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P151/175  Direct aspiration with EMBOVAC – first clinical experience and clot composition (results the “PERFECT’ study)
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  1. Kyriakos Lobotesis1,
  2. Olav Jansen2,
  3. Gaultier Marnat3,
  4. Benjamin Gory4,
  5. Hannes Nordmeyer5,
  6. Bernd Eckert6,
  7. Pedicelli Alessandro7,
  8. Christophe Cognard8,
  9. Christian Loehr9,
  10. Sandra Bracco10,
  11. Axel Schaefer9,
  12. Antonio Macera11,
  13. Jens Fiehler12,
  14. Karen Doyle13,
  15. Mariangela Piano11
  1. 1Charing Cross Hospital, Imaging Research Unit, London, UK
  2. 2University Hospital, Christian- Albrechts – University Kiel , Kiel, Germany
  3. 3University Hospital of Bordeaux, Department of Diagnostic and Interventional Neuroradiology, Bordeaux, France
  4. 4University of Lorraine, CHRU-Nancy, Department of Diagnostic and Therapeutic Neuroradiology, Nancy, France
  5. 5Alfried Krupp Krankenhaus Rüttenscheid, Department of Neuroradiology and Intracranial Endovascular Therapy, Essen, Germany
  6. 6Asklepios Klinik Altona, Department of Neuroradiology, Hamburg, Germany
  7. 7UOC Radiologia e Neuroradiologia, Rome, Italy
  8. 8HU de Toulouse – Hôpital Purpan, Toulouse, France
  9. 9Klinikum Vest Knappschaftskrankenhaus Recklinghausen, Department of Radiology and Neuroradiology, Recklinghausen, Germany
  10. 10Ospedale S. Maria delle Scotte-University Hospital, Interventional Neuroradiology and Stroke Units, Siena, Italy
  11. 11Ospedale Niguarda Ca’ Granda , Milan, Italy
  12. 12University Medical Center Hamburg Eppendorf, Hamburg, Germany
  13. 13National University of Ireland, Galway, Ireland
  14. *Live Presentation

Abstract

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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