Ascites Hepatic, Hydrothorax, Liver Diseases, Portal Hypertension, Vascular Diseases
Conditions
Keywords
Transjugular Intrahepatic Portosystemic Shunt, TIPS, Portal Vein Access
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.
Interventions
Procedure/Surgery: Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Sponsors
Argon Medical Devices
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1\. Scorpion or Scorpion X kit introduced into the vasculature as the initial device for portal vein access
Exclusion criteria
1. TIPS procedure was not initiated and/or no portion of the kit was introduced into the vasculature 2. Inaccessible medical records
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Technical Success | TIPS Procedure | Creation of the parenchymal tract between the hepatic vein and an intrahepatic branch of the portal vein and confirmed by portogram |
| Composite of Major Complications | Through 30 days post-TIPS procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Procedural Success | TIPS Procedure | Successful delivery of the shunt |
| Device-Related Complications | Through 30 days post-TIPS procedure | Incidence of complications related to the device as judged by the Investigator |
Other
| Measure | Time frame | Description |
|---|---|---|
| Portal Vein Access (PVA) Time | TIPS Procedure | Time (in minutes) from hepatic vein access to portal vein access |
| Change in Child-Pugh score | up to 30 days post-TIPs procedure | Change in score from Baseline Characteristics to Follow Up Data |
| Procedure duration | TIPS Procedure | Interval (in minutes) from first jugular access for TIPS creation to removal of catheters from subject |
| Fluoroscopy Time | TIPS Procedure | Measured in minutes |
| Change in MELD score | up to 30 days post-TIPs procedure | Change in score from Baseline Characteristics to Follow Up Data |
Countries
United States
Outcome results
None listed