Ischemic heart disease
Conditions
Interventions
investigational material(s)
Generic name etc : Sirolimus eluting stent system (NP024)
INN of investigational material :
Therapeutic category code : --- Other
Dosage and Administration for Investigati
Sponsors
NIPRO CORPORATION
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Outcome results
None listed