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

Vascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05765253
• Other study ID #: SCPVA01
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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