TerminatedNot Applicable

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

Stopped: Low patient accrual

United States3 participantsStarted 2023-07-13

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Number of Participants With Procedural Success

Timeframe: TIPS Procedure (Day 0), up to 93 minutes

Composite of Major Complications

Timeframe: Through 30 days post-TIPS procedure

Trial details

NCT IDNCT05765253

SponsorArgon Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-10-16

Results submitted2024-10-09

View on ClinicalTrials.gov More Portal Hypertension trials