Journal of Korean Neurosurgical Society

The Korean Neurosurgical Society (대한신경외과학회)
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Safety and Efficacy of Flow Diverter Therapy for Unruptured Intracranial Aneurysm Compared to Traditional Endovascular Strategy : A Multi-Center, Randomized, Open-Label Trial

  • Kim, Junhyung (Department of Neurosurgery, Severance Hospital, Yonsei University College of Medicine) ;
  • Hwang, Gyojun (Department of Neurosurgery, Bundang Jesaeng General Hospital) ;
  • Kim, Bum-Tae (Department of Neurosurgery, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine) ;
  • Park, Sukh Que (Department of Neurosurgery, Soonchunhyang University Seoul Hospital, Soonchunhyang University College of Medicine) ;
  • Oh, Jae Sang (Department of Neurosurgery, Soonchunhyang University Cheonan Hospital, Soonchunhyang University College of Medicine) ;
  • Ban, Seung Pil (Department of Neurosurgery, Seoul National University Bundang Hospital) ;
  • Kwon, O-Ki (Department of Neurosurgery, Seoul National University Bundang Hospital) ;
  • Chung, Joonho (Department of Neurosurgery, Severance Hospital, Yonsei University College of Medicine) ;
  • Committee of Multicenter Research, Korean Neuroendovascular Society, (Korean Neuroendovascular Society)
  • Received : 2022.02.25
  • Accepted : 2022.06.20
  • Published : 2022.11.01
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Abstract

Objective : Endovascular treatment of large, wide-necked intracranial aneurysms by coil embolization is often complicated by low rates of complete occlusion and high rates of recurrence. A flow diverter device has been shown to be safe and effective for the treatment of not only large and giant unruptured aneurysms, but small and medium aneurysms. However, in Korea, its use has only recently been approved for aneurysms <10 mm. This study aims to compare the safety and efficacy of flow diversion and coil embolization for the treatment of unruptured aneurysms ≥7 mm. Methods : The participants will include patients aged between 19 and 75 years to be treated for unruptured cerebral aneurysms ≥7 mm for the first time or for recurrent aneurysms after initial endovascular coil embolization. Participants assigned to a flow diversion cohort will be treated using any of the following devices : Pipeline Flex Embolization Device with Shield Technology (Medtronic, Minneapolis, MN, USA), Surpass Evolve (Stryker Neurovascular, Fremont, CA, USA), and FRED or FRED Jr. (MicroVention, Tustin, CA, USA). Participants assigned to a coil embolization cohort will undergo traditional endovascular coiling. The primary endpoint will be complete occlusion confirmed by cerebral angiography at 12 months after treatment. Secondary safety outcomes will evaluate periprocedural and post-procedural complications for up to 12 months. Results : The trial will begin enrollment in 2022, and clinical data will be available after enrollment and follow-up. Conclusion : This article describes the aim and design of a multi-center, randomized, open-label trial to compare the safety and efficacy of flow diversion versus traditional endovascular treatment for unruptured cerebral aneurysms ≥7 mm.

Keywords

Acknowledgement

This research is supported by Korean NeuroEndovascular Society research fund (Kones-2020-02) and a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the ministry & Welfare, Republic of Korea (grant number : HC20C0057). We also would like to thank Editage (www.editage.co.kr) for English language editing. Trial Registration : Clinical Research Information Service Identifier (KCT0006474).

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