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Abstract：
OBJECTIVE: In the present trial, the 24-month safety and effectiveness of the TCD-17187 drug-coated balloon (DCB) for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PA) were evaluated in Japanese patients.
METHODS: This was a prospective, multicenter, core laboratory-adjudicated, single-arm trial. From 2019 to 2020, 121 patients with symptomatic peripheral artery disease were enrolled. The primary effectiveness outcome measure was primary patency. The safety outcome measure was the major adverse event (MAE) rate.
RESULTS: Age was 74.5 ± 7.3 years, and diabetes mellitus was present in 67.5%. Lesion length and reference vessel diameter (RVD) were 106.0 ± 52.6 mm and 5.2 ± 0.8 mm, respectively. Chronic total occlusion (CTO) and bilateral calcification rate (Grade 3 and 4 by peripheral arterial calcium scoring system (PACSS)) were 17.5% and 50.8%, respectively. The 24-month primary patency rate by duplex ultrasound was 71.3%, while freedom from clinically driven target lesion revascularization (CD-TLR) was 87.0%. The MAE rate was 13.2% and all events consisted of CD-TLR. There were no instances of device- or procedure-related deaths major amputations throughout the 24 months. Multivariate Cox proportional hazards regression analysis revealed significant differences associated with loss of primary patency in the following characteristics: CTO, restenotic lesion and RVD.
CONCLUSIONS: This trial confirmed the safety and effectiveness of TCD-17187 DCB for atherosclerotic lesions of the SFA and/or proximal PA for up to 24 months.
METHODS: Level 3, Cohort study.
BACKGROUND: URL: https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000038612&type=summary&language=J:Registration ID: UMIN000034122. Registration Date: September 13, 2018.
METHODS: This was a prospective, multicenter, core laboratory-adjudicated, single-arm trial. From 2019 to 2020, 121 patients with symptomatic peripheral artery disease were enrolled. The primary effectiveness outcome measure was primary patency. The safety outcome measure was the major adverse event (MAE) rate.
RESULTS: Age was 74.5 ± 7.3 years, and diabetes mellitus was present in 67.5%. Lesion length and reference vessel diameter (RVD) were 106.0 ± 52.6 mm and 5.2 ± 0.8 mm, respectively. Chronic total occlusion (CTO) and bilateral calcification rate (Grade 3 and 4 by peripheral arterial calcium scoring system (PACSS)) were 17.5% and 50.8%, respectively. The 24-month primary patency rate by duplex ultrasound was 71.3%, while freedom from clinically driven target lesion revascularization (CD-TLR) was 87.0%. The MAE rate was 13.2% and all events consisted of CD-TLR. There were no instances of device- or procedure-related deaths major amputations throughout the 24 months. Multivariate Cox proportional hazards regression analysis revealed significant differences associated with loss of primary patency in the following characteristics: CTO, restenotic lesion and RVD.
CONCLUSIONS: This trial confirmed the safety and effectiveness of TCD-17187 DCB for atherosclerotic lesions of the SFA and/or proximal PA for up to 24 months.
METHODS: Level 3, Cohort study.
BACKGROUND: URL: https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000038612&type=summary&language=J:Registration ID: UMIN000034122. Registration Date: September 13, 2018.
摘要：
目的：在本试验中，在日本患者中评估了TCD-17187药物涂层球囊(DCB)治疗股浅动脉(SFA)和近端动脉(PA)动脉粥样硬化病变的24个月安全性和有效性.
方法：这是一个前瞻性的，多中心，核心实验室裁决，单臂试验。从2019年到2020年，纳入了121例症状性外周动脉疾病患者。主要有效性结果指标是主要通畅性。安全性结果指标是主要不良事件（MAE）率。
结果：年龄为74.5±7.3岁，糖尿病占67.5%。病变长度和参考血管直径（RVD）分别为106.0±52.6mm和5.2±0.8mm，分别。慢性完全闭塞(CTO)和双侧钙化率(外周动脉钙质评分系统(PACSS)3级和4级)分别为17.5%和50.8%,分别。经双工超声检查24个月原发性通畅率为71.3%，而无临床驱动的靶病变血运重建(CD-TLR)为87.0%。MAE率为13.2%，所有事件均为CD-TLR。在整个24个月中，没有发生与设备或手术相关的重大截肢死亡。多变量Cox比例风险回归分析显示，在以下特征中与原发性通畅性丧失相关的显著差异：再狭窄病变和RVD。
结论：该试验证实了TCD-17187DCB治疗SFA和/或近端PA动脉粥样硬化病变长达24个月的安全性和有效性。
方法：第3级，队列研究。
背景：URL：https://center6。乌明。AC.jp/cgi-open-bin/ctr/ctr。cgi？function=眉毛&action=眉毛&recptno=R000038612&type=summary&language=J：注册ID：UMIN000034122。注册日期：2018年9月13日。
方法：这是一个前瞻性的，多中心，核心实验室裁决，单臂试验。从2019年到2020年，纳入了121例症状性外周动脉疾病患者。主要有效性结果指标是主要通畅性。安全性结果指标是主要不良事件（MAE）率。
结果：年龄为74.5±7.3岁，糖尿病占67.5%。病变长度和参考血管直径（RVD）分别为106.0±52.6mm和5.2±0.8mm，分别。慢性完全闭塞(CTO)和双侧钙化率(外周动脉钙质评分系统(PACSS)3级和4级)分别为17.5%和50.8%,分别。经双工超声检查24个月原发性通畅率为71.3%，而无临床驱动的靶病变血运重建(CD-TLR)为87.0%。MAE率为13.2%，所有事件均为CD-TLR。在整个24个月中，没有发生与设备或手术相关的重大截肢死亡。多变量Cox比例风险回归分析显示，在以下特征中与原发性通畅性丧失相关的显著差异：再狭窄病变和RVD。
结论：该试验证实了TCD-17187DCB治疗SFA和/或近端PA动脉粥样硬化病变长达24个月的安全性和有效性。
方法：第3级，队列研究。
背景：URL：https://center6。乌明。AC.jp/cgi-open-bin/ctr/ctr。cgi？function=眉毛&action=眉毛&recptno=R000038612&type=summary&language=J：注册ID：UMIN000034122。注册日期：2018年9月13日。
