NCT07764094

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

August 13, 2026

Status Verified

August 1, 2026

Enrollment Period

1.3 years

First QC Date

August 9, 2026

Last Update Submit

August 9, 2026

Conditions

PCIDrug-coated BalloonCoronary Artery Disease

Keywords

Percutaneous coronary interventionDrug coated balloon

Outcome Measures

Primary Outcomes (1)

  • Target Lesion Restenosis

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

    6-12 months

Secondary Outcomes (1)

  • Target Vessel Failure

    6-12 months

Study Arms (1)

DCB-Treated De Novo Lesion

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 39236727BACKGROUND

  • 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.

    PMID: 41145110BACKGROUND

  • 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.

    PMID: 39714903BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Fei Ye, MD

CONTACT

18951670287doctor_ye@126.com

Tian-lei Zhang, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

August 9, 2026

First Posted

August 13, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

June 30, 2028

Last Updated

August 13, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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

Locations

CN(1)