Impact of Intravascular Ultrasound(IVUS)-Guided Chronic Total Occlusion Intervention With Drug-eluting Stents (CTO)
Coronary Artery Disease
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- Patient is ≥ 20 years or ≤ 80 years old
- On coronary angiography, complete obstruction of coronary blood flow (TIMI grade 0) with estimated occlusion duration ≥ 3months.
- On coronary angiography, Reference vessel diameter of 2.5 to 4.0mm by operator assessment
- On coronary angiography, Total length of total occluded lesion and main lesion is less than 80mm and lesions can be treated less than 4 stents.
- Guide wire can be passed through occluded lesion without complications
- Patients who can keep the dual antiplatelet treatment (aspirin, clopidogrel) more than 6 months after procedure
Exclusion Criteria:
- Hypersensitivity reaction or side effects to Aspirin, Clopidogrel, Biolimus A9 and Zotarolimus
- unprotected Left main disease
- Cardiogenic shock or LV ejection fraction ≤ 30%
- Previous stent restenotic lesion
- Treated within 2 weeks at the same lesion.
- Creatinine level ≥ 2.0 mg/dL or ESRD
- Severe tortuous and calcified lesion (Unobtainable IVUS image)
- Life expectancy < 1 year
- Severe hepatic dysfunction (3 times normal reference values)
- Pregnant women or women with potential childbearing
Sites / Locations
- Jang, Yang-SooRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Experimental
Active Comparator
Experimental
Non-IVUS guided endeavor-R group
IVUS guided endeavor-R group
Non-IVUS guided Nobori group
IVUS guided Nobori group
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.
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.
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.
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.