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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Istituto Dante Pazzanesw
São Paulo, Brazil
Azienda Ospedaliera Universitaria di Ferrara
Ferrara, Italy
In-stent late lumen loss
Time frame: 8-month
All-cause and cardiac mortality;
Time frame: up to 24 months
Myocardial infarction (MI): Q-wave and non-Q-wave, cumulative and individual
Time frame: 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
Time frame: 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
Time frame: up to 24 months
Stent strut coverage assessed by OCT
Time frame: 2 months
Late acquired incomplete stent apposition by IVUS
Time frame: 8-month
In stent & In segment angiographic parameters
Time frame: 8-month
Clinically Driven TLR
Time frame: up to 24 months
Clinically Driven TVR
Time frame: up to 24 months
Target Lesion Failure (TLF) defined as cardiac death, MI and ischemic Target Lesion Revascularization (TLR)
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Time frame: up to 24 months