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

NCT05765253 | Terminated Results FDA Device

• 1 other identifier: SCPVA01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 3

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.

Conditions

Portal Hypertension; Liver Diseases; Ascites Hepatic; Hydrothorax; Vascular Diseases

Keywords

Transjugular Intrahepatic Portosystemic Shunt; TIPS; Portal Vein Access

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  Through 30 days post-TIPS procedure

Secondary Outcomes (6)

• Portal Vein Access (PVA) Time

  TIPS Procedure (Day 0), up to 52 minutes

• Number of Participants With Technical Success

  TIPS Procedure (Day 0), up to 93 minutes

• Number of Needle Passes

  TIPS Procedure (Day 0), up to 93 minutes

• Procedure Duration

  TIPS Procedure (Day 0), up to 93 minutes

• Fluoroscopy Time

  TIPS Procedure (Day 0), up to 31.5 minutes

Study Arms (2)

TIPS with Scorpion Portal Vein Access Kit

ACTIVE COMPARATOR

Scorpion or Scorpion X access set

Device: Scorpion Portal Vein Access Kit; Procedure: Transjugular Intrahepatic Portosystemic Shunt (TIPS)

TIPS with Cook Transjugular Liver Access Set

ACTIVE COMPARATOR

Ring or Rosch-Uchida access set

Device: Cook Transjugular Liver Access Set; Procedure: Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Interventions

Scorpion Portal Vein Access Kit DEVICE

Portal Vein Access with Scorpion or Scorpion X set

TIPS with Scorpion Portal Vein Access Kit

Cook Transjugular Liver Access Set DEVICE

Portal Vein Access with Ring or Rosch-Uchida set

TIPS with Cook Transjugular Liver Access Set

Transjugular Intrahepatic Portosystemic Shunt (TIPS) PROCEDURE

Transjugular Intrahepatic Portosystemic Shunt (TIPS)

TIPS with Cook Transjugular Liver Access Set; TIPS with Scorpion Portal Vein Access Kit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age at the time of the TIPS procedure
• TIPS procedure initiated for refractory variceal bleeding, refractory ascites and/or hydrothorax
• Willing and able to provide written informed consent and HIPAA (Health Insurance Portability and Accountability Act) authorization
• Willing and able to comply with the study procedures and follow up schedule

You may not qualify if:

• Known active malignancy
• MELD score ≥ 18 at time of screening
• History of polycystic liver disease
• Active bleeding from any source
• Pulmonary hypertension, heart failure, severe tricuspid valve dysfunction, right to left cardiopulmonary shunt
• Chronic, occlusive portal vein thrombosis or complete portal vein thrombosis of the main or target portal vein on prior CT examination
• Active or uncontrolled hepatic encephalopathy
• Systemic infection/sepsis
• Biliary obstruction
• Uncorrectable coagulopathy
• Any diminutive or partially thrombosed right portal vein
• Hepatic vein thrombosis (i.e., no Budd-Chiari syndrome)
• Known sensitivity to contrast or serious contrast reaction such as anaphylaxis
• Pregnant women or women who are planning to become pregnant

Sponsors & Collaborators

• Argon Medical Devices: lead
• Avania: collaborator

Study Sites (3)

Emory University

Atlanta, Georgia, 30322, United States

Location

New York Presbyterian - Columbia University Medical Center

New York, New York, 10032, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Hypertension, Portal; Liver Diseases; Hydrothorax; Vascular Diseases

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Condition Hierarchy (Ancestors)

Digestive System Diseases; Pleural Diseases; Respiratory Tract Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, Surgical; Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures

Limitations and Caveats

The study was terminated early due to insufficient enrollment. Three (3) subjects were enrolled before the early termination leading to limited analyses.

Results Point of Contact

• Title: Danyel Carr
• Organization: Argon Medical Devices

Danyel.Carr@argonmedical.com

469-731-1421

Study Officials

• Venkatesh P. Krishnasamy, MD

  New York Presbyterian - Columbia University Medical Center

  PRINCIPAL INVESTIGATOR

• Danyel C Carr, MS

  Argon Medical Devices

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 13, 2023
• Study Start: July 13, 2023
• Primary Completion: October 16, 2023
• Study Completion: November 19, 2023
• Last Updated: December 11, 2024
• Results First Posted: December 11, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)