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

Coronary Artery Disease Clinical Trial

— CTO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01563952
• Other study ID #: 1-2010-0023
• Status: Recruiting
• Phase: Phase 4
• First received: March 12, 2012
• Last updated: March 26, 2012
• Start date: October 2010
• Est. completion date: October 2013

Study information

• Verified date: March 2012
• Source: Yonsei University
• Contact: Yang-Soo Jang, MD.PhD.
• Phone: +82 2 2228 8445
• Email: jangys1212[@]yuhs.ac
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• 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 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 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 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.

Locations

Country	Name	City	State
Korea, Republic of	Jang, Yang-Soo	Seoul	Seodaemun-gu/Sinchon-dong

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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	No