P028 clinical trial
- Conditions
- Superficial femoral artery and/or popliteal artery disease
- Registration Number
- JPRN-jRCT1080224100
- Lead Sponsor
- IPRO CORPORATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 207
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method