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

Last updated: April 1, 2024
Sponsor: Permed Biomedical Engineering Co., Ltd
Overall Status: Active - Enrolling

Phase

N/A

Condition

Vascular Diseases

Chest Pain

Aneurysm

Treatment

PerMed Stent Graft System In Surgical Operation

Endovastec CRONUS® Intraoperative stent system

Clinical Study ID

NCT05659641
IS-CT(CN)
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 and ≤ 75 years, male or female;
  2. Stanford type A aortic dissection subjects with involvement of the descending archaorta;
  3. Subjects treated with stent pictorial procedures as judged appropriate by theinvestigator;
  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 theinformed consent form.

Exclusion

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, gastrointestinalnecrosis 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, shockor multiple organ failure
  8. Subjects unable to tolerate anaesthesia and cardiopulmonary bypass
  9. Subjects who had undergone open surgical procedures of the cardiocerebral vasculaturewithin 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 toaortic 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 considersinappropriate for participation in the clinical trial.

Study Design

Total Participants: 259
Treatment Group(s): 2
Primary Treatment: PerMed Stent Graft System In Surgical Operation
Phase:
Study Start date:
January 18, 2023
Estimated Completion Date:
January 31, 2029

Study 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.

Connect with a study center

  • Anhui Provincial Hospital

    Hefei, Anhui 230002
    China

    Site Not Available

  • First Hospital Affiliated to the Army Medical University

    Chongqing, Chongqing 400037
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050030
    China

    Site Not Available

  • First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150020
    China

    Site Not Available

  • Wuhan Union Hospital, China

    Wuhan, Hubei 430022
    China

    Site Not Available

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

    Nanjing, Jiangsu 210000
    China

    Site Not Available

  • Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330038
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin 130061
    China

    Site Not Available

  • First Affiliated Hospital Xi'an Jiaotong University

    Xi'an, Shaanxi 710061
    China

    Site Not Available

  • Linyi People's Hospital

    Linyi, Shandong 276034
    China

    Site Not Available

  • Changhai Hospital

    Shanghai, Shanghai 200433
    China

    Site Not Available

  • Shanghai Zhongshan Hospital

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • The University of Hong Kong-Shenzhen Hospital

    Shenzhen, Shenzhen 518048
    China

    Site Not Available

  • West China Hospital

    Chendu, Sichuan 610041
    China

    Site Not Available

  • First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang 830011
    China

    Site Not Available

  • Yan 'an Hospital Affiliated to Kunming Medical University

    Kunming, Yunnan 650031
    China

    Site Not Available

  • Permed Biomedical Engineering Co., Ltd

    Beijing, 102600
    China

    Site Not Available

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