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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
The Best Trial - Brazilian and Italian Evaluation of Safety Using Tacrolimus-eluting Stent With Short-term Dual Antiplatelet Regimen

Conditions
-----------------
Stable Coronary Disease, Unstable Coronary Disease, Documented Silent Ischemia

Intervention / Treatment
-----------------
* Device: Drug Eluting Stent


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Drug Eluting Stent|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent late lumen loss |  | 8-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause and cardiac mortality; |  | up to 24 months | 
| Myocardial infarction (MI): Q-wave and non-Q-wave, cumulative and individual |  | up to 24 months | 
| 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 |  | up to 24 months | 
| Rate of stent thrombosis using ARC definition of definite and probable stent thrombosis and categorized as early, late or very late |  | up to 24 months | 
| Stent strut coverage assessed by OCT |  | 2 months | 
| Late acquired incomplete stent apposition by IVUS |  | 8-month | 
| In stent & In segment angiographic parameters |  | 8-month | 
| Clinically Driven TLR |  | up to 24 months | 
| Clinically Driven TVR |  | up to 24 months | 
| Target Lesion Failure (TLF) defined as cardiac death, MI and ischemic Target Lesion Revascularization (TLR) |  | up to 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Optima, Tacrolimus, Drug eluting stent