Clinical trial NCT01563952: Impact of Intravascular Ultrasound(IVUS)-Guided Chronic Total Occlusion Intervention With Drug-eluting Stents
Official title: Impact of IVUS-guided Chronic Total Occlusion InterVention With DrUg-eluting Stents on Mid-term Angiographic and Clinical Outcomes (CTO-IVUS Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-03-27
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: event rate of cardiac death within 12 months
timeFrame: 12 months after CTO intervention.
Secondary outcomes:
measure: Incidence of MACE after stent implantation.
timeFrame: 24 months after CTO intervention
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jang, Yang-Soo
state: Seodaemun-gu/Sinchon-dong
Study officials:
affiliation: Severance Hospital
name: Yang-Soo Jang, MD.PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim BK, Shin DH, Hong MK, Park HS, Rha SW, Mintz GS, Kim JS, Kim JS, Lee SJ, Kim HY, Hong BK, Kang WC, Choi JH, Jang Y; CTO-IVUS Study Investigators. Clinical Impact of Intravascular Ultrasound-Guided Chronic Total Occlusion Intervention With Zotarolimus-Eluting Versus Biolimus-Eluting Stent Implantation: Randomized Study. Circ Cardiovasc Interv. 2015 Jul;8(7):e002592. doi: 10.1161/CIRCINTERVENTIONS.115.002592.