Safety and Efficacy of Drug-Coated Balloon for De-novo Lesions in Patients With Acute Coronary Syndromes (DCB-ACS)
NCT04937803 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 216
Last updated 2024-07-17
Summary
The DCB-ACS trial is a prospective, multi-center, non-inferiority, randomized controlled trail. The purpose of this trial is to evaluate the safety and efficacy of drug-coated balloon(DCB) in de novo lesions for acute coronary syndromes (ACS) .
Conditions
- Drug-Coated Balloon
- De Novo Stenosis
- Acute Coronary Syndromes
- ACS
- DCB
- Clinical Trial
- Coronary Artery Disease
Interventions
- DEVICE
-
Drug-coated balloon
Drug-coated balloon is a fast-exchange balloon dilatation catheter, used to treat coronary artery stenosis lesions and improve myocardial blood flow.
- DEVICE
-
Zotarolimus-Eluting Coronary Stent
Zotarolimus-Eluting Coronary Stent is treated for coronary artery stenosis lesions .
Sponsors & Collaborators
-
Daqing Oil Field Hospital
collaborator OTHER -
Sichuan Provincial People's Hospital
collaborator OTHER -
Tianjin People's Hospital
collaborator OTHER -
Peking University First Hospital
collaborator OTHER -
Beijing Friendship Hospital
collaborator OTHER -
The Third Medical Center, Chinese PLA General Hospital
collaborator UNKNOWN -
Jining Medical University
collaborator OTHER -
Chinese Academy of Medical Sciences, Fuwai Hospital
collaborator OTHER -
The First Hospital of Jilin University
collaborator OTHER -
General Hospital of Taiyuan Iron & Steel Company
collaborator UNKNOWN -
Tongji Hospital
collaborator OTHER -
The First Affiliated Hospital with Nanjing Medical University
collaborator OTHER -
Second Affiliated Hospital of Zhengzhou University
collaborator OTHER -
Sir Run Run Shaw Hospital
collaborator OTHER -
Inner Mongolia People's Hospital
collaborator OTHER -
Harbin Medical University
lead OTHER
Principal Investigators
-
Bo Yu, MD,PhD · The Second Affiliated Hospital of Harbin Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-19
- Primary Completion
- 2023-02-18
- Completion
- 2023-11-17
Countries
- China
Study Locations
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