Taylor Eleanor, Downer Jonathan, Lamin Saleh, Chandran Arun, Koumellis Panayiotis, Gan Chee, Jadun Changez, Booth Thomas, Gholkar Anil, Leyon Joe, Lobotesis Kyriakos
Department of Neuroradiology, Imperial College Healthcare NHS Trust, London, UK.
Department of Neuroradiology, Royal Infirmary of Edinburgh, Edinburgh, UK.
Interv Neuroradiol. 2024 Dec 8:15910199241302123. doi: 10.1177/15910199241302123.
Flow diverting stents (FDS) are an established endovascular treatment for intracranial aneurysms but are reported to have varying rates of adequate occlusion and thromboembolic complications. This study reports clinical safety and efficacy results of the FRED and FRED Jr FDS in clinical practice in the UK at 6 months and 1 year.
The FRED-UK study is a single arm, multicentre, prospective, observational study conducted in the UK. Safety was reviewed by evaluating morbidity (modified Rankin Score ≤2) and mortality. Efficacy was assessed as adequate occlusion of the treated aneurysm. A clinical event committee and core laboratory independently assessed clinical and anatomical results.
Seven neurointerventional centers treated 61 patients, 57 of which met the full inclusion and exclusion criteria. Of these, 75.4% were treated with FRED and 24.6% with FRED Jr. The aneurysms were located on the cavernous or supraclinoid internal carotid artery (ICA) in 75.4%, on the anterior cerebral artery (ACA) or anterior communicating artery (Acom) in 21.1%, and on the middle cerebral artery (MCA) in 3.5%. 57.9% of aneurysms were small (<10 mm), 40.4% were large (10-24 mm) and 1.8% were giant (≥25 mm). All-cause morbidity and mortality were 0% at 6 and 12 months, and adequate occlusion was 86.7% at 12 months in the per protocol population.
The FRED and FRED Jr devices are safe and efficacious in the treatment of intracranial aneurysms.
血流导向支架（FDS）是颅内动脉瘤既定的血管内治疗方法，但据报道其完全闭塞率和血栓栓塞并发症发生率各不相同。本研究报告了FRED和FRED Jr FDS在英国临床实践中6个月和1年时的临床安全性和有效性结果。
FRED-UK研究是在英国进行的一项单臂、多中心、前瞻性观察性研究。通过评估发病率（改良Rankin评分≤2）和死亡率来审查安全性。疗效评估为治疗的动脉瘤完全闭塞。临床事件委员会和核心实验室独立评估临床和解剖学结果。
七个神经介入中心治疗了61例患者，其中57例符合完整的纳入和排除标准。其中，75.4%接受了FRED治疗，24.6%接受了FRED Jr治疗。动脉瘤位于海绵窦或床突上段颈内动脉（ICA）的占75.4%，位于大脑前动脉（ACA）或前交通动脉（Acom）的占21.1%，位于大脑中动脉（MCA）的占3.5%。57.9%的动脉瘤较小（<10 mm），40.4%为大型（10-24 mm），1.8%为巨大型（≥25 mm）。在符合方案人群中，6个月和12个月时的全因发病率和死亡率均为0%，12个月时的完全闭塞率为86.7%。
FRED和FRED Jr装置在治疗颅内动脉瘤方面安全有效。
