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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting; Aortic Dissection
• Intervention / Treatment: Device: PerMed Stent Graft System In Surgical Operation; Device: Endovastec CRONUS® Intraoperative stent system

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.

• Study Type: Interventional
• Enrollment (Estimated): 259
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 102600
    • Permed Biomedical Engineering Co., Ltd
  • Anhui
    • Hefei, Anhui, China, 230002
      • Anhui Provincial Hospital
  • Chongqing
    • Chongqing, Chongqing, China, 400037
      • First Hospital Affiliated to the Army Medical University
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Medical University Union Hospital
  • Hebei
    • Shijiazhuang, Hebei, China, 050030
      • The First Hospital of Hebei Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150020
      • First Affiliated Hospital of Harbin Medical University
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Wuhan Union Hospital, China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  • Jiangxi
    • Nanchang, Jiangxi, China, 330038
      • Second Affiliated Hospital of Nanchang University
  • Jilin
    • Changchun, Jilin, China, 130061
      • The First Hospital of Jilin University
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • First Affiliated Hospital Xi'an Jiaotong University
  • Shandong
    • Linyi, Shandong, China, 276034
      • Linyi people's hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Changhai Hospital
    • Shanghai, Shanghai, China, 200032
      • Shanghai Zhongshan Hospital
  • Shenzhen
    • Shenzhen, Shenzhen, China, 518048
      • The University of Hong Kong-Shenzhen Hospital
  • Sichuan
    • Chendu, Sichuan, China, 610041
      • West China Hospital
  • Xinjiang
    • Ürümqi, Xinjiang, China, 830011
      • First Affiliated Hospital of Xinjiang Medical University
  • Yunnan
    • Kunming, Yunnan, China, 650031
      • Yan 'an Hospital Affiliated to Kunming Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Branch Structure Stent Graft System single group; Beijing PerMed single branch intraoperative stent system	Device: PerMed Stent Graft System In Surgical Operation; PerMed Branch Stent Graft; Other Names: Stanford A aortic dissection open surgery
Other: CRONUS® Stent Graft System In Surgical Operation; Control group：CRONUS® Stent Graft	Device: Endovastec CRONUS® Intraoperative stent system; CRONUS® Branch Stent Graft; Other Names: Stanford A aortic dissection open surgery
Experimental: Branched Surgical Stent Graft System,; Learning curve case group Experimental: Beijing PerMed Branched Surgical Stent Graft System,Permedos apex.	Device: PerMed Stent Graft System In Surgical Operation; PerMed Branch Stent Graft; Other Names: Stanford A aortic dissection open surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality	Percentage of subjects who died from any cause within 12 months ±30 days	after procedure 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Operation success rate	It refers to the proportion of subjects who have completed the expected surgical treatment	Immediately after procedure
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
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
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 intervention rate of target lesions	The proportion of participants with unexpected re intervention due to the trial or control device.	1 year
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Permed Biomedical Engineering Co., Ltd
• Collaborators: Changhai Hospital; Shanghai Zhongshan Hospital; Southwest Hospital, China; West China Hospital; Qilu Hospital of Shandong University; First Affiliated Hospital Xi'an Jiaotong University; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; The First Hospital of Jilin University; Wuhan Union Hospital, China; Fujian Medical University Union Hospital; First Affiliated Hospital of Xinjiang Medical University; The First Hospital of Hebei Medical University; Second Affiliated Hospital of Nanchang University; The University of Hong Kong-Shenzhen Hospital; First Affiliated Hospital of Harbin Medical University; Anhui Provincial Hospital; Linyi People's Hospital; Xiamen Cardiovascular Hospital, Xiamen University; Yunnan Cardiovascular hospital
• Investigators: Principal Investigator: Chunsheng Wang, Dr, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2023
• Primary Completion (Actual): January 6, 2025
• Study Completion (Estimated): February 28, 2029

Study Registration Dates

• First Submitted: November 25, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 3, 2025
• Last Update Submitted That Met QC Criteria: May 28, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Stanford A aortic dissection
• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Aortic Diseases; Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aortic Dissection
• Other Study ID Numbers: IS-CT（CN）

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No