First In Human Study for Small to Medium-sized Abdominal Aortic Aneurysm (AAA) (AAA)

This is an interventional treatment trial for Abdominal Aortic Aneurysm focused on measuring Abdominal Aorta, Aneurysm Read More

Inclusion Criteria:

• Male or Female aged 18 years or older
• Subject can understand the purpose of the trial, voluntarily participate in the trial and sign the informed consent and is willing to complete the follow-up according to the requirements of the protocol.
• Infrarenal non-aneurysmal neck ≥15mm in length
• Aortic neck diameters ≤ 28mm
• Infrarenal neck angulation ≤ 60°
• Abdominal aneurysm from 3.5 cm to 5.0 cm.
• Overall AAA treatment length (distal renal to distal inferior margin of the aneurysm) not to exceed 10 cm
• Patient iliac or femoral arteries access vessels' size and morphology allow endovascular access of 14F introducer sheaths and catheters.
• Subject has > one-year life expectancy.
• Subject is American Society of Anesthesiology (ASA) grade 1 through 3, inclusive.
• Subject is able and willing to comply with 1, 3, 6, 12, 24 and 36-month follow-up.

Exclusion Criteria:

• Subject has an acutely ruptured or leaking or emergent aneurysm.
• Subject has a dissecting aneurysm.
• Subject has a mycotic or infected aneurysm.
• Subject has current vascular injury due to trauma.
• Subject's aneurysm is thoracic or suprarenal.
• Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm.
• Subject has thrombus, calcification, and/or plaque that may compromise delivery.
• Subject has had a myocardial infarction within six (6) months prior to enrollment.
• Subject has current angina or other active cardiac condition such as congestive heart failure, untreated or worsening atrial arrhythmia, ventricular arrhythmia, or valvular disease.
• Subject has undergone other major surgery within the 30 days prior to enrollment.
• Subjects with any transient ischemic attack (TIA) or ischemic stroke within 3 months.
• Known allergy to polyester or contrast material that cannot be pretreated.
• Subject is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta.
• Subject has connective tissue disease (e.g., Marfan syndrome, Eaton syndrome, or Bessel's disease).
• Known contraindication to undergoing angiography or anticoagulation.
• Subject has active systemic infection.
• Subject is participating in another research study.
• Subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment and the procedures and evaluations pre- and post-treatment.
• Women of childbearing potential who are pregnant, lactating, or planning to become pregnant during the course of the trial.
• Subject has dialysis dependent renal failure or baseline serum creatinine level >2.0mg/dl.
• Subjects with liver dysfunction: alanine transaminase (ALT) or aspartate transaminase (AST) is five times higher than the normal upper limit; serum total bilirubin (STB) is two times higher than the normal upper limit.
• Subjects who are not suitable for endovascular treatment, as judged by the investigator.