Phase
Condition
Chest Pain
Occlusions
Cardiovascular Disease
Treatment
WeFlow-Tbranch 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, no gender limitation;
- 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;
- Diagnosed as Stanford type B aortic dissection and needed reconstruction of the leftsubclavian artery;
- The diameter of the proximal anchoring area (the aorta at the posterior edge of theleft common carotid artery) range: 18~42mm;
- The length of the proximal anchoring area (the distance from the rear edge of the leftcommon carotid artery opening to the first breach) ≥15mm;
- The distance between the left common carotid artery and the left subclavian artery ≥5mm;
- 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
- With proper femoral artery, iliac artery, and brachial artery access, endovasculartreatment of the aorta can be performed.
Exclusion
Exclusion Criteria:
- Pregnant, breastfeeding or cannot contraception during the trial period;
- Participated in clinical trials of other drugs or devices during the same period;
- 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;
- Allergic to contrast agents, anesthetics, patches, and delivery materials;
- Cannot tolerate anesthesia;
- 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];
- True/false thoracic aortic aneurysm
- History of myocardial infarction, TIA or cerebral infarction within the past 3 months;
- Contraindications to antiplatelet drugs and anticoagulants
- Life expectancy is less than 12 months (such as advanced malignant tumors)
- Acute systemic infection
- Severe stenosis or calcification in the anchoring area at the proximal end of thestent, easily lead to the stent graft difficult adherent
- Investigator judged that not suitable for interventional treatment.
Study Design
Study Description
Connect with a study center
Chinese PLA General Hospital
Beijing,
ChinaSite Not Available
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing,
ChinaSite Not Available
Xiangya Hospital of Central South University
Changsha,
ChinaSite Not Available
West China Hospital of Sichuan University
Chengdu,
ChinaSite Not Available
Foshan First People's Hospital
Foshan,
ChinaSite Not Available
The First Affiliated Hospital of Fujian Medical University
Fuzhou,
ChinaSite Not Available
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou,
ChinaSite Not Available
First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou,
ChinaSite Not Available
Zhejiang Provincial People's Hospital
Hangzhou,
ChinaSite Not Available
Anhui Provincial Hospital
Hefei,
ChinaSite Not Available
Shandong Provincial Hospital
Jinan,
ChinaSite Not Available
The First People's Hospital of Yunnan Province
Kunming,
ChinaSite Not Available
Affiliated Hospital of Southwest Medical University
Luzhou,
ChinaSite Not Available
The Second Affiliated Hospital of Nanchang University
Nanchang,
ChinaSite Not Available
Jiangsu Provincial People's Hospital
Nanjing,
ChinaSite Not Available
Nanjing Gulou Hospital
Nanjing,
ChinaSite Not Available
The First Affiliated Hospital of Guangxi Medical University
Nanning,
ChinaSite Not Available
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai,
ChinaSite Not Available
Shanghai Jiaotong University Affiliated Ninth People's Hospital
Shanghai,
ChinaSite Not Available
The Second Affiliated Hospital of Naval Medical University
Shanghai,
ChinaSite Not Available
Zhongshan Hospital, Fudan University
Shanghai,
ChinaSite Not Available
The First Hospital of Hebei Medical University
Shijia Zhuang,
ChinaSite Not Available
The First Affiliated Hospital of Soochow University
Suzhou,
ChinaSite Not Available
Shanxi Bethune Hospital
Taiyuan,
ChinaSite Not Available
Tianjin Chest Hospital
Tianjin,
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
Yantai Yuhuangding Hospital
Yantai,
ChinaSite Not Available
First Affiliated Hospital of Zhengzhou University
Zhengzhou,
ChinaSite Not Available

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