A234 Final results of the DISTALS (distal ischemic stroke treatment with adjustable low-profile stentriever) randomized trial of TIGERTRIEVER 13-EVT for DMVO

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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 deployment in distal medium vessel occlusions (DMVO). Early (24h) outcome results were presented at ISC (February-2026). Objective/Purpose To present the full results, including 3-month outcomes. 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 global disability (mRS shift), the 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 were: non-/co-dominant M2-41%; M3-25%; PCA-25%; ACA-9%. LKWT-to-randomization was 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. The last patient 3-month follow-up will be completed in March 2026, allowing trial mRS, EQ-5D, MoCA, and mortality results to be presented at ESOC. Discussion/Conclusions/Learning Points Early outcome results of the randomized DISTALS trial demonstrate that the Tigertriever-13 is a safe and effective clot removal treatment strategy for DMVO patients. Clinical endpoint results will provide important additional insights into treatment outcomes.

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