Safety and Efficacy Study Of The Thoracic Aortic Stent Graft System Treating Aortic Dissection
NCT ID: NCT05430672
Last Updated: 2022-06-24
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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UNKNOWN
NA
120 participants
INTERVENTIONAL
2022-06-30
2024-08-31
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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Subjects with aortic dissection
Subjects receive endovascular treatment.
The Thoracic Aortic Stent Graft System (Zylox-Tonbridge Medical Technology Co., Ltd. )
This is a objective performance criteria-controlled study, all subjects meet the criteria will receive the same treatment using the thoracic aortic stent graft system (Zylox-Tonbridge Medical Technology Co., Ltd. ).
Interventions
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The Thoracic Aortic Stent Graft System (Zylox-Tonbridge Medical Technology Co., Ltd. )
This is a objective performance criteria-controlled study, all subjects meet the criteria will receive the same treatment using the thoracic aortic stent graft system (Zylox-Tonbridge Medical Technology Co., Ltd. ).
Eligibility Criteria
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Inclusion Criteria
* Subject or legal representative is able to understand the purpose of study, agrees to comply with protocol requirements and has provided written informed consent；
* Subjects who are diagnosed with Stanford type B aortic dissection requiring reconstruction of the left common carotid artery and left subclavian artery or requiring reconstruction of the left subclavian artery;
* Appropriate access to the femoral artery, iliac artery, brachial artery, etc. that can be used for endoluminal aortic therapy.
Exclusion Criteria
* History of surgery in the aortic arch or endovascular repair surgery;
* Severe stenosis or calcification or distortion in the anchoring area of the proximal end of the stent;
* Subjects with severe liver, kidney failure；
* Subjects with severe coagulation disorders；
* Female subjects who are pregnant, lactating within the study period or unable to contraception during the trail.
* History of allergies to anesthetics, contrast agents or the material of stent/ deliver system；
* Inability to tolerate anesthesia；
* History of acute myocardial infarction, cerebral infarction or cerebral hemorrhage within 3 months before surgery;
* Subjects who have participated in any other drug or medical device clinical investigations and haven't reach the primary endpoint.
* Subjects with acute systemic infection
* Other circumstances judged by researchers that are not suitable for enrollment .
18 Years
80 Years
ALL
No
Sponsors
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Zhejiang Zylox Medical Device Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Xinwu Lu
Role: PRINCIPAL_INVESTIGATOR
Shanghai Ninth People's Hostpital, Shanghai JiaoTong University School of Medicine
Locations
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The First Affiliated Hospital of Bengbu medical College
Bengbu, Anhui, China
The Second Hospital Of Anhui Medical University
Hefei, Anhui, China
Liuzhou Worker's Hospital
Liuzhou, Guangxi, China
Huaihe Hospital of Henan University
Kaifeng, Henan, China
The First Affiliated Hospital Of Zhengzhou University
Zhengzhou, Henan, China
Renmin Hospital Of Wuhan University
Wuhan, Hubei, China
Nanjing Drum Tower Hospital, the affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
The Second Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China
The First Affiliated Hospital of Xi'An Jiaotong University
Xi'an, Shaanxi, China
The First Hospital Of Zhejiang Province
Hanzhou, Zhejiang, China
The First Affiliated Hospital Of WMU
Wenzhou, Zhejiang, China
Peking Union Medical College Hospital
Beijing, , China
Shanghai Ninth People's Hostpital, Shanghai JiaoTong University School of Medicine
Shanghai, , China
Zhongshan Hospital
Shanghai, , China
Countries
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Central Contacts
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Other Identifiers
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V1.1/2021-11-16
Identifier Type: -
Identifier Source: org_study_id
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