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

Zhejiang Zylox Medical Device

Status

Not yet enrolling

Conditions

Aortic Dissection

Treatments

Device: The Thoracic Aortic Stent Graft System (Zylox-Tonbridge Medical Technology Co., Ltd. )

Study type

Interventional

Funder types

Industry

Identifiers

NCT05430672

V1.1/2021-11-16

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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 .