Guo's Endovascular Aortic Arch Replacement of Aortic Dissection by WeFlow-Tribranch Endoprothesis: a Multicenter Pilot Study(GRAFT Study)

Last updated: August 28, 2023
Sponsor: Hangzhou Endonom Medtech Co., Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aneurysm

Chest Pain

Heart Disease

Treatment

WeFlow-Tribranch Aortic Arch Stent Graft System

Clinical Study ID

NCT05754541
WeFlow-Tribranch V1.0
  • Ages 18-80
  • All Genders

Study Summary

To explore the effect and prognosis of endovascular interventional therapy in high-risk patients with aortic arch dissection and aneurysm

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients aged 18 to 80 years old.
  2. The patient was diagnosed with subacute or chronic aortic arch dissection, or Aorticarch aneurysms.
  3. Patients showing a suitable vascular condition, including:
  4. Ascending aorta length greater than 50 mm (from the aortic sinusoid junction tothe proximal cardiac margin of the innominate artery).
  5. Ascending aorta diameter ≥ 24 mm and ≤ 48 mm;
  6. Proximal anchoring zone length ≥ 30 mm;
  7. Innominate artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm;
  8. Left common carotid artery or left subclavian artery diameter ≤ 24 mm and ≥ 7 mm,length ≥ 20 mm;
  9. Suitable arterial access for endovascular interventional treatment ;
  10. Patients able to understand the purpose of the trial, participate in the trialvoluntarily with informed consent form signed by the subject him/herself or his or herlegal representative, and willing to complete follow-up visits as required under theprotocol.
  11. Patients evaluated by at least two vascular surgeons or cardiac surgeons as highsurgical risk patients or deemed to have significant surgical contraindications. (Therecommended reference criteria are: EuroSCORE score ≥ 6, or CFS score > 4, or ASAgrade 3-4, or there are other high-risk surgical factors that affect the prognosis ofthe subject, such as patients with a history of open surgery, other high-risk factorsjudged by a physician team, or patients who refuse open surgery.)

Exclusion

Exclusion Criteria:

  1. Patients that have experienced systemic infection during past three months;
  2. Neck surgery was performed within three months;
  3. Infectious aortic disease、Takayasu arteritis,Marfan syndrome (or other connectivetissue diseases );
  4. Patients with severe stenosis, calcification, thrombosis or tortuosity of theBrachiocephalic trunk, Left common carotid artery or left subclavian artery;
  5. Heart transplant patients;
  6. Patients that have suffered MI or stroke during past three months;
  7. Patients with Class IV heart function (NYHA classification) or LVEF<30%
  8. Active peptic ulcers or upper gastrointestinal bleeding occurring within the previousthree months;
  9. Hematological abnormality, defined as follows: Leukopenia (WBC < 3 × 109/L), acuteanemia (Hb < 90 g/L); thrombocytopenia (PLT count < 50 × 109/L);
  10. Patients with renal insufficiency, serum creatinine > 150 umol/l (or 3.0 mg/dl) and /or end-stage renal disease requiring renal dialysis shall be determined by theinvestigator after comprehensive analysis;
  11. Subjects with severe liver dysfunction and ALT or AST exceeding 3 times the upperlimit of normal; Subjects whose serum total bilirubin (STB) exceeds 2 times the upperlimit of normal;
  12. Patients with intestinal necrosis and lower limb ischemic necrosis;
  13. Paraplegic patients;
  14. Patients that are pregnant or breastfeeding;
  15. Patients with allergies to contrast agents;
  16. Patients with a life expectancy of less than 12 months;
  17. Patients currently participating in other drug or device research;
  18. Any other disease or abnormality that the investigators believe may hinderendovascular interventional treatment.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: WeFlow-Tribranch Aortic Arch Stent Graft System
Phase:
Study Start date:
November 10, 2022
Estimated Completion Date:
December 31, 2025

Study Description

The WeFlow-Tribranch Aortic Arch Stent Graft System first in man study is a prospective, multi-center, single arm trial, which will enroll a total of 20 patients. The goal of this study is to evaluate the safety and efficacy of WeFlow-Tribranch Aortic Arch Stent Graft System in the treatment of patients with aortic arch dissection and aneurysm.

Connect with a study center

  • Chinese PLA Gencral Hosptial

    Beijing, Beijing
    China

    Active - Recruiting

  • Nanjing First Hospital

    Nanjing, Jiangsu 210029
    China

    Active - Recruiting

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Chengdu, Sichuan
    China

    Site Not Available

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