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

Yonsei University

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease

Treatments: Device: IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo); Device: IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic); Device: Non-IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic); Device: Non-IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo)

Study type: Interventional

Funder types: Other

Identifiers

NCT01563952

1-2010-0023

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient is ≥ 20 years or ≤ 80 years old
2. On coronary angiography, complete obstruction of coronary blood flow (TIMI grade 0) with estimated occlusion duration ≥ 3months.
3. On coronary angiography, Reference vessel diameter of 2.5 to 4.0mm by operator assessment
4. 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.
5. Guide wire can be passed through occluded lesion without complications
6. Patients who can keep the dual antiplatelet treatment (aspirin, clopidogrel) more than 6 months after procedure

Exclusion criteria

1. Hypersensitivity reaction or side effects to Aspirin, Clopidogrel, Biolimus A9 and Zotarolimus
2. unprotected Left main disease
3. Cardiogenic shock or LV ejection fraction ≤ 30%
4. Previous stent restenotic lesion
5. Treated within 2 weeks at the same lesion.
6. Creatinine level ≥ 2.0 mg/dL or ESRD
7. Severe tortuous and calcified lesion (Unobtainable IVUS image)
8. Life expectancy < 1 year
9. Severe hepatic dysfunction (3 times normal reference values)
10. Pregnant women or women with potential childbearing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 4 patient groups

Non-IVUS guided endeavor-R group

Active Comparator group

Description:

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.

Treatment:

Device: Non-IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic)

IVUS guided endeavor-R group

Experimental group

Description:

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.

Treatment:

Device: IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic)

Non-IVUS guided Nobori group

Active Comparator group

Description:

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.

Treatment:

Device: Non-IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo)

IVUS guided Nobori group

Experimental group

Description:

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.

Treatment:

Device: IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo)