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Guidance of stenting by IVUS has been proposed as a method to reduce restenosis rates, because lumen and stent dimensions can be accurately determined by intravascular ultrasound (IVUS).
Guidance of stenting by IVUS has been proposed as a method to reduce restenosis rates, because lumen and stent dimensions can be accurately determined by intravascular ultrasound (IVUS). However, randomized studies investigating this strategy have yielded inconsistent results. Therefore, the investigators hypothesized that the potential advantages of IVUS guidance would be most apparent in Chronic Total Occlusion (CTO) intervention and try to evaluate the impact of IVUS-guided chronic total occlusion intervention with drug-eluting stents on mid-term angiographic, IVUS and clinical outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-IVUS guided endeavor-R group | Active Comparator | 2x2 randomization by the treatment of IVUS-guided intervention vs. Non-IVUS guided intervention and the types of the implanted DES, Endeavor-R vs. Nobori. |
|
| IVUS guided endeavor-R group | Experimental | 2x2 randomization by the treatment of IVUS-guided intervention vs. Non-IVUS guided intervention and the types of the implanted DES, Endeavor-R vs. Nobori. |
|
| Non-IVUS guided Nobori group | Active Comparator | 2x2 randomization by the treatment of IVUS-guided intervention vs. Non-IVUS guided intervention and the types of the implanted DES, Endeavor-R vs. Nobori. |
|
| IVUS guided Nobori group | Experimental | 2x2 randomization by the treatment of IVUS-guided intervention vs. Non-IVUS guided intervention and the types of the implanted DES, Endeavor-R vs. Nobori. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic) | Device | 2x2 randomization by the treatment of IVUS-guided intervention vs. Non-IVUS guided intervention and the types of the implanted DES, Endeavor-R vs. Nobori. |
| Measure | Description | Time Frame |
|---|---|---|
| event rate of cardiac death within 12 months | Between IVUS guided intervention and non-IVUS guided intervention in patient with chronic total occlusion, the difference of post-procedural success rate, the combined event rate of cardiac death, MI and target lesion revascularization within 12 months. And incidence of composite events in cross over case of IVUS duing CTO intervention | 12 months after CTO intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of MACE after stent implantation. |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang-Soo Jang, MD.PhD. | Contact | +82 2 2228 8445 | jangys1212@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Yang-Soo Jang, MD.PhD. | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jang, Yang-Soo | Recruiting | Seoul | Seodaemun-gu/Sinchon-dong | 120-752 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26156151 | Derived | Kim BK, Shin DH, Hong MK, Park HS, Rha SW, Mintz GS, Kim JS, Kim JS, Lee SJ, Kim HY, Hong BK, Kang WC, Choi JH, Jang Y; CTO-IVUS Study Investigators. Clinical Impact of Intravascular Ultrasound-Guided Chronic Total Occlusion Intervention With Zotarolimus-Eluting Versus Biolimus-Eluting Stent Implantation: Randomized Study. Circ Cardiovasc Interv. 2015 Jul;8(7):e002592. doi: 10.1161/CIRCINTERVENTIONS.115.002592. |
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| IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic) | Device | 2x2 randomization by the treatment of IVUS-guided intervention vs. Non-IVUS guided intervention and the types of the implanted DES, Endeavor-R vs. Nobori. |
|
| Non-IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo) | Device | 2x2 randomization by the treatment of IVUS-guided intervention vs. Non-IVUS guided intervention and the types of the implanted DES, Endeavor-R vs. Nobori. |
|
| IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo) | Device | 2x2 randomization by the treatment of IVUS-guided intervention vs. Non-IVUS guided intervention and the types of the implanted DES, Endeavor-R vs. Nobori. |
|
| 24 months after CTO intervention |
| 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 |
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