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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2020-12-31

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.

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Detailed Description

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Conditions

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Coronary Artery Obstructive Disease Chronic Total Occlusion Lesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pre-PCI CT scan group

Pre-PCI CT scan

Group Type EXPERIMENTAL

Pre-PCI coronary CT scan

Intervention Type DEVICE

Coronary CT scan before CTO PCI

Control group

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pre-PCI coronary CT scan

Coronary CT scan before CTO PCI

Intervention Type DEVICE

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No