Guo's Subclavian Artery Reconstruction: The Prospective, Multiple Center Study of WeFlow-Tbranch Stent Graft System(GUEST Study)
NCT ID: NCT04765605
Last Updated: 2024-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
120 participants
INTERVENTIONAL
2020-12-25
2026-12-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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WeFlow-Tbranch Stent Graft System
Participants will be treated with WeFlow-Tbranch Stent Graft System
WeFlow-Tbranch Stent Graft System
The single-embedded branch thoracic aorta stent graft system consists of the thoracic aorta stent graft system and the branch stent system. The main chest embedded stent graft system consists of the main chest embedded stent graft and its system conveyor, and the branch stent system consists of branch stents and its conveyor. The main chest embedded stent graft and the branch stent are pre-installed in the conveyor
Interventions
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WeFlow-Tbranch Stent Graft System
The single-embedded branch thoracic aorta stent graft system consists of the thoracic aorta stent graft system and the branch stent system. The main chest embedded stent graft system consists of the main chest embedded stent graft and its system conveyor, and the branch stent system consists of branch stents and its conveyor. The main chest embedded stent graft and the branch stent are pre-installed in the conveyor
Eligibility Criteria
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Inclusion Criteria
2. Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the patient him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol;
3. Diagnosed as Stanford type B aortic dissection and needed reconstruction of the left subclavian artery;
4. The diameter of the proximal anchoring area (the aorta at the posterior edge of the left common carotid artery) range: 18～42mm;
5. The length of the proximal anchoring area (the distance from the rear edge of the left common carotid artery opening to the first breach) ≥15mm;
6. The distance between the left common carotid artery and the left subclavian artery ≥5mm;
7. The distance between the left vertebral artery and the opening of the left subclavian artery is ≥15mm, the diameter of the starting part of the left subclavian artery is 6～20mm
8. With proper femoral artery, iliac artery, and brachial artery access, endovascular treatment of the aorta can be performed.
Exclusion Criteria
2. Participated in clinical trials of other drugs or devices during the same period;
3. The same operation requires intervention in other vascular diseases (such as coronary artery, renal artery, superior mesenteric artery, etc.), and the postoperative drug treatment plan is therefore affected;
4. Allergic to contrast agents, anesthetics, patches, and delivery materials;
5. Cannot tolerate anesthesia;
6. Severe liver, kidney, lung, and heart function abnormalities before surgery \[Serum creatinine exceeds 2 times the upper limit of normal; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds 5 times the upper limit of normal; Serum total bilirubin (STB) more than 2 times the upper limit of normal; Left ventricular ejection fraction is lower than normal by cardiac color Doppler ultrasound examination\];
7. True/false thoracic aortic aneurysm
8. History of myocardial infarction, TIA or cerebral infarction within the past 3 months;
9. Contraindications to antiplatelet drugs and anticoagulants
10. Life expectancy is less than 12 months (such as advanced malignant tumors)
11. Acute systemic infection
12. Severe stenosis or calcification in the anchoring area at the proximal end of the stent, easily lead to the stent graft difficult adherent
13. Investigator judged that not suitable for interventional treatment.
18 Years
80 Years
ALL
No
Sponsors
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Hangzhou Endonom Medtech Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Wei Guo, Professor
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Locations
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Chinese PLA General Hospital
Beijing, , China
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, , China
Xiangya Hospital of Central South University
Changsha, , China
West China Hospital of Sichuan University
Chengdu, , China
Foshan First People's Hospital
Foshan, , China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, , China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, , China
First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, , China
Zhejiang Provincial People's Hospital
Hangzhou, , China
Anhui Provincial Hospital
Hefei, , China
Shandong Provincial Hospital
Jinan, , China
The First People's Hospital of Yunnan Province
Kunming, , China
Affiliated Hospital of Southwest Medical University
Luzhou, , China
The Second Affiliated Hospital of Nanchang University
Nanchang, , China
Jiangsu Provincial People's Hospital
Nanjing, , China
Nanjing Gulou Hospital
Nanjing, , China
The First Affiliated Hospital of Guangxi Medical University
Nanning, , China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, , China
Shanghai Jiaotong University Affiliated Ninth People's Hospital
Shanghai, , China
The Second Affiliated Hospital of Naval Medical University
Shanghai, , China
Zhongshan Hospital, Fudan University
Shanghai, , China
The First Hospital of Hebei Medical University
Shijia Zhuang, , China
The First Affiliated Hospital of Soochow University
Suzhou, , China
Shanxi Bethune Hospital
Taiyuan, , China
Tianjin Chest Hospital
Tianjin, , China
Tianjin Medical University General Hospital
Tianjin, , China
The First Affiliated Hospital of PLA Air Force Military Medical University
Xi'an, , China
Yantai Yuhuangding Hospital
Yantai, , China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Countries
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Other Identifiers
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WeFlow001
Identifier Type: -
Identifier Source: org_study_id
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