Introduction EMBOVAC is a large bore aspiration catheter with an inner diameter of 0.071’.
Aim of Study PERFECT (NCT04531904, CERENOVUS) was a prospective, post-market, single-arm study to assess direct aspiration with EMBOVAC as first line therapy in patients with large vessel occlusion and analyse the composition of retrieved thrombus.
Methods Subjects were enrolled and followed across 11 European centres between October 2020 and July 2022. A minimum of 3 direct aspiration passes with EMBOVAC were mandated before switching strategy. The primary endpoint was core-lab assessed successful reperfusion (mTICI≥2b) post-procedure. Other outcomes included 90-day mRS by an independent evaluator, symptomatic intracerebral hemorrhage by an independent Clinical Events Committee, and clot analysis by an independent central clot lab.
Results Final mTICI≥2b was achieved in 98.0% (97/99) while final mTICI≥2c was reached in 86.9% (86/99) of patients. Final mTICI≥2b without rescue was reached in 87.9% (87/99). First pass mTICI≥2c without rescue was achieved in 53.5% (53/99). mRS≤2 at 90 days was 56.6% (56/99). All-cause mortality at 90 days was 12.9%. No patients experienced sICH at 24 hours post-procedure. One device-related SAE occurred within 90 days. Composition analysis revealed median 54.80% red blood cells and 24.90% fibrin.
Conclusion This is the first clinical evaluation of EMBOVAC. Direct aspiration with EMBOVAC as first line therapy resulted in high rates of reperfusion and favorable clinical outcomes. Clot composition analysis can aid in better understanding of the stroke etiology and means for effective clot removal.
Disclosure of Interest Acandis (OJ, CL, JF); Microvention (GM, CC, JF); Stryker (GM, CC, JF); Medtronic (GM, CC, JF); Surge2surgery (BG); MIVI (CC); Phenox (CL, JF); Penumbra (CL, JF); GSK (AS); German Ministry of Science & Education and Economy & Innovation, EU, Hamburgische Investitions-/Förderbank, Philips, Bayer, Boehringer Ingelheim, Cerenovus, Covidien, Evasc Neurovascular, MD Clinicals, Medina, Roche, Route92, Tonbridge, Transverse Medical, Tegus Medical, Vastrax (JF); Science Foundation Ireland (KD), KL, HN, BE, AP, SB, AM, MP: nothing to disclose.
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