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The objective of the study is to assess the superiority of the everolimus-eluting stent (Endeavor ResoluteĀ®) compared with the everolimus-eluting stent (XIENCE VĀ®) regarding uncovered stent strut segments.
The mid-term efficacy of drug-eluting stents has been well-established, but there is an ongoing debate on the potential of an increased incidence of late stent thrombosis, particularly after discontinuation of thienopyridine therapy, as well as of delayed onset of restenosis or catch-up phenomenon with permanent polymer-based DES. The extent of strut coverage with reduction of exposed thrombogenic material has been shown to be associated with the inflammatory reaction grade and with the incidence of stent thrombosis. The optical coherence tomography (OCT) is an intravascular imaging modality based on light. The principle is similar to intravascular ultrasound, but due to the much shorter wave length of light, it offers a much better resolution up to 10µm, enabling the exact determination of strut coverage, neointimal thickness, vessel size, presence of dissections, and even the presence of inflammation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | Everolimus-Eluting Stent |
|
| Arm 2 | Active Comparator | Zotarolimus-Eluting-Stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus-Eluting-Stent | Device | due randomization everolimus-eluting-stent will be implanted |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of stent strut coverage assessed by OCT for each visible strut segment | 6-8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of malapposed strut assessed by OCT | 6-8 months | |
| Percentage of uncovered malapposed struts assessed by OCT | 6-8 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klaus Tiroch, MD | Deutsches Herzzentrum Muenchen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deutsches Herzzentrum Muenchen | Munich | Bavaria | 80636 | Germany | ||
| Klinikum rechts der Isar |
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| Zotarolimus-Eluting-Stent | Device | due randomization zotarolimus-eluting-stent will be implanted |
|
|
| Munich |
| Bavaria |
| 81675 |
| Germany |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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