The study being conducted at Tampa General Hospital is evaluating whether a new, larger type of catheter removes blood clots in the brain more quickly and completely, thus improving outcomes for stroke patients.
Tampa General Hospital and faculty from the USF Health Morsani College of Medicine recently successfully treated a patient suffering from an ischemic stroke by removing, or aspirating, a blood clot in the patient’s brain with the Zoom™ 88 Large Distal Platform, a catheter manufactured by Imperative Care® that is currently FDA cleared for neurovascular access.
Tampa General and its academic affiliate, the USF Health Morsani College of Medicine, are the first to treat a patient as part of this national multi-site clinical trial.
“This is a paradigm shift in how strokes are being treated,” said Dr. Maxim Mokin, associate professor of neurology and neurosurgery at the Morsani College of Medicine and medical director of neuro-interventional surgery at TGH. “We believe this catheter will allow us to restore blood flow to brain vessels faster, with fewer attempts and shorter procedure time.”
The Zoom 88 catheter is the largest catheter now being used for stroke care that is flexible enough to enter blood vessels in the brain, which allows the catheter to get closer to the treatment site. Most other catheters of this size are stiffer and can’t travel past the neck.
The Imperative Care trial is one of several clinical trials now being conducted by TGH and USF Health at Tampa General to help offer stroke patients better care. Academic medical centers, such as Tampa General and USF Health, have more resources available to offer these kinds of novel treatments, access to clinical research, and advanced multidisciplinary care to patients. Tampa General, the first hospital on the west coast of Florida to obtain national comprehensive stroke accreditation status from the Accreditation Commission of Health Care, is a leader in providing rapid treatment with the latest techniques for stroke patients.
Tampa General is recognized as “high performing,” or ranked among the top 10% of U.S. hospitals, for stroke care, as well as for Neurology & Neurosurgery, by U.S. News & World Report for 2021-2022.
TGH also has received “Get with the Guidelines” Stroke Gold Plus Award and “Target: Stroke” Honor Roll-Elite recognition from the American Heart Association/American Stroke Association. The hospital’s 32-bed Neurosciences Intensive Care Unit is the largest on the West Coast of Florida. The multidisciplinary stroke team includes four stroke neurologists, three stroke interventionists, and a dedicated neurocritical care team providing 24/7 access to emergent stroke coverage.
Imperative Care’s Zoom Stroke Solution™ includes the Zoom 88 Large Distal Platform for neurovascular access, four Zoom aspiration catheters in various sizes, and a pump with accessories. In addition to the larger size, the catheters also feature a trademark tip that is both slanted and beveled.
“The catheter tip has a unique design to effectively trap and engage into the clot,” Mokin said.
Designed as a multispecialty study, the Imperative Trial will enroll 262 patients at up to 30 sites in the United States and includes investigators from several specialties trained to treat ischemic stroke, including neurosurgery, interventional radiology, and interventional neurology. The study is led by investigators at Emory University School of Medicine, the Keck School of Medicine at the University of Southern California, and Mt. Sinai Hospital in New York, N.Y. Dr. Mokin is the principal investigator for the TGH/USF Health arm of the trial.
“At Imperative Care, the concept of elevating stroke care doesn't end with innovative technology. We know that clinical data are foundational to validating technology and ensuring better patient care,” said
Daniel Davis, president and chief operating officer of Imperative Care. “We hope that this landmark study will position direct aspiration with the Zoom 88 to become another tool that enables physicians to effectively and expeditiously treat people suffering from a stroke.”
Stroke remains a largely unaddressed problem that affects over 800,000 Americans each year.1 The number of deaths due to stroke continues to rise,2 and a study published in The New England Journal of Medicine estimates that the global risk of stroke from age 25 onward is approximately 25% among both men and women.3 Treatment options have significantly improved over the last decade, but the need for improved effectiveness and efficiency remains.
Additional information about the trial, including eligibility criteria and a list of clinical trial sites, can be found at https://clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT04129125).
1. Mozzafarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, et al., on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2016 update: a report from the American Heart Association. Circulation2016;133(4):e38–360.
2. National Center for Health Statistics Mortality Data Report for 2017
3. The GBD 2016 Lifetime Risk of Stroke Collaborators, Global, Regional and Country-Specific Lifetime Risks of Stroke, 1990 and 2016. N Engl J Med 2018; 379:2429-2437 DOI: 10.1056/NEJMoa1804492
ABOUT TAMPA GENERAL HOSPITAL
Tampa General Hospital, a 1,041-bed non-profit academic medical center, is one of the largest hospitals in America and delivers world-class care as the region’s only center for Level l trauma and comprehensive burn care. Tampa General Hospital is the highest-ranked hospital in the market in U.S. News & World Report's 2021-22 Best Hospitals, and one of the top 4 hospitals in Florida, with five specialties ranking among the best programs in the United States. The academic medical center’s commitment to growing and developing its team members is recognized by two prestigious 2021 Forbes magazine rankings – America’s Best Employers by State, third out of 100 Florida companies and first among health care and social organizations and 13th nationally in America’s Best Employers for Women. Tampa General is the safety net hospital for the region, caring for everyone regardless of their ability to pay, and in fiscal 2020 provided a net community benefit worth more than $182.5 million in the form of health care for underinsured patients, community education and financial support to community health organizations in Tampa Bay. It is one of the nation’s busiest adult solid organ transplant centers and is the primary teaching hospital for the USF Health Morsani College of Medicine. With five medical helicopters, Tampa General Hospital transports critically injured or ill patients from 23 surrounding counties to receive the advanced care they need. Tampa General houses a nationally accredited comprehensive stroke center and its 32-bed Neuroscience Intensive Care Unit is the largest on the West Coast of Florida. It also is home to the Jennifer Leigh Muma 82-bed Level IV neonatal intensive care unit, and a nationally accredited rehabilitation center. Tampa General Hospital’s footprint includes 17 Tampa General Medical Group Primary Care offices, TGH Family Care Center Kennedy, TGH Brandon Healthplex, TGH Virtual Health and 19 outpatient Radiology Centers. Tampa Bay residents also receive world-class care from the TGH Urgent Care powered by Fast Track network of clinics, and they can even receive home visits in select areas through TGH Urgent Care at Home, powered by Fast Track. As one of the largest hospitals in the country, Tampa General Hospital is first in Florida to partner with GE Healthcare and open a clinical command center that uses artificial intelligence and predictive analytics to improve and better coordinate patient care at a lower cost. For more information, go to www.tgh.org.
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USF Health's mission is to envision and implement the future of health. It is the partnership of the USF Health Morsani College of Medicine, the College of Nursing, the College of Public Health, the Taneja College of Pharmacy, the School of Physical Therapy and Rehabilitation Sciences, the Biomedical Sciences Graduate and Postdoctoral Programs, and USF Health’s multispecialty physicians group. The University of South Florida is a high-impact global research university dedicated to student success. Over the past 10 years, no other public university in the country has risen faster in U.S. News & World Report’s national university rankings than USF. For more information, visit health.usf.edu.