RESTORE: REal-world analyses of Stroke-Thrombus Occlusion REtrieval study: effectiveness, safety, and technical outcomes

Background Mechanical thrombectomy has become the cornerstone of treatment for acute ischemic stroke (AIS) caused by large vessel occlusion. While randomized trials have established non-inferiority of aspiration-based approaches compared with stent retriever approaches, real-world evidence is essential to evaluate device performance across heterogeneous populations, anatomies, and procedural strategies. The objective of the RESTORE registry is to report the final results and contextualize its findings within the evolving landscape of large- and super-large-bore aspiration catheter technologies. Methods RESTORE (REal-world analyses of Stroke-Thrombus Occlusion REtrieval study) is a prospective, multicenter, observational registry enrolling AIS patients treated with Terumo Neuro devices as a first-line mechanical thrombectomy approach. Angiographic and safety outcomes were evaluated by an independent core laboratory and clinical events committee, respectively. Results Among 710 enrolled patients across 36 centers, 688 comprised the final analysis cohort. Final reperfusion (modified Thrombolysis In Cerebral Infarction (mTICI) ≥2b) was achieved in 93.0%, with first-pass mTICI ≥2b in 60.8%. Median puncture-to-clot contact and puncture-to-reperfusion times were 13 and 17 min, respectively. Symptomatic intracranial hemorrhage occurred in 0.6% of patients, and the all-cause mortality rate at 90 days was 16.3%. Embolization to new territory occurred in 0.4%, and 52.9% of patients achieved functional independence (modified Rankin Scale ≤2) at 90 days. Conclusions RESTORE represents one of the largest prospective real-world registries evaluating a SOFIA-dominant first-line thrombectomy approach using Terumo Neuro devices for AIS due to intracranial vessel occlusion. Under routine practice conditions, the registry demonstrated favorable angiographic, procedural, and clinical outcomes with a reassuring safety profile, supporting aspiration-dominant approaches as an effective and safe first-line strategy in this setting. However, because RESTORE was observational, single-arm, and descriptive, these findings should be interpreted as real-world evidence of feasibility and safety rather than proof of comparative efficacy or superiority over other thrombectomy strategies.

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Journal
Journal of NeuroInterventional Surgery
Published
2026-09-24
DOI
https://doi.org/10.1136/jnis-2026-025721
Primary Topic
Acute Ischemic Stroke Management
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article
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article

RESTORE: REal-world analyses of Stroke-Thrombus Occlusion REtrieval study: effectiveness, safety, and technical outcomes

Ricky Medel, Timothy Ryan Miller, Charles Joseph Prestigiacomo, Khaled Gharaibeh et al.
Journal of NeuroInterventional Surgery
Acute Ischemic Stroke Management
article

RESTORE: REal-world analyses of Stroke-Thrombus Occlusion REtrieval study: effectiveness, safety, and technical outcomes

Ricky Medel, Timothy Ryan Miller, Charles Joseph Prestigiacomo, Khaled Gharaibeh, Norman Ajiboye, Edward D. Greenberg, Yi Jonathan Zhang, Ghasan Ahmad, David J. Fiorella, Josser E Delgado Almandoz, Nitin Goyal, Arindam Rano Chatterjee, Imran Chaudry, Huanwen Alvin Chen, Hakeem J Shakir, Daniel H. Sahlein, Timothy G. White, Gabor G. Toth, Maxim Mokin, Jan Karl Burkhardt, Clemens Schirmer, Syed Zaidi, Daniel E Surdell, Scott Rahimi, Fazeel Siddiqui, Gary Rajah, Lucian Maidan, Dheeraj Gandhi, Sean Cullen
article en

Abstract

Background Mechanical thrombectomy has become the cornerstone of treatment for acute ischemic stroke (AIS) caused by large vessel occlusion. While randomized trials have established non-inferiority of aspiration-based approaches compared with stent retriever approaches, real-world evidence is essential to evaluate device performance across heterogeneous populations, anatomies, and procedural strategies. The objective of the RESTORE registry is to report the final results and contextualize its findings within the evolving landscape of large- and super-large-bore aspiration catheter technologies. Methods RESTORE (REal-world analyses of Stroke-Thrombus Occlusion REtrieval study) is a prospective, multicenter, observational registry enrolling AIS patients treated with Terumo Neuro devices as a first-line mechanical thrombectomy approach. Angiographic and safety outcomes were evaluated by an independent core laboratory and clinical events committee, respectively. Results Among 710 enrolled patients across 36 centers, 688 comprised the final analysis cohort. Final reperfusion (modified Thrombolysis In Cerebral Infarction (mTICI) ≥2b) was achieved in 93.0%, with first-pass mTICI ≥2b in 60.8%. Median puncture-to-clot contact and puncture-to-reperfusion times were 13 and 17 min, respectively. Symptomatic intracranial hemorrhage occurred in 0.6% of patients, and the all-cause mortality rate at 90 days was 16.3%. Embolization to new territory occurred in 0.4%, and 52.9% of patients achieved functional independence (modified Rankin Scale ≤2) at 90 days. Conclusions RESTORE represents one of the largest prospective real-world registries evaluating a SOFIA-dominant first-line thrombectomy approach using Terumo Neuro devices for AIS due to intracranial vessel occlusion. Under routine practice conditions, the registry demonstrated favorable angiographic, procedural, and clinical outcomes with a reassuring safety profile, supporting aspiration-dominant approaches as an effective and safe first-line strategy in this setting. However, because RESTORE was observational, single-arm, and descriptive, these findings should be interpreted as real-world evidence of feasibility and safety rather than proof of comparative efficacy or superiority over other thrombectomy strategies.

Journal of NeuroInterventional Surgery
Inova Health System (US), University of Toledo Medical Center (US), University of Maryland, Baltimore (US), Prisma Health (US), National Institutes of Health (US), Nebraska Medical Center (US), University of Maryland Medical Center (US), Munson Medical Center (US), Allina Health (US), Kaiser Permanente (US), University of South Florida (US), University of Michigan (US), Hospital of the University of Pennsylvania (US), University Health System (US), Mercy San Juan Medical Center (US), Kaiser Permanente Oakland Medical Center (US), ProMedica Toledo Hospital (US), Augusta University Health (US), Memorial Healthcare System (US), Mallinckrodt (United States) (US), Stony Brook Medicine (US), Queen's Medical Center (US), Donald & Barbara Zucker School of Medicine at Hofstra/Northwell (US), National Institute of Neurological Disorders and Stroke (US), Semmes Murphey Foundation (US), Neurological Surgery (US), Jersey Shore University Medical Center (US), ProMedica, University of Oklahoma Health Sciences Center (US), Geisinger Health System (US), University of Nebraska Medical Center (US), University of Cincinnati (US), University of Toledo (US)
Good health and well-being
Openalex Percentile: Top 11%
Acute Ischemic Stroke Management
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