CClinicalTrials.gg
Status unknownNCT02037698Updated Jan 23, 2020

Role of CT Scan for the Successful Recanalization of Chronic Total Occlusion; a Randomized Comparison Between 3D CT-guided PCI vs. Conventional Treatment (CT-CTO Trial)

An interventional study of Pre-PCI coronary CT scan in Coronary Artery Obstructive Disease and Chronic Total Occlusion Lesions, sponsored by Yonsei University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2020-01-23.

Sponsored by Yonsei University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
20 Years and older
Sex
All
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Study summary

The revascularization of chronic total occlusion of coronary arteries (CTO) is the most challenging procedure for the coronary intervention. For the initial period for CTO intervention, percutaneous coronary artery intervention (PCI) of CTO lesions are associated with low procedural success rates about 70%. Recently, the success rate of the recanalization of CTOs has been raised in several studies.

Coronary CT angiography (CCTA) is an effective noninvasive diagnostic modality for detecting coronary artery disease. CCTA can visualize the complete anatomy of coronary arteries in contrast to conventional coronary angiography, reducing the deferral rates from CTO intervention. Assessment of characteristics of CTO lesions by pre-procedural CCTA could help to determine revascularization strategy and estimate the procedure time, leading to lower procedural complications. We suggest that success rates and clinical outcome of intervention of CTO lesion can be improved by pre-procedural CCTA.

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Conditions studied

  • Coronary Artery Obstructive Disease
  • Chronic Total Occlusion Lesions

Keywords

  • CTO
  • CT
  • Revascularization
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In context

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients (age >19 years) with CTO (TIMI = 0 and estimated duration of occlusion at least 3 months)
  • Typical symptomatic angina or positive stress test in various functional studies evaluating ischemia
  • Eligible patients for pre-procedural CT scan and coronary angiogram

Exclusion criteria

Exclusion Criteria:

  • Cardiogenic shock or ejection fraction \< 25%
  • CTO lesions at DES restenosis or graft occlusion lesion
  • Significant left main stenosis
  • Retry of same CTO lesion within 2 weeks
  • Acute myocardial infarction within 48 hours
  • Hypersensitivity to aspirin, clopidogrel, or -limus families / or contraindication to antiplatelet agents
  • Severe hepatic dysfunction (≥3 times normal reference values)
  • Life expectancy \< 1 years
  • Pregnant women or women with potential childbearing
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    Pre-PCI CT scan group

    Pre-PCI CT scan

    Device: Pre-PCI coronary CT scan

  • No intervention
    Control group

    Control

Interventions

  • DevicePre-PCI coronary CT scan

    Coronary CT scan before CTO PCI

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What researchers measure

Primary outcomes

  1. Successful CTO recanalization

    Incidence of the successful CTO recanalization between pre-PCI CT scan group versus control group

    Time frame: Immediately after CTO PCI

Secondary outcomes

  1. Incidence of MACEs

    Comparison of major adverse cardiac events (MACE), between ZES and EES implantation.

    Time frame: 12 months after index PCI

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Study locations

1 of 1 sites recruiting
  • Division of Cardiology, Severance Cardiovascular Hospital
    Seoul, 120-752, Korea, Republic of
    Recruiting
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References and documents

Publications

  • Hong SJ, Kim BK, Cho I, Kim HY, Rha SW, Lee SH, Park SM, Kim YH, Chang HJ, Ahn CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y; CT-CTO Investigators. Effect of Coronary CTA on Chronic Total Occlusion Percutaneous Coronary Intervention: A Randomized Trial. JACC Cardiovasc Imaging. 2021 Oct;14(10):1993-2004. doi: 10.1016/j.jcmg.2021.04.013. Epub 2021 Jun 16. PubMed 34147439 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02037698
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Jan 16, 2014
Start date
Jan 2014
Primary completion
Dec 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Jan 23, 2020

Study contacts

Yangsoo Jang, MD
Contact
jangys1212@yuhs.ac
82-2-2228-8460

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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