Clinical trial NCT01581515: 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
Official title: 2-phased Randomized Comparison Between PromusTMElementTM Versus Xience PRIME® Stent
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-04-20
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patient is ≥ 20 years old
* 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:

* Complex lesion morphologies such as aorto-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, and restenosis
* 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

Primary outcomes:
measure: the ratio of the malapposed strut
timeFrame: Participants will be followed from first OCT invervention to 3month OCT following intervention
Secondary outcomes:
measure: Incidence of stent malapposition
timeFrame: 3months OCT following intervention
measure: Neointimal coverage(ANCHOR II)
timeFrame: 3 month-OCT after stent implantation
measure: Incidence of plaque prolapse
timeFrame: final postprocedural OCT
measure: Evaluation of stent expansion
timeFrame: an immediate and post-procedural OCT
measure: Stent malapposition
timeFrame: on 3 month OCT intervention
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
state: Seodaemun-gu/Sinchon-dong
Study officials:
affiliation: Severance Hospital
name: Myeong-Ki Hong, MD.PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.