Impact of Procedural Factors on Drug-Coated Balloon Outcomes in Coronary Artery Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry analyzes how specific drug-coated balloon procedural factors, such as Y-to-B delivery time and inflation duration, influence both angiographic results and clinical outcomes in patients with de novo coronary lesions undergoing PCI. The study collects data on procedural details and subsequent outcomes to identify potential optimization strategies for the DCB treatment process. Based on the findings, new techniques and pretreatment approaches may be proposed to improve effectiveness and safety of DCB use. The design focuses on real-world practice across several hospitals in Anhui and Jiangsu, with adults meeting defined eligibility criteria. Outcome assessment will emphasize both short-term and longer-term clinical and imaging endpoints.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years
2. Stable coronary artery disease or unstable angina
3. De novo coronary lesion (reference vessel diameter 2.25-4.0 mm; lesion length ≤40 mm)
4. Planned DCB strategy for PCI
5. Written informed consent

Exclusion Criteria:

1. Acute myocardial infarction within 72 hours
2. Severe heart failure (NYHA class IV)
3. Severe hepatic or renal insufficiency
4. Allergy to drug-coated balloon components or antiplatelet agents, or intolerance to dual antiplatelet therapy
5. Life expectancy \<12 months
6. Pregnancy or breastfeeding
7. Concurrent participation in another clinical trial
8. In-stent restenosis
9. Unsuccessful recanalization of main vessel or side branch chronic total occlusion
10. Hemodynamic instability

Where it's running

• Chuzhou First People's Hospital
  Chuzhou, Anhui, China Recruiting
• Tongling People's Hospital
  Tongling, Anhui, China Recruiting
• Huai'an Second People's Hospital
  Huai'an, Jiangsu, China Recruiting
• Lianyungang First People's Hospital
  Lianyungang, Jiangsu, China Recruiting
• Nanjing First Hospital
  Nanjing, Jiangsu, China Recruiting
• Xuzhou Second People's Hospital
  Xuzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Fei Ye, MD
• Email: doctor_ye@126.com
• Phone: 18951670287

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.