАЗКИ

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Freedom from Major Complications through 30 days post-Index Procedure
Временное ограничение: 30 days

The primary safety endpoint is Freedom from Major Complications through 30 days post-Index Procedure.

Major complications are defined as:

The following Adverse Events (if determined to be related to the device and/or procedure and to meet the definition of a Serious Adverse Event (SAE)):

  • Accelerated Liver Failure
  • Biliary Peritonitis
  • Caval Occlusion
  • Death
  • Hemobilia
  • Hemoperitoneum
  • Hepatic Artery Injury
  • Hepatic Infarction
  • Radiation Skin Burn
  • Renal Failure
  • Severe Hepatic Encephalopathy
  • Vascular Perforation (resulting from stent graft malposition due to excessive extension of the stent graft into the inferior vena cava or the right atrium)

The following Device Deficiencies, if having the potential to or if confirmed to have led to a Serious Adverse Event (SAE):

o Stent Migration (within the portal or systemic venous circulations resulting from stent graft malposition)
30 days
Freedom from Shunt Dysfunction through 6 months post-Treatment Completion
Временное ограничение: 6 months
The primary effectiveness endpoint is Freedom from Shunt Dysfunction through 6-months post-Treatment Completion. Shunt Dysfunction is defined as the proportion of subjects free from both a >50% reduction of the lumen of the stent (confirmed by direct shunt venography for subjects with suspected shunt dysfunction) and a PSG greater than the PSG achieved post-TIPS Index Procedure. Treatment Completion is defined as the latter to occur of (i) completion of the Index Procedure and (ii) if performed, the Tailored Expansion Procedure (TEP).
6 months

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Technical Success
Временное ограничение: Index Procedure
Technical Success, defined as the successful creation of a BD Liverty™ TIPS Stent Graft lined shunt between the hepatic vein and a branch of the portal vein, as assessed by the Investigator during the Index Procedure.
Index Procedure
Hemodynamic Success
Временное ограничение: Index Procedure
Hemodynamic Success, defined as the successful post-TIPS reduction of the portosystemic gradient (PSG) to an Investigator-determined target of ≤12 mmHg or by ≥50% from the baseline PSG, as assessed by the Investigator during the Index Procedure.
Index Procedure
Clinical Success for subjects with Recurrent or Refractory Ascites
Временное ограничение: 3, 6, 12, 18, and 24 months post-Treatment Completion
Clinical Success for subjects with recurrent or refractory ascites through 3, 6, 12, 18, and 24 months post-Treatment Completion, defined as freedom from large volume paracentesis (LVP) of >5L occurring >6 weeks post-Treatment Completion.
3, 6, 12, 18, and 24 months post-Treatment Completion
Clinical Success for subjects with Hepatic Hydrothorax
Временное ограничение: 3, 6, 12, 18, and 24 months post-Treatment Completion
Clinical Success for subjects with hepatic hydrothorax through 3, 6, 12, 18, and 24 months post-Treatment Completion, defined as freedom from thoracentesis of >1L occurring >6 weeks post-Treatment Completion.
3, 6, 12, 18, and 24 months post-Treatment Completion
Clinical Success for subjects with Esophagogastric Variceal Re-Bleeding
Временное ограничение: 3, 6, 12, 18, and 24 months post-Treatment Completion
Clinical Success for subjects with esophagogastric variceal bleeding through 1, 3, 6, 12, 18, and 24 months post-Treatment Completion, defined as freedom from endoscopically-confirmed esophagogastric variceal re-bleeding.
3, 6, 12, 18, and 24 months post-Treatment Completion
Freedom from Shunt Re-Intervention
Временное ограничение: 1, 3, 6, 12, 18, and 24 months post-Treatment Completion
Freedom from Shunt Re-Intervention through 1, 3, 6, 12, 18, and 24 months post-Treatment Completion.
1, 3, 6, 12, 18, and 24 months post-Treatment Completion
Freedom from Hepatic Encephalopathy of Grade ≥3 per West Haven Criteria
Временное ограничение: 1, 3, 6, 12, 18, and 24 months post-Treatment Completion
Freedom from Hepatic Encephalopathy of Grade ≥3 per West Haven Criteria through 1, 3, 6, 12, 18, and 24 months post-Treatment Completion.
1, 3, 6, 12, 18, and 24 months post-Treatment Completion
Liver Transplant-Free Survival
Временное ограничение: Through 24 months
Liver Transplant-Free Survival post-Index Procedure, defined as the proportion of subjects with freedom from death from any cause and from liver transplantation.
Through 24 months
Overall Survival
Временное ограничение: Through 24 months
Overall Survival post-Index Procedure, defined as the proportion of subjects with freedom from death from any cause.
Through 24 months
Health-Related Quality of Life (HRQoL) Questionnaire
Временное ограничение: 1, 3, 6, 12, 18, and 24 months post-Treatment Completion
Health-Related Quality of Life (HRQoL) at Screening and at 1, 3, 6, 12, 18, and 24 months post-Treatment Completion, as measured by PROMIS-29 Profile v2.1.
1, 3, 6, 12, 18, and 24 months post-Treatment Completion
Freedom from Shunt Dysfunction
Временное ограничение: 1, 3, 12, 18, and 24 months post-Treatment Completion
Freedom from Shunt Dysfunction through 1, 3, 12, 18, and 24 months post-Treatment Completion. Shunt Dysfunction is defined as the proportion of subjects free from both a >50% reduction of the lumen of the stent (confirmed by direct shunt venography for subjects with suspected shunt dysfunction) and a PSG greater than the PSG achieved post-TIPS Index Procedure.
1, 3, 12, 18, and 24 months post-Treatment Completion

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

C. R. Bard

Следователи

  • Главный следователь: Ziv Haskal, M.D., University of Virginia

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

8 августа 2023 г.

Первичное завершение (Действительный)

23 июня 2025 г.

Завершение исследования (Оцененный)

11 января 2027 г.

Даты регистрации исследования

Первый отправленный

19 января 2023 г.

Впервые представлено, что соответствует критериям контроля качества

31 января 2023 г.

Первый опубликованный (Действительный)

3 февраля 2023 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

27 августа 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

25 августа 2026 г.

Последняя проверка

1 июня 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • BDPI-20-004

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Да

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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