NCT04255563

Brief Summary

Drug-coated balloon (DCB) is an alternative choice for patients with coronary artery disease (CAD). This study is to investigate the efficacy and safety of DCB treatment in patients with CAD.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Feb 2020

Longer than P75 for all trials

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

Study Progress58%
Feb 2020Dec 2030

First Submitted

Initial submission to the registry

January 20, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
20 days until next milestone

Study Start

First participant enrolled

February 25, 2020

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2030

Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

10.9 years

First QC Date

January 20, 2020

Last Update Submit

November 13, 2024

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • target vessel failure (TVF) at 12 months

    TVF is defined as the composite of cardiac death, target-vessel myocardial infarction and ischemia-driven target- vessel revascularization.

    12 months

Secondary Outcomes (3)

  • Parameter by quantitative coronary angiography at 7 months

    7 months

  • Bleeding at 12 months

    12 months

  • Bailout drug-eluting stents (DES) implantation rate

    During procedure

Study Arms (1)

DCB treatment

DCB (Sequent® Please) treatment will be performed for suitable patients with CAD.

Device: DCB treatment

Interventions

DCB treatmentDEVICE

DCB (Sequent® Please) treatment for CAD patients will be enrolled. Intravascular ultrasound (Boston Scientific®) guidance is recommended.

DCB treatment

Eligibility Criteria

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

All subjects with coronary artery disease undergoing DCB treatment will be enrolled in this study.

You may qualify if:

  • Patients suitable for DCB treatment

You may not qualify if:

  • Pregnancy
  • Contraindications to contrast media, antiplatelet therapy, or paclitaxel
  • Expected life less than 12 months
  • Cardiac shock

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Shao-Liang Chen, MD

    Nanjing First Hospital, Nanjing Medical University

    STUDY CHAIR

Central Study Contacts

Jun-Jie Zhang, MD

CONTACT

025-52271350jameszll@163.com

Xiao-Fei Gao, MD

CONTACT

025-52271350gaoxiaofei2014@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice chief of the department of cardiology

Study Record Dates

First Submitted

January 20, 2020

First Posted

February 5, 2020

Study Start

February 25, 2020

Primary Completion (Estimated)

December 30, 2030

Study Completion (Estimated)

December 30, 2030

Last Updated

November 15, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)