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RecruitingNCT07764094DTUpdated Aug 28, 2026

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

An observational study in PCI, Drug-coated Balloon and Coronary Artery Disease, sponsored by Nanjing First Hospital, Nanjing Medical University. Recruiting at 7 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by Nanjing First Hospital, Nanjing Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • PCI
  • Drug-coated Balloon
  • Coronary Artery Disease

Keywords

  • Percutaneous coronary intervention
  • Drug coated balloon
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with de novo coronary lesions who are scheduled for planned drug-coated balloon PCI

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • DCB-Treated De Novo Lesion

    Patients undergoing drug-coated balloon treatment for de novo coronary lesions

05

What researchers measure

Primary outcomes

  1. Number of Participants with Target Lesion Restenosis

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

    Time frame: 6-12 months

Secondary outcomes

  1. Number of Participants with Target Vessel Failure

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

    Time frame: 6-12 months

06

Study locations

7 of 7 sites recruiting
  • Chuzhou First People's Hospital
    Chuzhou, Anhui 239000, China
    Recruiting
  • Tongling People's Hospital
    Tongling, Anhui 244000, China
    Recruiting
  • Huai'an Second People's Hospital
    Huai'an, Jiangsu 223000, China
    Recruiting
  • Lianyungang First People's Hospital
    Lianyungang, Jiangsu 222000, China
    Recruiting
  • Nanjing First Hospital
    Nanjing, Jiangsu 210006, China
    Recruiting
  • Xuzhou Second People's Hospital
    Xuzhou, Jiangsu 221000, China
    Recruiting
  • Yixing People's Hospital
    Yixing, Jiangsu 214200, China
    Recruiting
07

References and documents

Publications

  • 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. PubMed 39236727 ↗
  • 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. PubMed 41145110 ↗
  • 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. PubMed 39714903 ↗

Individual participant data

Plan to share: No — Due to privacy and ethical limitations, the data generated and analyzed in current study are not publicly available but could be obtained from principal investigator upon the approval of ethics committee

08

Registry details

Key details

Study ID
NCT07764094
Lead sponsor
Nanjing First Hospital, Nanjing Medical University
Responsible party
Ye-fei (chief physician, Nanjing First Hospital, Nanjing Medical University) — Principal investigator
First posted
Aug 13, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Aug 28, 2026

Study contacts

Fei Ye, MD
Contact
doctor_ye@126.com
18951670287 ext. +86
Tian-lei Zhang, MD
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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