Guo's Subclavian Artery Reconstruction: The Prospective, Multiple Center Study of WeFlow-Tbranch Stent Graft System(GUEST Study)

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

Phase

N/A

Condition

Chest Pain

Occlusions

Cardiovascular Disease

Treatment

WeFlow-Tbranch Stent Graft System

Clinical Study ID

NCT04765605
WeFlow001
  • Ages 18-80
  • All Genders

Study Summary

This study is a prospective, multiple center study to evaluate the safety and effectiveness of WeFlow-Tbranch single embedded branch thoracic aorta stent graft system manufactured by EndoNom Medtech (Hangzhou) Co., Ltd.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients aged 18 to 80 years old, no gender limitation;
  2. 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;
  3. Diagnosed as Stanford type B aortic dissection and needed reconstruction of the leftsubclavian artery;
  4. The diameter of the proximal anchoring area (the aorta at the posterior edge of theleft common carotid artery) range: 18~42mm;
  5. The length of the proximal anchoring area (the distance from the rear edge of the leftcommon carotid artery opening to the first breach) ≥15mm;
  6. The distance between the left common carotid artery and the left subclavian artery ≥5mm;
  7. The distance between the left vertebral artery and the opening of the left subclavianartery is ≥15mm, the diameter of the starting part of the left subclavian artery is 6~20mm
  8. With proper femoral artery, iliac artery, and brachial artery access, endovasculartreatment of the aorta can be performed.

Exclusion

Exclusion Criteria:

  1. Pregnant, breastfeeding or cannot contraception during the trial period;
  2. Participated in clinical trials of other drugs or devices during the same period;
  3. The same operation requires intervention in other vascular diseases (such as coronaryartery, renal artery, superior mesenteric artery, etc.), and the postoperative drugtreatment plan is therefore affected;
  4. Allergic to contrast agents, anesthetics, patches, and delivery materials;
  5. Cannot tolerate anesthesia;
  6. Severe liver, kidney, lung, and heart function abnormalities before surgery [Serumcreatinine exceeds 2 times the upper limit of normal; Alanine aminotransferase (ALT)or aspartate aminotransferase (AST) exceeds 5 times the upper limit of normal; Serumtotal bilirubin (STB) more than 2 times the upper limit of normal; Left ventricularejection fraction is lower than normal by cardiac color Doppler ultrasoundexamination];
  7. True/false thoracic aortic aneurysm
  8. History of myocardial infarction, TIA or cerebral infarction within the past 3 months;
  9. Contraindications to antiplatelet drugs and anticoagulants
  10. Life expectancy is less than 12 months (such as advanced malignant tumors)
  11. Acute systemic infection
  12. Severe stenosis or calcification in the anchoring area at the proximal end of thestent, easily lead to the stent graft difficult adherent
  13. Investigator judged that not suitable for interventional treatment.

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: WeFlow-Tbranch Stent Graft System
Phase:
Study Start date:
December 25, 2020
Estimated Completion Date:
December 25, 2026

Study Description

This study is a prospective, multiple center study to evaluate the safety and effectiveness of WeFlow-Tbranch single embedded branch thoracic aorta stent graft system in the treatment of Stanford type B dissection of the proximal left subclavian artery. It is expected to complete the implantation of 120 patients in 29 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

  • Chinese PLA General Hospital

    Beijing,
    China

    Site Not Available

  • Fuwai Hospital, Chinese Academy of Medical Sciences

    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

  • Foshan First People's Hospital

    Foshan,
    China

    Site Not Available

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou,
    China

    Site Not Available

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou,
    China

    Site Not Available

  • First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou,
    China

    Site Not Available

  • Zhejiang Provincial People's Hospital

    Hangzhou,
    China

    Site Not Available

  • Anhui Provincial Hospital

    Hefei,
    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

  • Affiliated Hospital of Southwest Medical University

    Luzhou,
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanchang University

    Nanchang,
    China

    Site Not Available

  • Jiangsu Provincial People's Hospital

    Nanjing,
    China

    Site Not Available

  • Nanjing Gulou Hospital

    Nanjing,
    China

    Site Not Available

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning,
    China

    Site Not Available

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai,
    China

    Site Not Available

  • Shanghai Jiaotong University Affiliated Ninth People's Hospital

    Shanghai,
    China

    Site Not Available

  • The Second Affiliated Hospital of Naval Medical University

    Shanghai,
    China

    Site Not Available

  • Zhongshan Hospital, Fudan University

    Shanghai,
    China

    Site Not Available

  • The First Hospital of Hebei Medical University

    Shijia Zhuang,
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou,
    China

    Site Not Available

  • Shanxi Bethune Hospital

    Taiyuan,
    China

    Site Not Available

  • Tianjin Chest Hospital

    Tianjin,
    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

  • Yantai Yuhuangding Hospital

    Yantai,
    China

    Site Not Available

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou,
    China

    Site Not Available

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