aortic arch pathologies
Conditions
Interventions
Interventional group:Treat the patients with aortic arch pathologies using aortic arch covered stentgraft manufactured by Shanghai MicroPort Endovascular MedTech(Group)Co., Ltd.
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Age 18 to 85; Aortic arch lesions diagnosed as requiring endovascular treatment, including aortic arch aneurysm, aortic arch pseudoaneurysm, Standford type B dissection involving the aortic arch, and aortic ulcer; Subjects judged by the experimenter to be suitable for endovascular treatment; Subjects who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to follow up. Anatomical conditions: the length of the ascending aorta is = 80mm; the diameter of the ascending aorta is =24mm and =40mm; the length of the proximal anchoring zone is = 30mm; the diameter of the innominate artery is =17mm and =9mm, the height of the ostium of the right common carotid artery is =20mm; the diameter of the left common carotid artery or the left subclavian artery is =11mm and =6mm, the length of the left common carotid artery is =20mm, and the height of the ostium of the left vertebral artery is =20mm.
Exclusion criteria
Exclusion criteria: Women who are pregnant or breastfeeding; The patient was clearly diagnosed with aorta-related connective tissue disease (such as Marfan syndrome, etc.); The patient has a clear history of allergies to nickel-titanium alloy materials, contrast media, etc.; Severe liver function abnormalities (alanine aminotransferase or aspartate aminotransferase 2.5 times higher than the upper limit of normal); Hematological abnormalities: leukopenia (WBC<3×10^9/L), acute anemia (Hb<90g/L), thrombocytopenia (PLT<50×10^9/L), history of severe bleeding or coagulation disorder; History of heart transplant; Myocardial infarction or stroke in the past month; Cardiac function class IV (NYHA classification); Uncontrolled infection, such as bacteremia or toxemia; Malignant tumors patients with life expectancy less than 12 months; The subject is participating in other clinical trials of drugs or medical devices and has not yet completed the primary endpoint of the trial; Patients who have poor compliance and are not expected to be followed up on time; Other situations judged by the experimenter to be inappropriate for endovascular treatment, such as severe stenosis, calcification, and thrombosis of the innominate artery, carotid artery, or subclavian artery, lack of suitable vascular access, or the subject's inability to cooperate, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of 30-day major adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Instant technical success rate;Instant surgical success rate;12-month clinical success rate;All-cause mortality;Aortic-related mortality;Incidence of neurological complication;Patency of supra-arch branches;Incidence of secondary intervention;Incidence of endoleak;Aortic aneurysm or dissection diameter and diameter changes;Incidence of major adverse event; | — |
Countries
China
Contacts
Public ContactLu Qingsheng
Department of Vascular Surgery, Shanghai Changhai Hospital
Outcome results
None listed