Superficial femoral artery and/or popliteal artery disease
Conditions
Interventions
investigational material(s)
Generic name etc : Paclitaxel coated balloon catheter (NP028)
INN of investigational material :
Therapeutic category code : --- Other
Dosage and Administration for Investi
Sponsors
NIPRO CORPORATION
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Outcome results
None listed