NCT05133921

Brief Summary

Drug-Coated Balloon (DCB) angioplasty is similar to plain old balloon angioplasty procedurally, but there is an anti-proliferative medication paclitaxel coated on the balloon. Treating in-stent restenosis (ISR) with the DCB has the theoretical advantage of avoiding multiple stent layers and respecting the vessel anatomy. DCB has shown promising results for the treatment of ISR. Currently, DCB has a Class I indication to treat ISR recommended by European Society of Cardiology (ESC) guidelines. In addition, some interventional cardiologist has also applied DCB in de novo lesions in their clinical practice. Although some small sample size RCTs and observational studies have suggested that the clinical prognosis of DCB in primary large vessels is non-inferior to drug-eluting stent (DES), there is no large-scale RCT or cohort studies to compare the clinical effects of DCB and DES. Despite several theoretical benefits of DCB, the procedural-related complications cannot be entirely prevented, such as acute elastic retraction and severe dissection, which would affect coronary blood flow or lead to acute vascular occlusion. Some studies have suggested that optimization of the procedural technique can reduce the occurrence of complications and target lesion failure in the long-term. Proposed criteria include adapting cutting or scoring balloon for pre-dilatation, residual stenosis\<30% post-DCB, maintaining TIMI flow=3, DCB dilation time\<60s, and appropriate balloon to vessel ratio\> 0.91. However, such proposed technique and criteria have not been evaluated in the real-world clinical practice. This current study is designed to investigate the efficacy and safety of DCB in the real world and exploring the optimal procedural configurations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,487

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 24, 2021

Completed
Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

5 years

First QC Date

November 22, 2021

Last Update Submit

February 10, 2026

Conditions

Coronary Heart DiseaseAngioplasty, Balloon

Keywords

Drug-coated balloonsDe-novoAll-comersIn-stent stenosis

Outcome Measures

Primary Outcomes (1)

  • Device-oriented Composite Endpoint (DoCE)

    DoCE is a composite clinical endpoint of cardiac death, target vessel myocardial infraction (TV-MI), and Clinically individual target lesion revascularization (CI-TLR)

    24 months

Other Outcomes (15)

  • Device-oriented Composite Endpoint (DoCE)

    1 month, 1, 2, 3, 5, 7, 10 years

  • POCE

    1 month, 1, 2, 3, 5, 7, 10 years

  • All-cause death

    1 month, 1, 2, 3, 5, 7, 10 years

  • +12 more other outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who received PCI with one or more drug-coated balloons (DCB) in the Xijing hospital of the Air Force Medical University from December 1, 2015 to December 1, 2019.

You may qualify if:

  • Patients who received PCI with one or more drug-coated balloons (DCB)
  • Patients who did not received drug-eluting stent implantation

You may not qualify if:

  • \. Currently participating in another trial or participants unable to comply to follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ling Tao

Xi'an, Shannxi, 710032, China

Location

Related Publications (1)

  • He X, Liu Y, Yin Z, Li F, van Geuns RJ, Garg S, Onuma Y, Serruys PW, Gao C, Tao L. Mid-term outcomes of paclitaxel-coated balloon for de novo non-small coronary lesions: a pooled analysis. BMC Med. 2025 Oct 31;23(1):598. doi: 10.1186/s12916-025-04429-9.

    PMID: 41174582DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Ling Tao, MD, Ph.D.

    Xijing Hospital

    STUDY CHAIR

  • Chao Gao, MD, Ph.D.

    Xijing Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Cardiology, Director of the department of Cardiology

Study Record Dates

First Submitted

November 22, 2021

First Posted

November 24, 2021

Study Start

December 1, 2015

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)