Department of Vascular Surgery, St. Antonius Hospital, PO box 2500, Nieuwegein, EM 3430, The Netherlands.
Trials. 2013 Mar 28;14:87. doi: 10.1186/1745-6215-14-87.
Restenosis after percutaneous transluminal angioplasty (PTA) of the superficial femoral artery (SFA) may occur in 45% of patients at 2 years follow-up. Paclitaxel-coated balloons have been found to reduce neointimal hyperplasia, and thus reduce restenosis. Recently, the Legflow(®) paclitaxel-coated balloon (Cardionovum Sp.z.o.o., Warsaw, Poland) (LPEB) has been introduced. This balloon is covered with shellac, a Food and Drug Administration (FDA) approved natural resin, to obtain an equally distributed tissue concentration of paclitaxel. The RAPID trial is designed to assess restenosis after PTA using the Legflow balloon combined with nitinol stenting versus uncoated balloons with nitinol stenting in SFA lesions >5 cm.
METHODS/DESIGN: A total of 176 adult patients with Rutherford class 2 to class 6 symptoms due to intermediate (5-15 cm) or long (>15 cm) atherosclerotic lesions in the SFA will be randomly allocated for treatment with LPEB with nitinol stenting or uncoated balloon angioplasty with stenting. Stenting will be performed using the Supera(®) stent in both groups (IDEV Technologies Inc., Webster, TX). The primary endpoint is the absence of binary restenosis of the treated SFA segment. Secondary outcomes are target lesion revascularization (TLR), clinical and hemodynamic outcome, amputation rate, mortality rate, adverse events, and device-specific adverse events. Follow up consists of four visits in which ankle-brachial indices (ABI), toe pressure measurements, and duplex ultrasound (DUS) will be performed. Furthermore, a peripheral artery questionnaire (PAQ) will be completed by the patients at each follow-up. In the event that DUS reveals a symptomatic >50% restenosis, or a >75% asymptomatic restenosis, additional digital subtraction angiography will be performed with any necessary re-intervention.
The RAPID trial is a multicenter randomized controlled patient blind trial that will provide evidence concerning whether the use of the Legflow paclitaxel/shellac coated balloons with nitinol stenting significantly reduces the frequency of restenosis in intermediate and long SFA lesions compared to standard PTA and stenting.
ISRCTN47846578.
经皮腔内血管成形术（PTA）治疗股浅动脉（SFA）后，45%的患者在 2 年随访时可能出现再狭窄。紫杉醇涂层球囊已被发现可减少新生内膜增生，从而降低再狭窄率。最近，引入了 Legflow®紫杉醇涂层球囊（Cardionovum Sp.z.o.o.，华沙，波兰）（LPEB）。这种球囊被虫胶覆盖，虫胶是一种获得美国食品和药物管理局（FDA）批准的天然树脂，以获得紫杉醇的均匀分布的组织浓度。RAPID 试验旨在评估使用 Legflow 球囊联合镍钛诺支架与单纯未涂层球囊治疗 SFA 病变>5cm 的患者的 PTA 后再狭窄情况。
方法/设计：共有 176 名患有 Rutherford 2 至 6 级症状的成年患者，其 SFA 中有中间（5-15cm）或长（>15cm）动脉粥样硬化病变，将被随机分配接受 LPEB 联合镍钛诺支架治疗或单纯未涂层球囊成形术联合支架治疗。两组均采用 Supera®支架进行支架置入（IDEV Technologies Inc.，Webster，TX）。主要终点是治疗的 SFA 节段无二进制再狭窄。次要终点是靶病变血运重建（TLR）、临床和血液动力学结果、截肢率、死亡率、不良事件和器械特异性不良事件。随访包括四次就诊，每次就诊均进行踝肱指数（ABI）、趾压测量和双功超声（DUS）检查。此外，患者在每次随访时还将完成外周动脉问卷（PAQ）。如果 DUS 显示有症状性>50%再狭窄或无症状性>75%再狭窄，将进行额外的数字减影血管造影，并进行必要的再介入治疗。
RAPID 试验是一项多中心随机对照患者盲法试验，将提供关于在中长 SFA 病变中，与标准 PTA 和支架置入相比，使用 Legflow 紫杉醇/虫胶涂层球囊联合镍钛诺支架是否能显著降低再狭窄频率的证据。
ISRCTN47846578。
