The Branch-based Intraoperative Stent System in the Treatment of Stanford A Aortic Dissection（BROAD）
NCT ID: NCT05659641
Last Updated: 2025-06-03
Study Results
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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ACTIVE_NOT_RECRUITING
NA
259 participants
INTERVENTIONAL
2023-01-18
2029-02-28
Brief Summary
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Detailed Description
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Plan Before the randomized controlled trial, each center will enroll one subject as a learning curve case（only use PerMed double branched structures）. 212 participants were planned to be enrolled from no less than 10 qualified clinical research institutions and randomly assigned 1:1 to the intraoperative stent systems of Endovastec and the branched type intraoperative stent systems of PerMed double branched structures. An additional 30 subjects were enrolled using a branched type intraoperative stent system with a single branch structure from PerMed, Beijing.
All enrolled participants were followed up clinically intraoperatively, before discharge or 30 days ± 7 days after procedure, 6 months ± 30 days after procedure, 12 months ± 30 days after procedure, and 2-5 years after procedure.Non inferiority of the trial product to the control product was assessed with the primary end point of all-cause mortality at 12 months after procedure. The statistical analysis and summary report will be conducted based on the 12-month follow-up data of all subjects, and the application for medical device registration will be carried out. The long-term efficacy and safety evaluation of the product will be carried out after long-term follow-up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Branched Surgical Stent Graft System,
Learning curve case group
Experimental: Beijing PerMed Branched Surgical Stent Graft System,Permedos apex.
PerMed Stent Graft System In Surgical Operation
PerMed Branch Stent Graft
Single Branch Structure Stent Graft System single group
Beijing PerMed single branch intraoperative stent system
PerMed Stent Graft System In Surgical Operation
PerMed Branch Stent Graft
CRONUS® Stent Graft System In Surgical Operation
Control group：CRONUS® Stent Graft
Endovastec CRONUS® Intraoperative stent system
CRONUS® Branch Stent Graft
Interventions
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PerMed Stent Graft System In Surgical Operation
PerMed Branch Stent Graft
Endovastec CRONUS® Intraoperative stent system
CRONUS® Branch Stent Graft
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Stanford type A aortic dissection subjects with involvement of the descending arch aorta；
3. Subjects treated with stent pictorial procedures as judged appropriate by the investigator；
4. 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.
Exclusion Criteria
2. 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)
3. Subjects with a left subclavian artery branch vessel diameter \< 7 mm or \> 16 mm
4. 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.)
5. Subjects with vertebral artery variants
6. Subjects with infectious aortic dissections
7. Subjects with acute systemic infection, severe infection and associated sepsis, shock or multiple organ failure
8. Subjects unable to tolerate anaesthesia and cardiopulmonary bypass
9. Subjects who had undergone open surgical procedures of the cardiocerebral vasculature within 90 days prior to surgery
10. Subjects with history of active bleeding, coagulopathy or refusal of blood transfusion
11. Subjects known to be allergic to materials such as contrast agents, nitinol alloys, coated artificial blood vessels
12. Subjects with a life expectancy of less than 12 months (other than disease due to aortic dissection)
13. Subjects being enrolled in other clinical trials
14. Pregnant and lactating women, and subjects with a recent pregnancy preparation
15. Subjects with poor compliance other conditions that the investigator considers inappropriate for participation in the clinical trial.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Fujian Medical University Union Hospital
OTHER
West China Hospital
OTHER
Changhai Hospital
OTHER
Yunnan Cardiovascular hospital
UNKNOWN
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Anhui Provincial Hospital
OTHER_GOV
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Southwest Hospital, China
OTHER
First Affiliated Hospital of Xinjiang Medical University
OTHER
Linyi People's Hospital
OTHER
The First Hospital of Jilin University
OTHER
Second Affiliated Hospital of Nanchang University
OTHER
First Affiliated Hospital of Harbin Medical University
OTHER
The First Hospital of Hebei Medical University
OTHER
The University of Hong Kong-Shenzhen Hospital
OTHER
Qilu Hospital of Shandong University
OTHER
Xiamen Cardiovascular Hospital, Xiamen University
OTHER
Permed Biomedical Engineering Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Chunsheng Wang, Dr
Role: PRINCIPAL_INVESTIGATOR
Shanghai Zhongshan Hospital
Locations
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Anhui Provincial Hospital
Hefei, Anhui, China
First Hospital Affiliated to the Army Medical University
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Wuhan Union Hospital, China
Wuhan, Hubei, China
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
First Affiliated Hospital Xi'an Jiaotong University
Xi'an, Shaanxi, China
Linyi People's Hospital
Linyi, Shandong, China
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Changhai Hospital
Shanghai, Shanghai Municipality, China
The University of Hong Kong-Shenzhen Hospital
Shenzhen, Shenzhen, China
West China Hospital
Chengdu, Sichuan, China
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Yan 'an Hospital Affiliated to Kunming Medical University
Kunming, Yunnan, China
Permed Biomedical Engineering Co., Ltd
Beijing, , China
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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IS-CT（CN）
Identifier Type: -
Identifier Source: org_study_id
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