Impact of Intravascular Ultrasound(IVUS)-Guided Chronic Total Occlusion Intervention With Drug-eluting Stents
CTO
Impact of IVUS-guided Chronic Total Occlusion InterVention With DrUg-eluting Stents on Mid-term Angiographic and Clinical Outcomes (CTO-IVUS Study)
1 other identifier
interventional
400
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 coronary-artery-disease
Started Oct 2010
Typical duration for phase_4 coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 12, 2012
CompletedFirst Posted
Study publicly available on registry
March 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedMarch 27, 2012
March 1, 2012
3 years
March 12, 2012
March 26, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (1)
Incidence of MACE after stent implantation.
24 months after CTO intervention
Study Arms (4)
Non-IVUS guided endeavor-R group
ACTIVE COMPARATOR2x2 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
EXPERIMENTAL2x2 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
ACTIVE COMPARATOR2x2 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
EXPERIMENTAL2x2 randomization by the treatment of IVUS-guided intervention vs. Non-IVUS guided intervention and the types of the implanted DES, Endeavor-R vs. Nobori.
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Patient is ≥ 20 years or ≤ 80 years old
- On coronary angiography, complete obstruction of coronary blood flow (TIMI grade 0) with estimated occlusion duration ≥ 3months.
- On coronary angiography, Reference vessel diameter of 2.5 to 4.0mm by operator assessment
- 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.
- Guide wire can be passed through occluded lesion without complications
- Patients who can keep the dual antiplatelet treatment (aspirin, clopidogrel) more than 6 months after procedure
You may not qualify if:
- Hypersensitivity reaction or side effects to Aspirin, Clopidogrel, Biolimus A9 and Zotarolimus
- unprotected Left main disease
- Cardiogenic shock or LV ejection fraction ≤ 30%
- Previous stent restenotic lesion
- Treated within 2 weeks at the same lesion.
- Creatinine level ≥ 2.0 mg/dL or ESRD
- Severe tortuous and calcified lesion (Unobtainable IVUS image)
- Life expectancy \< 1 year
- Severe hepatic dysfunction (3 times normal reference values)
- Pregnant women or women with potential childbearing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jang, Yang-Soo
Seoul, Seodaemun-gu/Sinchon-dong, 120-752, South Korea
Related Publications (1)
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.
PMID: 26156151DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yang-Soo Jang, MD.PhD.
Severance Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of cardiology
Study Record Dates
First Submitted
March 12, 2012
First Posted
March 27, 2012
Study Start
October 1, 2010
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
March 27, 2012
Record last verified: 2012-03