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

Primary Purpose

Portal Hypertension, Liver Diseases, Ascites Hepatic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Scorpion Portal Vein Access Kit
Cook Transjugular Liver Access Set
Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Sponsored by
Argon Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Portal Hypertension focused on measuring Transjugular Intrahepatic Portosystemic Shunt, TIPS, Portal Vein Access

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ≥ 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 Exclusion Criteria: 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

Sites / Locations

  • Emory University
  • New York Presbyterian - Columbia University Medical Center
  • University of North Carolina at Chapel HillRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TIPS with Scorpion Portal Vein Access Kit

TIPS with Cook Transjugular Liver Access Set

Arm Description

Scorpion or Scorpion X access set

Ring or Rosch-Uchida access set

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Portal Vein Access (PVA) time
Time (in minutes) from the initial needle throw to portal vein access as confirmed by portogram.
Technical Success
Creation of a shunt (stent bridging) between the portal and systemic veins.
Number of Needle Passes
Count of needle throws between the hepatic and portal vein to create the parenchymal tract.
Procedure Duration
Interval (in minutes) from first jugular access for TIPS creation to removal of catheters from the patient.
Fluoroscopy Time
Measured in minutes
Device-Related Complications
Incidence of complications related to the device as judged by the Investigator

Full Information

First Posted
March 1, 2023
Last Updated
July 17, 2023
Sponsor
Argon Medical Devices
Collaborators
Avania
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1. Study Identification

Unique Protocol Identification Number
NCT05765253
Brief Title
Achieving Portal Access With Scorpion Post-Approval Study (APASS)
Official Title
A Prospective, Multicenter, Randomized Study Evaluating Portal Vein Access Sets During Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Argon Medical Devices
Collaborators
Avania

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Portal Hypertension, Liver Diseases, Ascites Hepatic, Hydrothorax, Vascular Diseases
Keywords
Transjugular Intrahepatic Portosystemic Shunt, TIPS, Portal Vein Access

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TIPS with Scorpion Portal Vein Access Kit
Arm Type
Active Comparator
Arm Description
Scorpion or Scorpion X access set
Arm Title
TIPS with Cook Transjugular Liver Access Set
Arm Type
Active Comparator
Arm Description
Ring or Rosch-Uchida access set
Intervention Type
Device
Intervention Name(s)
Scorpion Portal Vein Access Kit
Intervention Description
Portal Vein Access with Scorpion or Scorpion X set
Intervention Type
Device
Intervention Name(s)
Cook Transjugular Liver Access Set
Intervention Description
Portal Vein Access with Ring or Rosch-Uchida set
Intervention Type
Procedure
Intervention Name(s)
Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Intervention Description
Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Primary Outcome Measure Information:
Title
Procedural Success
Description
Creation of the parenchymal tract between the hepatic vein and an intrahepatic branch of the portal vein confirmed by portogram (CO2/contrast).
Time Frame
Index Procedure
Title
Composite of Major Complications
Description
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.
Time Frame
Through 30 days post-TIPS procedure
Secondary Outcome Measure Information:
Title
Portal Vein Access (PVA) time
Description
Time (in minutes) from the initial needle throw to portal vein access as confirmed by portogram.
Time Frame
Index Procedure
Title
Technical Success
Description
Creation of a shunt (stent bridging) between the portal and systemic veins.
Time Frame
Index Procedure
Title
Number of Needle Passes
Description
Count of needle throws between the hepatic and portal vein to create the parenchymal tract.
Time Frame
Index Procedure
Title
Procedure Duration
Description
Interval (in minutes) from first jugular access for TIPS creation to removal of catheters from the patient.
Time Frame
Index Procedure
Title
Fluoroscopy Time
Description
Measured in minutes
Time Frame
Index Procedure
Title
Device-Related Complications
Description
Incidence of complications related to the device as judged by the Investigator
Time Frame
Through 30 days post-TIPS procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danyel C Carr, MS
Phone
4697311421
Email
Danyel.Carr@argonmedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Brent McClean
Email
Brent.McClean@argonmedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Venkatesh P. Krishnasamy, MD
Organizational Affiliation
New York Presbyterian - Columbia University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Danyel C Carr, MS
Organizational Affiliation
Argon Medical Devices
Official's Role
Study Director
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Rivas
Phone
404-712-7962
Email
mrivas2@emory.edu
First Name & Middle Initial & Last Name & Degree
Peter J Park, MD
Facility Name
New York Presbyterian - Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramona Jayasena
Email
rj2002@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Venkatesh Krishnasamy, MD
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Desma Jones
Email
desma_jones@med.unc.edu
First Name & Middle Initial & Last Name & Degree
Clayton Commander, MD
First Name & Middle Initial & Last Name & Degree
Hyeon Yu, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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