Clinical outcomes and independently adjudicated results of M2 aspiration thrombectomy: a subgroup analysis from the Imperative Trial

Justin R Mascitelli¹, Reade Andrew De Leacy², William Mack³, Raul Nogueira⁴, Shahram Majidi², Robert Dana Tomalty⁵, Maxim Mokin⁶, Jan Vargas⁷, Brett L Cucchiara⁸, Kenneth V Snyder⁹, Victoria Parada¹⁰, Hakeem J Shakir¹¹, David Rosenbaum-Halevi¹², Amin Aghaebrahim¹³, Daniel Hoit¹⁴, Benjamin Yim¹⁵, Matthew S Tenser¹⁶, Alhamza R Al-Bayati⁴, James M Milburn¹⁷, Shahid M Nimjee¹⁸, Neil Haranhalli¹⁹, Michael Nahhas²⁰, Darryn Shaff²¹, Kennith F Layton²², Narlin Beaty²³, Robert M Starke²⁴, Harris Hawk²⁵, Diogo C Haussen²⁶, Aqueel Pabaney²⁷, Christopher Paul Kellner², Jonathan A Grossberg²⁷

Affiliations

¹ Department of Neurosurgery, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA jmascite@gmail.com.
² Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
³ Department of Neurosurgery, Keck School of Medicine of USC Los Angeles, Los Angeles, California, USA.
⁴ Department of Neurology and Neurosurgery, University of Pittsburgh Medical Center Health System, Pittsburgh, Pennsylvania, USA.
⁵ Huntsville Hospital, Huntsville, Alabama, USA.
⁶ Department of Neurosurgery, University of South Florida, Tampa, Florida, USA.
⁷ Department of Neurosurgery, Prisma Health Upstate, Greenville, South Carolina, USA.
⁸ Department of Neurology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
⁹ Department of Neurosurgery, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York, USA.
¹⁰ Department of Neurology, Valley Baptist Medical Center/University of Texas Rio Grande Valley, Harlingen, Texas, USA.
¹¹ Department of Neurosurgery, The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.
¹² Department of Neurosurgery, Munson Medical Center, Traverse City, Michigan, USA.
¹³ Neurological Institute, Lyerley Neurosurgery, Baptist Medical Center Jacksonville, Jacksonville, Florida, USA.
¹⁴ Department of Neurosurgery, Semmes-Murphey Neurologic and Spine Institute, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.
¹⁵ Department of Neurosurgery, John Muir Health Medical Center, Walnut Creek, California, USA.
¹⁶ Department of Neurosurgery, University of Southern California, Los Angeles, California, USA.
¹⁷ Department of Radiology, Ochsner Medical System, New Orleans, Louisiana, USA.
¹⁸ Department of Neurological Surgery, Ohio State University, Columbus, Ohio, USA.
¹⁹ Department of Neurological Surgery, Montefiore Medical Center, New York, New York, USA.
²⁰ Department of Neurology, UTHealth McGovern Medical School, Houston, Texas, USA.
²¹ Department of Neurointerventional Radiology, Lehigh Valley Hospital, Allentown, Pennsylvania, USA.
²² Department of Neurointerventional Radiology, Baylor University Medical Center, Dallas, Texas, USA.
²³ Department of Neurosurgery, Tallahassee Memorial Hospital, Florida State University, Tallahassee, Florida, USA.
²⁴ Department of Neurosurgery, University of Miami Health System, Miami, Florida, USA.
²⁵ Department of Neurosurgery, Erlanger Health System, Chattanooga, Tennessee, USA.
²⁶ Department of Neurology, Emory University School of Medicine, Atlanta, Georgia, USA.
²⁷ Department of Neurosurgery, Radiology and Imaging Sciences, Emory University School of Medicine, Atlanta, Georgia, USA.

PMID: 40908129
DOI: 10.1136/jnis-2025-024023

Clinical outcomes and independently adjudicated results of M2 aspiration thrombectomy: a subgroup analysis from the Imperative Trial

Justin R Mascitelli et al. J Neurointerv Surg. 2025.

. 2025 Sep 4:jnis-2025-024023.

doi: 10.1136/jnis-2025-024023. Online ahead of print.

