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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients aged 18 to 80 years old.
- The patient was diagnosed with subacute or chronic aortic arch dissection, or Aorticarch aneurysms.
- Patients 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 ;
- 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.
- 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:
- Patients that have experienced systemic infection during past three months;
- Neck surgery was performed within three months;
- Infectious aortic disease、Takayasu arteritis,Marfan syndrome (or other connectivetissue diseases );
- Patients with severe stenosis, calcification, thrombosis or tortuosity of theBrachiocephalic trunk, Left common carotid artery or left subclavian artery;
- Heart transplant patients;
- Patients that have suffered MI or stroke during past three months;
- Patients with Class IV heart function (NYHA classification) or LVEF<30%
- Active peptic ulcers or upper gastrointestinal bleeding occurring within the previousthree months;
- Hematological abnormality, defined as follows: Leukopenia (WBC < 3 × 109/L), acuteanemia (Hb < 90 g/L); thrombocytopenia (PLT count < 50 × 109/L);
- 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;
- 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;
- Patients with intestinal necrosis and lower limb ischemic necrosis;
- Paraplegic patients;
- Patients that are pregnant or breastfeeding;
- Patients with allergies to contrast agents;
- Patients with a life expectancy of less than 12 months;
- Patients currently participating in other drug or device research;
- 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
Connect with a study center
Chinese PLA Gencral Hosptial
Beijing, Beijing
ChinaActive - Recruiting
Nanjing First Hospital
Nanjing, Jiangsu 210029
ChinaActive - Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai
ChinaSite Not Available
West China Hospital of Sichuan University
Chengdu, Sichuan
ChinaSite Not Available
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