Overview
To explore the effect and prognosis of endovascular interventional therapy in high-risk patients with aortic arch dissection and aneurysm
Description
The WeFlow-Tribranch Aortic Arch Stent Graft System first in man study is a prospective, multi-center, single arm trial, which will enroll a total of 20 patients. The goal of this study is to evaluate the safety and efficacy of WeFlow-Tribranch Aortic Arch Stent Graft System in the treatment of patients with aortic arch dissection and aneurysm.
Eligibility
Inclusion Criteria:
- Patients aged 18 to 80 years old.
- The patient was diagnosed with subacute or chronic aortic arch dissection, or Aortic arch aneurysms.
- Patients showing a suitable vascular condition, including:
- Ascending aorta length greater than 50 mm (from the aortic sinusoid junction to the proximal cardiac margin of the innominate artery).
- Ascending aorta diameter ≥ 24 mm and ≤ 48 mm;
- Proximal anchoring zone length ≥ 30 mm;
- Innominate artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm;
- Left common carotid artery or left subclavian artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm;
- Suitable arterial access for endovascular interventional treatment ;
- 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.
- 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 CFS score > 4, or ASA grade 3-4, 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:
- Patients that have experienced systemic infection during past three months;
- Neck surgery was performed within three months;
- Infectious aortic disease、Takayasu arteritis,Marfan syndrome (or other connective tissue diseases );
- Patients with severe stenosis, calcification, thrombosis or tortuosity of the Brachiocephalic trunk, Left common carotid artery or left subclavian artery;
- Heart transplant patients;
- Patients that have suffered MI or stroke during past three months;
- Patients with Class IV heart function (NYHA classification) or LVEF<30%
- Active peptic ulcers or upper gastrointestinal bleeding occurring within the previous three months;
- Hematological abnormality, defined as follows: Leukopenia (WBC < 3 × 109/L), acute anemia (Hb < 90 g/L); thrombocytopenia (PLT count < 50 × 109/L);
- Patients with renal insufficiency, serum creatinine > 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;
- 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;
- Patients with intestinal necrosis and lower limb ischemic necrosis;
- Paraplegic patients;
- Patients that are pregnant or breastfeeding;
- Patients with allergies to contrast agents;
- Patients with a life expectancy of less than 12 months;
- Patients currently participating in other drug or device research;
- Any other disease or abnormality that the investigators believe may hinder endovascular interventional treatment.