The purpose of this study is to compare vascular healing of the stented segment after deployment of titanium-nitride-oxide coated cobalt-chromium OPTIMAX™ bio-active stent (BAS) and SYNERGY™ everolimus-eluting stent (EES) in patients with acute coronary syndromes requiring percutaneous coronary intervention. Patients treated with BAS will be treated with DAPT for at least 4 weeks after the procedure followed by aspirin alone, while patients in the EES group will be treated with DAPT, at least for 6 months post procedure. In addition, this study will collect initial information about the safety and effectiveness of the BAS in comparison with EES group at 30 days, 6 months, and 12 months.
OPTIMAX-OCT is a prospective, randomized (1:1), study that will be conducted at 2-3 sites (Finland, Belgium) to evaluate OPTIMAX-BAS vascular healing patterns and thrombus formation with OCT at one (Study A) and six (Study B) month after stent implantation in comparison with SYNERGY-EES. Patients receiving BAS will receive dual antiplatelet treatment (DAPT) for at least four weeks followed by aspirin, while patients implanted with EES, will receive DAPT for at least 6 months followed by aspirin. Patients will be randomized to study A and B as follow: Study A: OPTIMAX-BAS (n=25) versus SYNERGY-EES (n=25). First 50 patients will be randomized to study A. OCT at 1 month follow up. Study B: OPTIMAX-BAS (n=30) versus SYNERGY-EES (n=30) Following 60 patients will be randomized to study B. OCT at 6 months follow up. Randomization is used at the time of recruitment with sealed envelopes. Patients will be randomized in 1:1 fashion. First 50 patients are randomized in study A and following 60 patients in study B. Patients in study A will have OCT follow up at 1 month after index procedure and patients in study B will have OCT at 6 months. OCT analyses will be performed blinded to patient's characteristics as well as the type of the stent used. Two (2-3) investigational sites: * Cardiovascular Center Aalst, Aalst, Belgium * Heart Center, Satakunta Central Hospital, Pori, Finland
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
110
In the study, either OPTIMAX or SYNERGY stent will be implanted in coronary artery lesion
Cardiovascular Center Aalst, OLV-Clinic, Aalst, Belgium
Aalst, Belgium
RECRUITINGHeart Center, Satakunta Central Hospital
Pori, Finland
RECRUITINGPrimary endpoint is the percentage of stent struts coverage per group
In Study A, time for the OCT primary endpoint is 1month
Time frame: 1 month
Primary endpoint is the percentage of stent struts coverage per group
In Study B, time for the OCT primary endpoint is 6 month
Time frame: 6 months
Percentage of stent strut malapposition
Time frame: 1 and 6 months
Maximum length of segment (mm) with uncovered stent struts
Time frame: 1 and 6 months
Maximum length of segment (mm) with malapposed stent struts
Time frame: 1 and 6 months
Maximum malapposition distance
Time frame: 1 and 6 months
Total malapposition volume
Time frame: 1 and 6 months
Mean neointimal thickness
Time frame: 1 and 6 months
Percentage of protruding struts per stent
Time frame: 1 and 6 months
Stent area
Time frame: 1 and 6 months
NIH volume
Time frame: 1 and 6 months
Thrombus formation
Time frame: 1 and 6 months
In-stent late loss
Time frame: 6 months
In-segment late loss
Time frame: 6 months
In-stent binary restenosis
Time frame: 6 months
In-segment binary restenosis
Time frame: 6 months
Major adverse cardiac events defined as a composite of death, MI (Q wave or non-Q wave), emergent coronary artery bypass surgery (CABG), or justified target lesion revascularization (TLR)
Time frame: 1, 6, and 12 months
Target vessel revascularization
Time frame: 6 months
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