Achieving Portal Access With Scorpion Post-Approval Study (APASS)

Study Overview
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Brief Summary
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Creation of the parenchymal tract between the portal vein and the hepatic vein is the most difficult and time consuming step in a TIPS procedure. The purpose of this study is to evaluate portal vein access sets during the TIPS procedure.

Official Title
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A Prospective, Multicenter, Randomized Study Evaluating Portal Vein Access Sets During Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedures

Conditions
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Portal Hypertension, Liver Diseases, Ascites Hepatic, Hydrothorax, Vascular Diseases

Intervention / Treatment
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* Device: Scorpion Portal Vein Access Kit
* Device: Cook Transjugular Liver Access Set
* Procedure: Transjugular Intrahepatic Portosystemic Shunt (TIPS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age at the time of the TIPS procedure TIPS procedure initiated for refractory variceal bleeding, refractory ascites and/or hydrothorax Willing and able to provide written informed consent and HIPAA (Health Insurance Portability and Accountability Act) authorization Willing and able to comply with the study procedures and follow up schedule Exclusion Criteria: Known active malignancy MELD score ≥ 18 at time of screening History of polycystic liver disease Active bleeding from any source Pulmonary hypertension, heart failure, severe tricuspid valve dysfunction, right to left cardiopulmonary shunt Chronic, occlusive portal vein thrombosis or complete portal vein thrombosis of the main or target portal vein on prior CT examination Active or uncontrolled hepatic encephalopathy Systemic infection/sepsis Biliary obstruction Uncorrectable coagulopathy Any diminutive or partially thrombosed right portal vein Hepatic vein thrombosis (i.e., no Budd-Chiari syndrome) Known sensitivity to contrast or serious contrast reaction such as anaphylaxis Pregnant women or women who are planning to become pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TIPS with Scorpion Portal Vein Access Kit<br>Scorpion or Scorpion X access set | Device: Scorpion Portal Vein Access Kit<br>* Portal Vein Access with Scorpion or Scorpion X set<br>Procedure: Transjugular Intrahepatic Portosystemic Shunt (TIPS)<br>* Transjugular Intrahepatic Portosystemic Shunt (TIPS)<br>|
| Active Comparator: TIPS with Cook Transjugular Liver Access Set<br>Ring or Rosch-Uchida access set | Device: Cook Transjugular Liver Access Set<br>* Portal Vein Access with Ring or Rosch-Uchida set<br>Procedure: Transjugular Intrahepatic Portosystemic Shunt (TIPS)<br>* Transjugular Intrahepatic Portosystemic Shunt (TIPS)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Success | Creation of the parenchymal tract between the hepatic vein and an intrahepatic branch of the portal vein confirmed by portogram (CO2/contrast). | Index Procedure | 
| Composite of Major Complications | Major complications associated with the procedure or study device and defined as complications resulting in an unplanned increase in the level of care, prolonged hospitalization, permanent adverse sequelae, or death. | Through 30 days post-TIPS procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Portal Vein Access (PVA) time | Time (in minutes) from the first forward motion of the needle to confirmation of portal vein access via portogram. | Index Procedure | 
| Technical Success | Creation of a shunt (stent bridging) between the portal and systemic veins. | Index Procedure | 
| Number of Needle Passes | Count of needle throws between the hepatic and portal vein to create the parenchymal tract. | Index Procedure | 
| Procedure Duration | Interval (in minutes) from first jugular access for TIPS creation to removal of catheters from the patient. | Index Procedure | 
| Fluoroscopy Time | Measured in minutes | Index Procedure | 
| Device-Related Complications | Incidence of complications related to the device as judged by the Investigator | Through 30 days post-TIPS procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Portal Vein Access, Transjugular Intrahepatic Portosystemic Shunt, TIPS