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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Patients receiving bio-active stent during the intervention |
|
| 2 | Active Comparator | Patients receiving everolimus-eluting stent during the intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous coronary intervention | Device | Intra-coronary stenting |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pasi P Karjalainen, MD, PhD | Satakunta Central Hospital, Pori, Finland | Principal Investigator |
| Antti Ylitalo, MD, PhD | Satakunta Central Hospital, Pori, Finland | Principal Investigator |
| Matti Niemela, MD, PhD | Oulu University Hospital | Principal Investigator |
| Juhani KE Airaksinen, Professor | Turku University Hospital, Turku, Finland | Principal Investigator |
| Otto Hess, Professor | Bern University Hospital, Bern, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Helsinki | Finland | ||||
| Jyvaskyla Central Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23996244 | Derived | Karjalainen P, Kiviniemi TO, Lehtinen T, Nammas W, Ylitalo A, Saraste A, Mikkelsson J, Pietila M, Biancari F, Airaksinen JK. Neointimal coverage and vasodilator response to titanium-nitride-oxide-coated bioactive stents and everolimus-eluting stents in patients with acute coronary syndrome: insights from the BASE-ACS trial. Int J Cardiovasc Imaging. 2013 Dec;29(8):1693-703. doi: 10.1007/s10554-013-0285-8. Epub 2013 Aug 31. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 1, 2015 | |
| Reset | Jun 17, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 1, 2015 | Jun 17, 2015 |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Percutaneous coronary intervention | Device | Intra-coronary stenting |
|
|
| Jyväskylä |
| Finland |
| Keski-Pohjanmaan Keskusairaala | Kokkola | Finland |
| Oulu University Hospital | Oulu | 90100 | Finland |
| Satakunta Central Hospital | Pori | 28500 | Finland |
| Turku University Hospital | Turku | Finland |
| D019060 | Minimally Invasive Surgical Procedures |