Article Text
Abstract
Introduction The Q Revascularization System is a novel thrombectomy device which aims to improve aspiration efficacy by increasing the system inner diameter. The larger diameter allows for greater impulse and acceleration of aspiration than traditional aspiration systems.
Aim of Study Report the results of the EVAQ clinical study,
Methods EVAQ is a prospective, single arm study with CEC and Core Lab assessed endpoints studying Q for the primary treatment of LVOs within 8hrs of symptom onset. Primary efficacy and safety endpoints are final mTICI2b-3 and sICH. Pre-specified secondary endpoints include revascularization after use of Q, first pass reperfusion and mRS0-2 at 90 days.
Results The EVAQ study enrolled one hundred twenty-three subjects at 17 centers in France and the US from November 2020 to April 2023. Mean age was 68.3. Females were 52.8%. Mean NIHSS and ASPECTS were 15.8±5.9 and 8.1±1.5 respectively. Sites of large vessel occlusion treatment were Basilar 3.3%, ICA 13.9%, M1 MCA 64.2%, M2 MCA 17.1%, and other anterior location 1.6%. IV thrombolysis was administered in 55.5% of subjects. Onset to arterial puncture was 4.58 hours ±2.04.
The primary outcome, final mTICI2b-3 by independent imaging core lab, was achieved in 93.9% of subjects. CEC adjudicated sICH per ECASS was 6.5%. Revascularization after the use of Q alone was 78.8% and first pass success was 56.7%. Time from groin puncture to successful revascularization was a mean of 38.2 minutes.
Conclusion The novel Q Revascularization System is safe and effective for revascularization of Large Vessel Occlusions in acute ischemic stroke.
Disclosure of Interest no.