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
Not provided
| Name | Class |
|---|---|
| CardioVascular Research Foundation, Korea | OTHER |
| Boston Scientific Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a non-randomized, prospective, open-label registry to compare the efficacy and safety of Promus Element stents versus first-generation drug-eluting stent (DES) in patients with coronary artery disease.
The Element Stent platform features a proprietary Platinum Chromium Alloy, designed specifically for coronary stents. This alloy, coupled with a new stent architecture, is designed to enable thinner struts, increased flexibility and a lower profile while improving radial strength, recoil and visibility. In addition, the PROMUS Element Stent System incorporates the new Apex™ Dilatation Catheter technology, designed to enhance deliverability to complex lesions.
Currently, there have been limited data regarding comparison of PROMUS Element stent with first-generation DES in routine clinical practice. Therefore, we perform large-scale real-world registry of PROMUS Element stents.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Promus Element stent | Patients receiving Promus Element stents |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) | 12 months post stenting procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Death (all-cause and cardiac) | 30 days | |
| Myocardial infarction | 30 days | |
| Composite of death or MI |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Coronary artery disease requiring drug eluting stents
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Seung-Jung Park, MD, PhD | Asan Medical Center | Principal Investigator |
| Ki Bae Seung, MD, PhD | Seoul St. Mary's Hospital, Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 38 Centers | Seoul | South Korea |
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 30 days |
| Composite of cardiac death or MI | 30 days |
| Target Vessel Revascularization | 30 days |
| Target lesion revascularization | 30 days |
| Stent thrombosis | 30 days |
| Procedural success(defined as achievement of a final diameter stenosis of <30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization) | At discharge from the index hospitalization, participants will be followed for the duration of hospital stay, an expected average of 3 days. | 3 days in average |
| Death (all cause and cardiac) | 6 months |
| Death (all cause and cardiac) | yearly up to 5 years |
| Myocardial infarction | 6 months |
| Myocardial infarction | yearly up to 5 years |
| Composite of death or MI | 6 months |
| Composite of death or MI | yearly up to 5 years |
| Composite of cardiac death or MI | 6 months |
| Composite of cardiac death or MI | yearly up to 5 years |
| Target Vessel Revascularization | 6 months |
| Target Vessel Revascularization | yearly up to 5 years |
| Target lesion revascularization | 6 months |
| Target lesion revascularization | yearly up to 5 years |
| Stent thrombosis | 6 months |
| Stent thrombosis | yearly up to 5 years |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |