Department of Vascular Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Shuaifuyuan 1st, Dongcheng District, Beijing, 100730, China.
BMC Cardiovasc Disord. 2023 Oct 16;23(1):510. doi: 10.1186/s12872-023-03484-5.
Renal artery stenosis (RAS) is a significant reason for secondary hypertension. Impaired renal function and subsequent cardiopulmonary dysfunction could also occur. Patients of non-atherosclerotic RAS has a relatively young age and long life expectancy. Revascularization with percutaneous transluminal angioplasty (PTA) is a viable treatment option. However, restenosis is unavoidable which limits its use. Drug-coated balloon (DCB) has been proven to be effective in restenosis prevention in femoropopliteal arterial diseases and in patients with renal artery stenosis. And PTA for Renal artery fibromuscular dysplasia is safe and clinically successful. Therefore, we could speculate that DCB might have potential efficacy in non-atherosclerotic RAS treatment.
This will be a randomized multi-center-controlled trial. Eighty-four eligible participants will be assigned randomly in a 1:1 ratio to the control group (plain old balloon, POB) and the experimental group (DCB). Subjects in the former group will receive balloon dilatation alone, and in the latter group will undergo the DCB angioplasty. The DCB used in this study will be a paclitaxel-coated balloon (Orchid, Acotec Scientific Holdings Limited, Beijing, China). Follow-up visits will be scheduled 1, 3, 6, 9, and 12 months after the intervention. Primary outcomes will include controlled blood pressure and primary patency in the 9-month follow-up. Secondary outcomes will include technical success rate, complication rate, and bail-out stenting rate.
ClinicalTrials.gov (number NCT05858190). Protocol version V.4 (3 May 2023).
肾动脉狭窄（RAS）是继发性高血压的一个重要原因。肾功能受损和随后的心肺功能障碍也可能发生。非动脉粥样硬化性 RAS 患者年龄相对较轻，预期寿命较长。经皮腔内血管成形术（PTA）血管重建是一种可行的治疗选择。然而，再狭窄是不可避免的，这限制了它的使用。药物涂层球囊（DCB）已被证明在股腘动脉疾病和肾动脉狭窄患者的再狭窄预防中有效。并且 PTA 治疗肾动脉纤维肌性发育不良是安全且临床成功的。因此，我们可以推测 DCB 可能在非动脉粥样硬化性 RAS 治疗中具有潜在疗效。
这将是一项随机多中心对照试验。84 名符合条件的参与者将以 1:1 的比例随机分配到对照组（普通球囊，POB）和实验组（DCB）。前者组的受试者将接受单纯球囊扩张，后者组将接受 DCB 血管成形术。本研究中使用的 DCB 将是紫杉醇涂层球囊（Orchid，Acotec Scientific Holdings Limited，北京，中国）。随访将在干预后 1、3、6、9 和 12 个月进行。主要结局将包括 9 个月随访时的血压控制和原发性通畅率。次要结局将包括技术成功率、并发症发生率和紧急支架置入率。
ClinicalTrials.gov（编号 NCT05858190）。方案版本 V.4（2023 年 5 月 3 日）。
