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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Dissection
• Intervention / Treatment: Device: The Thoracic Aortic Stent Graft System (Zylox-Tonbridge Medical Technology Co., Ltd. )

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking Union Medical College Hospital
  • Shanghai, China
    • Zhongshan Hospital
  • Shanghai, China
    • Shanghai Ninth People's Hostpital, Shanghai JiaoTong University School of Medicine
  • Anhui
    • Bengbu, Anhui, China
      • The First Affiliated Hospital of Bengbu Medical College
      • Principal Investigator: Chaowen Yu
    • Hefei, Anhui, China
      • The second hospital of Anhui medical university
  • Guangxi
    • Liuzhou, Guangxi, China
      • Liuzhou Worker's Hospital
      • Principal Investigator: Peiyong Hou
  • Henan
    • Kaifeng, Henan, China
      • Huaihe Hospital of Henan University
      • Principal Investigator: Jianbo Che
    • Zhengzhou, Henan, China
      • The first affiliated hospital of Zhengzhou university
      • Principal Investigator: Zhiwei Wang
  • Hubei
    • Wuhan, Hubei, China
      • Renmin Hospital of Wuhan University
      • Principal Investigator: Hongping Deng
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
  • Jiangxi
    • Nanchang, Jiangxi, China
      • The Second Affiliated Hospital of Nanchang University
  • Shaanxi
    • Xi'an, Shaanxi, China
      • The First Affiliated Hospital of Xi'an Jiaotong University
      • Principal Investigator: Jianlin Liu
  • Zhejiang
    • Hanzhou, Zhejiang, China
      • The First Hospital of Zhejiang Province
    • Wenzhou, Zhejiang, China
      • The First Affiliated Hospital of WMU
      • Principal Investigator: Jingyong Huang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Subjects with aortic dissection; Subjects receive endovascular treatment.	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. ).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Rate of all cause mortality	Death for any reason will be recorded.	Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Zhejiang Zylox Medical Device Co., Ltd.
• Investigators: Principal Investigator: Xinwu Lu, Shanghai Ninth People's Hostpital, Shanghai JiaoTong University School of Medicine

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2022
• Primary Completion (ANTICIPATED): August 1, 2023
• Study Completion (ANTICIPATED): August 1, 2024

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: June 19, 2022
• First Posted (ACTUAL): June 24, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 24, 2022
• Last Update Submitted That Met QC Criteria: June 19, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Stent graft; Aortic Dissection; Thoracic aortic
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting
• Other Study ID Numbers: V1.1/2021-11-16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No