Enrollment commences in Gore Early TIPS study for ascites at Indiana University Hospital

W. L. Gore & Associates (Gore) today reported the first patient enrolled in the Gore Early TIPS for Ascites Study. The patient was treated at Indiana University Hospital in Indianapolis, Ind. The objective of this prospective, randomized, multi-center clinical study is to evaluate whether the TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis improves transplant-free survival when compared to large volume paracentesis (LVP) in patients with cirrhosis of the liver and difficult to treat ascites. The study is expected to be the largest and most rigorous multi-disciplinary collaboration with hepatologists and interventional radiologists looking at early TIPS therapy. A total of 150 subjects will be enrolled at approximately 20 sites. At Indiana University Hospital the study is being led by Raj Vuppalanchi, MD, Assistant Professor of Clinical Medicine in the Division of Gastroenterology / Hepatology and David Agarwal, MD, Associate Professor of Clinical Radiology in the Department of Radiology.

“Most treatments for complications of portal hypertension improve the patient's condition without an impact on survival”

"Indiana University Hospital is pleased to be the first facility to treat a patient in this important study aimed at prolonging the lives of patients and providing more than just a bridge to transplant," said Drs. Vuppalanchi and Agarwal. "The possibility exists that we may reduce the need for alternative treatments such as medication and paracentesis; potentially improving the quality of lives for those with liver disease as well."

Ascites is the build up of fluid in the abdomen, a result of liver disease. The current standard of care for patients is drainage of the fluid via a procedure known as paracentesis, in combination with pharmacotherapy. TIPS therapy is a minimally invasive procedure with closed surgery, as only a small puncture is needed in the jugular vein for insertion of the GORE® VIATORR® TIPS Device. A TIPS creates a new channel to route blood flow through the damaged liver and into the main blood vessels that lead blood back to the heart.

The GORE® VIATORR® TIPS Endoprosthesis is the only covered stent that is indicated for TIPS creation and revision. Data shows that the device has changed the landscape in TIPS procedures and optimized primary patency rates in the process. Fundamental and significant improvements in TIPS therapy are seen when using a covered stent versus a bare metal stent.

"Most treatments for complications of portal hypertension improve the patient's condition without an impact on survival," said Thomas Boyer, MD, Chief of the Arizona Liver Institute and national principal investigator for the Gore clinical study. "We believe in this new TIPS study for early resistant ascites and that an improvement in survival will be seen."



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