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

• Sponsor: Argon Medical Devices (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05765253
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 7
• Patients Per Site Per Month: 8.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Portal Hypertension; Liver Diseases; Ascites Hepatic; Hydrothorax; Vascular Diseases	Device: Scorpion Portal Vein Access Kit; Device: Cook Transjugular Liver Access Set; Procedure: Transjugular Intrahepatic Portosystemic Shunt (TIPS)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Multicenter, Randomized Study Evaluating Portal Vein Access Sets During Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedures
• Anticipated Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Nov 1, 2023
• Anticipated Study Completion Date: Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: TIPS with Scorpion Portal Vein Access Kit Scorpion or Scorpion X access set	Device: Scorpion Portal Vein Access Kit; Portal Vein Access with Scorpion or Scorpion X set; Procedure: Transjugular Intrahepatic Portosystemic Shunt (TIPS); Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Active Comparator: TIPS with Cook Transjugular Liver Access Set Ring or Rosch-Uchida access set	Device: 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)

Outcome Measures

Primary Outcome Measures

1. Procedural Success [Index Procedure]

   Creation of the parenchymal tract between the hepatic vein and an intrahepatic branch of the portal vein confirmed by portogram (CO2/contrast).

2. 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 Outcome Measures

1. Portal Vein Access (PVA) time [Index Procedure]

   Time (in minutes) from the initial needle throw to portal vein access as confirmed by portogram.

2. Technical Success [Index Procedure]

   Creation of a shunt (stent bridging) between the portal and systemic veins.

3. Number of Needle Passes [Index Procedure]

   Count of needle throws between the hepatic and portal vein to create the parenchymal tract.

4. Procedure Duration [Index Procedure]

   Interval (in minutes) from first jugular access for TIPS creation to removal of catheters from the patient.

5. Fluoroscopy Time [Index Procedure]

   Measured in minutes

6. Device-Related Complications [Through 30 days post-TIPS procedure]

   Incidence of complications related to the device as judged by the Investigator

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. ≥ 18 years of age at the time of the index procedure

2. TIPS procedure initiated for refractory variceal bleeding, refractory ascites and/or hydrothorax

3. Willing and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization, either individually or through a legally authorized representative (LAR)

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 portal vein thrombosis or complete portal vein thrombosis of the portal vein on prior CT examination

7. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York Presbyterian - Columbia University Irving Medical Center	New York	New York	United States	10032

Sponsors and Collaborators

• Argon Medical Devices

Investigators

• Principal Investigator: Venkatesh P. Krishnasamy, MD, New York Presbyterian - Columbia University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Argon Medical Devices
• ClinicalTrials.gov Identifier: NCT05765253
• Other Study ID Numbers: SCPVA01
• First Posted: Mar 13, 2023
• Last Update Posted: Mar 20, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Argon Medical Devices: Transjugular Intrahepatic Portosystemic Shunt; TIPS; Portal Vein Access
• Additional relevant MeSH terms: Liver Diseases; Hypertension, Portal; Hydrothorax; Vascular Diseases; Ascites

Study Results

No Results Posted as of Mar 20, 2023