Multi-center prospective trial of NP028 for patients with peripheral artery disease
NP028 clinical trial
Sept. 30, 2022
No
version:
date:
NIPRO CORPORATION
+81-77-564-9467
NIPRO CORPORATION
+81-77-564-9467
completed
Nov. 16, 2018
207
Interventional
Multicenter, single arm trial
treatment purpose
3
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
investigational material(s)
Generic name etc : Paclitaxel coated balloon catheter (NP028)
INN of investigational material :
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : By standard percutaneous angioplasty, NP028 will be dilated at the target lesion.
control material(s)
Generic name etc : -
INN of investigational material :
Therapeutic category code :
Dosage and Administration for Investigational material : -
safety
efficacy
confirmatory
Primary patency rate at 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)
safety
efficacy
confirmatory
Efficacy
- Device success rate, procedure success rate
- Residual stenosis
- Acute gain
- Rutherford classification, EQ-5D, WIQ at 30 days, 6 months, 12 months
- ABI after procedure (in hospital), at 30 days, 6 months, 12 months
- PSVR by DUS at 30 days, 6 months, 12months
Safety
The avoidance rate of the following clinical events after procedure (in hospital, 30 days, 3 months, 6 months, 12 months)
- Death (Any cause)
- Death related to the target limb
- Amputation of the target limb
- Re-intervention of the target limb
- Vascular complications
- Re-admission due to cardiovascular events
