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

RECRUITINGSponsored by Nanjing First Hospital, Nanjing Medical University
Actively Recruiting
SponsorNanjing First Hospital, Nanjing Medical University
Started2026-09-01
Est. completion2027-12-31
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07764094

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

Age: 18 Years – 80 YearsHealthy volunteers accepted
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

Conditions4

Coronary Artery DiseaseDrug Coated BalloonHeart DiseasePCI

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