Back to resultsNeointimal 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
Primary Purpose
Stable Angina or Acute Coronary Syndrome Considered for Percutaneous Coronary Intervention With Dyslipidemia or Hypertension
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sirolimus-eluting stent
Biolimus-eluting stents
pravastatin 20mg/day after DES implantation
pitavastatin 2mg/day after DES implantation
Non-ARB /day after DES implantation
Eposartan 600mg/day after DES implantation
Sponsored by
About this trial
This is an interventional treatment trial for Stable Angina or Acute Coronary Syndrome Considered for Percutaneous Coronary Intervention With Dyslipidemia or Hypertension focused on measuring SES vs BES
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Active Comparator
Experimental
Active Comparator
Active Comparator
Active Comparator
Experimental
Arm Label
Cypher group
Nobori group
Pravastatin group
Pitivastatin group
Non-ARB group
ARB group
Arm Description
Outcomes
Primary Outcome Measures
neointimal coverage
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.
To compare the neointimal coverage on 6-month follow-up OCT according to the randomly assigned BES or SES implantation.
Secondary Outcome Measures
stent malapposition and thrombus
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01502904
Brief Title
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
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina or Acute Coronary Syndrome Considered for Percutaneous Coronary Intervention With Dyslipidemia or Hypertension
Keywords
SES vs BES
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cypher group
Arm Type
Active Comparator
Arm Title
Nobori group
Arm Type
Experimental
Arm Title
Pravastatin group
Arm Type
Active Comparator
Arm Title
Pitivastatin group
Arm Type
Active Comparator
Arm Title
Non-ARB group
Arm Type
Active Comparator
Arm Title
ARB group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Sirolimus-eluting stent
Intervention Description
2x2 randomization by the treatment of dyslipidemia and hypertension(In patients of dyslipidemia: pitavastatin 2mg/day vs. pravastatin 20mg/day, in patients of hypertension: eporsartan 600mg/day vs. Non-ARB) and the types of the implanted DES, SES vs BES.
Intervention Type
Device
Intervention Name(s)
Biolimus-eluting stents
Intervention Description
2x2 randomization by the treatment of dyslipidemia and hypertension(In patients of dyslipidemia: pitavastatin 2mg/day vs. pravastatin 20mg/day, in patients of hypertension: eporsartan 600mg/day vs. Non-ARB) and the types of the implanted DES, SES vs BES.
Intervention Type
Drug
Intervention Name(s)
pravastatin 20mg/day after DES implantation
Intervention Description
2x2 randomization by the treatment of dyslipidemia and hypertension(In patients of dyslipidemia: pitavastatin 2mg/day vs. pravastatin 20mg/day, in patients of hypertension: eporsartan 600mg/day vs. Non-ARB) and the types of the implanted DES, SES vs BES.
Intervention Type
Drug
Intervention Name(s)
pitavastatin 2mg/day after DES implantation
Intervention Description
2x2 randomization by the treatment of dyslipidemia and hypertension(In patients of dyslipidemia: pitavastatin 2mg/day vs. pravastatin 20mg/day, in patients of hypertension: eporsartan 600mg/day vs. Non-ARB) and the types of the implanted DES, SES vs BES.
Intervention Type
Drug
Intervention Name(s)
Non-ARB /day after DES implantation
Intervention Description
2x2 randomization by the treatment of dyslipidemia and hypertension(In patients of dyslipidemia: pitavastatin 2mg/day vs. pravastatin 20mg/day, in patients of hypertension: eporsartan 600mg/day vs. Non-ARB) and the types of the implanted DES, SES vs BES.
Intervention Type
Drug
Intervention Name(s)
Eposartan 600mg/day after DES implantation
Intervention Description
2x2 randomization by the treatment of dyslipidemia and hypertension(In patients of dyslipidemia: pitavastatin 2mg/day vs. pravastatin 20mg/day, in patients of hypertension: eporsartan 600mg/day vs. Non-ARB) and the types of the implanted DES, SES vs BES.
Primary Outcome Measure Information:
Title
neointimal coverage
Description
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.
To compare the neointimal coverage on 6-month follow-up OCT according to the randomly assigned BES or SES implantation.
Time Frame
6month
Secondary Outcome Measure Information:
Title
stent malapposition and thrombus
Description
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.
Time Frame
6month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myeong Ki Hong, Ph.D
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
24835329
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.
Results Reference
derived
PubMed Identifier
24531309
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.
Results Reference
derived
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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
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