Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Abbott | INDUSTRY |
| Boston Scientific Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to evaluate the safety and long-term effectiveness of coronary stenting with the everolimus-eluting stent (EES) and to determine clinical device and procedural success during commercial use of EES in the real world.
The investigators will compare EES (Xience/Promus, prospective arm) with sirolimus-eluting stent (SES, Cypher, retrospective arm).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xience/Promus | Active prospective registration of patients receiving everolimus eluting stent |
| |
| Cypher | Retrospective historical controls that received sirolimus-eluting stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xience/Promus | Device | Active prospective registration of patients receiving everolimus-eluting stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiac Events (composite of cardiac death, non-fatal MI, target lesion revascularization) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| In-stent & In-segment Late Loss | 9 months | |
| Stent Thrombosis | 1 year | |
| Target Vessel Failure (composite of cardiac death, MI, and TVR) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Approximately 4000 patients derived from a population of patients receiving percutaneous coronary intervention for ischemic heart disease will be enrolled in the present registry.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hyo-Soo Kim, MD,PhD | Seoul National University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dankook University Hospital | Cheonan | South Korea | ||||
| Soon Chun Hyang University Hospital Cheonan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26315734 | Result | Lee JM, Hahn JY, Kang J, Park KW, Chun WJ, Rha SW, Yu CW, Jeong JO, Jeong MH, Yoon JH, Jang Y, Tahk SJ, Gwon HC, Koo BK, Kim HS. Differential Prognostic Effect Between First- and Second-Generation Drug-Eluting Stents in Coronary Bifurcation Lesions: Patient-Level Analysis of the Korean Bifurcation Pooled Cohorts. JACC Cardiovasc Interv. 2015 Aug 24;8(10):1318-1331. doi: 10.1016/j.jcin.2015.05.014. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cypher | Device | Retrospective historical controls that received sirolimus-eluting stent |
|
|
| 12 months |
| Any death, cardiac death, MI, TLR, TVR | 1 year |
| Composite rate of cardiac death and any MI | 1 year |
| Composite rate of all death and any MI | 1 year |
| Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization | 1 year |
| Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy | 1 year |
| Clinical device and procedural success | During the health care facility stay |
| Cheonan |
| South Korea |
| Chungbuk National University Hospital | Cheongju-si | South Korea |
| Kwangju Veterans Hospital | Gwangju | South Korea |
| Chonbuk National University Hospital | Iksan | South Korea |
| Wonkwang University Hospital | Iksan | South Korea |
| Inje University Ilsan Paik Hospital | Ilsan | South Korea |
| Gachon Kil Medical Center | Inchon | South Korea |
| Presbyterian Medical Center | Jeonju | South Korea |
| Gyeongsang National University Hospital | Jinju | South Korea |
| Inje University Pusan Paik Hospital | Pusan | South Korea |
| Seoul National University Bundang Hospital | Seongnam | South Korea |
| Gangnam Severance Hospital | Seoul | South Korea |
| Kyung Hee University Medical Center | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Yonsei University Medical Center | Seoul | South Korea |
| St. Carollo Hospital | Suncheon | South Korea |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided