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

NCT05659641 | Active Not Recruiting DMC

• 1 other identifier: IS-CT（CN）
• Study Type: interventional
• Target: 259
• Locations: 1 country
• Sites: 18

Brief 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

Keywords

Stanford A aortic dissection

Outcome Measures

Primary Outcomes (1)

• All cause mortality

  Percentage of subjects who died from any cause within 12 months ±30 days

  after procedure 1 year

Secondary Outcomes (11)

• Device implantation success rate

  Immediately after implantation

• Operation success rate

  Immediately after procedure

• 30 day all-cause mortality after procedure

  30 day

• false-lumen thrombosis rates

  6 month, 1 year

• Branch patency

  1 year

Study Arms (3)

Branched Surgical Stent Graft System,

EXPERIMENTAL

Learning curve case group Experimental: Beijing PerMed Branched Surgical Stent Graft System,Permedos apex.

Device: PerMed Stent Graft System In Surgical Operation

Single Branch Structure Stent Graft System single group

EXPERIMENTAL

Beijing PerMed single branch intraoperative stent system

Device: PerMed Stent Graft System In Surgical Operation

CRONUS® Stent Graft System In Surgical Operation

OTHER

Control group：CRONUS® Stent Graft

Device: Endovastec CRONUS® Intraoperative stent system

Interventions

PerMed Stent Graft System In Surgical Operation DEVICE

PerMed Branch Stent Graft

Also known as: Stanford A aortic dissection open surgery

Branched Surgical Stent Graft System,; Single Branch Structure Stent Graft System single group

Endovastec CRONUS® Intraoperative stent system DEVICE

CRONUS® Branch Stent Graft

Also known as: Stanford A aortic dissection open surgery

CRONUS® Stent Graft System In Surgical Operation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤ 75 years, male or female;
• Stanford type A aortic dissection subjects with involvement of the descending arch aorta；
• Subjects treated with stent pictorial procedures as judged appropriate by the investigator；
• Subjects or their legal surrogates were able to understand the purpose of the study, had adequate compliance to the clinical study protocol, and voluntarily signed the informed consent form.

You may not qualify if:

• Subjects with aortic dissections confined to the ascending and / or arch
• Subjects with a left common carotid artery branch vessel diameter \< 5 mm or \> 16 mm (not applicable to subjects enrolled with a single branch structure)
• Subjects with a left subclavian artery branch vessel diameter \< 7 mm or \> 16 mm
• Subjects with aortic dissection with severe malperfusion syndrome preoperatively (e.g., subjects presenting with coma, paraplegia, need for dialysis, gastrointestinal necrosis or limb necrosis due to ischemia, etc.)
• Subjects with vertebral artery variants
• Subjects with infectious aortic dissections
• Subjects with acute systemic infection, severe infection and associated sepsis, shock or multiple organ failure
• Subjects unable to tolerate anaesthesia and cardiopulmonary bypass
• Subjects who had undergone open surgical procedures of the cardiocerebral vasculature within 90 days prior to surgery
• Subjects with history of active bleeding, coagulopathy or refusal of blood transfusion
• Subjects known to be allergic to materials such as contrast agents, nitinol alloys, coated artificial blood vessels
• Subjects with a life expectancy of less than 12 months (other than disease due to aortic dissection)
• Subjects being enrolled in other clinical trials
• Pregnant and lactating women, and subjects with a recent pregnancy preparation
• Subjects with poor compliance other conditions that the investigator considers inappropriate for participation in the clinical trial.

Sponsors & Collaborators

• Permed Biomedical Engineering Co., Ltd: lead
• Shanghai Zhongshan Hospital: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Fujian Medical University Union Hospital: collaborator
• West China Hospital: collaborator
• Changhai Hospital: collaborator
• Yunnan Cardiovascular hospital: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• Anhui Provincial Hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Southwest Hospital, China: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• Linyi People's Hospital: collaborator
• The First Hospital of Jilin University: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator
• First Affiliated Hospital of Harbin Medical University: collaborator
• The First Hospital of Hebei Medical University: collaborator
• The University of Hong Kong-Shenzhen Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• Xiamen Cardiovascular Hospital, Xiamen University: collaborator

Study Sites (18)

Anhui Provincial Hospital

Hefei, Anhui, 230002, China

Location

First Hospital Affiliated to the Army Medical University

Chongqing, Chongqing Municipality, 400037, China

Location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050030, China

Location

First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150020, China

Location

Wuhan Union Hospital, China

Wuhan, Hubei, 430022, China

Location

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210000, China

Location

Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330038, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130061, China

Location

First Affiliated Hospital Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Linyi People's Hospital

Linyi, Shandong, 276034, China

Location

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

The University of Hong Kong-Shenzhen Hospital

Shenzhen, Shenzhen, 518048, China

Location

West China Hospital

Chengdu, Sichuan, 610041, China

Location

First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830011, China

Location

Yan 'an Hospital Affiliated to Kunming Medical University

Kunming, Yunnan, 650031, China

Location

Permed Biomedical Engineering Co., Ltd

Beijing, 102600, China

Location

MeSH Terms

Conditions

Aortic Dissection; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Acute Aortic Syndrome; Aortic Diseases

Study Officials

• Chunsheng Wang, Dr

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Learning Curve+Parallel+Single Group

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: December 21, 2022
• Study Start: January 18, 2023
• Primary Completion: January 6, 2025
• Study Completion (Estimated): February 28, 2029
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (18)