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

Phase 4

Completed

• Conditions: Stable Angina or Acute Coronary Syndrome Considered for Percutaneous Coronary Intervention With Dyslipidemia or Hypertension
• Interventions: Drug: pravastatin 20mg/day after DES implantation; Device: Sirolimus-eluting stent; Device: Biolimus-eluting stents; Drug: pitavastatin 2mg/day after DES implantation; Drug: Non-ARB /day after DES implantation; Drug: Eposartan 600mg/day after DES implantation

• Registration Number: NCT01502904
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2011-12-29
• Study First Submitted QC: 2011-12-29
• Study First Posted: 2012-01-02
• Primary Completion: 2015-05
• Study Completion: 2015-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-25
• Last Update Posted: 2016-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pravastatin group	pravastatin 20mg/day after DES implantation	-
Cypher group	Sirolimus-eluting stent	-
Nobori group	Biolimus-eluting stents	-
Pitivastatin group	pitavastatin 2mg/day after DES implantation	-
Non-ARB group	Non-ARB /day after DES implantation	-
ARB group	Eposartan 600mg/day after DES implantation	-

Primary Outcome Measures

Name	Time	Method
neointimal coverage	6month	1. To compare the neointimal coverage on 6-month follow-up OCT according to specific drug treatment in 2 patient subgroups at 6-month after DES implantation.; 2. To compare the neointimal coverage on 6-month follow-up OCT according to the randomly assigned BES or SES implantation.

Secondary Outcome Measures

Name	Time	Method
stent malapposition and thrombus	6month	The secondary endpoint of this study is to compare percent of stent malapposition and thrombus at 6 months according to specific drug treatment in 2 patient subgroups or to the types of implanted DES, SES vs. BES by a 6-month follow-up OCT.

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of