W.L. Gore & Associates (Gore) today announced a new prospective, randomized, multi-center study at the Annual Meeting of the American Association for the Study of Liver Diseases. The hypothesis of the study is that early intervention with the GORE® VIATORR® TIPS Endoprosthesis improves transplant-free survival when compared to large volume paracentesis in patients with cirrhosis 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. Gore expects the study to involve 150 subjects at more than 20 sites. The lead co-investigators are Thomas Boyer, MD, Chief of the Arizona Liver Institute and Ziv Haskal, MD, Professor and Director of the Vascular & Interventional Radiology at the University of Maryland Medical Center. Gore is launching an informational website at clinical.goremedical.com/earlytips/
“Unlike a bare metal stent, the GORE VIATORR TIPS Endoprosthesis improves patency to such a degree that nearly all repeated invasive procedures on TIPS patients have disappeared”
The Gore study for ascites patients comes on the heels of a landmark study published in The New England Journal of Medicine comparing early TIPS intervention with the GORE VIATORR TIPS Endoprosthesis to pharmacotherapy / endoscopic band ligation in high risk variceal bleeding patients with positive results. Ascites is the build up of fluid in the abdomen and variceal bleeding involves the rupture of veins in the gastrointestinal system, both a result of liver disease.
TIPS therapy is a minimally invasive procedure done with closed surgery, as only a small puncture is made in the jugular vein for insertion of the 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. With the TIPS procedure, alternative treatments such as medications and paracentesis for ascites, and the treatment of varices may not be needed as often.
The GORE VIATORR TIPS Endoprosthesis is the only covered stent that is indicated for TIPS creation and revision. Trial data shows that the device has changed the landscape in TIPS procedures and optimized primary patency rates in the process. According to Dr. Haskal, fundamental and significant improvements in TIPS therapy are seen when using a covered stent versus a bare metal stent.
"Unlike a bare metal stent, the GORE VIATORR TIPS Endoprosthesis improves patency to such a degree that nearly all repeated invasive procedures on TIPS patients have disappeared," said Dr. Haskal. "New data concerning covered stents forced us to take a fresh look at all earlier randomized studies comparing bare metal TIPS to other treatments. The possibility that we may prolong patient lives is one of the most exciting new questions in TIPS therapy that we must answer."
According to Dr. Sanyal, "TIPS therapy studies in the 1990s may have failed to demonstrate increasing life expectancy for patients because only end stage patients were included. Previous trials with bare metal stents showed TIPS was a bridge to transplant at best. By including patients in earlier stages of the disease course we hope to show there is an improvement in lifespan," said Dr. Sanyal who is also on the steering committee for the new Gore Early TIPS for Ascites Study. "By capturing patients a little earlier we may be able to impact their quality of life, as TIPS therapy may improve the ascites and slow the disease progression."
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