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

No results posted yet for this study

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04937803 on ClinicalTrials.gov