Evidence map›Paper›PMID 40695608›Full record

Trial reportJournal of neurointerventional surgery2026

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

William Mack, Reade Andrew De Leacy, Jonathan A Grossberg, Shahram Majidi, Robert Dana Tomalty, Maxim Mokin, Jan Vargas, Brett L Cucchiara, Kenneth V Snyder, Justin Mascitelli and 21 more

Registry-linked trialAbstract readMulticenter StudyClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of neurointerventional surgery, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04129125 (A Prospective, Multi-center, Open Label and Single Arm Clinical Investigation to Evaluate the Safety and Efficacy of Using the Zoom Reperfusion System in Thrombectomy Procedures to Treat Acute Ischemic Stroke Patients), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04129125 nacompletednot on this map

A Prospective, Multi-center, Open Label and Single Arm Clinical Investigation to Evaluate the Safety and Efficacy of Using the Zoom Reperfusion System in Thrombectomy Procedures to Treat Acute Ischemic Stroke Patients

TypeinterventionalSponsorImperative Care, Inc.Ran2021 to 2024Enrolled328ConditionsIschemic Stroke, Acute StrokeArmsZoom Reperfusion System
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

31 authors.

William Mack *Department of Neurosurgery, USC Keck School of Medicine, Los Angeles, California, USA.
Reade Andrew De Leacy *Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, New York, USA.ORCID http://orcid.org/0000-0001-9447-5338
Jonathan A GrossbergDepartment of Neurosurgery, Radiology, and Imaging Sciences, Emory University School of Medicine, Atlanta, Georgia, USA.ORCID http://orcid.org/0000-0002-1152-8826
Shahram MajidiDepartment of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, New York, USA.ORCID http://orcid.org/0000-0003-2971-6216
Robert Dana TomaltyHuntsville Hospital, Huntsville, Alabama, USA.
Maxim MokinDepartment of Neurosurgery, University of South Florida College of Medicine, Tampa, Florida, USA.ORCID http://orcid.org/0000-0003-4270-8667
Jan VargasDepartment of Neurosurgery, Prisma Health Upstate, Greenville, South Carolina, USA.ORCID http://orcid.org/0000-0001-7164-1479
Brett L CucchiaraDepartment of Neurology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Kenneth V SnyderDepartment of Neurosurgery, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA.ORCID http://orcid.org/0000-0002-0842-9026
Justin MascitelliDepartment of Neurosurgery, The University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.
Victoria ParadaDepartment of Neurology, Valley Baptist Medical Center, Harlingen, Texas, USA.
Hakeem J ShakirDepartment of Neurosurgery, The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.ORCID http://orcid.org/0000-0003-4234-340X
David Rosenbaum-HaleviDepartment of Neurosurgery, Munson Medical Center, Traverse City, Michigan, USA.
Amin AghaebrahimBaptist Neurological Institute, Lyerly Neurosurgery, Jacksonville, Florida, USA.
Daniel HoitDepartment of Neurosurgery, Semmes-Murphey Neurologic and Spine Institute, Memphis, Tennessee, USA.
Benjamin YimDepartment of Neurosurgery, John Muir Health, Walnut Creek, California, USA.ORCID http://orcid.org/0000-0003-3629-3194
Matthew S TenserDepartment of Neurosurgery, University of Southern California, Los Angeles, California, USA.
Alhamza R Al-BayatiDepartment of Neurology and Neurosurgery, University of Pittsburgh Medical Center, UPMC Stroke Institute, Pittsburgh, Pennsylvania, USA.ORCID http://orcid.org/0000-0001-8103-1930
James M MilburnDepartment of Radiology, Ochsner Medical Center, New Orleans, Louisiana, USA.ORCID http://orcid.org/0000-0003-3403-2628
Shahid M NimjeeDepartment of Neurological Surgery, Ohio State University, Columbus, Ohio, USA.ORCID http://orcid.org/0000-0002-0317-8731
Neil HaranhalliDepartment of Neurosurgery, Montefiore Hospital and Medical Center, New York, New York, USA.
Michael NahhasDepartment of Neurology, University of Texas McGovern Medical School, Houston, Texas, USA.ORCID http://orcid.org/0000-0001-8198-7676
Darryn ShaffDepartment of Neurointerventional Radiology, Lehigh Valley Health Network, Allentown, Pennsylvania, USA.
Kennith F LaytonDepartment of Neurointerventional Radiology, Baylor University Medical Center at Dallas, Dallas, Texas, USA.
Narlin BeatyDepartment of Neurosurgery, Tallahassee Memorial Hospital, Florida State University, Tallahassee, Florida, USA.
Robert M StarkeDepartment of Neurosurgery, University of Miami Health System, Miami, Florida, USA.
Harris HawkDepartment of Neurosurgery, Erlanger Health System, Chattanooga, Tennessee, USA.
Diogo C HaussenDepartment of Neurology, Emory University School of Medicine, Atlanta, Georgia, USA.
Aqueel PabaneyDepartment of Neurology, Emory University School of Medicine, Atlanta, Georgia, USA.
Christopher Paul KellnerDepartment of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, New York, USA.ORCID http://orcid.org/0000-0003-4604-8205
Raul G Nogueira *Department of Neurology and Neurosurgery, University of Pittsburgh Medical Center, UPMC Stroke Institute, Pittsburgh, Pennsylvania, USA raul.g.nogueira@icloud.com.ORCID http://orcid.org/0000-0003-4532-153X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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

objectiveTo 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.

methodsProspective, 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.

resultsAmong 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%.

conclusionsThe 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.

Indexed as

CathetersIschemic StrokeReperfusionStrokeThrombectomyAgedAged, 80 and overFemaleHumansMaleMiddle AgedProspective StudiesTreatment OutcomeCatheterReperfusionStrokeThrombectomy

Identifiers

PMID40695608
PMCPMC13217112

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.