The BD Liverty™ TIPS Stent Graft Study (ARCH)

The BD Liverty™ TIPS Stent Graft Study - A Global, Prospective, Multi-Center, Single-Arm Clinical Study for the Treatment of Complications From Portal Hypertension

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Portal Hypertension; TIPS
• Intervention / Treatment: Device: BD Liverty™ TIPS Stent Graft

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 177
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects; Subjects that are treated with the BD Liverty™ TIPS Stent Graft	Device: 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.; Other Names: TIPS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from Major Complications through 30 days post-Index Procedure	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success	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	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	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	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	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	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	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	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	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	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	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

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: Ziv Haskal, M.D., University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2023
• Primary Completion (Actual): June 23, 2025
• Study Completion (Estimated): January 11, 2027

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: January 31, 2023
• First Posted (Actual): February 3, 2023

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: portal hypertension; variceal bleeding; ascites; tips; hepatic hydrothorax
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Pathological Conditions, Signs and Symptoms; Hypertension, Portal; Ascites; Surgical Procedures, Operative; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Portasystemic Shunt, Surgical; Anastomosis, Surgical; Vascular Grafting; Portasystemic Shunt, Transjugular Intrahepatic
• Other Study ID Numbers: BDPI-20-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes