Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study)

Last updated: May 21, 2024
Sponsor: Hangzhou Endonom Medtech Co., Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aneurysm

Treatment

WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system

Clinical Study ID

NCT06385379
WQ21-2301
  • Ages 18-80
  • All Genders

Study Summary

A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true/pseudo aortic arch aneurysms and ulcers involving aortic arch . (GENIUS Study)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients aged 18 to 80 years old;

  2. Diagnosed with aortic arch lesions requiring intervention, including true aorticarch aneurysms, 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;

  • Branch arteries to be reconstructed were ≤ 24 mm and ≥ 6 mm in diameter and ≥ 20 mm in length;

  • Suitable arterial access for endovascular interventional treatment;

  1. Able to understand the purpose of the trial, participate in the trial voluntarilywith informed 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. Subjects were assessed as high risk for surgery by at least two investigators orjudged to have significant surgical contraindications. Recommended referencecriteria were a European system for cardiac operative risk evaluation (EuroScore)score of 6 or higher or other surgical risk factors as judged by the physician team.

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 branch artery to bereconstructed;

  6. Heart transplant;

  7. Suffered Myocardial Infarction or Stroke during past three months;

  8. Class IV heart function (NYHA classification);

  9. Active peptic ulcers or upper gastrointestinal bleeding occurring within theprevious three months;

  10. Hematological abnormality, defined as follows: Leukopenia (WBC < 3 ×109/L), acuteanemia (Hb < 90 g/L), Coagulation disorders, thrombocytopenia (PLT count < 50 × 109/L);

  11. Renal insufficiency, creatinine > 150 umol/L and/or end-stage renal diseaserequiring renal dialysis;

  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: 90
Treatment Group(s): 1
Primary Treatment: WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system
Phase:
Study Start date:
June 30, 2024
Estimated Completion Date:
December 31, 2030

Study Description

This study is a prospective ,multiple center study about the safety and efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System , it is expected to complete the implantation of 90 patients in 20 centers within 20 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 24th month, 36th month, 48th month and 60th month postoperatively.

Connect with a study center

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing,
    China

    Active - Recruiting

  • Chinese PLA Gencral Hosptial

    Beijing,
    China

    Active - Recruiting

  • The First Hospital of Jilin University

    Changchun,
    China

    Active - Recruiting

  • Xiangya Hospital of Central South University

    Changsha,
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Chengdu,
    China

    Active - Recruiting

  • Guangdong Provincial Hospital of Traditional Chinese Medicine

    Guangzhou,
    China

    Active - Recruiting

  • The First Affiliated Hospital ,Sun Yat-sen University

    Guangzhou,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Harbin Medical University

    Harbin,
    China

    Active - Recruiting

  • Shandong Provincial Hospital

    Jinan,
    China

    Active - Recruiting

  • The First People's Hospital of Yunnan Province

    Kunming,
    China

    Active - Recruiting

  • The Second Affiliated Hospital Of Nanchang University

    Nanchang,
    China

    Active - Recruiting

  • Nanjing First Hospital

    Nanjing,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing,
    China

    Active - Recruiting

  • The Affiliated Hospital Of Qingdao University

    Qingdao,
    China

    Active - Recruiting

  • Shanghai Chest Hospital

    Shanghai,
    China

    Active - Recruiting

  • Zhongshan Hospital, Fudan University

    Shanghai,
    China

    Active - Recruiting

  • The First Affiliated Hospital of China Medical University

    Shenyang,
    China

    Active - Recruiting

  • Xiamen Cardiovascular Hospital

    Xiamen,
    China

    Active - Recruiting

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

    Xian,
    China

    Active - Recruiting

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou,
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.