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The primary objective of this study is:
The secondary outcomes are a comparison of (using OCT):
The aim of this multicenter, prospective, randomized trial with a core lab analysis is to assess the safety and effectiveness (at 9-month follow-up) of third generation DES (biolimus A9 and everolimus) in patients with evolving STEMI with the OCT guidance (to optimize a stent implantation) A serial OCT analysis will be performed to assess the number of either uncovered or malaposed stents strut and a degree of in-stent neointimal hyperplasia. Furthermore, the in-segment vessel wall response to DES implantation will also be analysed. The goal is to enroll 400 patients (200 in each group) with OCT guidance in 100 patients in each group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biolimus A9 | Device | 200 patients with STEMI will be treated using Biomatrix stent. |
|
| Measure | Description | Time Frame |
|---|---|---|
| to compare a safety and effectiveness of third generation DES (biolimus A9 and everolimus) in patients with STEMI treated by primary PCI with OCT guidance with assessment of a MACE's at 9 month follow-up | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| number of uncovered stent struts | 2 years | |
| number of malaposed stents struts | 2 years | |
| in-stent neointimal volume |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pavel Cervinka, MD,PhD | Contact | +420477117886 | pavel.cervinka@mnul.cz |
| Name | Affiliation | Role |
|---|---|---|
| Pavel Cervinka, MD, PhD | Krajska zdravotni a.s., Masarzk hospital Usti nad Labem | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Masaryk hospital and University of JEP | Ústí nad Labem | 40113 | Czechia |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| everolimus | Device | 200 patients with STEMI will be treated with PROMUS DES. |
|
|
| 2 years |
| in-segment assessment of vessel wall response to DES | 2 years |