An observational study in Coronary Artery Disease, sponsored by Xuzhou Central Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-22.
Sponsored by Xuzhou Central Hospital · Observational
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 100 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Xuzhou Central Hospital is the lead sponsor of 20 studies on the registry; 5 are open to participants now.
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Among CTO lesions previously treated with DCB, the incidence of restenosis was 11.8%, with a sample size of 90-110. This is an observational study on the treatment of CTO, and all patients with CTO lesions were nonselectively enrolled. Continuous enrollment of CTO patients from September 2023 to August 2024 (an estimated 100 cases) was designed to observe the clinical effect of IVUS-directed DCB therapy on CTO lesions.
Exclusion Criteria:
CTO patients treated by DCB
Procedure: PCI
CTO patients treated by DCB
Rate of major adverse cardiovascular events (MACE) in 12 month
cardiovascular death, nonfatal myocardial infarction, and target vessel revascularization
Time frame: 12 month
Rate of cardiovascular death in 12 month
Time frame: 12 month
Rate of nonfatal myocardial infarction in 12 month
Time frame: 12 month
Rate of target vessel revascularization in 12 month
Time frame: 12 month
Rate of procedure success rate after PCI
Time frame: 1 day
Rate of technical success after PCI
Time frame: 1 day
Rate of minor bleeding events
Time frame: 12 month
Rate of major bleeding events
Time frame: 12 month
Plan to share: No
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Xuzhou Central Hospital