Aortic Disease
Conditions
Interventions
A:in-situ fenestration using the original sheath alignment technique-the JD method in the TEVAR treatment of Stanford type B aortic lesions involving left subclavian artery
Sponsors
Renji Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Only those who meet all the following criteria can be selected: 1. The patient's age is >= 18 years old, male or non pregnant female; 2. Diagnosis of aortic syndrome (including aortic ulcer, aortic intramural hematoma, aortic dissection), or chronic aortic dissection, or traumatic aortic rupture, or aortic aneurysm; 3. The patients with Stanford type B aortic disease who need TEVAR and whose planned landing zone needs to cover the left subclavian artery blood supply completely (the planned landing zone is located in zone 2 of aorta); 4. The proximal part of the lesion involved the proximal aorta within 1.5cm from the posterior edge of the LSA opening, but did not involve the left common carotid artery (LCCA); 5. There are suitable femoral, iliac and brachial artery approaches for endovascular treatment; 6. The patient can understand the purpose of the study and voluntarily participate in the study, and the informed consent form is signed by the subject or his / her legal representative; 7. The patients are willing to carry out follow-up evaluation according to the requirements of the study protocol.
Exclusion criteria
Exclusion criteria: If ANY of the following criteria is met, it will not be selected: 1. The lesions involved the aorta (zone 0 and zone 1) near the opening of LCCA; 2. The patient is definitely a connective tissue disease (such as Marfan syndrome); 3. The subjects had a history of endovascular repair of thoracic aorta; 4. The patient has a clear history of allergy to stent related materials; 5. Patients who have or may have severe allergic reactions to contrast media (anaphylactic shock, exfoliative dermatitis, etc.); 6. Patients with contraindications to antiplatelet and anticoagulant drugs; 7. The patient's compliance is poor, and it is expected that they can not be followed up on time; 8. The life expectancy of patients is less than 12 months (such as advanced cancer); 9. Acute systemic infection; 10. The patients who are not suitable for endovascular treatment according to the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment success rate of 12 months;Immune rate of major adverse event (MAE) within 30 days after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of type I or type III endoleakage;Incidence of aortic stent graft migration;Patency rate of fenestration branches after operation;Success rate of aortic remodeling;rate of conversion to open surgery or secondary intervention due to aortic and left subclavian artery injury;Incidence of poor blood supply in left upper limb;All cause mortality;Aortic disease related mortality;Incidence of serious adverse events;Incidence of device related adverse events;Incidence of left upper limb ischemia; | — |
Countries
China
Contacts
Public ContactLiu Jidong
Renji Hospital, Shanghai Jiaotong University School of Medicine
Outcome results
None listed