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

July 25, 2016 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cypher group
Device: Sirolimus-eluting stent
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.
Experimental: Nobori group
Device: Biolimus-eluting stents
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.
Active Comparator: Pravastatin group
Drug: pravastatin 20mg/day after DES implantation
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.
Active Comparator: Pitivastatin group
Drug: pitavastatin 2mg/day after DES implantation
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.
Active Comparator: Non-ARB group
Drug: Non-ARB /day after DES implantation
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.
Experimental: ARB group
Drug: Eposartan 600mg/day after DES implantation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neointimal coverage
Time Frame: 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.
6month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stent malapposition and thrombus
Time Frame: 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.
6month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Myeong Ki Hong, Ph.D, Severance Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

December 29, 2011

First Submitted That Met QC Criteria

December 29, 2011

First Posted (Estimate)

January 2, 2012

Study Record Updates

Last Update Posted (Estimate)

July 27, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-2010-0007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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