Stroke thrombectomy with a novel reperfusion system including a 0.088'' aspiration catheter: the Imperative Trial

William Mack^#¹, Reade Andrew De Leacy^#², Jonathan A Grossberg³, Shahram Majidi², Robert Dana Tomalty⁴, Maxim Mokin⁵, Jan Vargas⁶, Brett L Cucchiara⁷, Kenneth V Snyder⁸, Justin Mascitelli⁹, Victoria Parada^{10

11}, Hakeem J Shakir¹², David Rosenbaum-Halevi¹³, Amin Aghaebrahim¹⁴, Daniel Hoit^{15

16}, Benjamin Yim¹⁷, Matthew S Tenser¹⁸, Alhamza R Al-Bayati¹⁹, James M Milburn²⁰, Shahid M Nimjee²¹, Neil Haranhalli^{22

23}, Michael Nahhas²⁴, Darryn Shaff²⁵, Kennith F Layton²⁶, Narlin Beaty²⁷, Robert M Starke²⁸, Harris Hawk²⁹, Diogo C Haussen³⁰, Aqueel Pabaney³⁰, Christopher Paul Kellner², Raul G Nogueira^#³¹

Affiliations

¹ Department of Neurosurgery, USC Keck School of Medicine, Los Angeles, California, USA.
² Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
³ Department of Neurosurgery, Radiology, and Imaging Sciences, Emory University School of Medicine, Atlanta, Georgia, USA.
⁴ Huntsville Hospital, Huntsville, Alabama, USA.
⁵ Department of Neurosurgery, University of South Florida College of Medicine, Tampa, Florida, USA.
⁶ Department of Neurosurgery, Prisma Health Upstate, Greenville, South Carolina, USA.
⁷ Department of Neurology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
⁸ Department of Neurosurgery, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA.
⁹ Department of Neurosurgery, The University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.
¹⁰ Department of Neurology, Valley Baptist Medical Center, Harlingen, Texas, USA.
¹¹ Department of Neurology, The University of Texas Rio Grande Valley, Brownsville, Texas, USA.
¹² Department of Neurosurgery, The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.
¹³ Department of Neurosurgery, Munson Medical Center, Traverse City, Michigan, USA.
¹⁴ Baptist Neurological Institute, Lyerly Neurosurgery, Jacksonville, Florida, USA.
¹⁵ Department of Neurosurgery, Semmes-Murphey Neurologic and Spine Institute, Memphis, Tennessee, USA.
¹⁶ Department of Neurosurgery, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.
¹⁷ Department of Neurosurgery, John Muir Health, Walnut Creek, California, USA.
¹⁸ Department of Neurosurgery, University of Southern California, Los Angeles, California, USA.
¹⁹ Department of Neurology and Neurosurgery, University of Pittsburgh Medical Center, UPMC Stroke Institute, Pittsburgh, Pennsylvania, USA.
²⁰ Department of Radiology, Ochsner Medical Center, New Orleans, Louisiana, USA.
²¹ Department of Neurological Surgery, Ohio State University, Columbus, Ohio, USA.
²² Department of Neurosurgery, Montefiore Hospital and Medical Center, New York, New York, USA.
²³ Department of Neurosurgery, Albert Einstein College of Medicine, New York, New York, USA.
²⁴ Department of Neurology, University of Texas McGovern Medical School, Houston, Texas, USA.
²⁵ Department of Neurointerventional Radiology, Lehigh Valley Health Network, Allentown, Pennsylvania, USA.
²⁶ Department of Neurointerventional Radiology, Baylor University Medical Center at Dallas, Dallas, Texas, USA.
²⁷ Department of Neurosurgery, Tallahassee Memorial Hospital, Florida State University, Tallahassee, Florida, USA.
²⁸ Department of Neurosurgery, University of Miami Health System, Miami, Florida, USA.
²⁹ Department of Neurosurgery, Erlanger Health System, Chattanooga, Tennessee, USA.
³⁰ Department of Neurology, Emory University School of Medicine, Atlanta, Georgia, USA.
³¹ Department of Neurology and Neurosurgery, University of Pittsburgh Medical Center, UPMC Stroke Institute, Pittsburgh, Pennsylvania, USA raul.g.nogueira@icloud.com.

^# Contributed equally.

PMID: 40695608
DOI: 10.1136/jnis-2025-023719

Stroke thrombectomy with a novel reperfusion system including a 0.088'' aspiration catheter: the Imperative Trial

William Mack et al. J Neurointerv Surg. 2025.

. 2025 Jul 22:jnis-2025-023719.

doi: 10.1136/jnis-2025-023719. Online ahead of print.

