Analysis of Equipoise Shift in CLOTBUST-ER Has Been Published

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Therapeutic Advances in Neurological Disorders has published “Endovascular equipoise shift in a phase III randomized clinical trial of sonothrombolysis for acute ischemic stroke”. This paper presents a case study of the CLOTBUST-ER trial, showing that the “increasing implementation of endovascular therapies across major academic stroke centers raises significant challenges for clinical trials aiming to test noninterventional or adjuvant reperfusion strategies “. With the rise of EVT during the course of the trial, the segment of the eligible stroke population who were most likely to receive the best outcomes from sonothrombolysis were disproportionately redirected away from the trial. The paper includes a post hoc analysis suggesting that this shift negatively impacted the CLOTBUST-ER results. This analysis reinforces the importance of the improvements that Cerevast is implementing in the phase 3 TRUST study.

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Cerevast Medical Enters Into Strategic Collaboration With Lantheus Medical Imaging for Retinal Vein Occlusion Treatment

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Under a development and commercial supply agreement, Lantheus’ microbubble will be used in combination with Cerevast’s ocular ultrasound device to target improving blood flow in occluded retinal veins in the eye. Cerevast’s RVO Technology will combine intravenous administration of Lantheus’ microbubbles with non-invasive ultrasound delivered across the closed eyelid. By treating the underlying cause of the disease as opposed to the symptoms, this therapy has the potential to reduce or eliminate the need for chronic maintenance therapy and improve the quality of life for those patients inflicted by RVO. Cerevast’s RVO Technology is expected to enter a Phase 2B clinical trial in the second half of 2019. Cerevast has received an investigational device exemption (IDE) from the U.S. FDA, which allows its investigational ocular ultrasound device to be used in a clinical study in order to collect safety and effectiveness data. If approved, the RVO Technology could be commercialized in 2023.

Further Reading

CLOTBUST-ER Results Published in Lancet Neurology

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The results of the CLOTBUST-ER trial, the first phase 3 trial to assess the safety and efficacy of sonothrombolysis, have been published in the April 2019 edition of Lancet Neurology. Though the trial did not meet its primary endpoint, the article and accompanying independent commentary offer a cogent review of the obstacles and shortcomings which may have impaired the CLOTBUST-ER trial, and highlights the continued promise of sonothrombolysis as a safe and effective option for acute ischemic stroke treatment. The publication also introduces the Cerevast Medical sponsored phase 3 TRUST study as an opportunity to incorporate the lessons learned from CLOTBUST-ER and unlock the potential of sonothrombolysis to advance the standard of care.

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