Subacute or chronic aortic arch dissection
Conditions
Interventions
Single Arm:Endovascular interventional treatment
Sponsors
Department of Cardiovascular Surgery, West China Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 to 80 years old; 2. The patient was diagnosed with subacute or chronic aortic arch dissection; 3. Patients showing a suitable vascular condition, including: Ascending aorta length > 50 mm (from the aortic sinusoid junction to the proximal cardiac margin of the innominate artery); Ascending aorta diameter >= 24 mm and = 30 mm; Innominate artery diameter = 7 mm, length >= 20 mm; Left common carotid artery or left subclavian artery diameter = 7 mm, length >= 20 mm; Suitable arterial access for endovascular interventional treatment ; 4. Patients able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the subject him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol; 5. Patients evaluated by at least two vascular surgeons or cardiac surgeons as high surgical risk patients or deemed to have significant surgical contraindications. (The recommended reference criteria are: EuroSCORE score >= 6, or ASA grade 3-4, or CFS score > 4, or there are other high-risk surgical factors that affect the prognosis of the subject, such as patients with a history of open surgery, other high-risk factors judged by a physician team, or patients who refuse open surgery.
Exclusion criteria
Exclusion criteria: 1. Patients that have experienced systemic infection during past three months; 2. Neck surgery was performed within three months; 3. Infectious aortic disease, Takayasus arteritis, Marfan syndrome (or other connective tissue diseases ); 4. Patients with severe stenosis, calcification, thrombosis or tortuosity of the Brachiocephalic trunk, Left common carotid artery or left subclavian artery; 5. Heart transplant patients; 6. Patients that have suffered MI or stroke during past three months; 7. Patients with Class IV heart function (NYHA classification) or LVEF 150 umol/l (or 3.0 mg/dl) and / or end-stage renal disease requiring renal dialysis shall be determined by the investigator after comprehensive analysis; 11. Subjects with severe liver dysfunction and ALT or AST exceeding 3 times the upper limit of normal; Subjects whose serum total bilirubin (STB) exceeds 2 times the upper limit of normal; 12. Patients with intestinal necrosis and lower limb ischemic necrosis; 13. Paraplegic patients; 14. Patients that are pregnant or breastfeeding; 15. Patients with allergies to contrast agents; 16. Patients with a life expectancy of less than 12 months; 17. Patients currently participating in other drug or device research; 18. Any other disease or abnormality that the investigators believe may hinder endovascular interventional treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality and major stroke within 12 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate postoperative technical success rate;Aortic remodeling results;Incidence of type I or III endoleak;Incidence of aortic stent displacement;Postoperative branch vessel patency rate;Incidence of surgical conversion of new aortic dissection to thoracotomy or secondary interventional;Major adverse events occurring within 30 days after surgery;Aortic dissection-related mortality within 12 months post operation;Incidence of severe adverse events;Incidence of device related adverse events; | — |
Countries
China
Contacts
Public ContactJia Hu
Department of Cardiovascular Surgery, West China Hospital
Outcome results
None listed