Multi-vessel Diseases, Angina Clinical Trial
| Verified date | July 2016 |
| Source | Yonsei University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Ministry of Food and Drug Safety |
| Study type | Interventional |
This study is a prospective open-labeled, randomized study to compare the neointimal coverage at 3 months and 12 months and its serial changes between 3 months and 12 months according to the implanted DES and evaluate the serial changes in the proximal portions of 3 epicardial coronary artery and left main artery including the assessment of fibrous cap thickness and lipid pool for vulnerable plaques by OCT. In addition, the investigators will compare the changes such as plaques and neointimal coverage from serial OCT follow-up according to the different statin strategy.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | October 2014 |
| Est. primary completion date | March 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
Inclusion Criteria: - Patient is = 20 years old - Patients with typical angina who are considered for coronary revascularization. - Multi-vessel diseases: more than 2 significant coronary de novo lesions (> 70% by quantitative angiographic analysis); one of the target lesions is the most significant tight stenotic lesion causing the ischemic symptom and requiring the immediate revascularization but the others are significant but non-tight lesions to be delayed or observed for 3 months and not requiring immediate PCI for the complete revascularization of all coronary arteries. Exclusion Criteria: - ST-elevation MI - Cardiogenic shock or hemodynamically unstable status - Lesions requiring the immediate complete revascularization of all coronary stenotic lesions - Contraindication to anti-platelet agents - Treated with any DES within 6 months at other vessel - Creatinine level = 2.0 mg/dL or ESRD - Severe hepatic dysfunction (3 times normal reference values) - Pregnant women or women with potential childbearing - Life expectancy 1 year - Complex lesion morphologies (bifurcation lesions treated with 2-stent techniques, untreated significant unprotected left main diseases, chronic total occlusion, in-stent restenosis, and vein graft lesion) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, 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 according to the implanted DES; Xience vs. Cypher | Neointimal coverage means percentage of uncovered struts on OCT. The percentages of uncovered struts were compared between EES and SES. | up to 12month after stent implantation | No |