Clinical trial NCT01502904: Neointimal Coverage After Implantation of Biolimus Eluting Stent With Biodegradable Polymer: Optical Coherence Tomographic Assessment According to the Treatment of Dyslipidemia and Hypertension and the Types of Implanted Drug-eluting Stents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stable Angina or Acute Coronary Syndrome Considered for Percutaneous Coronary Intervention With Dyslipidemia or Hypertension
Keywords: SES vs BES
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-01-02
Enrollment: 120
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: There has been little research on neointimal coverage and malapposition after BES implantation using OCT in human coronary artery. Furthermore, specific drug may possibly influence the vascular healing after stent implantation. Therefore, this study will investigate 1) neointimal coverage and malapposition on OCT after BES versus SES implantation and 2) relationship of specific drug treatment and neointimal coverage or late malapposition by the prospective, randomized study.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 20 year old
2. In the case that the blood pressure at rest is greater than systolic 140mmHg or more than diastolic 90mmHg
3. When someone is taking Anti-Hypertensive medication
4. If total cholesterol is more than 200mg/dL and LDL-cholesterol is greater than 130mg/dL or if you are taking a statin
5. Significant coronary de novo lesion (\> 70% by quantitative angiographic analysis)
6. Patients with stable angina or acute coronary syndrome considered for percutaneous coronary intervention.
7. Reference vessel diameter of 2.5 to 3.5 mm by operator assessment
8. Stent size of 2.5 to 3.5 mm and stent length ≤ 24 mm

Exclusion Criteria:

1. Contraindication to anti-platelet agents
2. Proximal leison within 15 mm from ostium
3. Creatinine level 2.0 mg/dL or end stage renal disease on dialysis
4. Pregnant women or women with potential childbearing
5. Life expectancy less than 1 year
6. Complex lesion morphologies (aorto-ostial, bifurcation with \>2.0 mm side branch, unprotected Left main, thrombus, severe calcification, chronic total occlusion)
7. Vein graft lesion

Primary outcomes:
measure: neointimal coverage
timeFrame: 6month
Secondary outcomes:
measure: stent malapposition and thrombus
timeFrame: 6month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Myeong Ki Hong, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim JS, Ha J, Kim BK, Shin DH, Ko YG, Choi D, Jang Y, Hong MK. The relationship between post-stent strut apposition and follow-up strut coverage assessed by a contour plot optical coherence tomography analysis. JACC Cardiovasc Interv. 2014 Jun;7(6):641-51. doi: 10.1016/j.jcin.2013.12.205. Epub 2014 May 14.
citation: Kim BK, Ha J, Mintz GS, Kim JS, Shin DH, Ko YG, Choi D, Jang Y, Hong MK. Randomised comparison of strut coverage between Nobori biolimus-eluting and sirolimus-eluting stents: an optical coherence tomography analysis. EuroIntervention. 2014;9(12):1389-97. doi: 10.4244/EIJV9I12A236.