Comparison of Bio-Active-Stent to the Everolimus-Eluting Stent in Acute Coronary Syndrome

Study Overview
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Brief Summary
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The purpose of the trial is to compare the safety and effectiveness of bio-active-stent (BAS) and everolimus-eluting stent (EES) in patients presenting with acute coronary syndrome.

Detailed Description
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The BASE-ACS trial is an academic study, which will be conceived and conducted as a multicenter (multi-country) study by experienced interventional cardiologists. This study is independent of commercial interests. The purpose of the trial is to compare the safety and effectiveness of bio-active-stent (Titan-2®) and everolimus-eluting stent (Xience V®, Promus®) in patients presenting with acute coronary syndrome. A total of 850 patients will be included in the randomized study. The primary end point (MACE) is the composite of cardiac death, myocardial infarction and target lesion revascularization during 12 months of follow-up. Enrollment of patients will start in November 2008 and end in 2009.

Official Title
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Comparison of Bio-Active-Stent to the Everolimus-Eluting Stent in Acute Coronary Syndrome (A Prospective, Randomized and a Multicenter Clinical Study)

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Device: Percutaneous coronary intervention
* Device: Percutaneous coronary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients presenting with acute coronary syndrome (unstable angina, non-st-elevation myocardial infarction or st-elevation myocardial infarction)and undergoing percutaneous coronary intervention Written informed consent Exclusion Criteria: Age < 18 years Expected survival < 1 year Allergy to aspirin, clopidogrel or ticlopidine 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 Thrombolysis therapy Planned surgery within 12 months of PCI unless the dual antiplatelet therapy could be maintained throughout the perisurgical period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients receiving bio-active stent during the intervention | Device: Percutaneous coronary intervention<br>* Intra-coronary stenting<br>* Other names: Hexacath, France;|
| Active Comparator: 2<br>Patients receiving everolimus-eluting stent during the intervention | Device: Percutaneous coronary intervention<br>* Intra-coronary stenting<br>* Other names: Xience-V (abbott, Usa);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end point (MACE) is the composite of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR) during 12 months of follow-up. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause death, cardiac death, MI, stent thrombosis and TLR at 1, 6, 12 and 18 months, and at 2, 3, 4 and 5 years. |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Titanium, everolimus, drug eluting stent, stent thrombosis, restenosis, percutaneous coronary intervention, acute coronary syndrome