Clinical trial NCT05659641: The Branch-based Intraoperative Stent System in the Treatment of Stanford A Aortic Dissection（BROAD）
Official title: A Prospective, Multicenter, Open, Randomized Controlled, Non Inferiority Clinical Trial to Evaluate the Safety and Efficacy the Branch-based Intraoperative Stent System in the Treatment of Stanford A Aortic Dissection
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aortic Dissection
Aneurysm, Dissecting
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Keywords: Stanford A aortic dissection
Lead sponsor: Permed Biomedical Engineering Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Zhongshan Hospital
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Fujian Medical University Union Hospital
name: West China Hospital
name: Changhai Hospital
name: Yunnan Cardiovascular hospital
name: First Affiliated Hospital Xi'an Jiaotong University
name: Anhui Provincial Hospital
name: Wuhan Union Hospital, China
name: Southwest Hospital, China
name: First Affiliated Hospital of Xinjiang Medical University
name: Linyi People's Hospital
name: The First Hospital of Jilin University
name: Second Affiliated Hospital of Nanchang University
name: First Affiliated Hospital of Harbin Medical University
name: The First Hospital of Hebei Medical University
name: The University of Hong Kong-Shenzhen Hospital
name: Qilu Hospital of Shandong University
name: Xiamen Cardiovascular Hospital, Xiamen University
First posted: 2022-12-21
Enrollment: 259
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Learning Curve+Parallel+Single Group
Primary purpose: TREATMENT

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

Detailed description: Types The clinical trial design was prospective, muticenter, open, randomized controlled design with an additional single group design.

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 and ≤ 75 years, male or female;
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:

1. Subjects with aortic dissections confined to the ascending and / or arch
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.

Primary outcomes:
measure: All cause mortality
timeFrame: after procedure 1 year
Secondary outcomes:
measure: Device implantation success rate
timeFrame: Immediately after implantation
measure: Operation success rate
timeFrame: Immediately after procedure
measure: 30 day all-cause mortality after procedure
timeFrame: 30 day
measure: false-lumen thrombosis rates
timeFrame: 6 month, 1 year
measure: Branch patency
timeFrame: 1 year
measure: Secondary intervention rate of target lesions
timeFrame: 1 year
measure: stroke rate
timeFrame: 1 year
measure: Incidence of spinal cord ischemia
timeFrame: 1 year
measure: Incidence of acute kidney injury
timeFrame: 1 year
measure: Mortality associated with aortic dissection
timeFrame: 30 day
measure: Incidence of device-related adverse events
timeFrame: 6month，1 year，5 year
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Chongqing
country: China
facility: First Hospital Affiliated to the Army Medical University
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Wuhan
country: China
facility: Wuhan Union Hospital, China
state: Hubei
city: Nanjing
country: China
facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
city: Nanchang
country: China
facility: Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Xi'an
country: China
facility: First Affiliated Hospital Xi'an Jiaotong University
state: Shaanxi
city: Linyi
country: China
facility: Linyi People's Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
city: Shenzhen
country: China
facility: The University of Hong Kong-Shenzhen Hospital
state: Shenzhen
city: Chendu
country: China
facility: West China Hospital
state: Sichuan
city: Ürümqi
country: China
facility: First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Kunming
country: China
facility: Yan 'an Hospital Affiliated to Kunming Medical University
state: Yunnan
city: Beijing
country: China
facility: Permed Biomedical Engineering Co., Ltd
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Chunsheng Wang, Dr
role: PRINCIPAL_INVESTIGATOR
References: