NCT00819923

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 825 (actual)
• Sponsor: The Hospital District of Satakunta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DEVICE	Percutaneous coronary intervention	Intra-coronary stenting
DEVICE	Percutaneous coronary intervention	Intra-coronary stenting

Timeline

• Start date: 2008-11-01
• Primary completion: 2013-05-01
• Completion: 2014-12-01
• First posted: 2009-01-09
• Last updated: 2011-05-05

Locations

6 sites across 1 country: Finland