Guo's Aortic Arch Reconstruction :The Prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System (GIANT Study)

Last updated: April 28, 2024
Sponsor: Hangzhou Endonom Medtech Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Aneurysm

Treatment

WeFlow-Arch Modeler Embedded Branch Stent Graft System

Clinical Study ID

NCT04765592
WEIQIANG202001
  • Ages 18-80
  • All Genders

Study Summary

A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true/false aortic arch aneurysms and ulcers involving aortic arch . (GIANT Study)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients aged 18 to 80 years old;
  2. Diagnosed with aortic arch lesions requiring intervention, including true aortic archaneurysms, pseudo-aortic arch aneurysms, and ulcers involving the aortic arch;
  3. Showing a suitable vascular condition, including:
  • Ascending aorta length greater than 50 mm (from the aortic sinusoid junction tothe proximal cardiac margin of the innominate artery).
  • Ascending aorta diameter ≥ 24 mm and ≤ 48 mm;
  • Proximal anchoring zone length ≥ 30 mm;
  • Innominate artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm;
  • Left common carotid artery or left subclavian artery diameter ≤ 24 mm and ≥ 7 mm,length ≥ 20 mm;
  • Suitable arterial access for endovascular interventional treatment;
  1. Able to understand the purpose of the trial, participate in the trial voluntarily withinformed consent form signed by the patient him/herself or his or her legalrepresentative, and willing to complete follow-up visits as required under theprotocol.
  2. Evaluated by at least two vascular surgeons or cardiac surgeons as high surgical riskpatients or deemed to have significant surgical contraindications.

Exclusion

Exclusion Criteria:

  1. Experienced systemic infection during past three months;
  2. Neck surgery was performed within 3 months;
  3. Previous endovascular interventional treatment involving the aortic arch wasperformed;
  4. Infectious aortic disease、Takayasu arteritis,Marfan syndrome (or other connectivetissue diseases );
  5. Severe stenosis, calcification, thrombosis, or tortuosity of the carotid or subclavianartery;
  6. Heart transplant;
  7. Suffered MI or stroke during past three months;
  8. Class IV heart function (NYHA classification);
  9. Active peptic ulcers or upper gastrointestinal bleeding occurring within the previousthree months;
  10. Hematological abnormality, defined as follows: Leukopenia (WBC < 3 × 109/L), acuteanemia (Hb < 90 g/L); thrombocytopenia (PLT count < 50 × 109/L), history of bleedingor coagulopathy;
  11. Renal insufficiency, creatinine > 265 umol/L (or 3.0mg/dL) and/or end-stage renaldisease requiring renal dialysis, as determined by an investigator after a thoroughanalysis;
  12. Pregnant or breastfeeding;
  13. Allergies to contrast agents;
  14. Life expectancy of less than 12 months;
  15. Participating in another drug or device research;
  16. Any other disease or abnormality that the investigators believe may hinderendovascular interventional treatment.

Study Design

Total Participants: 88
Treatment Group(s): 1
Primary Treatment: WeFlow-Arch Modeler Embedded Branch Stent Graft System
Phase:
Study Start date:
June 07, 2021
Estimated Completion Date:
February 05, 2029

Study Description

This study is a prospective ,multiple center study about the safety and efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System, it is expected to complete the implantation of 80 patients in 23 centers within 12 months, and interim follow-up was conducted before discharge, 30 days after surgery, 6 months after surgery and 12 months after surgery, long-term follow-up will be performed at 24 months postoperatively, 36 months postoperatively, 48 months postoperatively and 60 months postoperatively.

Connect with a study center

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing,
    China

    Site Not Available

  • Chinese PLA General Hospital

    Beijing,
    China

    Site Not Available

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing,
    China

    Site Not Available

  • Peking University People's Hospital

    Beijing,
    China

    Site Not Available

  • Xiangya Hospital of Central South University

    Changsha,
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Chengdu,
    China

    Site Not Available

  • The First Affiliated Hospital ,Sun Yat-sen University

    Guangzhou,
    China

    Site Not Available

  • First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou,
    China

    Site Not Available

  • Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou,
    China

    Site Not Available

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin,
    China

    Site Not Available

  • Shandong Provincial Hospital

    Jinan,
    China

    Site Not Available

  • The First People's Hospital of Yunnan Province

    Kunming,
    China

    Site Not Available

  • Nanjing Drum Tower Hospital

    Nanjing,
    China

    Site Not Available

  • Nanjing First Hospital

    Nanjing,
    China

    Site Not Available

  • The Affiliated Hospital Of Qingdao University

    Qingdao,
    China

    Site Not Available

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai,
    China

    Site Not Available

  • The Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai,
    China

    Site Not Available

  • Zhongshan Hospital, Fudan University

    Shanghai,
    China

    Site Not Available

  • The First Affiliated Hospital of China Medical University

    Shenyang,
    China

    Site Not Available

  • The First Affiliated Hospital Of Soochow University

    Suzhou,
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin,
    China

    Site Not Available

  • The First Affiliated Hospital of PLA Air Force Military Medical University

    Xian,
    China

    Site Not Available

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou,
    China

    Site Not Available

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