Background Since the International Subarachnoid Aneurysm Trail (ISAT) there has been ongoing interest in coil embolization for the treatment of intracranial aneurysms. This has led to the development of new and improved coils and adjunctive devices, which have expanded the scope of endovascular practice to include more challenging lesions than could be treated previously.
Method The i-ED Coil System consists of the embolization coils and the i-ED Electro Detachment Generator. The Kaneka Endovascular Embolization and Protection (KEEP) study is a post-market registry to obtain, assess and describe real-world clinical data and characterize the acute and long-term performance of the i-ED COILs when used alone or in combination with adjunctive device(s), in patients treated for intracranial aneurysms. This is a prospective, multi-center, single-arm, post-market registry for bifurcation and sidewall aneurysms, 4 to 14 mm in size, and includes both ruptured and unruptured aneurysms. The study will enroll up to 164 patients with 147 evaluable patients. Detailed results from enrollment through 1-year outcomes will be published upon completion of the registry. The primary objective is the proportion of patients, assessed by the independent core lab, who achieve adequate occlusion (Modified Raymond Roy Classification I or II (MRRC)) of the target aneurysm at 12 months without retreatment. The secondary outcomes include packing density, defined as the ratio of the aneurysm volume to the volume of coil, change(s) in long-term aneurysm occlusion rate using the MRRC Scale, and independent functional outcome using the modified Rankin Scale (mRS). Procedure and/or device/iED COIL related serious adverse events will be adjudicated by a medical monitor.
Results The first patient was enrolled in December 2022. With ongoing enrollment of the147 evaluable patients, 7 patients have been enrolled to date that met the inclusion and exclusion criteria with aneurysms in both the anterior and posterior circulation; six-month follow-up will be available on all of these patients in the first half of this year. In this multicenter post-market registry, 5/7 aneurysms achieved immediate adequate occlusion. One-year, long-term follow-up is not yet available. Good clinical outcome (mRS 0-2) at discharge was seen in 7/7 patients and at six (6) months the mRS will be available and reported on. No serious adverse events have been reported. The updated dataset will be presented at the SNIS meeting.
Conclusion One-year data will be published when available and will include long-term occlusion status, coil durability, and recurrence rates as well as clinical outcomes. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT:05563051
Disclosures M. Hussain: 6; C; Principal Investigator. A. Puri: 6; C; Principal Investigator. W. Mack: 6; C; Principal Investigator. J. Tsai: None. J. Tsai: None. G. Toth: None. J. Singh: None. A. Cheema: None. R. Ortiz: None. A. Majjhoo: None. B. Naravelta: None.
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