Abstract Background and aims The DISTALS randomized trial evaluates the safety and effectiveness of the TIGERTRIEVER13 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); full, results, including 3-month outcomes, will be presented at ESOC-2026. Methods DISTALS is a US/Europe, multicenter, prospective, randomized, blinded endpoint, FDA/IDE trial in patients ineligible for IV thrombolysis. Trial objective is to evaluate Tigertriever13 safety/effectiveness in restoring blood flow in DMVO patients presenting within 24h of onset. The primary outcome is successful reperfusion (24h/CTP) 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 Between May 2022 and December 2025, 149 patients were enrolled, 31 lead-in and 118 randomized. Mean age was 69 (±11); 39%-women; 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. The primary endpoint, successful reperfusion without sICH, favored the treatment arm, 86.3% vs. 27.7%, p0.001. sICH events were 1.6% vs 0% (p=1), ITT, with 0 sICH in randomized patients treated with Tigertriever13. The last patient 3-month follow-up will be completed in March 2026, allowing secondary outcomes results to be presented at ESOC. Conclusions Early outcome results of the DISTALS trial demonstrate that the Tigertriever13 is a safe and effective clot removal treatment strategy for DMVO patients. Clinical endpoint results will provide important additional insights into treatment outcomes. Conflict of interest
Saver et al. (Fri,) studied this question.