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

Cardiovascular Diseases Clinical Trial

— 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05659641
• Other study ID #: IS-CT(CN)
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 18, 2023
• Est. completion date: January 2029

Study information

• Verified date: April 2023
• Source: Permed Biomedical Engineering Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 259
• Est. completion date: January 2029
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• PerMed Stent Graft System In Surgical Operation
PerMed Branch Stent Graft
• Endovastec CRONUS® Intraoperative stent system
CRONUS® Branch Stent Graft

Locations

Country	Name	City	State
China	Permed Biomedical Engineering Co., Ltd	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	West China Hospital	Chendu	Sichuan
China	First Hospital Affiliated to the Army Medical University	Chongqing	Chongqing
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	First Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Anhui Provincial Hospital	Hefei	Anhui
China	Yan 'an Hospital Affiliated to Kunming Medical University	Kunming	Yunnan
China	Linyi People's Hospital	Linyi	Shandong
China	Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu
China	Changhai Hospital	Shanghai	Shanghai
China	Shanghai Zhongshan Hospital	Shanghai	Shanghai
China	The University of Hong Kong-Shenzhen Hospital	Shenzhen	Shenzhen
China	The First Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	First Affiliated Hospital of Xinjiang Medical University	Ürümqi	Xinjiang
China	Wuhan Union Hospital, China	Wuhan	Hubei
China	First Affiliated Hospital Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (18)

Lead Sponsor

Collaborator

Permed Biomedical Engineering Co., Ltd

Anhui Provincial Hospital, Changhai Hospital, First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Xinjiang Medical University, First Affiliated Hospital Xi'an Jiaotong University, Fujian Medical University Union Hospital, Linyi People's Hospital, Second Affiliated Hospital of Nanchang University, Shanghai Zhongshan Hospital, Southwest Hospital, China, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Hospital of Hebei Medical University, The First Hospital of Jilin University, The University of Hong Kong-Shenzhen Hospital, West China Hospital, Wuhan Union Hospital, China, Yunnan Cardiovascular hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality	Percentage of subjects who died from any cause within 12 months ±30 days	after procedure 1 year
Secondary	Device implantation success rate	Refers to the proportion of successful device implantation. That is, the test product or control product was successfully introduced into the true lumen of the vessel and successfully released, the delivery system was successfully withdrawn, and the anastomosis was completed with the artificial vessel.	Immediately after implantation
Secondary	Operation success rate	It refers to the proportion of subjects who have completed the expected surgical treatment	Immediately after procedure
Secondary	30 day all-cause mortality after procedure	It refers to the proportion of dead subjects within 30 days (including 30 days) after operation	30 day
Secondary	false-lumen thrombosis rates	Complete thrombosis refers to the rate of complete thrombosis of the entire aortic false lumen on arterial phase and delayed phase imaging.; Partial thrombogenicity refers to the rate of presence of thrombus in the false lumen but residual flow in the arterial and delayed phases. Details are described in the 2022 ACC guidelines for the diagnosis and management of AHA aortic disease.	6 month, 1 year
Secondary	Branch patency	The proportion of subjects with stenosis degree of left subclavian artery and/or left common carotid artery less than 50% within 12 months after procedure.	1 year
Secondary	Secondary intervention rate of target lesions	The proportion of participants with unexpected re intervention due to the trial or control device.	1 year
Secondary	stroke rate	It refers to a cerebrovascular event caused by the implantation of the test product or control product, which shows partial or complete loss of movement or sensation, and lasts for more than 24 hours	1 year
Secondary	Incidence of spinal cord ischemia	It refers to the ratio of subjects with spinal cord functional defects caused by ischemia after the implantation of the experimental or control device. Except those caused by tumor, trauma, tuberculosis and other factors with clear causes	1 year
Secondary	Incidence of acute kidney injury	Renal hypofunction refers to the increase of serum creatinine (SCR) = 50% compared with the basic value (SCR value in screening period) and (or) urine volume<0.5 ml/(kg · h)>6 h. Except for acute renal injury caused by poisoning and other clear causes.	1 year
Secondary	Mortality associated with aortic dissection	It refers to the proportion of subjects who died of aortic dissection within 30 days (inclusive) after operation or within 30 days (inclusive) after the secondary intervention of target lesion	30 day
Secondary	Incidence of device-related adverse events	It refers to the ratio of device related adverse events occurring after the implantation of the test product in the follow-up period to the total adverse events.	6month,1 year,5 year