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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to examine the safety and effectiveness of coronary stenting with the Cilotax stent compared to the Xience Prime stent in the treatment of diabetic patients.
Prospective, randomized multi-center trial of 300 patients will be enrolled at 7 centers in Korea. Following angiography, diabetic patients with significant diameter stenosis >50% by visual estimation have documented myocardial ischemia or symptoms of angina, and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) Cilotax stent vs. b) Xience Prime stent. All patients will be followed for at least 1 year. Angiographic follow-up at 9-months is routinely recommended.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xience Prime stent | Active Comparator | everolimus eluting stent |
|
| Cilotax stent | Experimental | paclitaxel with cilostazol dual drug eluting stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xience Prime | Device | everolimus-eluting stent implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| In-segment late luminal loss | at 9 month angiographic follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| All Death | 12 months | |
| Cardiac death | 12 months | |
| Myocardial infarction |
Not provided
Inclusion Criteria:
Clinical:
Angiographic:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Cheol-Whan Lee, MD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soon Chun Hyang University Hospital Cheonan | Cheonan | South Korea | ||||
| Daegu Catholic University Medical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cilotax stent | Device | paclitaxel with cilostazol dual drug eluting stent implantation |
|
|
| 12 months |
| Target vessel revascularization (ischemia-driven) | 12 months |
| Target lesion revascularization (ischemia-driven) | 12 months |
| Stent thrombosis (by ARC definition) | 12 months |
| Binary restenosis in both in-stent and in-segment | at 9 month angiographic follow-up |
| Angiographic pattern of restenosis | at 9 month angiographic follow-up |
| Procedural success | achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion during the hospital stay | At discharge from the index hospitalization, an expected average of 3 days. |
| All Death | 1 month |
| All Death | 4 months |
| All Death | 9 months |
| Cardiac death | 1 month |
| Cardiac death | 4 months |
| Cardiac death | 9 months |
| Myocardial infarction | 1 month |
| Myocardial infarction | 4 months |
| Myocardial infarction | 9 months |
| Target vessel revascularization (ischemia-driven) | 1 month |
| Target vessel revascularization (ischemia-driven) | 4 months |
| Target vessel revascularization (ischemia-driven) | 9 months |
| Target lesion revascularization (ischemia-driven) | 1 month |
| Target lesion revascularization (ischemia-driven) | 4 months |
| Target lesion revascularization (ischemia-driven) | 9 months |
| Stent thrombosis (by ARC definition) | 1 month |
| Stent thrombosis (by ARC definition) | 4 months |
| Stent thrombosis (by ARC definition) | 9 months |
| Daegu |
| South Korea |
| Keimyung University Dongsan Medical Center | Daegu | South Korea |
| Chungnam National University Hospital | Daejeon | South Korea |
| The Catholic University of Korea, Daejeon ST. Mary's Hospital | Daejeon | South Korea |
| Gangneung Asan Hospital | Gangneung | South Korea |
| Inje University Pusan Paik Hospital | Pusan | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Ulsan University Hospital | Ulsan | 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