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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05765253
Other study ID # SCPVA01
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date July 13, 2023
Est. completion date November 19, 2023

Study information

Verified date March 2024
Source Argon Medical Devices
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date November 19, 2023
Est. primary completion date October 16, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
Scorpion Portal Vein Access Kit
Portal Vein Access with Scorpion or Scorpion X set
Cook Transjugular Liver Access Set
Portal Vein Access with Ring or Rosch-Uchida set
Procedure:
Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Locations

Country Name City State
United States Emory University Atlanta Georgia
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States New York Presbyterian - Columbia University Medical Center New York New York

Sponsors (2)

Lead Sponsor Collaborator
Argon Medical Devices Avania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary Technical Success Creation of a shunt (stent bridging) between the portal and systemic veins. Index Procedure
Secondary Number of Needle Passes Count of needle throws between the hepatic and portal vein to create the parenchymal tract. Index Procedure
Secondary Procedure Duration Interval (in minutes) from first jugular access for TIPS creation to removal of catheters from the patient. Index Procedure
Secondary Fluoroscopy Time Measured in minutes Index Procedure
Secondary Device-Related Complications Incidence of complications related to the device as judged by the Investigator Through 30 days post-TIPS procedure
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