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[미국 FDA의 승인 또는 허가를 받지 않은 기기의 시험] (ARCH)

2026년 8월 25일 업데이트: 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).

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

177

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Subjects
Subjects that are treated with the BD Liverty™ TIPS Stent Graft
장치: 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.
다른 이름들:
  • 팁

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Freedom from Major Complications through 30 days post-Index Procedure
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Technical Success
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

C. R. Bard

수사관

  • 수석 연구원: Ziv Haskal, M.D., University of Virginia

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 8월 8일

기본 완료 (실제)

2025년 6월 23일

연구 완료 (추정된)

2027년 1월 11일

연구 등록 날짜

최초 제출

2023년 1월 19일

QC 기준을 충족하는 최초 제출

2023년 1월 31일

처음 게시됨 (실제)

2023년 2월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 25일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • BDPI-20-004

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

예

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다