Aortic arch lesions
Conditions
Interventions
Test group:Multi-Branch Thoracic stent graft system
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patient age 18-80 years old; 2. Diagnosed with aortic arch lesions requiring treatment, including true aortic arch aneurysm, pseudoaortic arch aneurysm, and ulcers involving the aortic arch; 3. Subjects who are judged by the investigator to be suitable for endocavitary therapy; 4. Subjects who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to follow up; 5. Anatomical conditions: Ascending aorta length >=50mm; Ascending aorta diameter >=26mm and =20mm; The diameter of the innominate artery is =9mm, and the length of the innotable artery is >=20mm. The diameter of the left common carotid artery and left subclavian artery is =5mm, the length of the left common carotid artery is >=20mm, and the length of the left vertebral artery opening from the left subclavian artery at the aortic opening is >=20mm; 6. Patients assessed by the investigator as high-risk of surgery or judged to have significant contraindications to surgery.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or breastfeeding; 2. The patient has been diagnosed with a connective tissue disease related to the aorta (such as Marfan syndrome); 3. Infective aortic disease, takayasu arteritis; 4. Patients who have undergone endovascular treatment of the ascending aorta or aortic arch; 5. The patient has a clear history of allergy to nickel-titanium alloy materials, contrast agents, etc; 6. Severe renal failure (creatinine level more than twice the upper limit of normal, except for dialysis patients); 7. Hematological abnormalities: leukopenia (WBC < 3×10^9/L), anemia (Hb < 70g/L); coagulation dysfunction: thrombocytopenia (PLT count < 50×10^9/L); 8. Patients who have undergone heart transplantation; 9. Suffered from myocardial infarction or stroke in the past 3 months; 10. Cardiac function class IV (NYHA classification); 11. Active infection, such as bacteremia or toxemia; 12. Patients with an expected lifespan of less than 12 months; 13. Patients who have undergone mechanical valve replacement of the aortic valve, which affects the safe introduction of the trial device; 14. The subject is participating in other drug or medical device clinical trials and has not yet completed the primary endpoint of that trial; 15. Patients with poor compliance and expected inability to undergo follow-up on time; 16. Other situations where the researcher deems it inappropriate to perform intracavitary treatment, such as severe vascular stenosis, calcification, tortuosity, thrombosis, or the subject's inability to cooperate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30-day major adverse event (MAE) rate;Treatment success rate through 12 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate technical success rate;all-cause mortality;Mortality related to aortic lesions;incidence of paraplegia;incidence of stroke;Incidence of secondary intervention;Branch stent patency rate;incidence of endoleak;Incidence of stent fracture/twisting/collapse;Incidence of stent migration;Maximum diameter and diameter change of aortic lesions; | — |
Countries
China
Contacts
Public ContactLu Qingsheng
Shanghai Changhai Hospital
Outcome results
None listed