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The trial will enroll patients in a 1:1 randomization and will be conducted independently through an academic research organization.
May 5, 2025
By: Michael Barbella
Managing Editor
Imperative Care Inc. is funding an investigator-initiated, multicenter clinical trial comparing aspiration thrombectomy with the Zoom Stroke System plus best medical treatment versus best medical treatment alone. The study will examine treatments in patients suffering from acute ischemic stroke due to a primary occlusion of the middle cerebral artery’s M2 segment within eight hours of symptoms.
“We believe it is our responsibility to support the launch of independent randomized controlled trials that rigorously evaluate treatment approaches with the ultimate goal of improving patient outcomes,” Imperative Care Chairman/CEO Fred Khosravi stated. “This investment reflects our deep commitment to clinical evidence and innovation. We are grateful to the leading clinicians participating in this trial, and we look forward to the impact these findings will ultimately have on patients.”
The randomized controlled trial will enroll patients in a one-to-one randomization and will be conducted independently through an academic research organization. The primary efficacy endpoint will measure clinical outcomes using the 90-day modified Rankin Scale (mRS) score, which reflects a patient’s disability level after a stroke. Patients randomized to the arm evaluating the Zoom Stroke System plus best medical treatment will be treated with dual aspiration using the Continuous Dual Aspiration Technique (CDAT), which applies continuous vacuum on two Zoom catheters simultaneously, incorporating the company’s DuoPort technology.
“Recent randomized controlled trials, which have entailed the use of stent retrievers, have raised questions about the clinical benefit of mechanical thrombectomy in patients with M2 occlusions,”1,2 said Adam Arthur, M.D., study principal investigator, chair of Neurosurgery at University of Tennessee Health Sciences Center, and director of Cerebrovascular and Endovascular Neurosurgery at Semmes Murphey Clinic in Memphis. “This is the first trial designed to look at an aspiration approach specifically for M2 occlusions and will help us better understand the potential impact of aspiration thrombectomy on these patients. I commend Imperative Care for taking a bold step to fund this independent trial that may help the field answer important clinical questions and support physicians in their evidence-based decision-making when treating their stroke patients.”
The Zoom Stroke System is a complete system (from access through reperfusion) to quickly and effectively remove clots in patients suffering from acute ischemic stroke. The system includes the Zoom 6F Insert Catheters, Zoom 88 and Zoom 88 Support Large Distal Platform, and Zoom RDL Radial Access Platform, the Zoom 35, 45, 55 and 71 Catheters, Zoom Pump, Zoom POD, Zoom DuoPort, and accessories. All Zoom Catheters are designed with the unique TRX Tip, which provides 15% greater clot engagement area at the catheter tip3 and are designed to enable smooth tracking through challenging vasculature.
Imperative Care is a commercial-stage medical technology company researching and developing connected innovations to elevate care for patients affected by vascular diseases. The company is focused on addressing specific gaps in treatment and care to make an impact across the entire patient journey. Imperative Care is based in Campbell, Calif.
References1 Goyal et al., 2025. The New England Journal of Medicine. Endovascular Treatment of Stroke Due to Medium-Vessel Occlusion2 Psychogios et al., 2025. The New England Journal of Medicine. Endovascular treatment for stroke due to occlusion of medium or distal vessels.3 Vargas J, Blalock J, Venkatraman A, et al. Efficacy of beveled tip aspiration catheter in mechanical thrombectomy for acute ischemic stroke. Journal of NeuroInterventional Surgery 2021;13:823-826.
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