Clinical trial NCT05430672: Safety and Efficacy Study Of The Thoracic Aortic Stent Graft System Treating Aortic Dissection
Official title: A Prospective, Multicenter, Objective Performance Criteria-Controlled Study for National Medical Products Administration Approval Of The Thoracic Aortic Stent Graft System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Dissection
Keywords: Aortic Dissection
Thoracic aortic
Stent graft
Lead sponsor: Zhejiang Zylox Medical Device Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-06-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, multicenter and single-arm trail to study the safety and efficacy of the thoracic aortic stent graft system that specially designed for treating aortic dissection.

Detailed description: This trail is conducted in several centers all around China. In about 18 months, 120 subjects with aortic dissection will be recruited, all of which receive endovascular treatment using the thoracic aortic stent graft system (Zylox-Tonbridge Medical Technology Co., Ltd. ). The subjects will be followed up in 30 days/ 6 months/ 12 months/ 2-5 years.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 80 years;
* 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:

* The same surgery requires intervention for other vascular lesions；
* 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 .

Primary outcomes:
measure: Rate of no Major Adverse Event (MAE)
timeFrame: Immediately after the intervention
measure: Rate of no Major Adverse Event (MAE)
timeFrame: 30 days
measure: Success rate of endovascular treatment
timeFrame: Up to 12 months
Secondary outcomes:
measure: Rate of aortic dissection related mortality
timeFrame: Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
measure: Rate of all cause mortality
timeFrame: Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
measure: Rate of Adverse Events(AE)
timeFrame: Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
measure: Rate of Serious Adverse Events(SAE)
timeFrame: Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
measure: Rate of technique success
timeFrame: Immediately after the intervention
measure: Incidence of stent displacement
timeFrame: 30 days/ 6 months/ 12 months
measure: Success rate of endovascular repair
timeFrame: 30 days/ 6 months/ 12 months
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu medical College
state: Anhui
city: Hefei
country: China
facility: The Second Hospital Of Anhui Medical University
state: Anhui
city: Liuzhou
country: China
facility: Liuzhou Worker's Hospital
state: Guangxi
city: Kaifeng
country: China
facility: Huaihe Hospital of Henan University
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital Of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Renmin Hospital Of Wuhan University
state: Hubei
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital, the affiliated Hospital of Nanjing University Medical School
state: Jiangsu
city: Nanchang
country: China
facility: The Second Affiliated Hospital Of Nanchang University
state: Jiangxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'An Jiaotong University
state: Shaanxi
city: Hanzhou
country: China
facility: The First Hospital Of Zhejiang Province
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital Of WMU
state: Zhejiang
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Shanghai
country: China
facility: Shanghai Ninth People's Hostpital, Shanghai JiaoTong University School of Medicine
city: Shanghai
country: China
facility: Zhongshan Hospital
Study officials:
affiliation: Shanghai Ninth People's Hostpital, Shanghai JiaoTong University School of Medicine
name: Xinwu Lu
role: PRINCIPAL_INVESTIGATOR
References: