A324 Final results of the DISTALS randomized trial: adjustable low-profile stentriever treatment for distal medium vessel occlusion

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Background/Introduction The DISTALS randomized trial evaluates the safety and effectiveness of the TIGERTRIEVER-13 Revascularization Device, a radially-adjustable stent-retriever designed for distal medium vessel occlusions (DMVO). Objective/Purpose Early (24h) outcome results were presented at ISC 2026; full results, including 3-month outcomes, will be presented. Methods/Case Description DISTALS is a US/Europe, multicenter, prospective, randomized, blinded endpoint, FDA IDE trial in patients ineligible for IV thrombolysis. Trial objective is to evaluate Tigertriever-13 safety/effectiveness in restoring blood flow in DMVO patients presenting within 24h of onset. The primary outcome is successful reperfusion (24h CTP/PWI-MR) without symptomatic intracranial hemorrhage (sICH). Clinical efficacy/safety secondary outcomes include 90d disability (mRS shift), EQ-5D, MoCA, mortality and any ICH. Results/Findings Between May 2022 and December 2025, 149 patients were enrolled, 31 lead-in and 118 randomized. Mean age was 69 (±11); 39%-women; region US 68%-US, EU-32%; baseline NIHSS 7.3 (±4.5). Occlusion locations: non-/co-dominant M2-41%; M3-25%; PCA-25%; ACA-9%. LKWT-to-randomization 511 minutes (IQR 245-884). The primary endpoint, successful reperfusion without sICH, favored the treatment arm, 86.3% vs. 27.7%, p<0.001. sICH events were 1.6% vs 0% (p=1), ITT, with 0 sICH in randomized patients treated with Tigertriever-13. There was a clear trend in the treatment arm, in shifting patients towards less disability as assessed by improvement of one or more points in mRS at 90 days compared with the mRS assessed at admission. More patients reported perfect helth (5Q-HD) in the treatment arm at 3 months. Treated patients with recanalization (mTICI 2-b3) or perfusion at 24 hours, mRS 0-1 was significantly higher compared to controls. Discussion/Conclusions/Learning Points These data indicate that the Tigertriever 13 can safely and effectively reperfuse the affected tissue in patients with DMVOs within 24 hours. This study also demonstrates the value of radiological endpoints in identifying DMVO treatment indication, as well as igniting a debate on how we measure clinical benefit in this heterogenous, underserved population.

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