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首页> 外文期刊>Journal of endovascular therapy: an official journal of the International Society of Endovascular Specialists >IN.PACT SFA Clinical Study Using the IN.PACT Admiral Drug-Coated Balloon in a Chinese Patient Population
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IN.PACT SFA Clinical Study Using the IN.PACT Admiral Drug-Coated Balloon in a Chinese Patient Population

机译：in.pact SFA临床研究使用in.pact海军上将药物涂层气球在中国患者人口中

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Purpose: To confirm the safety and effectiveness of the IN.PACT Admiral drug-coated balloon (DCB) as a treatment for de novo and native artery restenotic lesions in the superficial femoral artery (SFA) and/or proximal popliteal artery in Chinese subjects. Materials and Methods: IN.PACT SFA China (ClinicalTrials.gov identifier NCT02118532) was a single-arm, independently adjudicated, prospective, premarket study that enrolled 143 subjects (mean age 66.8 +/- 7.7 years; 107 men) at 15 centers. The predominant risk factors were hypertension (104, 72.7%) and diabetes mellitus (66, 46.2%). The majority of subjects were classified as Rutherford category 2 or 3 [69 (48.3%) and 55 (38.5%), respectively]; 19 (13.3%) subjects had critical limb ischemia (Rutherford category 4). The mean lesion length was 10.4 +/- 6.51 cm; more than half of the lesions (75, 52.4%) were chronic total occlusions. Calcification was found in 66 (46.2%) lesions. Outcomes at 12 months were compared with DCB safety and effectiveness performance goals derived from the literature. The 30-day primary safety outcome was a composite of freedom from device- and procedure-related mortality, major target limb amputation, and clinically-driven target lesion revascularization (CD-TLR). Results: The primary safety outcome was 99.3% at 30 days. Follow-up compliance at 12 months was 92.6%. Estimated 1-year primary patency using Kaplan-Meier analysis was 90.9% and freedom from CD-TLR was 97.1%. The rate of CD-TLR at 12 months was 2.9%. The Rutherford category status improved significantly (p<0.001) between baseline and 12 months. Conclusion: Results from IN.PACT SFA China demonstrated high rates of patency and low rates of CD-TLR in Chinese subjects through 12 months despite patient and lesion complexity. These data are consistent with the results of other IN.PACT DCB trials.
机译：目的：确认in.Pact海军上将药物涂层球囊（DCB）的安全性和有效性作为中国受试者浅层股动脉（SFA）和/或近端Popliteal动脉中的Novo和天然动脉重新衰退的治疗。材料和方法：IN.PACT SFA中国（Clinicaltrials.gov标识符NCT02118532）是一个单一的独立裁决，预期的预兆，预先招待的研究，注册了143名科目（平均年龄为66.8 +/- 7.7岁; 107名男子）在15个中心。主要危险因素是高血压（104,72.7％）和糖尿病（66,46.2％）。大多数受试者分为卢瑟福类别2或3 [69（48.3％）和55（38.5％）]; 19（13.3％）受试者具有临界肢体缺血（Rutherford类别4）。平均病变长度为10.4 +/- 6.51厘米;超过一半的病变（75,52.4％）是慢性总咬合。在66（46.2％）病变中发现了钙化。与从文献中的DCB安全和有效性绩效目标进行比较12个月的结果。为期30天的主要安全结果是免受设备和程序相关死亡率，主要目标肢体截肢和临床驱动的目标病变血运重建（CD-TLR）的复合物。结果：30天的主要安全结果为99.3％。 12个月的后续遵从性为92.6％。估计使用Kaplan-Meier分析的1年初级通畅是90.9％，CD-TLR自由为97.1％。 12个月的CD-TLR率为2.9％。基线和12个月之间的Rutherford类别状态显着改善（P <0.001）。结论：尽管患者和病变复杂性，但依照in.Pact SFA中国的结果展示了中国受试者的高密和低密度的高密和低速率。这些数据与其他数据的结果一致.Pact DCB试验。

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