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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up index procedure
Awards & highlights
Study Summary
This trial evaluated techniques for accessing the portal vein during a TIPS procedure to make it quicker and easier.
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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ index procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~index procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite of Major Complications
Procedural Success
Secondary outcome measures
Device-Related Complications
Fluoroscopy Time
Number of Needle Passes
+3 moreTrial 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
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Who is running the clinical trial?
Argon Medical DevicesLead Sponsor
3 Previous Clinical Trials
1,553 Total Patients Enrolled
AvaniaIndustry Sponsor
45 Previous Clinical Trials
8,841 Total Patients Enrolled
Danyel C Carr, MSStudy DirectorArgon Medical Devices
1 Previous Clinical Trials
125 Total Patients Enrolled
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the primary focus of this investigation?
"The primary endpoint of this clinical trial, evaluated over a specific timeframe, is the Composite of Major Complications. Secondary endpoints include Technical Success (creating a shunt between portal and systemic veins), Number of Needle Passes (needles thrown to create parenchymal tract) and Procedure Duration (interval from first jugular access until catheters are removed)."
Answered by AI
Is recruitment ongoing for this research endeavor?
"Clinicaltrials.gov reveals that this trial, which was initially made public on April 1st 2023, is no longer recruiting participants. However, there are over four-hundred other trials actively registering patients right now."
Answered by AI
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