Coronary Artery Disease
Conditions
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.
Interventions
DEVICENon-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.
DEVICEIVUS 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.
DEVICENon-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.
DEVICEIVUS 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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Contacts
Primary ContactYang-Soo Jang, MD.PhD.
Outcome results
None listed