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April 15, 2025

Imperative Care’s Zoom Stroke System Will Be Evaluated for Treatment of M2 Occlusions in Investigator-Initiated RCT

April 15, 2025—Imperative Care, Inc. announced it will fund an investigator-initiated, multicenter, randomized controlled trial (RCT) comparing aspiration thrombectomy using the company’s Zoom stroke system plus best medical treatment versus best medical treatment alone. The study will examine treatments in patients experiencing acute ischemic stroke caused by a primary occlusion of the M2 segment of the middle cerebral artery within 8 hours of symptom onset.

According to the company, the trial will enroll patients in a 1:1 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 score.

The company stated that 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, which applies continuous vacuum on two Zoom catheters simultaneously, incorporating the company’s DuoPort technology.

“Recent RCTs, which have entailed the use of stent retrievers, have raised questions about the clinical benefit of mechanical thrombectomy in patients with M2 occlusions,” commented Adam Arthur, MD, in the company’s press release, referencing Mayank Goyal, MD, et al for the ESCAPE-MeVO investigators (N Engl J Med. 2025;392:1385-1395) and Marios Psychogios, MD, et al for the DISTAL investigators (N Engl J Med. 2025;392:1374-1384).

Dr. Arthur, who serves as a principal investigator for the study, is Chair of Neurosurgery at the University of Tennessee Health Sciences Center and Director of Cerebrovascular and Endovascular Neurosurgery at Semmes Murphey Clinic in Memphis, Tennessee.

He continued, “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.”

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