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

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: 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)

• Registration Number: NCT01563952
• Lead Sponsor: Yonsei University

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-10
• Status Verified: 2012-03
• Study First Submitted: 2012-03-12
• Study First Submitted QC: 2012-03-26
• Last Update Submitted: 2012-03-26
• Study First Posted: 2012-03-27
• Last Update Posted: 2012-03-27
• Primary Completion: 2013-10
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-IVUS guided endeavor-R group	Non-IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic)	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	IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic)	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	Non-IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo)	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	IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo)	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.

Primary Outcome Measures

Name	Time	Method
event rate of cardiac death within 12 months	12 months after CTO intervention.	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

Secondary Outcome Measures

Name	Time	Method
Incidence of MACE after stent implantation.	24 months after CTO intervention	1. Incidence of cardiac death, MI, TLR and ST for 9, 12 and 24 months after stent implantation.; 2. Binary restenosis, late loss, restenosis %, restenosis type and follow-up MLD on follow-up angiography 1 year after CTO intervention; 3. 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.

Trial Locations

Locations (1)

Jang, Yang-Soo; 🇰🇷 Seoul, Seodaemun-gu/Sinchon-dong, Korea, Republic of