Clinical trial NCT05765253: Achieving Portal Access With Scorpion Post-Approval Study (APASS)
Official title: A Prospective, Multicenter, Randomized Study Evaluating Portal Vein Access Sets During Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Portal Hypertension
Liver Diseases
Ascites Hepatic
Hydrothorax
Vascular Diseases
Keywords: Transjugular Intrahepatic Portosystemic Shunt
TIPS
Portal Vein Access
Lead sponsor: Argon Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: Avania
First posted: 2023-03-13
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. ≥ 18 years of age at the time of the TIPS procedure
2. TIPS procedure initiated for refractory variceal bleeding, refractory ascites and/or hydrothorax
3. Willing and able to provide written informed consent and HIPAA (Health Insurance Portability and Accountability Act) authorization
4. Willing and able to comply with the study procedures and follow up schedule

Exclusion Criteria:

1. Known active malignancy
2. MELD score ≥ 18 at time of screening
3. History of polycystic liver disease
4. Active bleeding from any source
5. Pulmonary hypertension, heart failure, severe tricuspid valve dysfunction, right to left cardiopulmonary shunt
6. Chronic, occlusive portal vein thrombosis or complete portal vein thrombosis of the main or target portal vein on prior CT examination
7. Active or uncontrolled hepatic encephalopathy
8. Systemic infection/sepsis
9. Biliary obstruction
10. Uncorrectable coagulopathy
11. Any diminutive or partially thrombosed right portal vein
12. Hepatic vein thrombosis (i.e., no Budd-Chiari syndrome)
13. Known sensitivity to contrast or serious contrast reaction such as anaphylaxis
14. Pregnant women or women who are planning to become pregnant

Primary outcomes:
measure: Number of Participants With Procedural Success
timeFrame: TIPS Procedure (Day 0), up to 93 minutes
measure: Composite of Major Complications
timeFrame: Through 30 days post-TIPS procedure
Secondary outcomes:
measure: Portal Vein Access (PVA) Time
timeFrame: TIPS Procedure (Day 0), up to 52 minutes
measure: Number of Participants With Technical Success
timeFrame: TIPS Procedure (Day 0), up to 93 minutes
measure: Number of Needle Passes
timeFrame: TIPS Procedure (Day 0), up to 93 minutes
measure: Procedure Duration
timeFrame: TIPS Procedure (Day 0), up to 93 minutes
measure: Fluoroscopy Time
timeFrame: TIPS Procedure (Day 0), up to 31.5 minutes
measure: Device-Related Complications
timeFrame: Through 30 days post-TIPS procedure
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: New York
country: United States
facility: New York Presbyterian - Columbia University Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: New York Presbyterian - Columbia University Medical Center
name: Venkatesh P. Krishnasamy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Argon Medical Devices
name: Danyel C Carr, MS
role: STUDY_DIRECTOR
References: