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

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

Recruiting
18-80 years
All
Phase N/A

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Overview

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.

Description

This study aimed to systematically investigate drug-coated balloon procedural factors including Y-to-B delivery time, inflation duration among patients with de novo coronary lesions undergoing PCI.The impact of these procedural factors on angiographic and clinical outcomes will be analyzed.Based on these findings, novel techniques and pretreatment strategies may be proposed to optimize the DCB treatment process

Eligibility

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

Study details
    PCI
    Drug-coated Balloon
    Coronary Artery Disease

NCT07764094

Nanjing First Hospital, Nanjing Medical University

15 August 2026

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