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

Primary Purpose

Aortic Dissection, Aneurysm, Dissecting, Aneurysm

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PerMed Stent Graft System In Surgical Operation
Endovastec CRONUS® Intraoperative stent system
Sponsored by
Permed Biomedical Engineering Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Dissection focused on measuring Stanford A aortic dissection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Experimental

Other

Arm Label

Branch-type intraoperative stent system with double branch structure

Single Branch Structure Stent Graft System single group

CRONUS® Stent Graft System In Surgical Operation

Arm Description

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

Outcomes

Primary Outcome Measures

All cause mortality
Percentage of subjects who died from any cause within 12 months ±30 days

Secondary Outcome Measures

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.
Operation success rate
It refers to the proportion of subjects who have completed the expected surgical treatment
30 day all-cause mortality after procedure
It refers to the proportion of dead subjects within 30 days (including 30 days) after operation
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.
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.
Secondary intervention rate of target lesions
The proportion of participants with unexpected re intervention due to the trial or control device.
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
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
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.
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
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.

Full Information

First Posted
November 25, 2022
Last Updated
March 27, 2023
Sponsor
Permed Biomedical Engineering Co., Ltd
Collaborators
Shanghai Zhongshan Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Fujian Medical University Union Hospital, West China Hospital, Changhai Hospital, Yunnan Cardiovascular hospital, First Affiliated Hospital Xi'an Jiaotong University, Anhui Provincial Hospital, Wuhan Union Hospital, China, First Hospital Affiliated to the Army Medical University, First Affiliated Hospital of Xinjiang Medical University, Linyi People's Hospital, The First Hospital of Jilin University, Second Affiliated Hospital of Nanchang University, First Affiliated Hospital of Harbin Medical University, The First Hospital of Hebei Medical University, The University of Hong Kong-Shenzhen Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05659641
Brief Title
The Branch-based Intraoperative Stent System in the Treatment of Stanford A Aortic Dissection(BROAD)
Acronym
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 18, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Permed Biomedical Engineering Co., Ltd
Collaborators
Shanghai Zhongshan Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Fujian Medical University Union Hospital, West China Hospital, Changhai Hospital, Yunnan Cardiovascular hospital, First Affiliated Hospital Xi'an Jiaotong University, Anhui Provincial Hospital, Wuhan Union Hospital, China, First Hospital Affiliated to the Army Medical University, First Affiliated Hospital of Xinjiang Medical University, Linyi People's Hospital, The First Hospital of Jilin University, Second Affiliated Hospital of Nanchang University, First Affiliated Hospital of Harbin Medical University, The First Hospital of Hebei Medical University, The University of Hong Kong-Shenzhen Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Dissection, Aneurysm, Dissecting, Aneurysm, Vascular Diseases, Cardiovascular Diseases
Keywords
Stanford A aortic dissection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Learning Curve+Parallel+Single Group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
259 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Branch-type intraoperative stent system with double branch structure
Arm Type
Experimental
Arm Description
Learning curve case group Experimental: Beijing PerMed branch-type intraoperative stent system with double branch structure.
Arm Title
Single Branch Structure Stent Graft System single group
Arm Type
Experimental
Arm Description
Beijing PerMed single branch intraoperative stent system
Arm Title
CRONUS® Stent Graft System In Surgical Operation
Arm Type
Other
Arm Description
Control group:CRONUS® Stent Graft
Intervention Type
Device
Intervention Name(s)
PerMed Stent Graft System In Surgical Operation
Other Intervention Name(s)
Stanford A aortic dissection open surgery
Intervention Description
PerMed Branch Stent Graft
Intervention Type
Device
Intervention Name(s)
Endovastec CRONUS® Intraoperative stent system
Other Intervention Name(s)
Stanford A aortic dissection open surgery
Intervention Description
CRONUS® Branch Stent Graft
Primary Outcome Measure Information:
Title
All cause mortality
Description
Percentage of subjects who died from any cause within 12 months ±30 days
Time Frame
after procedure 1 year
Secondary Outcome Measure Information:
Title
Device implantation success rate
Description
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.
Time Frame
Immediately after implantation
Title
Operation success rate
Description
It refers to the proportion of subjects who have completed the expected surgical treatment
Time Frame
Immediately after procedure
Title
30 day all-cause mortality after procedure
Description
It refers to the proportion of dead subjects within 30 days (including 30 days) after operation
Time Frame
30 day
Title
false-lumen thrombosis rates
Description
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.
Time Frame
6 month, 1 year
Title
Branch patency
Description
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.
Time Frame
1 year
Title
Secondary intervention rate of target lesions
Description
The proportion of participants with unexpected re intervention due to the trial or control device.
Time Frame
1 year
Title
stroke rate
Description
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
Time Frame
1 year
Title
Incidence of spinal cord ischemia
Description
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
Time Frame
1 year
Title
Incidence of acute kidney injury
Description
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.
Time Frame
1 year
Title
Mortality associated with aortic dissection
Description
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
Time Frame
30 day
Title
Incidence of device-related adverse events
Description
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.
Time Frame
6month,1 year,5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chunsheng Wang, Dr
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230002
Country
China
Facility Name
First Hospital Affiliated to the Army Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400037
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
The First Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050030
Country
China
Facility Name
First Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150020
Country
China
Facility Name
Wuhan Union Hospital, China
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
Second Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330038
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130061
Country
China
Facility Name
First Affiliated Hospital Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Linyi People's Hospital
City
Linyi
State/Province
Shandong
ZIP/Postal Code
276034
Country
China
Facility Name
Shanghai Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
The University of Hong Kong-Shenzhen Hospital
City
Shenzhen
State/Province
Shenzhen
ZIP/Postal Code
518048
Country
China
Facility Name
West China Hospital
City
Chendu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
First Affiliated Hospital of Xinjiang Medical University
City
Ürümqi
State/Province
Xinjiang
ZIP/Postal Code
830011
Country
China
Facility Name
Yan 'an Hospital Affiliated to Kunming Medical University
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650031
Country
China
Facility Name
Permed Biomedical Engineering Co., Ltd
City
Beijing
ZIP/Postal Code
102600
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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