Imperative Care, Inc. announced on April 15, 2025, that it will fund an investigator-initiated, multicenter randomized controlled trial (RCT) to evaluate the efficacy of aspiration thrombectomy for stroke patients with M2 occlusions. The study will compare the company's Zoom Stroke System plus best medical treatment versus best medical treatment alone in patients with acute ischemic stroke caused by primary occlusion of the M2 segment of the middle cerebral artery.
The trial will enroll patients within eight hours of symptom onset in a 1:1 randomization ratio 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 level of disability post-stroke.
First Trial Specifically Designed for Aspiration Approach in M2 Occlusions
Dr. Adam Arthur, Principal Investigator for the study and Chair of Neurosurgery at the University of Tennessee Health Sciences Center, highlighted the significance of this trial: "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."
Dr. Arthur referenced two recent studies published in the New England Journal of Medicine by the ESCAPE-MeVO and DISTAL investigators that cast doubt on the benefits of mechanical thrombectomy using stent retrievers for M2 occlusions.
"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," Dr. Arthur explained. "I commend Imperative Care for taking a bold step to fund this independent trial that may help the field answer important clinical questions."
Novel Dual Aspiration Technique
Patients randomized to the intervention arm 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. This approach differs from the stent retriever methods used in previous trials.
The Zoom Stroke System includes several components designed for clot removal in acute ischemic stroke patients. All Zoom Catheters feature the unique TRX™ Tip, which provides 15% greater clot engagement area at the catheter tip and is designed to enable smooth tracking through challenging vasculature.
Clinical Context and Significance
Stroke remains a leading cause of death and disability worldwide. While mechanical thrombectomy has become standard care for large vessel occlusions, the optimal approach for medium vessel occlusions, particularly those in the M2 segment, remains controversial.
Fred Khosravi, Chairman and CEO of Imperative Care, emphasized the company's commitment to clinical evidence: "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. This investment reflects our deep commitment to clinical evidence and innovation."
M2 Occlusions: A Clinical Challenge
The M2 segment of the middle cerebral artery presents unique challenges for endovascular treatment due to its smaller diameter and more distal location compared to larger vessels. Recent trials have questioned whether the benefits of mechanical thrombectomy seen in large vessel occlusions extend to these medium vessel occlusions.
The ESCAPE-MeVO trial by Goyal et al. and the DISTAL trial by Psychogios et al., both published in 2025, raised significant questions about the clinical benefit of mechanical thrombectomy using stent retrievers in patients with M2 occlusions.
This new trial aims to determine whether an aspiration-based approach might yield different results than the stent retriever techniques used in previous studies. The findings could potentially change clinical practice guidelines for this specific patient population.
Trial Design and Implementation
The multicenter trial will be conducted independently through an academic research organization, with Imperative Care providing funding but not directing the research. This approach helps ensure scientific integrity and reduces potential bias in the results.
The use of the 90-day modified Rankin Scale as the primary endpoint aligns with standard practice in stroke trials, allowing for direct comparison with previous studies. This scale measures the degree of disability in patients who have suffered a stroke, with scores ranging from 0 (no symptoms) to 6 (death).
The trial represents an important step in addressing a specific gap in stroke treatment evidence and could potentially expand treatment options for patients with M2 occlusions who currently face uncertain benefits from mechanical thrombectomy.
