Safety and Efficacy Study Of The Thoracic Aortic Stent Graft System Treating Aortic Dissection
A Prospective, Multicenter, Objective Performance Criteria-Controlled Study for National Medical Products Administration Approval Of The Thoracic Aortic Stent Graft System
1 other identifier
interventional
120
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2022
Typical duration for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2022
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedFirst Posted
Study publicly available on registry
June 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedJune 24, 2022
January 1, 2022
1.2 years
January 25, 2022
June 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Rate of no Major Adverse Event (MAE)
MAE was defined as aortic dissection related death, disabling stoke or paraplegic.
Immediately after the intervention
Rate of no Major Adverse Event (MAE)
MAE was defined as aortic dissection related death, disabling stoke or paraplegic.
30 days
Success rate of endovascular treatment
* Technique success: the delivery system was successfully delivered to the predetermined position, the stent was accurately positioned and successfully deployed, and the delivery system could be safely withdrawn from the body, no type I or type III endoleak can be found during angiography. * No stent displacement during 12 months follow up time. * No secondary surgical intervention during 12 months follow up.
Up to 12 months
Secondary Outcomes (7)
Rate of aortic dissection related mortality
Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
Rate of all cause mortality
Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
Rate of Adverse Events(AE)
Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
Rate of Serious Adverse Events(SAE)
Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
Rate of technique success
Immediately after the intervention
- +2 more secondary outcomes
Study Arms (1)
Subjects with aortic dissection
OTHERSubjects receive endovascular treatment.
Interventions
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
You may qualify if:
- 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.
You may not qualify if:
- 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 .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
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
Liuchow, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xinwu Lu
Shanghai Ninth People's Hostpital, Shanghai JiaoTong University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2022
First Posted
June 24, 2022
Study Start
June 1, 2022
Primary Completion
August 1, 2023
Study Completion
August 1, 2024
Last Updated
June 24, 2022
Record last verified: 2022-01