The Branch-based Intraoperative Stent System in the Treatment of Stanford A Aortic Dissection（BROAD）

Summary

The purpose of the study was to evaluate the safety and efficacy of a branched type intraoperative stent system for the treatment of Stanford type A aortic dissection

Conditions

• Aortic Dissection
• Aneurysm, Dissecting
• Aneurysm
• Vascular Diseases
• Cardiovascular Diseases

Interventions

DEVICE

PerMed Stent Graft System In Surgical Operation

PerMed Branch Stent Graft

DEVICE

Endovastec CRONUS® Intraoperative stent system

CRONUS® Branch Stent Graft

Sponsors & Collaborators

• Shanghai Zhongshan Hospital

  collaborator OTHER

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  collaborator OTHER

• Fujian Medical University Union Hospital

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Changhai Hospital

  collaborator OTHER

• Yunnan Cardiovascular hospital

  collaborator UNKNOWN

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• Anhui Provincial Hospital

  collaborator OTHER_GOV

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Southwest Hospital, China

  collaborator OTHER

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• Linyi People's Hospital

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• Second Affiliated Hospital of Nanchang University

  collaborator OTHER

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• The First Hospital of Hebei Medical University

  collaborator OTHER

• The University of Hong Kong-Shenzhen Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Xiamen Cardiovascular Hospital, Xiamen University

  collaborator OTHER

• Permed Biomedical Engineering Co., Ltd

  lead INDUSTRY

Principal Investigators

• Chunsheng Wang, Dr · Shanghai Zhongshan Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-18

Primary Completion

2025-01-06

Completion

2029-02-28

Countries

• China

Study Locations