Status:
COMPLETED
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
Lead Sponsor:
Yonsei University
Conditions:
Stable Angina or Acute Coronary Syndrome Considered for Percutaneous Coronary Intervention With Dyslipidemia or Hypertension
Eligibility:
All Genders
20-80 years
Phase:
PHASE4
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 healin...
Eligibility Criteria
Inclusion
- Age ≥ 20 year old
- In the case that the blood pressure at rest is greater than systolic 140mmHg or more than diastolic 90mmHg
- When someone is taking Anti-Hypertensive medication
- If total cholesterol is more than 200mg/dL and LDL-cholesterol is greater than 130mg/dL or if you are taking a statin
- Significant coronary de novo lesion (\> 70% by quantitative angiographic analysis)
- Patients with stable angina or acute coronary syndrome considered for percutaneous coronary intervention.
- Reference vessel diameter of 2.5 to 3.5 mm by operator assessment
- Stent size of 2.5 to 3.5 mm and stent length ≤ 24 mm
Exclusion
- Contraindication to anti-platelet agents
- Proximal leison within 15 mm from ostium
- Creatinine level 2.0 mg/dL or end stage renal disease on dialysis
- Pregnant women or women with potential childbearing
- Life expectancy less than 1 year
- Complex lesion morphologies (aorto-ostial, bifurcation with \>2.0 mm side branch, unprotected Left main, thrombus, severe calcification, chronic total occlusion)
- Vein graft lesion
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01502904
Start Date
July 1 2010
End Date
June 1 2015
Last Update
July 27 2016
Active Locations (1)
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1
Severance Hospital
Seoul, Seoul, South Korea, 120-752