Prospective evaluation to characterize the real-world performance of the EMBOVAC aspiration catheter for neurothrombectomy: a post-market clinical follow-up trial.

BACKGROUND

A direct aspiration first pass technique (ADAPT) is an effective alternative to stent retriever thrombectomy for patients with large vessel occlusion (LVO). The PERFECT study evaluated direct aspiration with the EMBOVAC large bore aspiration catheter in patients with LVO strokes.

METHODS

PERFECT was a prospective, post-market, single-arm, multicenter, observational study of patients enrolled across 11 European centers between October 2020 and July 2022. Three direct aspiration passes with EMBOVAC were mandated before switching strategy. The primary endpoint was core-lab assessed successful reperfusion (modified Thrombolysis In Cerebral Infarction (mTICI) ≥2b) post-procedure. Other outcomes included first pass mTICI ≥2c, independent 90-day modified Rankin Scale (mRS) evaluation, and symptomatic intracerebral hemorrhage (sICH) at 24 hours by a clinical events committee.

RESULTS

EMBOVAC was used in 100 patients (mean age 70.4±14.0 years, 59.0% (59/100) female). Final mTICI ≥2b was achieved in 98.0% (97/99), final mTICI ≥2b with no change in frontline therapy or thrombolytics use during the procedure was achieved in 87.9% (87/99), final mTICI ≥2c in 86.9% (86/99), and first pass mTICI ≥2c in 53.5% (53/99). sICH at 24 hours was 0%. The 90-day mRS ≤2 rate was 56.6% (56/99) and all-cause mortality was 12.9%. One device-related serious adverse event occurred within 90 days (1.0%).

CONCLUSIONS

PERFECT demonstrates that EMBOVAC achieves successful reperfusion rates and favorable clinical outcomes when used in the endovascular treatment of acute ischemic stroke (AIS) using a direct aspiration technique as first line therapy in a real-world setting in patients with AIS secondary to large vessel occlusion.

TRIAL REGISTRATION

www.

CLINICALTRIALS

gov Unique identifier: NCT04531904.

Informations de copyright

© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: OJ: personal fees: Fa. Arcandis/Germany. GM: payment/honoraria for lectures, presentations, Speakers Bureaus, manuscript writing, educational events: Medtronic, Microvention; consulting fees: Stryker Neurovascular, Microvention Europe, Balt SAS, Sim and Size; paid lectures: Medtronic 675, Cerenovus, Bracco, Phenox. BG: consulting fees: Surge2surgery. HN: payment/honoraria for lectures, presentations, educational events: Acandis, Cerenovus, Phenox, Rapid medical. CC: payment/honoraria for lectures, presentations, Speakers bureaus, manuscript writing, educational events: Medtronic, Microvention, MIVI, Stryker. CL: proctoring/consultant services: Phenox; consultant services: Penumbra; travel and meeting expenses: Acandis, Penumbra; payment of honoraria for lectures and support for attending meetings: Phenox, Penumbra, Acandis. AS: employed by/holds shares: GSK. JF: research support: German Ministry of Science and Education, German Ministry of Economy and Innovation, German Research Foundation, European Union, Hamburgische Investitions-/ Förderbank, Medtronic, Microvention, Philips, Stryker; consultancy appointments: Acandis, Bayer, Boehringer Ingelheim, Cerenovus, Medtronic, Microvention, Penumbra, Phenox, Roche, Route92, Stryker, Tonbridge, TG Medical; stock holdings: Tegus Medical, Vastrax, Eppdata. KD: academic grants: Science Foundation Ireland. MP, BE, AP, MZ, AM, KL: nothing to disclose.