NCT05937230

Brief Summary

Drug-eluting stents (DES) have long been recommended as the default device for patients undergoing percutaneous coronary intervention (PCI). 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. DCB angioplasty has the following advantages compared to DES implantation: Firstly, the drug in DCB is uniformly distributed and released, whereas the drug release of DES via the stent platform is uneven -85% of the vascular wall is not covered by the stent strut. Secondly, there is no alloy in the vessel after DCB angioplasty, while the coronary stent platform and polymer might cause temporal or persistent inflammatory response leading to intimal hyperplasia. Finally, there is no metal cage restraining vessel motion after DCB, and the physiological function of coronary arteries would be maintained. Currently, DCB constitutes an important treatment option in ISR, which is endorsed by the 2018 European Society of Cardiology Guidelines on myocardial revascularization. In addition, some interventional cardiologist has also applied DCB in de novo lesions in their clinical practice. Diabetes is associated with worse outcomes after coronary revascularization and has been identified as an independent predictor of adverse events in patients with cardiovascular disease. Although some small sample size RCTs and observational studies have suggested that the clinical prognosis of DCB is non-inferior to the drug-eluting stent (DES), there is still a lack of evidence comparing the DCB versus DES for de novo or ISR coronary lesions in diabetic patients. The current study aims to compare the long-term efficacy of DCB to DES in de novo or ISR coronary lesions in diabetic patients.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not 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

Study Start

First participant enrolled

June 1, 2015

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

7.8 years

First QC Date

June 29, 2023

Last Update Submit

February 10, 2026

Conditions

Coronary Heart DiseaseAngioplasty, Balloon

Keywords

Drug-eluting stentsDrug-coated balloonsDiabeticDe-novoIn-stent stenosisAll-comers

Outcome Measures

Primary Outcomes (1)

  • Device-oriented Composite Endpoint (DoCE)

    DoCE is a composite clinical endpoint of Cardiac cause death, Target vessel myocardial infarction (TV-MI), and clinically indicated target lesion revascularization (CI-TLR).

    24 months

Other Outcomes (10)

  • POCE

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

  • All-cause death

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

  • Non-fatal myocardial infarction (MI)

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

  • +7 more other outcomes

Study Arms (2)

Drug-coated balloon

Paclitaxel coated balloon

Device: Drug-coated balloon

Drug-eluting stent

Second-generation eluting stents

Device: Drug-eluting stents

Interventions

Drug-eluting stentsDEVICE

Drug-eluting stent is composed of a metal stent, primer, and drug coating.

Drug-eluting stent
Drug-coated balloonDEVICE

Paclitaxel is a pharmacologically active substance for anti-neointima.

Drug-coated balloon

Eligibility Criteria

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

All diabetic patients who received PCI with one or more drug-coated balloons only or drug-eluting stents only to treat ISR or de novo lesions

You may qualify if:

  • Patients with diabetes mellitus
  • Received PCI by a drug-coated balloons only strategy or drug-eluting stents only strategy

You may not qualify if:

  • Under the age of 18
  • Unable to give informed consent
  • 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

MeSH Terms

Conditions

Coronary Disease

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

StentsProstheses and ImplantsEquipment and Supplies

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

June 29, 2023

First Posted

July 10, 2023

Study Start

June 1, 2015

Primary Completion

March 1, 2023

Study Completion

March 1, 2026

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)