Authors

Affiliations

¹ Department of Neurosurgery, USC Keck School of Medicine, Los Angeles, California, USA.
² Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
³ Department of Neurosurgery, Radiology, and Imaging Sciences, Emory University School of Medicine, Atlanta, Georgia, USA.
⁴ Huntsville Hospital, Huntsville, Alabama, USA.
⁵ Department of Neurosurgery, University of South Florida College of Medicine, Tampa, Florida, USA.
⁶ Department of Neurosurgery, Prisma Health Upstate, Greenville, South Carolina, USA.
⁷ Department of Neurology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
⁸ Department of Neurosurgery, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA.
⁹ Department of Neurosurgery, The University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.
¹⁰ Department of Neurology, Valley Baptist Medical Center, Harlingen, Texas, USA.
¹¹ Department of Neurology, The University of Texas Rio Grande Valley, Brownsville, Texas, USA.
¹² Department of Neurosurgery, The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.
¹³ Department of Neurosurgery, Munson Medical Center, Traverse City, Michigan, USA.
¹⁴ Baptist Neurological Institute, Lyerly Neurosurgery, Jacksonville, Florida, USA.
¹⁵ Department of Neurosurgery, Semmes-Murphey Neurologic and Spine Institute, Memphis, Tennessee, USA.
¹⁶ Department of Neurosurgery, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.
¹⁷ Department of Neurosurgery, John Muir Health, Walnut Creek, California, USA.
¹⁸ Department of Neurosurgery, University of Southern California, Los Angeles, California, USA.
¹⁹ Department of Neurology and Neurosurgery, University of Pittsburgh Medical Center, UPMC Stroke Institute, Pittsburgh, Pennsylvania, USA.
²⁰ Department of Radiology, Ochsner Medical Center, New Orleans, Louisiana, USA.
²¹ Department of Neurological Surgery, Ohio State University, Columbus, Ohio, USA.
²² Department of Neurosurgery, Montefiore Hospital and Medical Center, New York, New York, USA.
²³ Department of Neurosurgery, Albert Einstein College of Medicine, New York, New York, USA.
²⁴ Department of Neurology, University of Texas McGovern Medical School, Houston, Texas, USA.
²⁵ Department of Neurointerventional Radiology, Lehigh Valley Health Network, Allentown, Pennsylvania, USA.
²⁶ Department of Neurointerventional Radiology, Baylor University Medical Center at Dallas, Dallas, Texas, USA.
²⁷ Department of Neurosurgery, Tallahassee Memorial Hospital, Florida State University, Tallahassee, Florida, USA.
²⁸ Department of Neurosurgery, University of Miami Health System, Miami, Florida, USA.
²⁹ Department of Neurosurgery, Erlanger Health System, Chattanooga, Tennessee, USA.
³⁰ Department of Neurology, Emory University School of Medicine, Atlanta, Georgia, USA.
³¹ Department of Neurology and Neurosurgery, University of Pittsburgh Medical Center, UPMC Stroke Institute, Pittsburgh, Pennsylvania, USA raul.g.nogueira@icloud.com.

^# Contributed equally.

PMID: 40695608
DOI: 10.1136/jnis-2025-023719

Abstract

Background: Mechanical thrombectomy is the standard of care for large vessel occlusion (LVO) stroke, yet most device trials focus on individual technologies rather than complete systems.

Objective: To evaluate the safety and efficacy of the Zoom Reperfusion System compared with performance goals derived from a meta-analysis of trials using established thrombectomy technologies.

Methods: Prospective, multicenter, non-randomized, investigational device exemption trial conducted across 26 United States centers from October 2021 to March 2024. Adults with anterior circulation LVO stroke within 8 hours of onset were treated using the Zoom System, which includes aspiration catheters ranging from 0.035″ to 0.071″, and a novel 0.088″ intracranial guide/aspiration catheter. The primary efficacy endpoint was successful reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) 2b-3) within three passes using Zoom-only components, adjudicated by an independent core laboratory. The primary safety endpoint was symptomatic intracranial hemorrhage (sICH). Secondary outcomes included final reperfusion, first-pass success, time to reperfusion, 90-day modified Rankin Scale (mRS), and mortality.

Results: Among 260 patients (median age 68 years; median National Institutes of Health Stroke Scale (NIHSS) 15), successful reperfusion within three passes was achieved in 83% (216/259; 95% CI: 78% to 89%), exceeding the performance goal (p<0.001). Final reperfusion was 92%, with 5.5% requiring rescue devices. First-pass mTICI 2b-3 success was 57%. Median puncture-to-reperfusion time was 19 min. At 90 days, 55% achieved mRS 0-2. The sICH rate was 1.9%, and 90-day mortality was 12.7%.

Conclusions: The Zoom Reperfusion System demonstrated a safety and efficacy profile exceeding prespecified contemporary performance metrics with potential to significantly shorten reperfusion times and reduce the need for rescue therapy.

Trial registration number: ClinicalTrials.gov--Identifier:NCT04129125.

Keywords: Catheter; Reperfusion; Stroke; Thrombectomy.

PubMed Disclaimer

Conflict of interest statement

Competing interests: 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. RADL: Consultant: Hyprevention, Imperative Care, J&J, Medical Device Business Services, Scientia Vascular, Stryker; Stock: Endostream, Q’Apel, Spartan Micro, Synchron, Van Vascular, Vastrax. 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. 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: National Institutes of Health (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. JM: Consultant: Imperative Care, Stryker. VP: None. HJS: Consultant: Imperative Care, Q’Apel Medical, Stryker. DR-H: 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-B: 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. RGN: 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.

Associated data

Actions
- Search in PubMed
- Search in ClinicalTrials.gov

LinkOut - more resources

Full Text Sources
- HighWire

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Stroke thrombectomy with a novel reperfusion system including a 0.088'' aspiration catheter: the Imperative Trial

Affiliations

Stroke thrombectomy with a novel reperfusion system including a 0.088'' aspiration catheter: the Imperative Trial

Authors

Affiliations

Abstract

Conflict of interest statement

Associated data

LinkOut - more resources

Full Text Sources