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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Portal Vein Access with Scorpion or Scorpion X set
Portal Vein Access with Ring or Rosch-Uchida set
Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Emory University
Atlanta, Georgia, United States
New York Presbyterian - Columbia University Medical Center
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Number of Participants With Procedural Success
Creation of the parenchymal tract between the hepatic vein and an intrahepatic branch of the portal vein confirmed by portogram (CO2/contrast).
Time frame: TIPS Procedure (Day 0), up to 93 minutes
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.
Time frame: Through 30 days post-TIPS procedure
Portal Vein Access (PVA) Time
Time (in minutes) from the first forward motion of the needle to confirmation of portal vein access via portogram.
Time frame: TIPS Procedure (Day 0), up to 52 minutes
Number of Participants With Technical Success
Creation of a shunt (stent bridging) between the portal and systemic veins.
Time frame: TIPS Procedure (Day 0), up to 93 minutes
Number of Needle Passes
Count of needle throws between the hepatic and portal vein to create the parenchymal tract.
Time frame: TIPS Procedure (Day 0), up to 93 minutes
Procedure Duration
Interval (in minutes) from first jugular access for TIPS creation to removal of catheters from the patient.
Time frame: TIPS Procedure (Day 0), up to 93 minutes
Fluoroscopy Time
Measured in minutes
Time frame: TIPS Procedure (Day 0), up to 31.5 minutes
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Device-Related Complications
Incidence of complications related to the device as judged by the Investigator
Time frame: Through 30 days post-TIPS procedure