Documented Silent Ischemia, Stable Coronary Disease, Unstable Coronary Disease
Conditions
Keywords
Optima, Tacrolimus, Drug eluting stent
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.
Interventions
DEVICEDrug Eluting Stent
Sponsors
Contract research Organization: Cardiovascular Research Center - Sao Paulo, Brazil
CID - Carbostent & Implantable Devices
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-stent late lumen loss | 8-month |
Secondary
| Measure | 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 |
| Target Lesion Failure (TLF) defined as cardiac death, MI and ischemic Target Lesion Revascularization (TLR) | up to 24 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 |
| Stent strut coverage assessed by OCT | 2 months |
Countries
Brazil, Italy
Outcome results
None listed