Comparison of Bio-Active-Stent to the Everolimus-Eluting Stent in Acute Coronary Syndrome (BASE-ACS)

The Hospital District of Satakunta

Status and phase: Unknown; Phase 3

Conditions: Acute Coronary Syndrome

Treatments: Device: Percutaneous coronary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT00819923

SA-003

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 825 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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825 participants in 2 patient groups

1

Experimental group

Description:

Patients receiving bio-active stent during the intervention

Treatment:

Device: Percutaneous coronary intervention

Device: Percutaneous coronary intervention

2

Active Comparator group

Description:

Patients receiving everolimus-eluting stent during the intervention

Treatment:

Device: Percutaneous coronary intervention

Device: Percutaneous coronary intervention