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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07764094

Acronym

Enrollment

500

Registered

2026-08-13

Start date

2026-09-01

Completion date

2028-06-30

Last updated

2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Drug-coated Balloon, PCI

Keywords

Percutaneous coronary intervention, Drug coated balloon

Brief 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.

Detailed 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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Number of Participants with Target Vessel Failure	6-12 months	Composite of cardiac death, target-vessel myocardial infarction (TVMI), and clinically driven target-vessel revascularization(TVR)

Countries

China

Contacts

CONTACTFei Ye, MD

doctor_ye@126.com18951670287

CONTACTTian-lei Zhang, MD

Outcome results