Abstract：
BACKGROUND: The Woven EndoBridge (WEB) device is designed to treat wide-necked bifurcation aneurysms. The WEB 17 is the latest iteration and can be delivered through a 0.017″ microcatheter. The CLEVER study demonstrated that WEB 17 is safe and effective for providing protection against bleeding or rebleeding at 1 month and 1 year.
OBJECTIVE: To evaluate angiographic stability at 1 year.
METHODS: The CLEVER study was a prospective multicenter study conducted in 17 European centers, involved 163 subjects, comprising 60 ruptured and 103 unruptured aneurysms. Independent assessment of 1-year follow-up imaging was incorporated into the study design.
RESULTS: Aneurysm diameters ranged from 2.0 to 9.2 mm, with 95.7% being broad-based (dome-to-neck ratio <2). Follow-up imaging at 1 year was completed for 146 out of 163 subjects (89.6%) and evaluated by an independent core laboratory. The primary efficacy endpoint of adequate occlusion without re-treatment at 1 year was achieved for 120 (82.2%) of all subjects. At 1 year, the adequate occlusion rate was 86.5% for ruptured aneurysms (73.1% complete occlusion) and 82.4% for unruptured aneurysms (57.1% complete occlusion). The overall re-treatment rate at 1 year was 2.6% (4/152), with 3.1% (3/97) for unruptured aneurysms and 1.8% (1/55) for ruptured aneurysms CONCLUSION: Delivery of the WEB 17 via 0.017 inch catheters represents a significant evolution of the WEB design. The results of CLEVER presented here demonstrate that it maintains the same efficacy as previous generations of WEB.
OBJECTIVE: To evaluate angiographic stability at 1 year.
METHODS: The CLEVER study was a prospective multicenter study conducted in 17 European centers, involved 163 subjects, comprising 60 ruptured and 103 unruptured aneurysms. Independent assessment of 1-year follow-up imaging was incorporated into the study design.
RESULTS: Aneurysm diameters ranged from 2.0 to 9.2 mm, with 95.7% being broad-based (dome-to-neck ratio <2). Follow-up imaging at 1 year was completed for 146 out of 163 subjects (89.6%) and evaluated by an independent core laboratory. The primary efficacy endpoint of adequate occlusion without re-treatment at 1 year was achieved for 120 (82.2%) of all subjects. At 1 year, the adequate occlusion rate was 86.5% for ruptured aneurysms (73.1% complete occlusion) and 82.4% for unruptured aneurysms (57.1% complete occlusion). The overall re-treatment rate at 1 year was 2.6% (4/152), with 3.1% (3/97) for unruptured aneurysms and 1.8% (1/55) for ruptured aneurysms CONCLUSION: Delivery of the WEB 17 via 0.017 inch catheters represents a significant evolution of the WEB design. The results of CLEVER presented here demonstrate that it maintains the same efficacy as previous generations of WEB.
摘要：
背景：WovenEndoBridge（WEB）设备旨在治疗宽颈分叉动脉瘤。WEB17是最新的迭代，可以通过0.017英寸的微导管输送。CLEVER研究表明，WEB17在1个月和1年时提供预防出血或再出血的保护是安全有效的。
目的：评估1年时血管造影的稳定性。
方法：CLEVER研究是一项在17个欧洲中心进行的前瞻性多中心研究，涉及163名受试者，包括60个破裂动脉瘤和103个未破裂动脉瘤。1年随访影像学的独立评估纳入研究设计。
结果：动脉瘤直径范围为2.0至9.2mm，95.7%为宽基(圆顶与颈部之比<2)。163名受试者中的146名（89.6％）完成了1年的随访成像，并由独立的核心实验室进行了评估。所有受试者中的120名（82.2％）在1年时达到了充分闭塞而无需再治疗的主要疗效终点。在1年,破裂动脉瘤的充分闭塞率为86.5%(完全闭塞率为73.1%),未破裂动脉瘤的充分闭塞率为82.4%(完全闭塞率为57.1%).1年总再治疗率为2.6%(4/152),3.1%（3/97）用于未破裂动脉瘤，1.8%（1/55）用于破裂动脉瘤。结论：通过0.017英寸导管输送WEB17代表WEB设计的重大发展。此处介绍的CLEVER结果表明，它与前几代WEB保持相同的功效。
目的：评估1年时血管造影的稳定性。
方法：CLEVER研究是一项在17个欧洲中心进行的前瞻性多中心研究，涉及163名受试者，包括60个破裂动脉瘤和103个未破裂动脉瘤。1年随访影像学的独立评估纳入研究设计。
结果：动脉瘤直径范围为2.0至9.2mm，95.7%为宽基(圆顶与颈部之比<2)。163名受试者中的146名（89.6％）完成了1年的随访成像，并由独立的核心实验室进行了评估。所有受试者中的120名（82.2％）在1年时达到了充分闭塞而无需再治疗的主要疗效终点。在1年,破裂动脉瘤的充分闭塞率为86.5%(完全闭塞率为73.1%),未破裂动脉瘤的充分闭塞率为82.4%(完全闭塞率为57.1%).1年总再治疗率为2.6%(4/152),3.1%（3/97）用于未破裂动脉瘤，1.8%（1/55）用于破裂动脉瘤。结论：通过0.017英寸导管输送WEB17代表WEB设计的重大发展。此处介绍的CLEVER结果表明，它与前几代WEB保持相同的功效。
