The BD Liverty™ TIPS Stent Graft Study - A Global, Prospective, Multi-Center, Single-Arm Clinical Study for the Treatment of Complications From Portal Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 177
- 试验地点
- 26
- 主要终点
- Freedom from Major Complications through 30 days post-Index Procedure
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≤
- •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.
排除标准
- •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
- •Uncontrolled Systemic Infection or Sepsis
- •Unrelieved Biliary Obstruction
- •Acute Kidney Injury, Renal Failure, or Dialysis
- •Uncontrolled Blood Coagulation/Bleeding Disorder
- •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.
- •The subject has a known allergy or hypersensitivity to any of the device materials including nickel-titanium (nitinol) or tantalum.
- •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.
- •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.
研究组 & 干预措施
Subjects
Subjects that are treated with the BD Liverty™ TIPS Stent Graft
干预措施: BD Liverty™ TIPS Stent Graft (Device)
结局指标
主要结局
Freedom from Major Complications through 30 days post-Index Procedure
时间窗: 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)
Freedom from Shunt Dysfunction through 6 months post-Treatment Completion
时间窗: 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).
次要结局
- 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)
- Freedom from Shunt Re-Intervention(1, 3, 6, 12, 18, and 24 months post-Treatment Completion)
- Freedom from Hepatic Encephalopathy of Grade ≥3 per West Haven Criteria(1, 3, 6, 12, 18, and 24 months post-Treatment Completion)
- Liver Transplant-Free Survival(Through 24 months)
- Overall Survival(Through 24 months)
- Health-Related Quality of Life (HRQoL) Questionnaire(1, 3, 6, 12, 18, and 24 months post-Treatment Completion)
- Freedom from Shunt Dysfunction(1, 3, 12, 18, and 24 months post-Treatment Completion)