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The purpose of this study is to compare the degree of stent malapposition on an immediate optical coherence tomography (OCT) after nominal stent pressure and at a final post-procedure OCT (ANCHOR-I) and the neointimal coverage on 3-months OCT following the intervention with the randomly assigned two drug-eluting stents (DES), PromusTMElementTM stents versus Xience PRIME® stents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P-E group | Active Comparator | Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime |
|
| X-P group | Active Comparator | Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Promus Element everolimus eluting coronary stent | Device | Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime |
| Measure | Description | Time Frame |
|---|---|---|
| the ratio of the malapposed strut | The ratio of the malapposed strut, on an immediate OCT after nominal stent pressure and at a final post-procedure between two different DES; ANCHOR-I | Participants will be followed from first OCT invervention to 3month OCT following intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of stent malapposition | 3months OCT following intervention | |
| Neointimal coverage(ANCHOR II) | 3 month-OCT after stent implantation | |
| Incidence of plaque prolapse |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Myeong-Ki Hong, MD.PhD. | Contact | +82 2 2228 8458 | mkhong61@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Myeong-Ki Hong, MD.PhD. | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Recruiting | Seoul | Seodaemun-gu/Sinchon-dong | 120-752 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25345751 | Derived | Kim BK, Shin DH, Kim JS, Ko YG, Choi D, Jang Y, Hong MK. Randomized comparison of acute stent malapposition between platinum-chromium versus cobalt-chromium everolimus-eluting stents. Int J Cardiovasc Imaging. 2015 Feb;31(2):269-77. doi: 10.1007/s10554-014-0557-y. Epub 2014 Oct 28. |
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| Xience Prime everolimus eluting coronary stent | Device | Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime |
|
| final postprocedural OCT |
| Evaluation of stent expansion | an immediate and post-procedural OCT |
| Stent malapposition | on 3 month OCT intervention |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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