Impact of Intravascular Ultrasound(IVUS)-Guided Chronic Total Occlusion Intervention With Drug-eluting Stents

Study Overview
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Brief Summary
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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).

Detailed Description
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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). 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.

Official Title
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Impact of IVUS-guided Chronic Total Occlusion InterVention With DrUg-eluting Stents on Mid-term Angiographic and Clinical Outcomes (CTO-IVUS Study)

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Non-IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic)
* Device: IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic)
* Device: Non-IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo)
* Device: IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non-IVUS guided endeavor-R group<br>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. | Device: Non-IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic)<br>* 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.<br>|
| Experimental: IVUS guided endeavor-R group<br>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. | Device: IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic)<br>* 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.<br>|
| Active Comparator: Non-IVUS guided Nobori group<br>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. | Device: Non-IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo)<br>* 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.<br>|
| Experimental: IVUS guided Nobori group<br>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. | Device: IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of MACE after stent implantation. | Incidence of cardiac death, MI, TLR and ST for 9, 12 and 24 months after stent implantation. Binary restenosis, late loss, restenosis %, restenosis type and follow-up MLD on follow-up angiography 1 year after CTO intervention Subgroup analysis; : Among the IVUS guided intervention group, Non-IVUS giuded intervention group and total patient group, To analyse difference of clinical outcome and angiographical outcome between Endeavor Resolute and Nobori stent. To analyse change of Stenting distal part using IVUS parameters. | 24 months after CTO intervention |