I hope the efficacy tested includes full recovery instead of just preventing death. I don't believe tPA was adequately tested since it doesn't always lead to full recovery. That should have led to more searches right after it was approved in 1996, rather than 16 years later.
http://www.newswise.com/articles/vanderbilt-leading-international-therapy-trial-to-study-benefits-of-combined-drug-and-interventional-therapy-approach-for-stroke-victims
Researchers at Vanderbilt University Medical Center are leading an
international clinical trial to examine the functional benefits of a
combined therapy to treat acute ischemic stroke, a type of stroke where a
blood clot becomes lodged in an artery within the brain, reducing blood
flow and depriving brain cells of oxygen. Eighty-seven percent of
strokes are ischemic.
The THERAPY trial involves use of the
standard-of-care, clot-busting intravenous drug tPA (tissue plasminogen
activator) and an interventional device treatment, the Penumbra System,
that gently suctions away blood clots to restore blood flow to the
brain’s affected area.
The trial will evaluate a combined
therapy using IV tPA and interventional clot removal with the Penumbra
System, compared to IV tPA treatment alone.
During the
minimally invasive procedure a catheter is threaded to the clot and the
Penumbra System’s technology gently suctions away the mass to restore
blood flow. The Penumbra System, which was FDA-approved in December
2007, has been used in approximately 15,000 stroke treatment procedures
in the U.S.
Principal investigator J Mocco, M.D., associate
professor of Neurological Surgery, said the trial hopes to involve 75
stroke treatment centers worldwide to participate, with a target
enrollment of 692 patients.
“When patients come in with a
stroke they are distressed,” Mocco said. “They can’t move half their
body, they often can’t talk, and they can’t understand language. They
are often headed toward permanent disability, or death.”
“The
device evaluated in this trial works like a straw, it literally sucks
the clot out. 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 fourth leading cause of death in the
U.S. and the leading cause of long-term adult disability, affecting
800,000 Americans every year. Common stroke symptoms include numbness,
weakness or paralysis along one side of the body, slurred speech, and
difficulty understanding speech and/or trouble walking.
The
standard of care for acute ischemic stroke in most stroke centers
involves administration of intravenous (IV) tPA within 3 to 4 1/2 hours
of the onset of symptoms. However, most patients do not arrive in time,
and the treatment may fail if a clot is too large or difficult to
dissolve. If this occurs, alternative minimally invasive,
inside-the-artery clot removal can be used up to eight hours after onset
of symptoms.
The trial will also examine the use of certain
patient selection criteria to determine if interventional therapy is
appropriate. Recent advancements in CT scan imaging have helped
physicians better assess the size and location of a patient’s clot and
whether inside-the-artery clot removal will work.
“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.
“Acute
stroke intervention technology has grown by leaps and bounds. In fact,
it has only been in the past decade that any technology has been
available to mechanically remove clots causing stroke,” Mocco said.
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