jRCT1080224100已完成3 期
Multi-center prospective trial of NP028 for patients with peripheral artery disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Primary patency rate at 12 months after procedure
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Multicenter, single arm trial
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Clinical inclusion criteria
- •Rutherford classification of 2-4 in the target limb
- •Patient is eligible for percutaneous transluminal angioplasty
- •Angiographic inclusion criteria (by visual estimation)
- •Target lesion that meets any of the following
- •a. de novo lesion
- •New lesion, or restenosis, reoccluded lesion after 3 months or more has passed after treatment by plain, non-slipping, or cutting balloon catheter (without stent)
- •b. ISR lesion
- •Restenosis, reoccluded lesion which is the after 6 months or more has passed after treatment by bare-metal stent, or the after 12 months or more has passed after treatment by drug eluting stent.
- •Target lesion that meets any of the following
- •a. Lesion having a stenosis rate of 70% or more and less than 100%, and a lesion length of 5 cm or more and 20 cm or less
- •b. Occluded lesion having a lesion length of 5 cm or more and 10 cm or less
- •c. Tandem lesion having a stenosis rate of 70% or more, and a total combined lesion length of 5 cm or more and 20 cm or less (if there is an occluded part, the length of that lesion should be 10 cm or less)
- •Target vessel diameter should be 4.0 mm to 8.0 mm
排除标准
- •Clinical exclusion criteria
- •Not a suitable candidate for DAPT
- •Known allergy to contrast agent
- •Dialysis, history or complication of renal dysfunction (Creatinine value exceeds 2.0 mg/dl)
- •Female of child-bearing potential
- •Currently participating in an investigational drug or device study, or clinical trial
- •In cases where the Investigator determines that the patient's participation in the trial is inappropriate
- •Angiographic exclusion criteria
- •Vessel having an untreated thrombus
- •Vessel which is necessary to treat by stent, DCB, penetration device, atherectomy, laser catheter, or unapproved device, before using NP028 during procedure
- •Severe calcified lesion judged to be less than 50 % residual stenosis rate by treatment with PTA balloon catheter
- •Restenosis or reoccluded lesion which has been performed multiple treatments in the past
- •ISR lesion which is an only second time restenosis or reocclusion that is more than 3 months after treatment with balloon catheter can be included
结局指标
主要结局
Primary patency rate at 12 months after procedure
时间窗: 12 months after procedure
Percentage of cases falling under any of the following (%) - There is no occurrence of TLR (Clinically Driven TLR) based on clinical findings - There is no restenosis as determined by DUS (PSVR is 2.4 or less)
次要结局
- Death (Any cause)(in hospital, 30 days, 3 months, 6 months, 12 months)
- Death related to the target limb(in hospital, 30 days, 3 months, 6 months, 12 months)
- Amputation of the target limb(in hospital, 30 days, 3 months, 6 months, 12 months)
- Re-intervention of the target limb(in hospital, 30 days, 3 months, 6 months, 12 months)
- Vascular complications(in hospital, 30 days, 3 months, 6 months, 12 months)
- Re-admission due to cardiovascular events(in hospital, 30 days, 3 months, 6 months, 12 months)
研究者
研究点 (1)
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