The BD Liverty™ TIPS Stent Graft Study

NCT05711316 | Active Not Recruiting DMC FDA Device

• 1 other identifier: BDPI-20-004
• Study Type: interventional
• Target: 177
• Locations: 3 countries
• Sites: 26

Brief Summary

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).

Conditions

Portal Hypertension; TIPS

Keywords

portal hypertension; ascites; hepatic hydrothorax; variceal bleeding; tips

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Technical Success

  Index Procedure

• Hemodynamic Success

  Index Procedure

• Clinical Success for subjects with Recurrent or Refractory Ascites

  3, 6, 12, 18, and 24 months post-Treatment Completion

• Clinical Success for subjects with Hepatic Hydrothorax

  3, 6, 12, 18, and 24 months post-Treatment Completion

• Clinical Success for subjects with Esophagogastric Variceal Re-Bleeding

  3, 6, 12, 18, and 24 months post-Treatment Completion

Study Arms (1)

Subjects

EXPERIMENTAL

Subjects that are treated with the BD Liverty™ TIPS Stent Graft

Device: BD Liverty™ TIPS Stent Graft

Interventions

BD Liverty™ TIPS Stent Graft DEVICE

Treatment of portal hypertension complications with placement of the BD Liverty™ TIPS Stent Graft after creation of a Transjugular Intrahepatic Portosystemic Shunt.

Also known as: TIPS

Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• 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).
• 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.
• The subject must be willing and able to comply with protocol requirements, including all study visits and procedures.
• 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:
• Recurrent, or Refractory Ascites (defined as ascites that cannot be mobilized or recurs after large volume paracentesis despite dietary sodium restriction and diuretic therapy)
• Hepatic Hydrothorax
• Esophageal Variceal Bleeding that is Endoscopically, Medically, or Balloon Tamponade-Controlled Esophageal Variceal Bleeding, or Recurrent Esophageal Variceal Bleeding
• Gastric Variceal Bleeding that is Endoscopically, Medically, or Balloon Tamponade-Controlled Gastric Variceal Bleeding, or Recurrent Gastric Variceal Bleeding
• 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.
• 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.

You may not qualify if:

• Subjects are excluded from the study if any of the following criteria apply:
• The subject is pregnant. Subjects of child-bearing potential must have a negative pregnancy test (urine or serum).
• 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.
• The subject has undergone prior stent or stent graft placement in the hepatic vein, portal vein and/or inferior vena cava (IVC).
• The subject is hemodynamically unstable with uncontrolled bleeding.
• The subject has hepatic and/or portal vein thrombosis (PVT). Note: Subjects with partial non-flow-limiting, non-malignant PVT may be enrolled.
• 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.
• The subject has extrahepatic or hepatic malignancy or a history of previous hepatic malignancy, unless treated curatively ≥5 years prior to enrollment.
• The subject has overt (West Haven Criteria Grade ≥2), controlled or uncontrolled hepatic encephalopathy.
• The subject has any of the following medical conditions contraindicated to placement of TIPS:
• Congestive Heart Failure or Pulmonary Edema
• Severe Tricuspid Regurgitation
• Elevated Right or Left Heart Pressures
• Polycystic Liver Disease
• Moderate or Severe Pulmonary Hypertension or Severe Hepatopulmonary Syndrome

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (26)

Stanford University

Palo Alto, California, 94305, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Trustees of Indiana University ("IU")/ Indiana University Health, Inc.

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Medical Center Research Institute, Inc.

Kansas City, Kansas, 66160, United States

Location

The General Hospital Corporation d/b/a Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center, Inc.

Boston, Massachusetts, 02215, United States

Location

Washington University - Mallinckrodt Institute of Radiology

St Louis, Missouri, 63110, United States

Location

Rutgers, The State University of New Jersey

Newark, New Jersey, 07103, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

The Trustees of Columbia University in the City of New York

New York, New York, 10032, United States

Location

Charlotte Radiology

Charlotte, North Carolina, 28203, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19125, United States

Location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Medical College of Wisconsin / Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Centre Hospitalier Regional Universitaire de Tours

Chambray-lès-Tours, 37170, France

Location

CHU Dijon Bourgogne

Dijon, 21079, France

Location

Hospices Civils de Lyon

Lyon, 69002, France

Location

Charité-Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

Universitatsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

Location

University Hospital Frankfurt

Frankfurt, 60590, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Westfälische Wilhelms-Universität

Münster, 48149, Germany

Location

MeSH Terms

Conditions

Hypertension, Portal; Ascites

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, Surgical; Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures

Study Officials

• Ziv Haskal, M.D.

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: February 3, 2023
• Study Start: August 8, 2023
• Primary Completion: June 23, 2025
• Study Completion (Estimated): January 11, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-06

Locations

FR (3); DE (6); US (17)