Authors

Affiliations

¹ Department of Neurosurgery, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA jmascite@gmail.com.
² Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
³ Department of Neurosurgery, Keck School of Medicine of USC Los Angeles, Los Angeles, California, USA.
⁴ Department of Neurology and Neurosurgery, University of Pittsburgh Medical Center Health System, Pittsburgh, Pennsylvania, USA.
⁵ Huntsville Hospital, Huntsville, Alabama, USA.
⁶ Department of Neurosurgery, University of South Florida, Tampa, Florida, USA.
⁷ Department of Neurosurgery, Prisma Health Upstate, Greenville, South Carolina, USA.
⁸ Department of Neurology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
⁹ Department of Neurosurgery, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York, USA.
¹⁰ Department of Neurology, Valley Baptist Medical Center/University of Texas Rio Grande Valley, Harlingen, Texas, USA.
¹¹ Department of Neurosurgery, The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.
¹² Department of Neurosurgery, Munson Medical Center, Traverse City, Michigan, USA.
¹³ Neurological Institute, Lyerley Neurosurgery, Baptist Medical Center Jacksonville, Jacksonville, Florida, USA.
¹⁴ Department of Neurosurgery, Semmes-Murphey Neurologic and Spine Institute, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.
¹⁵ Department of Neurosurgery, John Muir Health Medical Center, Walnut Creek, California, USA.
¹⁶ Department of Neurosurgery, University of Southern California, Los Angeles, California, USA.
¹⁷ Department of Radiology, Ochsner Medical System, New Orleans, Louisiana, USA.
¹⁸ Department of Neurological Surgery, Ohio State University, Columbus, Ohio, USA.
¹⁹ Department of Neurological Surgery, Montefiore Medical Center, New York, New York, USA.
²⁰ Department of Neurology, UTHealth McGovern Medical School, Houston, Texas, USA.
²¹ Department of Neurointerventional Radiology, Lehigh Valley Hospital, Allentown, Pennsylvania, USA.
²² Department of Neurointerventional Radiology, Baylor University Medical Center, Dallas, Texas, USA.
²³ Department of Neurosurgery, Tallahassee Memorial Hospital, Florida State University, Tallahassee, Florida, USA.
²⁴ Department of Neurosurgery, University of Miami Health System, Miami, Florida, USA.
²⁵ Department of Neurosurgery, Erlanger Health System, Chattanooga, Tennessee, USA.
²⁶ Department of Neurology, Emory University School of Medicine, Atlanta, Georgia, USA.
²⁷ Department of Neurosurgery, Radiology and Imaging Sciences, Emory University School of Medicine, Atlanta, Georgia, USA.

PMID: 40908129
DOI: 10.1136/jnis-2025-024023

Abstract

Background: The ESCAPE-MeVO (Endovascular Treatment to Improve Outcomes for Medium Vessel Occlusions) and DISTAL (Endovascular Therapy plus Best Medical Treatment vs Best Medical Treatment Alone for Medium Vessel Occlusion Stroke) trials failed to demonstrate the superiority of endovascular thrombectomy over best medical management for medium and small vessel occlusions. Potential limitations of these trials include older patient populations, lower presenting National Institutes of Health Stroke Scale (NIHSS) scores, higher rates of premorbid disability, delayed revascularization times, inclusion of both medium and small vessel occlusions, and widespread use of stent retrievers. Here we present M2 occlusion data from the Imperative Trial, evaluating aspiration thrombectomy with the Zoom System.

Methods: The Imperative Trial is a prospective, multicenter, single-arm trial with independent core lab and safety board adjudication, evaluating aspiration thrombectomy with the Zoom System (Imperative Care, Campbell, CA, USA) for large vessel, including M2, occlusions. This subanalysis includes patients with primary M2 occlusions. Angiographic outcomes were defined as modified Treatment in Cerebral Infarction (mTICI) score ≥2b (good) and ≥2c (excellent). Clinical outcomes were defined as modified Rankin Scale score (mRS) 0-2 (good) and 0-1 (excellent) at 90 days. Safety was assessed by all-cause mortality, symptomatic intracranial hemorrhage (sICH), and all hemorrhage.

Results: Of 260 enrolled patients, 25% (65/260) had primary M2 occlusions. Median age was 69 years; median NIHSS was 13. Good and excellent reperfusion were achieved in 88% (57/65) and 66% (43/65), respectively. At 90 days, good and excellent clinical outcomes occurred in 62% (39/63) and 56% (35/63), respectively. Mortality, sICH, and any hemorrhage were 4.6% (3/65), 1.5% (1/65), and 18% (12/65), respectively.

Conclusions: The Zoom System demonstrated excellent safety and efficacy in M2 occlusions. These findings support aspiration thrombectomy for M2 occlusions as a viable treatment in well-selected patients.

