DCB Treatment in CTO Guided by IVUS

Study Overview
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Brief Summary
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The percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) coronary artery disease is difficult, the success rate is low, and the incidence of re-occlusion and restenosis is high. With the wide application of imaging technology represented by intravascular ultrasound (IVUS), the success rate of CTO PCI has been significantly improved. Drug-coated balloons (DCB), as a treatment without metal implantation, has lower lumen loss and no significant increase in the rate of revascularization. Through IVUS measurement of vascular lumen after CTO opening, appropriate instruments can be selected for adequate dilation, and appropriate treatment methods can be selected according to different lumen structures. Therefore, the purpose of this study was to evaluate the clinical effect of IVUS-guided DCB therapy on CTO lesions.

Official Title
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Drug-coated Balloons Treatment in Chronic Total Occlusion Coronary Artery Disease Guided by Intravascular Ultrasound

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: PCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over the age of 18, male or female; Patients who meet the diagnostic criteria for coronary heart disease, have clinical symptoms and seek interventional treatment; Coronary angiography confirmed that the blood vessels met the diagnostic criteria of CTO; Sign informed consent and be willing to undergo follow-up for at least 12 months. Exclusion Criteria: Patients with severe contrast allergy who cannot tolerate coronary angiography; Patients known allergy to drug balloon coating; Patients who is pregnant or breastfeeding; Bleeding or other diseases, such as digestive tract ulcers, blood system diseases, etc., limit the use of platelet aggregation inhibitors and anticoagulation therapy; Patients with cardiac shock; Patients with a life expectancy of less than 1 year; Other situations deemed unsuitable for inclusion by the researcher.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DCB group<br>CTO patients treated by DCB | Procedure: PCI<br>* CTO patients treated by DCB<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of major adverse cardiovascular events (MACE) in 12 month | cardiovascular death, nonfatal myocardial infarction, and target vessel revascularization | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of cardiovascular death in 12 month |  | 12 month | 
| Rate of nonfatal myocardial infarction in 12 month |  | 12 month | 
| Rate of target vessel revascularization in 12 month |  | 12 month | 
| Rate of procedure success rate after PCI |  | 1 day | 
| Rate of technical success after PCI |  | 1 day | 
| Rate of minor bleeding events |  | 12 month | 
| Rate of major bleeding events |  | 12 month |