NCT02464397

Comparison of Strut Coverage With OPTIMAX Versus SYNERGY Stents

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: The Hospital District of Satakunta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DEVICE	Stent	In the study, either OPTIMAX or SYNERGY stent will be implanted in coronary artery lesion

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-08-01
• Completion: 2017-08-01
• First posted: 2015-06-08
• Last updated: 2015-06-08

Locations

2 sites across 2 countries: Belgium, Finland