E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
|
|
E.4 | Principal exclusion criteria |
- Female of childbearing potential - Documented left ventricular ejection fraction (LVEF) < 30% - Evidence of an acute Q-wave or non-Q-wave myocardial infarction within 72 hours preceding the index procedure, unless the CK and CK-MB enzymes are less than twice the Upper Normal Limit - Known allergies to the following: aspirin, Clopidogrel bisulfate (Plavix®) or Ticlopidine (Ticlid®), heparin, cobalt-chromium alloy, contrast agent (that cannot be adequately pre-medicated) or drugs similar to tacrolimus - A platelet count <100,000 cells/mm3 or >700,000 cells/mm3 or a WBC <3,000 cells/mm3 - Acute or chronic renal dysfunction (creatinine >2.0 mg/dl or <150µmol/L) - Total occlusion (TIMI 0 or 1 (one)) - Target vessel has evidence of thrombus or is excessively tortuous that makes it unsuitable for proper stent delivery and deployment; - Previous bare metal stenting (less than 1 year) anywhere within the target vessel - Previous drug-eluting stenting anywhere within the target vessel; - The target lesion requires treatment with a device other than PTCA prior to stent placement (e.g. but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.) - Significant (>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
|
|
E.5 End points |
E.5.1 | 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. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |