Investigator-initiated trial to compare aspiration thrombectomy with the Zoom Stroke System plus best medical treatment versus best medical treatment alone for M2 vessel occlusions
CAMPBELL, Calif.--(BUSINESS WIRE)--Imperative Care, Inc. today announced it will fund an investigator-initiated, multicenter, randomized, controlled 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 M2 segment of the middle cerebral artery within eight hours of symptom onset.
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 (mRS) score, which reflects a patient’s level of disability post-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 novel 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 occlusions1,2,” said Dr. Adam Arthur, M.D., Principal Investigator for the study and 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,” said Dr. Arthur.
“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,” said Fred Khosravi, Chairman and CEO of Imperative Care. “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.”
About the Zoom Stroke System
The Zoom Stroke System is a complete stroke system from access through reperfusion designed for fast and effective clot removal in patients presenting with acute ischemic stroke. The comprehensive 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 tip of the catheter3 and are designed to enable smooth tracking through challenging vasculature. For complete product information, including indications, contraindications, warnings, precautions and adverse events, visit: https://bit.ly/3yWkfEJ.
About Imperative Care, Inc.
Imperative Care is a commercial-stage medical technology company researching and developing connected innovations to elevate care for people affected by devastating vascular diseases such as stroke and pulmonary embolism. 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. https://imperativecare.com.
1. Goyal et al., 2025. The New England Journal of Medicine. Endovascular Treatment of Stroke Due to Medium-Vessel Occlusion
2. 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.
Contacts
Media Contact:
Lara Lingenbrink
Imperative Care, Inc.
858-525-1414
llingenbrink@imperativecare.com
Investor Contact:
Phil Nalbone
Imperative Care, Inc.
pnalbone@imperativecare.com
