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Scorpion Portal Vein Access for TIPS in Portal Hypertension
N/A
Waitlist Available
Led By Venkatesh P. Krishnasamy, MD
Research Sponsored by Argon Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
TIPS procedure initiated for refractory variceal bleeding, refractory ascites and/or hydrothorax
≥ 18 years of age at the time of the TIPS procedure
Must not have
Uncorrectable coagulopathy
Active or uncontrolled hepatic encephalopathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up index procedure
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing special tools that help doctors connect two veins in the liver more easily during a TIPS procedure. It focuses on patients who need this specific liver treatment to see if these tools can make the process quicker and simpler. TIPS (transjugular intrahepatic portosystemic shunt) is a procedure first performed in 1988, used to treat portal hypertension and variceal bleeding, and has since been improved for wider clinical use.
Who is the study for?
This trial is for adults over 18 needing a TIPS procedure for severe variceal bleeding, ascites, or hydrothorax. Candidates must consent to study rules and follow-ups. Exclusions include polycystic liver disease, active cancer, certain vein conditions or thrombosis, high MELD score (≥18), infections, biliary obstruction, coagulopathy issues, contrast allergies, pregnancy plans in women, uncontrolled hepatic encephalopathy or active bleeding.
What is being tested?
The APASS study evaluates the effectiveness of portal vein access kits used during TIPS procedures which connect the portal and hepatic veins in patients with liver diseases. It compares Scorpion Portal Vein Access Kit with Cook Transjugular Liver Access Set to see which helps better in creating this connection.
What are the potential side effects?
Potential side effects from using these access kits could include discomfort at the insertion site, risk of infection due to invasive nature of procedure; possible allergic reactions to materials used; and complications related to TIPS such as heart strain or worsening encephalopathy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had a TIPS procedure for severe bleeding, fluid in the abdomen, or fluid around the lungs.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a blood clotting disorder that cannot be corrected.
Select...
I do not have active or uncontrolled brain issues due to liver disease.
Select...
I have a blockage in my bile ducts.
Select...
I do not have a widespread infection or sepsis.
Select...
I have been diagnosed with polycystic liver disease.
Select...
I have an active cancer diagnosis.
Select...
I do not have a blood clot in the liver veins (Budd-Chiari syndrome).
Select...
I am currently experiencing bleeding from any part of my body.
Select...
I do not have severe heart or lung blood pressure issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ index procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~index procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Composite of Major Complications
Procedural Success
Secondary study objectives
Device-Related Complications
Fluoroscopy Time
Number of Needle Passes
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: TIPS with Cook Transjugular Liver Access SetActive Control2 Interventions
Ring or Rosch-Uchida access set
Group II: TIPS with Scorpion Portal Vein Access KitActive Control2 Interventions
Scorpion or Scorpion X access set
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for liver disease include the TIPS procedure, which creates a parenchymal tract between the portal vein and hepatic vein to reduce portal hypertension and prevent complications like variceal bleeding. Other treatments such as TACE and RT target liver tumors, while antiviral therapies aim to eradicate viral infections like HCV and HBV.
These treatments are essential as they address both the symptoms and underlying causes of liver disease, thereby improving patient outcomes and quality of life.
Role of band ligation for secondary prophylaxis of variceal bleeding.
Role of band ligation for secondary prophylaxis of variceal bleeding.
Find a Location
Who is running the clinical trial?
Argon Medical DevicesLead Sponsor
3 Previous Clinical Trials
1,553 Total Patients Enrolled
AvaniaIndustry Sponsor
52 Previous Clinical Trials
9,978 Total Patients Enrolled
Danyel C Carr, MSStudy DirectorArgon Medical Devices
1 Previous Clinical Trials
125 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a small or partially blocked vein in your liver.I have a blood clotting disorder that cannot be corrected.I do not have active or uncontrolled brain issues due to liver disease.I have a blockage in my bile ducts.I do not have a widespread infection or sepsis.I have been diagnosed with polycystic liver disease.You have a chronic blockage in the main or target portal vein.I have an active cancer diagnosis.Your MELD score is 18 or higher when checked at the screening.I do not have a blood clot in the liver veins (Budd-Chiari syndrome).You have had a serious allergic reaction to contrast dye in the past.I had a TIPS procedure for severe bleeding, fluid in the abdomen, or fluid around the lungs.I am currently experiencing bleeding from any part of my body.I am 18 years old or older.I do not have severe heart or lung blood pressure issues.
Research Study Groups:
This trial has the following groups:- Group 1: TIPS with Cook Transjugular Liver Access Set
- Group 2: TIPS with Scorpion Portal Vein Access Kit
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.