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

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.