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)

Study Overview
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Brief Summary
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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.

Conditions
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Coronary Artery Obstructive Disease, Chronic Total Occlusion Lesions

Intervention / Treatment
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* Device: Pre-PCI coronary CT scan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-PCI CT scan group<br>Pre-PCI CT scan | Device: Pre-PCI coronary CT scan<br>* Coronary CT scan before CTO PCI<br>|
| No Intervention: Control group<br>Control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful CTO recanalization | Incidence of the successful CTO recanalization between pre-PCI CT scan group versus control group | Immediately after CTO PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of MACEs | Comparison of major adverse cardiac events (MACE), between ZES and EES implantation. | 12 months after index PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CTO, CT, Revascularization