Keywords: Catheter; Reperfusion; Stroke; Thrombectomy.

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Conflict of interest statement

Competing interests: JRM: Consultant: Stryker, Penumbra, Imperative Care; RADL: Consultant: Hyprevention, Imperative Care, J&J, Medical Device Business Services, Scientia Vascular, Stryker; Stock: Endostream, Q’Apel, Spartan Micro, Synchron, Van Vascular, Vastrax; WM: Consultant: Egret, Imperative Care, Integra LifeSciences, Q’Apel, Rebound Therapeutics, Spartan Micro, Stream Biomedical, Stryker, Viseon; Stock: Borvo, Cerebrotech, Egret, Endostream, Q’Apel, Radical Catheters, Rebound Therapeutics, Spartan Micro, Stream Biomedical, Vastrax, Viseon; RN: Consultant fees: Anaconda, Biogen, Cerenovus, Genentech, Philips, Hybernia, Hyperfine, Imperative Care, Medtronic, Phenox, Philips, Prolong Pharmaceuticals, Stryker Neurovascular, Shanghai Wallaby, Synchron, and stock options for advisory roles: Astrocyte, Brainomix, Cerebrotech, Ceretrieve, Corindus Vascular Robotics, CrestecBio Inc., Euphrates Vascular, Inc., Vesalio, Viz-AI, RapidPulse and Perfuze. Principal Investigator (PI) of the ENDOLOW trial with funding from Cerenovus to Emory University. PI of the DUSK trial with funding from Stryker Neurovascular to University of Pittsburgh. Investor: Viz-AI, Perfuze, Cerebrotech, Reist/Q’Apel Medical, Truvic, Tulavi Therapeutics, Vastrax, Piraeus Medical, Brain4Care, Quantanosis AI, and Viseon. SM: Consultant: DePuy Synthes, Imperative Care, Medical Device Business Services, Rapid Medical; RDT: Consultant: Imperative Care; Payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational event: Inari Medical; MM: Grant: NIH; Consultant: Balt USA, Canon Medical, Imperative Care, J&J, Medtronic, MicroVention, Rapid Pulse; Stock: Bendit Technology, Borvo Medical, Brain Q, Endostream, QAS.AI, Quantanosis.AI, Radical Catheter Technologies, Serenity Medical, Sim&Cure, Synchrone, VICIS; JV: Consultant: Viz.AI, Imperative Care, Precision Neuro, Q’Apel, Medtronic and Microvention; Stock: Viz.AI, Imperative Care, Borvo, Radical, Synchron; BLC: None; KVS: Consultant: Boston Scientific, Canon Medical Systems, MicroVention, Medtronic, Stryker; Payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational event: Canon Medical Systems USA Inc; Stock or stock options: Boston Scientific, Access Closure, Niagara Gorge Medical; VP: None; HJS: Consultant: Imperative Care, Q’Apel Medical, Stryker; DRH: None; AA: Payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational event: Penumbra; DH: Consultant: Imperative Care, Stryker; Payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational event: Medtronic, MicroVention; BY: Consultant: Imperative Care, Q’Apel Medical; MST: None; ARA: Consultant: Medical Device Business Services, Stryker; JMM: Consultant: Imperative Care, MicroVention; SMN: Consultant: Medical Device Business Services, Baskin Biosciences; Payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational event: Medtronic; NH: None; MN: None; DS: None; KFL: Consultant: Stryker; NB: Consultant: Stryker; RMS: Payment or honoraria for lectures, presentations, speakers’ bureaus,manuscript writing, or educational event: Medtronic, Penumbra; HH: None; DCH: Consultant: Chiesi USA, DePuy Synthes, Stryker; AP: None; CPK: Consultant: Integra LifeSciences; Grant: Cerenovus, Medtronic; JAG: Grant: Emory Medical Care Foundation, Emory Neurosurgery Catalyst, Georgia Research Alliance, National Institute of Neurological Disorders and Stroke, Uniformed Services University-Surgical Critical Care Initiative; Consultant: Cognition, Imperative Care, NTI, Route 92.

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Clinical outcomes and independently adjudicated results of M2 aspiration thrombectomy: a subgroup analysis from the Imperative Trial

Affiliations

Clinical outcomes and independently adjudicated results of M2 aspiration thrombectomy: a subgroup analysis from the Imperative Trial

Authors

Affiliations

Abstract

Conflict of interest statement

LinkOut - more resources

Full Text Sources

Miscellaneous