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

Registry ID: NCT07764094
Source registry: NCT
Status: RECRUITING
Study type: OBSERVATIONAL
Sponsor: Nanjing First Hospital, Nanjing Medical University
Enrollment: 500
Start date: 2026-09-01
Completion date: 2028-06-30
Last update: 2026-08-13

Conditions

PCI
Drug-coated Balloon
Coronary Artery Disease

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

Inclusion criteria

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

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 outcomes

[{"measure":"Target Lesion Restenosis","timeFrame":"6-12 months"}]

Locations

Nanjing First Hospital, Nanjing, China

Publications

Kiyohara Y, Aikawa T, Saito T, Casso Dominguez A, Wiley J, Kolte D, Secemsky EA, Yeh RW, Laham RJ, Latib A, Bhatt DL, Kuno T. Comparison of Limus and Paclitaxel Drug-Coated Balloons, Second-Generation or Newer Drug-Eluting Stents, and Balloon Angioplasty: A Network Meta-Analysis of Randomized Controlled Trials. Circ Cardiovasc Interv. 2026 Jan;19(1):e016005. doi: 10.1161/CIRCINTERVENTIONS.125.016005. Epub 2025 Oct 27.
Gao C, He X, Ouyang F, Zhang Z, Shen G, Wu M, Yang P, Ma L, Yang F, Ji Z, Wang H, Wu Y, Fang Z, Jiang H, Wen S, Liu Y, Li F, Zhou J, Zhu B, Liu Y, Zhang R, Zhang T, Wang P, Liu J, Jiang Z, Xia J, van Geuns RJ, Capodanno D, Garg S, Onuma Y, Wang D, Serruys PW, Tao L; REC-CAGEFREE I Investigators. Drug-coated balloon angioplasty with rescue stenting versus intended stenting for the treatment of patients with de novo coronary artery lesions (REC-CAGEFREE I): an open-label, randomised, non-inferiority trial. Lancet. 2024 Sep 14;404(10457):1040-1050. doi: 10.1016/S0140-6736(24)01594-0. Epub 2024 Sep 2.
Camaj A, Leone PP, Colombo A, Vinayak M, Stone GW, Mehran R, Dangas G, Kini A, Sharma SK. Drug-Coated Balloons for the Treatment of Coronary Artery Disease: A Review. JAMA Cardiol. 2025 Feb 1;10(2):189-198. doi: 10.1001/jamacardio.2024.4244.

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