DCB Treatment in CTO Guided by IVUS

Recruiting

• Conditions: Coronary Artery Disease
• Interventions: Procedure: PCI

• Registration Number: NCT06050096
• Lead Sponsor: Xuzhou Central Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study Start: 2023-09-01
• Study First Submitted: 2023-09-08
• Study First Submitted QC: 2023-09-16
• Last Update Submitted: 2023-09-16
• Study First Posted: 2023-09-22
• Last Update Posted: 2023-09-22
• Primary Completion: 2025-08-31
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Over the age of 18, male or female;
2. Patients who meet the diagnostic criteria for coronary heart disease, have clinical symptoms and seek interventional treatment;
3. Coronary angiography confirmed that the blood vessels met the diagnostic criteria of CTO;
4. Sign informed consent and be willing to undergo follow-up for at least 12 months.

Exclusion Criteria

1. Patients with severe contrast allergy who cannot tolerate coronary angiography;
2. Patients known allergy to drug balloon coating;
3. Patients who is pregnant or breastfeeding;
4. Bleeding or other diseases, such as digestive tract ulcers, blood system diseases, etc., limit the use of platelet aggregation inhibitors and anticoagulation therapy;
5. Patients with cardiac shock;
6. Patients with a life expectancy of less than 1 year;
7. Other situations deemed unsuitable for inclusion by the researcher.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DCB group	PCI	CTO patients treated by DCB

Primary Outcome Measures

Name	Time	Method
Rate of major adverse cardiovascular events (MACE) in 12 month	12 month	cardiovascular death, nonfatal myocardial infarction, and target vessel revascularization

Secondary Outcome Measures

Name	Time	Method
Rate of cardiovascular death in 12 month	12 month
Rate of technical success after PCI	1 day
Rate of target vessel revascularization in 12 month	12 month
Rate of procedure success rate after PCI	1 day
Rate of minor bleeding events	12 month
Rate of major bleeding events	12 month
Rate of nonfatal myocardial infarction in 12 month	12 month

Trial Locations

Locations (1)

Xuzhou Central Hospital; 🇨🇳 Xuzhou, Jiangsu, China