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The purpose of this study is to compare vascular healing of the stented segment after deployment of titanium-nitride-oxide coated cobalt-chromium OPTIMAXâ„¢ bio-active stent (BAS) and SYNERGYâ„¢ 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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPTIMAX-BAS 1 | Experimental | Titanium-nitride-oxide coated cobalt-chromium OPTIMAXâ„¢ bio-active stent (BAS). Patients will have OCT follow-up 1 month after the index procedure. |
|
| SYNERGY-EES 1 | Active Comparator | SYNERGYâ„¢ everolimus eluting stent (EES). Patients will have OCT follow-up 1 month after the index procedure. |
|
| OPTIMAX-OCT 6 | Experimental | Titanium-nitride-oxide coated cobalt-chromium OPTIMAXâ„¢ bio-active stent (BAS). Patients will have OCT follow-up 6 months after the index procedure. |
|
| SYNERGY-EES 6 | Active Comparator | SYNERGYâ„¢ everolimus eluting stent (EES). Patients will have OCT follow-up 6 months after the index procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stent | Device | In the study, either OPTIMAX or SYNERGY stent will be implanted in coronary artery lesion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary endpoint is the percentage of stent struts coverage per group | In Study A, time for the OCT primary endpoint is 1month | 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of stent strut malapposition | 1 and 6 months | |
| Maximum length of segment (mm) with uncovered stent struts | 1 and 6 months | |
| Maximum length of segment (mm) with malapposed stent struts |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pasi P Karjalainen, MD, PhD | Contact | +358 2 627 7500 | pasi.karjalainen@satshp.fi |
| Name | Affiliation | Role |
|---|---|---|
| Pasi P Karjalainen, MD, phd | Heart Center, Satakunta Central Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Center Aalst, OLV-Clinic, Aalst, Belgium | Recruiting | Aalst | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35752571 | Derived | Sia J, Nammas W, Collet C, De Bruyne B, Karjalainen PP. Comparative study of neointimal coverage between titanium-nitric oxide-coated and everolimus-eluting stents in acute coronary syndromes. Rev Esp Cardiol (Engl Ed). 2023 Mar;76(3):150-156. doi: 10.1016/j.rec.2022.05.017. Epub 2022 Jun 2. English, Spanish. |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D015607 | Stents |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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|
| 1 and 6 months |
| Maximum malapposition distance | 1 and 6 months |
| Total malapposition volume | 1 and 6 months |
| Mean neointimal thickness | 1 and 6 months |
| Percentage of protruding struts per stent | 1 and 6 months |
| Stent area | 1 and 6 months |
| NIH volume | 1 and 6 months |
| Thrombus formation | 1 and 6 months |
| In-stent late loss | 6 months |
| In-segment late loss | 6 months |
| In-stent binary restenosis | 6 months |
| In-segment binary restenosis | 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) | 1, 6, and 12 months |
| Target vessel revascularization | 6 months |
| Heart Center, Satakunta Central Hospital | Recruiting | Pori | 28500 | Finland |
|