Aortic Dissection
Conditions
Interventions
Intervention group:Device: ZIPPER TM Aotic Arch Stent-graft System
Total endovascular arch repair using ZIPPER TM Aotic Arch Stent-graft System for Aortic Dissections?
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) Patients diagnosed with aortic dissections requiring intervention, including non-A-non-B aortic dissection, or residual dissection after type A ascending aortic repair;. (3) Patients with suitable vascular conditions, including: a. Ascending aorta (including surgical graft) length greater than 30 mm (from the aortic sinusoid junction to the proximal cardiac margin of the innominate artery). b. Proximal anchoring zone diameter = 24 mm and = 47 mm; c. Proximal anchoring zone length = 20 mm; d. Innominate artery, left common carotid artery and left subclavian artery diameter = 24 mm and = 7 mm, length = 20 mm; e. 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) Evaluated by at least two investigators that the subjects are high-risk patients with more complications, poor general condition, high risk of deep hypothermic circulatory arrest, and not suitable for total arch replacement and other surgical procedures.
Exclusion criteria
Exclusion criteria: (1) Previously received open surgery or endovascular intervention for descending aorta or abdominal aorta; (2) Infectious aortic disease, takayasu arteritis, Marfan syndrome (or other connective tissue diseases ); (3) Patients that have experienced systemic infection within past three months; (4) Neck surgery was performed within past three months; (5) Patients with severe stenosis, calcification, thrombosis or tortuosity in the brachiocephalic trunk, left common carotid artery or left subclavian artery; (6) Patients with intestinal necrosis and lower limb ischemic necrosis; (7) Paraplegic patients; (8) Heart transplant patients; (9) Patients that have suffered MI or stroke within past three months; (10) 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 dialysis, shall be determined by the investigator after a comprehensive analysis; (14) Patients with severe liver dysfunction: ALT or AST exceeding 3 times the upper limit of norma, serum total bilirubin (STB) exceeds 2 times the upper limit of normal; (15) Patients who are allergic to contrast agents; (16) Patients that are pregnant or breastfeeding; (17) Patients with severe comorbidities who cannot tolerate anesthesia and surgery; (18) Patients with a life expectancy of less than 12 months; (19) Patients currently participating in other drug or device study; (20) The investigator assessed that the patient was ineligible for the study for other diseases or abnormalities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from major device/procedure-related adverse events within 30 days post-operation ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate postoperative technical success;Incidence of Type I or Type III endoleaks;Incidence of aortic arch stent graft migration;Postoperative branch vessel patency rate;Results of aortic remodeling after aortic dissection surgery;Incidence of surgically induced de novo aortic dissection converted to open-heart surgery or secondary intervention;Aortic-related mortality at 12 months post operation;All-cause mortality and major stroke within 12 months post-procedure;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