The Branch-based Intraoperative Stent System in the Treatment of Stanford A Aortic Dissection(BROAD) (BROAD)
Aortic Dissection, Aneurysm, Dissecting, Aneurysm
About this trial
This is an interventional treatment trial for Aortic Dissection focused on measuring Stanford A aortic dissection
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- Anhui Provincial Hospital
- First Hospital Affiliated to the Army Medical University
- Fujian Medical University Union Hospital
- The First Hospital of Hebei Medical University
- First Affiliated Hospital of Harbin Medical University
- Wuhan Union Hospital, China
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Second Affiliated Hospital of Nanchang University
- The First Hospital of Jilin University
- First Affiliated Hospital Xi'an Jiaotong University
- Linyi People's Hospital
- Shanghai Zhongshan Hospital
- Changhai Hospital
- The University of Hong Kong-Shenzhen Hospital
- West China Hospital
- First Affiliated Hospital of Xinjiang Medical University
- Yan 'an Hospital Affiliated to Kunming Medical University
- Permed Biomedical Engineering Co., Ltd
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Other
Branch-type intraoperative stent system with double branch structure
Single Branch Structure Stent Graft System single group
CRONUS® Stent Graft System In Surgical Operation
Learning curve case group Experimental: Beijing PerMed branch-type intraoperative stent system with double branch structure.
Beijing PerMed single branch intraoperative stent system
Control group:CRONUS® Stent Graft