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