LB-006 Final results – EVAQ study of the Q revascularization system in acute ischemic stroke

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Introduction The Q revascularization System is a novel thrombectomy device that improves aspiration efficacy by increasing the system inner diameter while shortening the aspiration distance during thrombectomy (figure 1). We report the final results of the EVAQ study of the Q revascularization system. Methods The EVAQ study is a prospective, single arm, core lab adjudicated, blinded clinical endpoint IDE study of the Q revascularization system in patients undergoing thrombectomy within 8 hours of symptom onset. The primary efficacy and safety endpoints were mTICI 2b-3 at the completion of the procedure and SICH.Pre-specified secondary endpoints included successful revascularization (mTICI 2b-3) after aspiration with Q, mTICI 2b-3 flow after the first aspiration attempt with Q, and mRS of 0-2 at 90 days.The primary effectiveness and safety endpoints were determined by demonstrating non-inferiority using the Clopper-Pearson method with one-sided 97.5% exact binomial confidence intervals compared to historical performance goals. Results The study was conducted in 17 centers (10 US & 7 French) from November 2020 to April 2023. One hundred and twenty-three patients, 84 (68.3%) in France, were enrolled. The average age of patients was 68.3 (SD ± 14.0),NIHSS 15.8 (SD ± 5.9), and ASPECTS 8.1 (SD ± 1.5), and 52.8% were female. The sites of occlusion were Basilar 3.3%, ICA 13.9%, MCA(M1) 64.2%, MCA(M2) 17.1%, other 1.6%. The average last known well to arrival time was 3.44 hours (SD ± 2.31). IV Thrombolysis was administered in 55.5% of patients. The average onset to arterial puncture time was 4.58 hours (SD ± 2.04). Final mTICI 2b-3 at the completion of the procedure was achieved in 93.9% of patients versus the 70% historical performance goal thus satisfying the primary effectiveness goal of non-inferiority (p < 0.001). The primary safety endpoint was met with a SICH rate of 6.5% which was statistically non-inferior to the performance goal of 15.4%, p=0.0045. The rate of mTICI 2b-3 flow after the first aspiration attempt with Q was 56.7%, mTICI2b-3 flow after all use of Q was 78.8%, and ENT occurred in 2.5% of cases. The mRS of 0-2 and mortality at 90 days were 46.5% and 18.6%.Time from groin puncture to successful revascularization was 38.2 minutes (SD ± 26.7). Rescue therapy (switching from Q alone before achieving TICI2b-3) occurred in 19.2% of cases. Conclusions The Q system is safe and effective for revascularization of LVO strokes. This novel aspiration system demonstrated a very high complete revascularization and first pass effect. Disclosures L. Elijovich: 1; C; MIVI. 2; C; Medtronic, VizAI, Scientia, Cerenovus, Microvention, Siemens. B. Jankowtiz: None. B. Gory: None. R. Bourcier: None. X. Barreau: None. F. Di Maria: None. L. Spelle: None. M. Mokin: None. A. Siddiqui: None. J. Soomro: None. O. Eker: None. C. Schrimer: None. A. Jadhav: None. H. Shaikh: None. C. Matouk: None. M. Stiefel: None. A. Taqi: None. J. Darcourt: None. L. Ikka: None. M. Gaultier: None. G. Bellanger: None. F. Gariel: None. A. SGreccia: None. P. Alexandre: None. L. Liao: None. M. Laubacher: None. J. Davies: None. A. Januel: None. H. Desal: None. O. Mir: None. R. Riva: None. S. Pizzuto: None. D. Liebeskind: None. C. Cognard: None.

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