Advocate Lutheran General Hospital in Park Ridge, Illinois, has joined a clinical trial studying an investigational stroke treatment device for difficult-to-reach blood clots.
“Called distal vessel occlusions, these strokes are caused by blood clots in the small arteries higher up in the brain, as opposed to the larger arteries in the neck and base of the brain,” said neurosurgeon Demetrius Lopes, MD, Advocate Aurora Research Institute’s principal investigator for the study. “Traditionally, these blood clots were dissolved by using intravenous thrombolytic drugs, but they don’t always work. As technology has evolved, researchers are now studying mechanical endovascular devices that can physically remove these types of clots.”
Nearly 800,000 people in the U.S. suffer from a stroke each year – that’s one person every 40 seconds, according to the U.S. Centers for Disease Control and Prevention (CDC). Strokes are the number one cause of long-term disability and the fifth leading cause of death.
Almost 90% of strokes are caused by blood vessel blockages, according to the CDC.
The clinical trial will evaluate the safety and effectiveness of the Tigertriever 13 device in restoring blood flow to the brain by removing the affecting blood clot within 24 hours of stroke onset in people who are not eligible for intravenous thrombolysis therapy.
Tigertriever 13 is approved in Europe for treatment of distal vessel occlusions, but not currently in the U.S., which is why it is considered investigational in this study.
The device is designed to be inserted through a small incision in the groin or wrist and then guided via a catheter through the body’s chain of blood vessels to the location of the blood clot. The Tigertriever 13 is then expanded to capture the clot. Doctors can then slowly remove the device, catheter and clot from the body together.
“Using intravenous thromboyltic drugs to break up a blood clot has traditionally worked better in distal occlusions in these smaller blood vessels,” said Melissa Kadar, Director of Advocate Aurora Research Institute’s Center of Excellence in Neuroscience Research. “Still, prior research shows that thrombolytics fail to restore proper blood flow in up to two-thirds of distal vessel occlusions, creating a clear need for mechanical endovascular treatments that can physically remove the blood clot.”
Researchers plan to enroll approximately 170 participants in the study, “Distal ischemic stroke treatment with adjustable low-profile stentriever (DISTALS),” which is sponsored by Rapid Medical, manufacturer of the Tigertriever 13 device.
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