Drug-coating Balloon Treatment in Coronary Artery Disease

NCT ID: NCT04255563

Last Updated: 2024-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-25

Study Completion Date

2030-12-30

Brief Summary

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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.

Detailed Description

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This is a prospective, multi-center, registry to enroll patients undergoing DCB treatment.

All subjects undergoing DCB treatment will be enrolled in this study without strict inclusion and exclusion criteria. Data and images will be collected during the index procedure, and at the clinical and angiographic follow-up.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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DCB treatment

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

DCB treatment

Intervention Type DEVICE

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

Interventions

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DCB treatment

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients suitable for DCB treatment

Exclusion Criteria

* Pregnancy
* Contraindications to contrast media, antiplatelet therapy, or paclitaxel
* Expected life less than 12 months
* Cardiac shock
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Junjie Zhang

Vice chief of the department of cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shao-Liang Chen, MD

Role: STUDY_CHAIR

Nanjing First Hospital, Nanjing Medical University

Locations

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Nanjing First Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jun-Jie Zhang, MD

Role: CONTACT

025-52271350

Xiao-Fei Gao, MD

Role: CONTACT

025-52271350

Facility Contacts

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Shaoliang Chen, MD

Role: primary

13605157029

Other Identifiers

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KY20200110-03

Identifier Type: -

Identifier Source: org_study_id

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