Safety and Efficacy Study Of The Thoracic Aortic Stent Graft System Treating Aortic Dissection

Aortic Dissection Clinical Trial

Official title:

A Prospective, Multicenter, Objective Performance Criteria-Controlled Study for National Medical Products Administration Approval Of The Thoracic Aortic Stent Graft System

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05430672
• Other study ID #: V1.1/2021-11-16
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2022
• Est. completion date: August 2024

Study information

• Verified date: January 2022
• Source: Zhejiang Zylox Medical Device Co., Ltd.
• Contact: Jie Liang
• Phone: 13819565660
• Email: jie.liang[@]zyloxmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: August 2024
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Aortic Dissection

Intervention

Device:
• 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. ).

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing
China	The First Affiliated Hospital of Bengbu medical College	Bengbu	Anhui
China	The First Hospital Of Zhejiang Province	Hanzhou	Zhejiang
China	The Second Hospital Of Anhui Medical University	Hefei	Anhui
China	Huaihe Hospital of Henan University	Kaifeng	Henan
China	Liuzhou Worker's Hospital	Liuzhou	Guangxi
China	The Second Affiliated Hospital Of Nanchang University	Nanchang	Jiangxi
China	Nanjing Drum Tower Hospital, the affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu
China	Shanghai Ninth People's Hostpital, Shanghai JiaoTong University School of Medicine	Shanghai
China	Zhongshan Hospital	Shanghai
China	The First Affiliated Hospital Of WMU	Wenzhou	Zhejiang
China	Renmin Hospital Of Wuhan University	Wuhan	Hubei
China	The First Affiliated Hospital of Xi'An Jiaotong University	Xi'an	Shaanxi
China	The First Affiliated Hospital Of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Zylox Medical Device Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of no Major Adverse Event (MAE)	MAE was defined as aortic dissection related death, disabling stoke or paraplegic.	Immediately after the intervention
Primary	Rate of no Major Adverse Event (MAE)	MAE was defined as aortic dissection related death, disabling stoke or paraplegic.	30 days
Primary	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	Rate of aortic dissection related mortality	Death caused by aortic dissection rupture or related treatment.	Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
Secondary	Rate of all cause mortality	Death for any reason will be recorded.	Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
Secondary	Rate of Adverse Events(AE)	The definition of AE(Adverse Event) refers to International Organization for Standardization (ISO) 14155, AE should be distinguished from normal postoperative stress response.	Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
Secondary	Rate of Serious Adverse Events(SAE)	The definition of SAE (Serious Adverse Event) refers to ISO 14155.	Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
Secondary	Rate of 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.	Immediately after the intervention
Secondary	Incidence of stent displacement	Stent displacement was defined as the aortic and branch stent-grafts displacing by more than 10 mm from the post-implantation position.	30 days/ 6 months/ 12 months
Secondary	Success rate of endovascular repair	Comparison of CTA results before surgery and within 30 days, 6 months, and 12 months after surgery. Changes in the diameter of the stent covered by aortic dissection and thrombosis of the false lumen are used to determine whether the vessel is successfully repaired.	30 days/ 6 months/ 12 months