Brazilian and Italian Evaluation of Safety Using Tacrolimus-eluting Stent With Short-term Dual Antiplatelet Regimen (BEST)

• All-cause and cardiac mortality; [ Time Frame: up to 24 months ] [ Designated as safety issue: Yes ]
• Myocardial infarction (MI): Q-wave and non-Q-wave, cumulative and individual [ Time Frame: up to 24 months ] [ Designated as safety issue: Yes ]
• Major Adverse Cardiac Event (MACE) defined as a composite of cardiac death, MI (Q wave or non-Q wave), emergent coronary artery bypass surgery (CABG), or target lesion revascularization (TLR) by repeat PTCA or CABG [ Time Frame: up to 24 months ] [ Designated as safety issue: Yes ]
• Rate of stent thrombosis using ARC definition of definite and probable stent thrombosis and categorized as early, late or very late [ Time Frame: up to 24 months ] [ Designated as safety issue: Yes ]
• Stent strut coverage assessed by OCT [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
• Late acquired incomplete stent apposition by IVUS [ Time Frame: 8-month ] [ Designated as safety issue: Yes ]
• In stent & In segment angiographic parameters [ Time Frame: 8-month ] [ Designated as safety issue: No ]
• Clinically Driven TLR [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
• Clinically Driven TVR [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
• Target Lesion Failure (TLF) defined as cardiac death, MI and ischemic Target Lesion Revascularization (TLR) [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]

To evaluate the safety and efficacy of the Janus OPTIMA Tacrolimus-Eluting Stent (Optima TES, CID) for the treatment of de novo coronary lesions when associated with short-term (two months) dual antiplatelet (aspirin + clopidogrel) regimen.

The present study is a post-market, prospective, international, two-center, single arm study involving 60 patients with single, de novo non-complex coronary lesions.

Enrolled patients will be asked to return for follow-up clinical evaluation at 1, 6, 12 and 24 months. At 3 months there will be an additional follow-up by phone contact.

Furthermore, the first 15 patients should undergo angiographic and OCT follow-up at two months. The remaining 45 patients should undergo angiographic and IVUS follow-up at 8 months.

• Stable Coronary Disease
• Unstable Coronary Disease
• Documented Silent Ischemia

Inclusion Criteria:

• Patient with >18 years of age;
• Symptoms of stable or unstable angina and/or presence of a positive functional test for ischemia;
• Presence of a single de novo target lesion located in a native coronary vessel suitable for percutaneous treatment with the study stents;
• Acceptable candidate for coronary artery bypass graft(CABG)surgery;
• The subject is willing to sign a written informed consent prior to procedure, and is willing to undergo ALL study protocol follow-ups,including angiographic, IVUS and OCT assessments.
• Single, de novo lesion
• Target lesion located in a major epicardial coronary vessel with reference of 2.5-3.5mm in diameter (by on-line QCA)
• Target lesions ≤19mm in length (by visual estimation) that can be treated (covered) by one single study stent (19 or 24mm in length);
• ≥50% and <100% diameter stenosis;
• TIMI (Thrombolysis In Myocardial Infarction) flow grade ≥2.

Exclusion Criteria:

• Known hypersensitivity or contraindication to tacrolimus, heparin,any required medications including thienopyridines, and contrast media which cannot be adequately pre medicated;
• Patient is a female with childbearing potential;
• Pre-treatment of the target lesion with any devices other than balloon angioplasty;
• Previous brachytherapy in the target vessel;
• Presence of non-target vessel lesions which require staged procedure(s) <30 days of the index procedure;
• Prior CABG surgery to target vessel;
• Previous percutaneous coronary intervention (PCI) or CABG surgery <30 days to the index procedure date;
• Acute myocardial infarction <3 days, with cardiac enzyme elevation including total creatine kinase (CK) >2 times the upper normal limit value and/or CK-MB above the upper normal limit value within the past 72 hours;
• CK and/or CK-MB levels elevated above the upper normal limit value at the time of the index procedure;
• Documented left ventricular ejection fraction <30%;
• Renal insufficiency determined by a baseline serum creatinine >2.0 mg/dl;
• Thrombocytopenia with a baseline platelet count <100,000 cells/mm3;
• Anemia with baseline hemoglobin <10g/dL;
• Extensive peripheral vascular disease or extreme anticoagulation that precludes safe >5 French sheath insertion;
• History of bleeding diathesis, coagulopathy, or refusal of blood transfusions;
• Patients has suffered a stroke, transient ischemic attack (TIA),or cerebrovascular accident (CVA) within the past 6 months;
• Significant gastrointestinal or genitourinary bleed within the past 6 months;
• Patient is a recipient of a heart transplant;
• Any elective surgical procedure is planned within 12 months of the index procedure;
• Known illness or any serious clinical condition with life expectancy <2 years;
• Participation in the active or follow-up phase of any other clinicaltrial within 6 months;
• Impossibility to comply with anti-platelet therapy during the study clinical follow-up;
• Any impossibility to comply with all protocol follow-ups.
• Target lesion or vessel with angiographic evidence of moderate or severe calcification;
• Presence of severe tortuosity;
• Presence of severe angulation (>60o);
• Presence of intraluminal thrombus;
• Target lesion involving a bifurcation (side branch ≥2.0mm);
• Target lesion located in the left main stem;
• Aorto-ostial lesion location;
• Target lesion involving a side branch with reference diameter≥2.0mm;
• Presence of a significant stenosis (>40%) in the target vessel either proximal or distal to the target lesion that will be untreated;
• Previous placement of a stent within 10mm of the target lesion;
• Total occlusion (TIMI flow grade 0 or 1);
• Target lesion located in an arterial or vein graft;
• Target lesion due to in-stent restenosis;
• Coronary anatomy unsuitable for percutaneous treatment with implantation of the available study stents.