Assessment of Stent Malapposition and Neointimal Coverage on Optical coHerence Tomography at Post-procedure and 3 Months After Platinum Chromium Alloy Of the Element™ Stent Implantation
NCT ID: NCT01581515
Last Updated: 2012-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2012-01-31
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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P-E group
Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime
Promus Element everolimus eluting coronary stent
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
Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime
Xience Prime everolimus eluting coronary stent
Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime
Interventions
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Promus Element everolimus eluting coronary stent
Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime
Xience Prime everolimus eluting coronary stent
Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime
Eligibility Criteria
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Inclusion Criteria
* Significant coronary de novo lesion (\> 70% by quantitative angiographic analysis) treated by single DES in each vessel.
* Patients with stable angina who are considered for coronary revascularization with stent implantation.
* Reference vessel diameter of 2.5 to 3.5 mm by operator assessment
Exclusion Criteria
* Reference vessel diameter \< 2.5 mm or \> 4.0mm and lesion length \> 28 mm
* Heavy calcified lesions (definite calcified lesions on angiogram)
* Lesions requiring more than 2 DES in each vessel
* Acute coronary syndrome
* Contraindication to anti-platelet agents
* Treated with any DES within 3 months at other vessel
* Creatinine level ≥ 2.0 mg/dL or ESRD
* Severe hepatic dysfunction (3 times normal reference values)
* Pregnant women or women with potential childbearing
* Life expectancy 1 year
20 Years
80 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Myeong-Ki Hong
MD, Ph D
Principal Investigators
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Myeong-Ki Hong, MD.PhD.
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Locations
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Severance Hospital
Seoul, Seodaemun-gu/Sinchon-dong, South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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1-2011-0080
Identifier Type: -
Identifier Source: org_study_id
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