Abstract Background and aims The Millipede AspiRation for Revascularization in Stroke (MARRS) pivotal study was a prospective, single-arm investigation to assess the performance and safety of the Millipede System in subjects with acute ischemic stroke due to large vessel occlusion (LVO) within 8 hours. This is the first presentation of the final study results. Methods Enrolment occurred at 22 US and European sites. 180 subjects with ICA, M1, M2, and basilar artery occlusions were treated. To meet FDA study requirements, users measured the target vessel and selected the catheter size ensuring the vessel diameter exceeded ≥2.74 mm for Millipede88 and ≥2.21 mm for Millipede70, respectively. Results Median age was 69 years, 51% were male, with mean baseline NIHSS 17 and ASPECTS 8.6. M1 was the most common occlusion location (62%). Direct first-pass aspiration was performed using Millipede88 and Millipede70 in 115 and 64 subjects, respectively. Successful delivery of Superbore Millipede88 was 96%. In M1 occlusions, the FPE rate (mTICI ≥2c) with Millipede88 was 77% (PP). Overall Millipede88 FPE rate was 61% (PP), exceeding prior meta-analyses and large registries (27.0–46.6%). A final mTICI ≥2c rate of 85% was achieved (PP). Rates of sICH and intracranial dissection were low (2.3% and 1.1%, ITT). No significant differences in reperfusion success were observed between higher and lower-enrolling sites. 56% of patients treated with Millipede88 on first-pass (PP) achieved mRS 0-2 at 90 days. Conclusions Millipede88 achieved the highest reperfusion rates reported among prospective thrombectomy trials to date. Outcomes were particularly favorable in M1 occlusions, likely reflecting optimal vessel-to-catheter diameter matching. Conflict of interest Raul G. Nogueira (RGN) reports consulting fees from Anaconda, Biogen, Boehringer Ingelheim, Cerenovus, Genentech, Philips, Hybernia, Hyperfine, Imperative Care, Medtronic, Phenox, Philips, Prolong Pharmaceuticals, Stryker Neurovascular, Shanghai Wallaby, Synchron, Takeda Pharmaceutical, and stock options for consulting from Astrocyte, Brainomix, Cerebrotech, Ceretrieve, Corindus Vascular Robotics, CrestecBio Inc., Euphrates Vascular, Inc., Vesalio, Viz-AI, RapidPulse, Sensome, and Perfuze. RGN is a PI for the ENDOLOW trial with funding provided by Cerenovus to Emory University and a PI for the DUSK trial with funding provided by Stryker to University of Pittsburgh. RGN is an investor in Viz-AI, Perfuze, Cerebrotech, Reist/Q’Apel Medical, Truvic, Tulavi Therapeutics, Vastrax, Piraeus Medical, Brain4Care, Quantanosis AI, and Unity Medical, and Viseon. Manuel Requena: reported receiving personal fees from iVascular. Jaydevsinh N. Dolia: none. Syed F. Zaidi: none. Pedro Navia: Consultant for Penumbra, Balt, Stryker and Terumo. Gaultier Marnat: reported receiving personal fees from Perfuze, Stryker, Balt, Terumo Neuro, Johnson SELECT, DAWN, SELECT 2, EXPEDITE II, EMBOLISE, CLEAR, ENVI, DELPHI, DISTALS, Rapid Pulse. DSMB; COMAND trial. Supported by grants from: Asahi, Balt, Scientia, Valley Baptist, GE Healthcare, and Viz.ai. Co-Founder; Quantanosis.ai, SWIFT Path, 3N Neurovascular, QRA, and Quanta Therapeutikos. Tareq Kass-Hout: none. Ricardo A. Hanel: Consultant: Medtronic, Stryker, J&J, Microvention, Balt, Phenox, Rapid Medical, Q’Apel, MMI, NeuroFine, Crowd Range Medical, Spryte, Hyperion, Phillips, NV MedTech, Mentice, Sentante. Stock or stock options: InNeuroCo, Endostream, Three Rivers Medical Inc, Scientia, RisT, BlinkCNS, Prometheus, Tulavi, Radical Catheters, CFI Neurolutions, REIST, Galaxy, IHeal, Deinde, NeuroFine, Hyperion, Synchron, Quantanosis, Basecamp Vascular, Borvo, FreeOx, Kandu Health, Lets Go Proof, Serenity, Sheperd Vascular, Stroke Diagnostics LLC, Unity, Robeaute. Grants / Research Support: NIH, Microvention, CNX, Interline Endowment, Stryker. Benjamin Gory: none. Marc Ribó: reported receiving personal fees from: Perfuze, Anaconda Biomed, AptaTargets, Johnson&Johnson, Medtronic, Methinks, Philips, Sanofi, Stryker, Balt, Siemens, Nora Health and Rapid AI.
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Raul Nogueira
Manuel Requena
Jaydevsinh Dolia
European Stroke Journal
Yale University
Oregon Health & Science University
University of Rochester Medical Center
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Nogueira et al. (Fri,) studied this question.
www.synapsesocial.com/papers/69fd7f0dbfa21ec5bbf076ef — DOI: https://doi.org/10.1093/esj/aakag023.573
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