Acute Coronary Syndrome Clinical Trial
Official title:
A Randomized Prospective Multicenter Trial to Examine Vascular Healing at 1 and 6 Month(s) After Deployment of TItanium-nitride-oxide-coated OPTIMAX™ Bio-active-stent (BAS) Stent and SYNERGY™ Everolimus-Eluting Stent (EES) in Patients With Acute Coronary Syndromes by Means of Optical Coherence Tomography
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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