Comparison of Titanium-Nitride-Oxide coated Bio-Active-Stent (Optimax*) to the Drug (Everolimus) -Eluting Stent (Synergy*) in Acute Coronary Syndrome

Phase 4

Recruiting

• Conditions: Atherosclerosis; coronary stenting; Myocardial Infarction; 10011082

• Registration Number: NL-OMON40709
• Lead Sponsor: S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 500

Inclusion Criteria

Patients presenting with non ST-elevation or ST-elevation acute coronary syndrome

Exclusion Criteria

- Age < 18 years
- Expected survival < 1 year
- Allergy to aspirin, clopidogrel, prasugrel or ticagrelol
- Allergy to heparins, glycoprotein IIb/IIIa inhibitors or bivalirudin
- Allergy to everolimus
- Active bleeding or significant increased risk of bleeding
- Stent length longer than 28 mm needed
- Stent diameter > 4.0 mm needed
- Previous coronary artery bypass surgery (CABG)
- Aorto-ostial lesion
- Previous coronary stenting of the target vessel
- Thrombolysis therapy
- Cardiogenic shock
- Planned surgery within 12 months of PCI unless the dual antiplatelet therapy could be maintained throughout the perisurgical period

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary end point (MACE) is the composite of cardiac death, myocardial<br /><br>infarction (MI) and target lesion revascularization (TLR) during 12 months of<br /><br>follow-up (non-inferiority).<br /><br><br /><br>Co-Primary end point is the composite of cardiac death, any myocardial<br /><br>infarction and major bleeding during 18 months of follow-up (superiority).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-Device oriented composite endpoint, defined as cardiac death, MI, stent<br /><br>thrombosis (ST) and (Target Lesion Revascularization) TLR at 1, 6, 12 and 18<br /><br>months and at 2, 3, 4 and 5 years.<br /><br><br /><br>-Cardiac death or MI at 1, 6, 12 and 18 months and at 2, 3, 4 and 5 years.<br /><br><br /><br>-Cardiac death at 1, 6, 12 and 18 months and at 2, 3, 4 and 5 years.<br /><br><br /><br>-MI at 1, 6, 12 and 18 months and at 2, 3, 4 and 5 years.<br /><br><br /><br>-ST at 1, 6, 12 and 18 months and at 2, 3, 4 and 5 years.<br /><br><br /><br>-All cause death at 1, 6, 12 and 18 months and at 2, 3, 4 and 5 years.<br /><br><br /><br>-TLR at 1, 6, 12 and 18 months and at 2, 3, 4 and 5 years.<br /><br><br /><br>-Target vessel revascularization (TVR) at 1, 6, 12 and 18 months and at 2, 3, 4<br /><br>and 5 years.<br /><br><br /><br>-Major bleeding (ARC-definition) at 1, 6, 12 and 18 months.</p><br>