Status:
UNKNOWN
Comparison of Bio-Active-Stent to the Everolimus-Eluting Stent in Acute Coronary Syndrome
Lead Sponsor:
The Hospital District of Satakunta
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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
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 commerci...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
825 Patients enrolled
Trial Details
Trial ID
NCT00819923
Start Date
November 1 2008
End Date
December 1 2014
Last Update
May 5 2011
Active Locations (6)
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1
Helsinki University Hospital
Helsinki, Finland
2
Jyvaskyla Central Hospital
Jyväskylä, Finland
3
Keski-Pohjanmaan Keskusairaala
Kokkola, Finland
4
Oulu University Hospital
Oulu, Finland, 90100