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

Not Applicable

• Conditions: Aortic Dissection

• Registration Number: NCT05430672
• Lead Sponsor: Zhejiang Zylox Medical Device Co., Ltd.

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.

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-25
• Study Start: 2022-06
• Study First Submitted QC: 2022-06-19
• Last Update Submitted: 2022-06-19
• Study First Posted: 2022-06-24
• Last Update Posted: 2022-06-24
• Primary Completion: 2023-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Rate of no Major Adverse Event (MAE)	30 days	MAE was defined as aortic dissection related death, disabling stoke or paraplegic.
Success rate of endovascular treatment	Up to 12 months	* 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.

Secondary Outcome Measures

Name	Time	Method
Success rate of endovascular repair	30 days/ 6 months/ 12 months	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.
Rate of all cause mortality	Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years	Death for any reason will be recorded.
Rate of Adverse Events(AE)	Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years	The definition of AE(Adverse Event) refers to International Organization for Standardization (ISO) 14155, AE should be distinguished from normal postoperative stress response.
Rate of aortic dissection related mortality	Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years	Death caused by aortic dissection rupture or related treatment.
Rate of Serious Adverse Events(SAE)	Intraoperation/ 30 days/ 6 months/ 12 months/ up to 2-5 years	The definition of SAE (Serious Adverse Event) refers to ISO 14155.
Rate of technique success	Immediately after the intervention	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.
Incidence of stent displacement	30 days/ 6 months/ 12 months	Stent displacement was defined as the aortic and branch stent-grafts displacing by more than 10 mm from the post-implantation position.

Trial Locations

Locations (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; 🇨🇳 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

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