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

NCT ID: NCT05765253

Last Updated: 2024-12-11

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-13

Study Completion Date

2023-11-19

Brief Summary

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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.

Detailed Description

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Conditions

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Portal Hypertension Liver Diseases Ascites Hepatic Hydrothorax Vascular Diseases

Keywords

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Transjugular Intrahepatic Portosystemic Shunt TIPS Portal Vein Access

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TIPS with Scorpion Portal Vein Access Kit

Scorpion or Scorpion X access set

Group Type ACTIVE_COMPARATOR

Scorpion Portal Vein Access Kit

Intervention Type DEVICE

Portal Vein Access with Scorpion or Scorpion X set

Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Intervention Type PROCEDURE

Transjugular Intrahepatic Portosystemic Shunt (TIPS)

TIPS with Cook Transjugular Liver Access Set

Ring or Rosch-Uchida access set

Group Type ACTIVE_COMPARATOR

Cook Transjugular Liver Access Set

Intervention Type DEVICE

Portal Vein Access with Ring or Rosch-Uchida set

Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Intervention Type PROCEDURE

Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Interventions

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Scorpion Portal Vein Access Kit

Portal Vein Access with Scorpion or Scorpion X set

Intervention Type DEVICE

Cook Transjugular Liver Access Set

Portal Vein Access with Ring or Rosch-Uchida set

Intervention Type DEVICE

Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Avania

INDUSTRY

Sponsor Role collaborator

Argon Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Venkatesh P. Krishnasamy, MD

Role: PRINCIPAL_INVESTIGATOR

New York Presbyterian - Columbia University Medical Center

Danyel C Carr, MS

Role: STUDY_DIRECTOR

Argon Medical Devices

Locations

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Emory University

Atlanta, Georgia, United States

Site Status

New York Presbyterian - Columbia University Medical Center

New York, New York, United States

Site Status

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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SCPVA01

Identifier Type: -

Identifier Source: org_study_id