The study will be performed in patients with symptomatic coronary artery disease (chronic stable angina, silent ischemia, and acute coronary syndrome, excluding ST-elevation myocardial infarction) who qualify for percutaneous coronary intervention.
Conditions
Interventions
Product Name: MAHOROBA stent
Pharmaceutical Form:
CAS Number: 1049 87-11-3
Concentration unit: µg microgram(s)
Concentration type: range
Concentration number: 103 nominal value-+/- 10%
Sponsors
KANEKA coorporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient is > 18 years old - Patient is eligible for percutaneous coronary intervention (PCI); - Patient is acceptable candidate for CABG - Clinical evidence of ischemic heart disease and/or a positive territorial functional study. Documented stable angina pectoris ((Canadian Cardiovascular Society (CCS) Classification 1, 2, 3 or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C, or IIIB-C), or documented silent ischemia - The target lesion is a single de novo coronary artery lesion with more or equal to 50 and less than 100% stenosis, in one or 2 vessels in all major epicardial territories (LAD, LCX or RCA). A second lesion in another major epicardial vessel could be treated and this second lesion should fit with inclusion/exclusion criteria and will receive the same type of stent - The target lesion must be covered by one study stent; (18mm) preferably with a margin of at least 4mm on each side of the lesion - The target reference vessel diameter must be more than or equal to 3.0mm and less than or equal to 3.5mm - Patient or the patient’s legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Female of childbearing potential - Documented left ventricular ejection fraction (LVEF) 700,000 cells/mm3 or a WBC 2.0 mg/dl or 50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off; - Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated - Target lesion is located or supplied by an arterial or venous bypass graft - Ostial target lesion - Target lesion involves a side branch >2.0mm in diameter with an ostial disease - Patient is currently participating in an investigational drug or device study that clinically interferes with the current study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials) - Within 30 days prior procedure patient has underwent a previous coronary interventional procedure of any kind - Within 60 days post-procedure patient requires planned interventional treatment of any non-target vessel. Planned intervention of the target vessel after the index procedure is not allowed - Stroke or transient ischemic attack within the prior 6 months; - Unprotected Left Main (LM) coronary artery disease (stenosis >50%) - In the investigators opinion patient has a co-morbid condition(s) that could limit the patient’s ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study - Planned surgery within 6 months after index procedure - Life expectancy less than 1 year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this first feasibility study is to evaluate the performance of MAHOROBA stent and an alternate formulation tacrolimus-eluting stent in de novo native coronary artery lesions. This study will provide the longest follow-up experience available.;Secondary Objective: ;Primary end point(s): • In-stent late-loss at 4 and 12 months (as measured by QCA), defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up angiographic MLD. | — |
Countries
Netherlands
Outcome results
None listed