Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

Clinical trial: EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study

Summary: Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System.

Detailed description: This study will evaluate the safety and effectiveness of the Nellix System among a wide range of physicians and in consecutively enrolled subjects to assess safety and effectiveness outcomes. Following appropriate government and ethics committee/IRB approval the Nellix® EndoVascular Sealing System will be implanted into eligible patients who are adequately informed and have consented to join the study. Enrolled patients will undergo a high resolution, contrast-enhanced computed tomography angiography (CT) scan of the relevant aortic and aortoiliac vasculature within three months of the scheduled procedure and at specified follow-up intervals post-implantation. Follow-up visits will occur at 30 days, 6 months, and annually to 5 years to assess aneurysm morphology, the status of the implanted devices, and relevant laboratory test results.

Eligibility: INCLUSION CRITERIA
  A patient who meets all of the following criteria potentially may be included in the study:
  1. Male or female at least 18 years old;
  2. Informed consent form understood and signed
  3. Patient agrees to all follow-up visits;
  4. Abdominal aortic aneurysm with sac diameter ≥5.0cm, or ≥4.5cm which has increased by ≥0.5cm within the last 6 months, or or which exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment. No AAA <4 cm will be included.
  5. Anatomically eligible for the Nellix System (per Instructions For Use):
  1. Adequate iliac/femoral access compatible with the required delivery systems (diameter ≥6 mm);
  2. Aneurysm blood lumen diameter ≤60mm;
  3. Proximal non-aneurysmal aortic neck: length ≥10mm; diameter 18 to 28mm; angle ≤60° to the aneurysm sac;
  4. Most caudal renal artery to each hypogastric artery length ≥100mm;
  5. Common iliac artery lumen diameter between 9 and 35mm;
  6. Distal iliac artery seal zone with length of ≥10mm and diameter range of 9 to 25mm;
  7. Ability to preserve at least one hypogastric artery.
  8. Ratio of maximum aortic aneurysm diameter to maximum aortic blood lumen diameter <1.40
  EXCLUSION CRITERIA
  A patient who meets none of the following criteria potentially may be included in the study:
  1. Life expectancy <2 years as judged by the Investigator;
  2. Psychiatric or other condition that may interfere with the study;
  3. Participating in another clinical study;
  4. Known allergy or contraindication to any device material;
  5. Coagulopathy or uncontrolled bleeding disorder;
  6. Ruptured, leaking or mycotic aneurysm;
  7. Serum creatinine (S-Cr) level >2.0 mg/dL;
  8. CVA or MI within three months of enrollment/treatment;
  9. Aneurysmal disease of the descending thoracic aorta;
  10. Clinically significant mural thrombus within the proximal landing zone (minimum 10mm) of the infrarenal non-aneurysmal neck (>5mm thickness over >50% circumference);
  11. Connective tissue diseases (e.g., Marfan Syndrome);
  12. Unsuitable vascular anatomy that may interfere with device introduction or deployment;
  13. Pregnant (female of childbearing potential only).

Relevance to patient case: not relevant