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)

Yonsei University

Status

Unknown

Conditions

Coronary Artery Obstructive Disease

Chronic Total Occlusion Lesions

Treatments

Device: Pre-PCI coronary CT scan

Study type

Interventional

Funder types

Other

Identifiers

NCT02037698

1-2013-0062

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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