Researchers at Vanderbilt University Medical Center are leading an international clinical trial to test the benefits of a hybrid therapy to treat acute ischemic stroke. Acute ischemic stroke is where a blood clot lodges in an artery in the brain, reducing blood flow and oxygen supply. Nearly 90% of strokes are ischemic.

The THERAPY trial has two parts:

• The standard-of-care, clot-busting drug tPA (tissue plasminogen activator)
• A device treatment, the Penumbra System, that gently suctions away blood clots to restore blood flow to the brain

The trial will test a combined therapy using IV tPA with the Penumbra System, compared to IV tPA treatment alone.

The Penumbra System, which was FDA-approved in December 2007, has been used in about 15,000 stroke treatment procedures in the U.S.

Principal investigator J Mocco, M.D., said the trial hopes to involve 75 stroke treatment centers worldwide, with a target of 692 patients enrolled.

“The device evaluated in this trial works like a straw; it literally sucks the clot out,” he said. “In our recent experience at Vanderbilt, almost half of the treated patients are completely independent afterwards. These are patients who otherwise would likely be devastated with severe disability.”

Stroke is the 4th leading cause of death in the U.S. and the leading cause of long-term adult disability. It affects about 800,000 Americans every year. Common symptoms include:

• Numbness
• Weakness or paralysis along one side of the body
• Slurred speech
• Difficulty understanding speech
• Trouble walking

“If successful, the THERAPY trial will help to identify a patient population most likely to benefit from interventional therapy, as well as reveal a treatment paradigm that may have a true impact on improving the standard of care for ischemic stroke patients,” Mocco said.