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Multi-center prospective trial with external control of Sirolimus Eluting Stent System (NP024)

NP024 clinical trial

NIPRO CORPORATION

NIPRO CORPORATION

+81-77-564-9467

completed

Nov. 15, 2018

Interventional

Multicenter, Non-randomized clinical trial with external control

treatment purpose

3

Clinical inclusion criteria
- Patient with stable or unstable angina pectoris or documented silent ischemia
- Patient is eligible for percutaneous coronary intervention
- Patient is acceptable candidate for CABG

Angiographic inclusion criteria (by visual estimation)
- Native coronary artery
- De novo lesion
- The stenosis of target lesion is 50% or more to less than 100%
- Target vessel diameter is 2.5 mm to 4.25 mm

Clinical exclusion criteria
- Known allergy to L-605 CoCr alloy (cobalt, chromium, nickel, tungsten)
- Not a suitable candidate for DAPT
- Known allergy to contrast agent
- LVEF of the patient is not more than 30%
- Renal dysfunction (Creatinine value exceeds 2.0 mg/dl or in case artificial dialysis)
- AMI within 72 hours before baseline procedure.
- Female of child-bearing potential
- Currently participating in an investigational drug or device study
- In cases where the Investigator determines that the patient's participation in the trial is inappropriate

Angiographic exclusion criteria
- Within 9 months after implementing PCI on the target vessel or its branch
- Lesion in left main coronary trunk
- Lesion within 3 mm from the ostium right coronary artery
- Lesion within 2 mm from the ostium left anterior descending/the ostium left circumflex branch
- Bifurcation lesion that need stenting of main and side branch
- Total occlusion

Both

Ischemic heart disease

investigational material(s)
Generic name etc : Sirolimus eluting stent system (NP024)
INN of investigational material :
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : A sirolimus eluting stent is implanted in 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
Freedom from Target Lesion Failure (TLF), a device oriented composite endpoint (cardiac death and MI not clearly attributable to a non-target vessel, and clinically driven Target Lesion Revascularization (TLR)) at 9 months post stent implantation

safety
confirmatory
Efficacy
- Device success rate, procedure success rate
- Residual stenosis
- Acute gain
- %diameter stenosis at 11 months
- Late lumen loss at 11months
- Freedom from restenosis at 11months
- Freedom from TLR at 9months

Safety (in hospital, 30 days, 6 months, 9 months, 12 months, 2 years, 3 years, 4 years and 5 years)
- TLR, TLF, TVR, TVF
- Myocardial Infarction (QMI, NQMI)
- Cardiac death, non-cardiovascular death
- Stent thrombosis (per Academic Research Consortium [ARC] definition)

Oct. 18, 2018