Status:
UNKNOWN
Safety and Efficacy Study Of The Thoracic Aortic Stent Graft System Treating Aortic Dissection
Lead Sponsor:
Zhejiang Zylox Medical Device Co., Ltd.
Conditions:
Aortic Dissection
Eligibility:
All Genders
18-80 years
Phase:
NA
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 a...
Eligibility Criteria
Inclusion
- 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
- 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 .
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05430672
Start Date
June 1 2022
End Date
August 1 2024
Last Update
June 24 2022
Active Locations (14)
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1
The First Affiliated Hospital of Bengbu medical College
Bengbu, Anhui, China
2
The Second Hospital Of Anhui Medical University
Hefei, Anhui, China
3
Liuzhou Worker's Hospital
Liuchow, Guangxi, China
4
Huaihe Hospital of Henan University
Kaifeng, Henan, China