Stable Angina or Acute Coronary Syndrome Considered for Percutaneous Coronary Intervention With Dyslipidemia or Hypertension Clinical Trial
| Verified date | July 2016 |
| Source | Yonsei University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | South Korea: Korea Food and Drug Administration (KFDA) |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | June 2015 |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 80 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Severance Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. |
6month | No |
| Secondary | 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. | 6month | No |