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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

825 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2014-12-31

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.

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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.

Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Patients receiving bio-active stent during the intervention

Group Type EXPERIMENTAL

Percutaneous coronary intervention

Intervention Type DEVICE

Intra-coronary stenting

2

Patients receiving everolimus-eluting stent during the intervention

Group Type ACTIVE_COMPARATOR

Percutaneous coronary intervention

Intervention Type DEVICE

Intra-coronary stenting

Interventions

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Percutaneous coronary intervention

Intra-coronary stenting

Intervention Type DEVICE

Percutaneous coronary intervention

Intra-coronary stenting

Intervention Type DEVICE

Other Intervention Names

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TITAN-2 stent, Hexacath, France Promus (Boston,USA) Xience-V (abbott, Usa)

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No