Phase
Condition
Aneurysm
Treatment
WeFlow-Arch Modeler Embedded Branch 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 aortic archaneurysms, 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;
- 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;
- 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.
- Evaluated by at least two vascular surgeons or cardiac surgeons as high surgical riskpatients or deemed to have significant surgical contraindications.
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 carotid or subclavianartery;
- Heart transplant;
- Suffered MI or stroke during past three months;
- Class IV heart function (NYHA classification);
- 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), history of bleedingor coagulopathy;
- Renal insufficiency, creatinine > 265 umol/L (or 3.0mg/dL) and/or end-stage renaldisease requiring renal dialysis, as determined by an investigator after a thoroughanalysis;
- 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,
ChinaSite Not Available
Chinese PLA General Hospital
Beijing,
ChinaSite Not Available
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing,
ChinaSite Not Available
Peking University People's Hospital
Beijing,
ChinaSite Not Available
Xiangya Hospital of Central South University
Changsha,
ChinaSite Not Available
West China Hospital of Sichuan University
Chengdu,
ChinaSite Not Available
The First Affiliated Hospital ,Sun Yat-sen University
Guangzhou,
ChinaSite Not Available
First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou,
ChinaSite Not Available
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou,
ChinaSite Not Available
The Second Affiliated Hospital of Harbin Medical University
Harbin,
ChinaSite Not Available
Shandong Provincial Hospital
Jinan,
ChinaSite Not Available
The First People's Hospital of Yunnan Province
Kunming,
ChinaSite Not Available
Nanjing Drum Tower Hospital
Nanjing,
ChinaSite Not Available
Nanjing First Hospital
Nanjing,
ChinaSite Not Available
The Affiliated Hospital Of Qingdao University
Qingdao,
ChinaSite Not Available
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai,
ChinaSite Not Available
The Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai,
ChinaSite Not Available
Zhongshan Hospital, Fudan University
Shanghai,
ChinaSite Not Available
The First Affiliated Hospital of China Medical University
Shenyang,
ChinaSite Not Available
The First Affiliated Hospital Of Soochow University
Suzhou,
ChinaSite Not Available
Tianjin Medical University General Hospital
Tianjin,
ChinaSite Not Available
The First Affiliated Hospital of PLA Air Force Military Medical University
Xian,
ChinaSite Not Available
First Affiliated Hospital of Zhengzhou University
Zhengzhou,
ChinaSite Not Available
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