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Aortic DissectionBROADNCT05659641

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

A study testing PerMed Stent Graft System In Surgical Operation and Endovastec CRONUS® Intraoperative stent system in people with Aortic Dissection and Aneurysm, Dissecting, run by Permed Biomedical Engineering Co., Ltd at 18 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Aortic Dissection, Aneurysm, Dissecting, Aneurysm
What is being tested?
PerMed Stent Graft System In Surgical Operation and Endovastec CRONUS® Intraoperative stent system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
259 participants
Where
18 sitesChina
Study dates
18 Jan 2023to 28 Feb 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 15Show fewer
  • 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.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

China18 sites

  • Permed Biomedical Engineering Co., Ltd

    Beijing, 102600

  • The First Hospital of Jilin University

    Changchun, Jilin, 130061

  • West China Hospital

    Chengdu, Sichuan, 610041

  • First Hospital Affiliated to the Army Medical University

    Chongqing, Chongqing Municipality, 400037

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150020

  • Anhui Provincial Hospital

    Hefei, Anhui, 230002

  • Yan 'an Hospital Affiliated to Kunming Medical University

    Kunming, Yunnan, 650031

  • Linyi People's Hospital

    Linyi, Shandong, 276034

  • Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330038

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210000

  • Shanghai Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200032

  • Changhai Hospital

    Shanghai, Shanghai Municipality, 200433

  • The University of Hong Kong-Shenzhen Hospital

    Shenzhen, Shenzhen, 518048

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050030

  • First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830011

  • Wuhan Union Hospital, China

    Wuhan, Hubei, 430022

  • First Affiliated Hospital Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

Other trials in China

About this study

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

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

Read the 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.

Being tested
PerMed Stent Graft System In Surgical Operation, Endovastec CRONUS® Intraoperative stent system
Keywords
Stanford A aortic dissection
Medical subject headings
Aortic Dissection, Aneurysm, Vascular Diseases, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PerMed Stent Graft System In Surgical OperationDevice

    Also called Stanford A aortic dissection open surgery

    PerMed Branch Stent Graft

  • Endovastec CRONUS® Intraoperative stent systemDevice

    Also called Stanford A aortic dissection open surgery

    CRONUS® Branch Stent Graft

Study groups in NCT05659641
Study groupRoleWhat they receive
Branched Surgical Stent Graft System,ExperimentalLearning curve case group Experimental: Beijing PerMed Branched Surgical Stent Graft System,Permedos apex.
Receives: Device: PerMed Stent Graft System In Surgical Operation
Single Branch Structure Stent Graft System single groupExperimentalBeijing PerMed single branch intraoperative stent system
Receives: Device: PerMed Stent Graft System In Surgical Operation
CRONUS® Stent Graft System In Surgical OperationOtherControl group：CRONUS® Stent Graft
Receives: Device: Endovastec CRONUS® Intraoperative stent system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All cause mortality

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

    Measured: after procedure 1 year

Secondary outcomes (11)

  1. 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.

    Measured: Immediately after implantation

  2. Operation success rate

    It refers to the proportion of subjects who have completed the expected surgical treatment

    Measured: Immediately after procedure

  3. 30 day all-cause mortality after procedure

    It refers to the proportion of dead subjects within 30 days (including 30 days) after operation

    Measured: 30 day

  4. 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.

    Measured: 6 month, 1 year

  5. 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.

    Measured: 1 year

  6. Secondary intervention rate of target lesions

    The proportion of participants with unexpected re intervention due to the trial or control device.

    Measured: 1 year

  7. 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

    Measured: 1 year

  8. 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

    Measured: 1 year

  9. 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.

    Measured: 1 year

  10. 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

    Measured: 30 day

  11. 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.

    Measured: 6month，1 year，5 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2022
  2. Study start18 Jan 2023
  3. Primary completion6 Jan 2025
  4. Study completion28 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Learning Curve+Parallel+Single Group
Masking
None (open label)
Enrolment
259 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05659641
Sponsor's protocol ID
IS-CT（CN）
Acronym
BROAD
Status last verified
May 2025
First submitted
25 Nov 2022
Last updated
3 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing PerMed Stent Graft System In Surgical Operation and Endovastec CRONUS® Intraoperative stent system in people with Aortic Dissection and Aneurysm, Dissecting, run by Permed Biomedical Engineering Co., Ltd at 18 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All cause mortality (time frame: after procedure 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05659641.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.

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