Department of Vascular and Interventional Radiology, OSF St. Francis Medical Center, 530 NE Glen Oak, Peoria IL 61637, USA.
J Vasc Interv Radiol. 2013 May;24(5):609-21. doi: 10.1016/j.jvir.2013.01.489.
To evaluate the safety and effectiveness of the Crux vena cava filter in patients at risk for pulmonary embolism (PE).
The Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System trial was an international prospective, multicenter, single-arm clinical trial in 125 patients implanted with the Crux filter between June 2010 and June 2011. Follow-up was 180 days after filter placement and 30 days after filter retrieval. The primary objective was to determine whether the clinical success rate was at least 80%. Clinical success was defined as technical success of deployment and freedom from definite PE, filter migration, and device-related adverse events requiring intervention.
The clinical success rate was 96.0% (120 of 125), with a one-sided lower limit of the 95% confidence interval of 91.8%. The rate of technical success was 98.4% (123 of 125). There were three cases of definite PE (2.4%), two cases of deployment failure, and no cases of device migration, embolization, fracture, or tilting. Investigators observed nine cases of thrombus (all nonocclusive) in or near the filter (six during retrieval evaluation vena cavography, two during computed tomography [CT] scans for PE symptoms, and one during CT for cancer management) and 13 cases of deep vein thrombosis. Device retrieval was attempted at a mean of 84.6 days±57.6 (range, 6-190 d) after implantation and was successful for 98.1% of patients (53 of 54). All deaths (n = 14) were determined to be unrelated to the filter or PE.
The Crux vena cava filter performed safely, with high rates of clinical, technical, and retrieval success.
评估 Crux 腔静脉滤器在有发生肺栓塞（PE）风险的患者中的安全性和有效性。
Crux 生物医学公司对 Crux 下腔静脉滤器系统的评估试验是一项国际性前瞻性、多中心、单臂临床试验，于 2010 年 6 月至 2011 年 6 月期间对 125 例植入 Crux 滤器的患者进行了研究。在滤器植入后 180 天和滤器取出后 30 天进行随访。主要目的是确定临床成功率是否至少为 80%。临床成功定义为植入的技术成功，无明确的 PE、滤器迁移以及需要介入的与器械相关的不良事件。
临床成功率为 96.0%（125 例中有 120 例），95%置信区间单侧下限为 91.8%。技术成功率为 98.4%（125 例中有 123 例）。有 3 例明确的 PE（2.4%），2 例植入失败，无滤器迁移、栓塞、断裂或倾斜的情况。研究者观察到 9 例滤器内或附近（5 例在取出评估时行腔静脉造影，2 例在因 PE 症状行 CT 扫描时，1 例在因癌症管理行 CT 扫描时）血栓（均为非闭塞性）和 13 例深静脉血栓形成。滤器取出尝试在植入后平均 84.6 天±57.6（范围，6-190 天）进行，98.1%的患者（54 例中的 53 例）成功取出。所有死亡（n=14）均被认为与滤器或 PE 无关。
Crux 腔静脉滤器安全性能良好，临床、技术和取出成功率均较高。
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