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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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02037698
Enrollment
400
Registered
2014-01-16
Start date
2014-01-31
Completion date
2020-12-31
Last updated
2020-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Total Occlusion Lesions, Coronary Artery Obstructive Disease

Keywords

CTO, CT, Revascularization

Brief 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.

Interventions

DEVICEPre-PCI coronary CT scan

Coronary CT scan before CTO PCI

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Successful CTO recanalizationImmediately after CTO PCIIncidence of the successful CTO recanalization between pre-PCI CT scan group versus control group

Secondary

MeasureTime frameDescription
Incidence of MACEs12 months after index PCIComparison of major adverse cardiac events (MACE), between ZES and EES implantation.

Countries

South Korea

Contacts

Primary ContactYangsoo Jang, MD
jangys1212@yuhs.ac82-2-2228-8460

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026