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CLOTBUST-HF: Hands-free ultrasound plus tPA safe for ischemic stroke
Sonothrombolysis with a hands-free ultrasound device used in conjunction with a tissue-type plasminogen activator proved safe for patients with stroke, according to the results of a phase 2 study.
Investigators placed the hands-free ultrasound device (CLOTBUST, Cerevast Therapeutics) on the heads of patients for 2 hours to enhance the performance of tissue-type plasminogen activator (tPA). The device uses 2-MHz pulsed wave technology to deliver energy through 18 separate transducers.
Previous research has shown that sonothrombolysis plus tPA has similar safety to and better efficacy for treating stroke than tPA alone, according to information from the study background. However, the researchers wrote, conventional sonothrombolysis requires extensive operator training; therefore, there was a need to develop an operator-independent device that could target the proximal intracranial arteries without specialized operator training.
Researchers enrolled 20 patients with ischemic stroke (60% men; mean age, 63 years; median NIH Stroke Scale, 15) in the phase 2 CLOTBUST-HF study. The primary outcome was incidence of symptomatic intracerebral hemorrhage. Patients underwent transcranial CT angiography or Doppler ultrasound before and after treatment. NIH Stroke Scale scores were calculated at 2 hours and modified Rankin scale at 90 days.
None of the 20 patients developed symptomatic intracerebral hemorrhage, no serious adverse events related to the device were reported, and the tPA was tolerated by all patients, the researchers reported.
The rate of complete 2-hour recanalization was 40% (95% CI, 19-64). The rate of partial 2-hour recanalization was 10% (95% CI, 1-32). Those with middle cerebral artery occlusion had the highest rate of complete recanalization (57%; 95% CI, 29-82). At 90 days, 25% of patients (95% CI, 7-49) had a modified Rankin scale of 0 to 1.
According to the researchers, the device appears safe and may improve recanalization. Its efficacy is being tested in CLOTBUST-ER, a phase 3 trial.
Disclosure: The study was funded by the NIH. One researcher is a consultant for Cerevast Therapeutics. The other researchers report no relevant financial disclosures.
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