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Recruiting Observational

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

NCT07764094 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2026-09-01
Last updated
2026-08-28

Condition(s) studied

PCIDrug-coated BalloonCoronary Artery Disease

Study summary

This registry aimed to investigate drug-coated balloon procedural factors (particularly delivery time and inflation duration) to evaluate the impact on angiographic and clinical outcomes in patients undergoing percutaneous coronary intervention for de novo coronary lesions.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of Participants with Target Lesion Restenosis — 6-12 months
    Percentage diameter stenosis at the target lesion as assessed by angiography at follow-up

Trial sites (7)

FacilityCityRegionStatus
Chuzhou First People's Hospital Chuzhou Anhui Recruiting
Tongling People's Hospital Tongling Anhui Recruiting
Huai'an Second People's Hospital Huai'an Jiangsu Recruiting
Lianyungang First People's Hospital Lianyungang Jiangsu Recruiting
Nanjing First Hospital Nanjing Jiangsu Recruiting
Xuzhou Second People's Hospital Xuzhou Jiangsu Recruiting
Yixing People's Hospital Yixing Jiangsu Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07764094 on ClinicalTrials.gov ↗ ← All trials in China