Multi-center prospective trial of NP028 for patients with peripheral artery disease

IPRO CORPORATIO0 个研究点目标入组 207 人开始时间: 2018年10月18日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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

•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

发起方

IPRO CORPORATIO