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NCT Number: NCT07764094

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

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.

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Key information

Conditions

PCI Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Drug-coated Balloon Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location status: Recruiting

Location contact

Fei Ye, MD

CONTACT

[email protected]

18951670287 ext. +86

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Target Lesion Restenosis

    Time frame: 6-12 months

    Percentage diameter stenosis at the target lesion as assessed by angiography at follow-up

Secondary outcomes

  1. Target Vessel Failure

    Time frame: 6-12 months

    Composite of cardiac death, target-vessel myocardial infarction (TVMI), and clinically driven target-vessel revascularization(TVR)

Study contacts

Contact information is provided by the study sponsor or research team.

Fei Ye, MD

CONTACT

[email protected]

18951670287 ext. +86

Tian-lei Zhang, MD

CONTACT

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

Impact of Drug-Coated Balloon Procedural Factors on Angiographic and Clinical Outcomes of Percutaneous Coronary Intervention for De Novo Lesions: A Multicenter, Prospective, Observational Registry

Acronym: DT

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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