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| Name | Class |
|---|---|
| Catholic Medical Center | OTHER |
| KangWon National University Hospital | OTHER |
| Kyungpook National University Hospital | OTHER |
| Kunyang University Medical center |
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The purpose of this study is to evaluate the feasibility, safety, and effectiveness of EndeavorTM ResoluteTM and Xience VTM stent implantation in patients with restenosis following drug-eluting stent (DES) implantation. The investigators will evaluate clinical, angiographic and intravascular ultrasound (IVUS) assessment of 9-month efficacy of EndeavorTM ResoluteTM or Xience VTM implantation in DES restenosis and assess the vascular changes of re-treatment with DES for DES restenosis using follow-up IVUS analysis. In addition, the investigators will evaluate the effectiveness of retreatment with EndeavorTM ResoluteTM or Xience VTM stent implantation in patients with restenosis after DES
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xience V, drug-eluting stent | Active Comparator | randomized implantation for DES restenotic lesion |
|
| Endeavor Resolute, drug-eluting stent | Active Comparator | randomized implantation for DES restenotic lesion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xiene V stent, Endeavor Resolute stent | Device | for each lesion, randomized either Xience V stent or Endeavor Resolute stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| In-stent neointimal volume index | 9 months on IVUS |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiovascular events | Safety end-point; to evaluate the procedural success and the incidence of 12-month death, MI, target-vessel failure (TVF), or stent thrombosis | 12 months |
| Efficacy end-point |
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Inclusion Criteria:
Exclusion Criteria:
Lesion & Procedural exclusion criteria
IVUS unavailable lesion
Restenotic lesions following PCI of de novo lesion like as below;
Restenotic lesions following 2.25mm DES implantation
Prior history of repeat DES implantation for DES restenosis (only conventional or cutting ballooning treatment for DES restenosis is included in this study)
Simultaneous implantation of different types of DES on restenotic or another de novo lesions (Only same DES implantation is allowed on the restenotic or another de novo lesions)
Patients with little possibility of performing follow-up angiogram and IVUS
General exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Korea University Anam Hospital Ahn, MD, PhD | Contact | +82-2-920-5445 | drcello@kumc.or.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yousei Universty Healthcare System | Recruiting | Seoul | South Korea |
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| UNKNOWN |
| Kyunghee University Medical Center | OTHER |
| Kyemyeong Univerisity Medical Center | UNKNOWN |
| Korea University Guro Hospital | OTHER |
| Kwandong Univerisity Medical Center | UNKNOWN |
| Kwangjoo Veteran Hospital | UNKNOWN |
| Eulji University | OTHER |
| Dankook University | OTHER |
| Daegoo Catholic Medical College | UNKNOWN |
| Dong-A University | OTHER |
| Sejong General Hospital | OTHER |
| Busan University Medical Center | UNKNOWN |
| Seoul National University Medical Center | UNKNOWN |
| Sunkyungwan Univeristy Medical Center | UNKNOWN |
| Suncheonyang University Medical Center | UNKNOWN |
| Yonsei University | OTHER |
| Yongnam University Medical Center | UNKNOWN |
| Wonkwang University | OTHER |
| Inje Univerisity Medical Center | UNKNOWN |
| Chonnam National University | OTHER |
| Chung-Ang University | OTHER |
| Hallym University Medical Center | OTHER |
| Chungnam National University | OTHER |
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Efficacy end-point; to evaluate the 9-month binary angiographic restenosis (≥50 percent in-stent diameter stenosis) and late loss, vascular remodeling during follow-up
| 9 months |