By Kevin King (Southeast Texas Vital Signs, Fall 2018)
Baptist Hospital in Beaumont has been chosen as the initial site for a clinical study involving its stroke patients. The TRUST study is sponsored and monitored by Cerevast, a medical technology company from Washington State that develops medical devices for acute ischemic stroke.
“This is a very proud moment and it’s a good thing for our community,” said Kellie DeMary, administrative director of Emergency Services at Baptist Hospital in Beaumont. “This will help us to take care of these patients even better.”
Cerevast, Dr. Andrew D. Barreto at Memorial Hermann – Texas Medical Center (TMC) in Houston and other medical professionals involved in the study will evaluate the Aureva Pulse as a therapy for Baptist’s stroke patients, who do not have immediate access to mechanical thrombectomy and must undergo lengthy transport times to receive this treatment at Hermann Memorial hospitals in Houston. These patients are usually transported by air medical services to receive a mechanical thrombectomy.
Ischemic strokes happen when a blood clot (thrombus) or a fatty deposit blocks an artery supplying blood to the brain. Mechanical thrombectomy is a procedure in which a long catheter is used to physically break up the clot. This represents a newer device-based approach to treating ischemic stroke that has been shown to be highly effective at removing large vessel occlusions. How-ever, because this procedure re-quires specialized facilities and trained medical staff, the majority of mechanical thrombectomy cases performed in the United States are limited to a small percentage of primary stroke centers and approximately 125 Joint Commission certified comprehensive stroke centers, such as TMC in Houston.
Stroke patients are frequently admitted to outlying community-based hospitals without the required facilities or capabilities to perform mechanical thrombectomy, forcing transport to a comprehensive or primary stroke center following the initial diagnosis and initiation of tissue plasminogen activator (tPA), clot-busting agent used in the treatment of heart attack and stroke. These transfers often involve significant time delays during which brain tissue remains deprived of oxygen.
Since being approved by the U.S. Food and Drug Administration in 1996, tPA remains the only approved drug in the United States for the treatment of ischemic stroke, according to an article pub-lished in the U.S. National Library of Medicine National Institutes of Health. Although tPA is generally effective at dissolving smaller blood clots, it is only effective at dissolving larger proximal vessel occlusions in 15-25 percent of all cases, several studies have shown.
Barreto said a previous study published in the New England Journal of Medicine found that using ultra-sonic waves, like those the Aureva Pulse uses, along with tPA tripled the effectiveness of dis-solving blood clots in stroke patients.
“The ultrasound helps tPA work better, or the ultra-sound may vibrate the clot and break it up better than tPA alone,” Barreto said.
By breaking up these clots in a more effective manner, strokes could be smaller and patients could have less disability.
“It could save lives or reduce disability,” Barreto said.
Cerevast claims the Aureva Pulse, a device that is placed on the head almost like a king’s crown, represents a first-in-class stroke treatment device designed to address this treatment gap.
“Used in combination with tPA during the acute phase of ischemic stroke to help Baptist Hospital chosen as initial site for study that may have global implications, impact future of treating stroke patients break-up blood clots and restore blood flows to the ischemic regions of the brain, the device consists of the ultrasonic head-frame that properly orients the ultrasound transducer into the proper location on the patient’s head and a control box that gen-erates the ultrasound signal and provides the user interface controls,” a release by the company states.
According to Cerevast, features of the device enable the ultrasound to be directed to the target region of the brain without the need for a trained ultrasound technician to deliver the therapy. Based on the portable nature of the device, therapy can be administered while stroke patients are undergoing transport via ambulance or helicopter to a primary or comprehensive stroke center to receive thrombectomy.
Baptist is one of around 20 U.S. medical facilities whose patients may consent to the study. If successful in the United States, the study will be expanded to more than 70 medical facilities world-wide likely in Europe, Eastern Asia, and South America, said Joyce Su, director of Clinical Affairs for Cerevast.
Beaumont is one of the “spoke” hospitals in the southeast Texas region that feed into the hub at Memorial Hermann – Tex-as Medical Center (TMC) in Houston, Su said. “One of the region’s leading stroke neurologists, Dr. Andrew D. Barreto at TMC, is an outspoken proponent of using ultrasound to enhance the clotbusting effect of tPA for stroke. Dr. Barreto provides telemedicine neurology services to many outlying hospitals in Southeast Texas, including Baptist (in) Beaumont. Dr. Barreto wanted TMC to be a part of the TRUST trial and he specifically requested that Baptist Beaumont be the first spoke site in the trial, which they have graciously accepted to agree to participate.”
The hospital hosted a presentation by Cerevast to introduce and train medical staff to use the Aureva Pulse and to educate staff on the study and what their role and the role of patients who agree (possibly through family members who are legally designated to make medical decisions for them on-site) to participate in the study.
“Cerevast Medical is exceedingly pleased that Baptist Beaumont, Hermann Memorial TMC and Dr. Barreto have agreed to work on the study,” said John Alleman, Chief Operations Officer at Cerevast. “We simply could not ask for a better group of professionals to work with. We believe that this therapy can provide a substantial life-saving benefit to stroke patients and we are lucky to have a champion like Dr. Barreto.”
Su also wanted to stress that Dr. Barre-to has no financial ties to Cerevast Medical nor has derived any financial benefit in assisting with the study.
Cerevast hopes to have the lead-in phase of the study completed in early 2019 and then complete the subsequent primary phase in late 2020.