Phase
Condition
Aneurysm
Treatment
WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients aged 18 to 80 years old;
Diagnosed with aortic arch lesions requiring intervention, including true aorticarch aneurysms, pseudo-aortic arch aneurysms, and ulcers involving the aortic arch;
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;
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.
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:
Experienced systemic infection during past three months;
Neck surgery was performed within 3 months;
Previous endovascular interventional treatment involving the aortic arch wasperformed;
Infectious aortic disease, Takayasu arteritis, Marfan syndrome (or other connectivetissue diseases );
Severe stenosis, calcification, thrombosis, or tortuosity of the branch artery to bereconstructed;
Heart transplant;
Suffered Myocardial Infarction or Stroke during past three months;
Class IV heart function (NYHA classification);
Active peptic ulcers or upper gastrointestinal bleeding occurring within theprevious three months;
Hematological abnormality, defined as follows: Leukopenia (WBC < 3 ×109/L), acuteanemia (Hb < 90 g/L), Coagulation disorders, thrombocytopenia (PLT count < 50 × 109/L);
Renal insufficiency, creatinine > 150 umol/L and/or end-stage renal diseaserequiring renal dialysis;
Pregnant or breastfeeding;
Allergies to contrast agents;
Life expectancy of less than 12 months;
Participating in another drug or device research;
Any other disease or abnormality that the investigators believe may hinderendovascular interventional treatment.
Study Design
Study Description
Connect with a study center
Beijing Anzhen Hospital, Capital Medical University
Beijing,
ChinaActive - Recruiting
Chinese PLA Gencral Hosptial
Beijing,
ChinaActive - Recruiting
The First Hospital of Jilin University
Changchun,
ChinaActive - Recruiting
Xiangya Hospital of Central South University
Changsha,
ChinaActive - Recruiting
West China Hospital of Sichuan University
Chengdu,
ChinaActive - Recruiting
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou,
ChinaActive - Recruiting
The First Affiliated Hospital ,Sun Yat-sen University
Guangzhou,
ChinaActive - Recruiting
The First Affiliated Hospital of Harbin Medical University
Harbin,
ChinaActive - Recruiting
Shandong Provincial Hospital
Jinan,
ChinaActive - Recruiting
The First People's Hospital of Yunnan Province
Kunming,
ChinaActive - Recruiting
The Second Affiliated Hospital Of Nanchang University
Nanchang,
ChinaActive - Recruiting
Nanjing First Hospital
Nanjing,
ChinaActive - Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing,
ChinaActive - Recruiting
The Affiliated Hospital Of Qingdao University
Qingdao,
ChinaActive - Recruiting
Shanghai Chest Hospital
Shanghai,
ChinaActive - Recruiting
Zhongshan Hospital, Fudan University
Shanghai,
ChinaActive - Recruiting
The First Affiliated Hospital of China Medical University
Shenyang,
ChinaActive - Recruiting
Xiamen Cardiovascular Hospital
Xiamen,
ChinaActive - Recruiting
The First Affiliated Hospital of PLA Air Force Military Medical University
Xian,
ChinaActive - Recruiting
First Affiliated Hospital of Zhengzhou University
Zhengzhou,
ChinaActive - Recruiting
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