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

Clinical trial: Safety and Effectiveness Trial of the Ventana Fenestrated Stent Graft System

Summary: The purpose of this trial is to determine if the Ventana Fenestrated Stent Graft System is safe and effective for the endovascular repair of juxtarenal or pararenal aortic aneurysms.


Eligibility: Inclusion Criteria:
  -  Male or female at least 18 years old;
  -  Informed consent understood and signed and patient agrees to all follow-up visits;
  -  Have aortic aneurysm with maximum diameter ≥5.5cm, or between 4.5 and 5.5cm and rapidly expanding (>0.5cm in six months), or >50% larger than the normal aortic diameter
  -  Anatomically eligible for the Bifurcated System per the FDA-approved indications for use (IFU) and for the Fenestrated Stent Graft System:
  -  Adequate iliac/femoral access compatible with the required delivery systems
  -  Non-aneurysmal infrarenal aortic neck <15mm in length;
  -  Most caudal renal artery to aortoiliac bifurcation length ≥70mm
  -  SMA to aortoiliac bifurcation length ≥90mm;
  -  Proximal non-aneurysmal aortic neck below the SMA with: diameter 18 to 34 mm; length ≥15 mm; angle ≤60° to the aneurysm sac;
  -  Angle ≤60° (clock face) between the SMA and CA
  -  Renal arteries both distal to the SMA by ≤35mm, within 30mm of each other axially, with 4 to 8mm lumen diameter, and with clock face angle of 90° to 210° to each other .Common iliac artery distal fixation site with: distal fixation length ≥15 mm; ability to preserve at least one hypogastric artery; diameter ≥10 mm and ≤23 mm; angle ≤90° to the aortic bifurcation.
  -  The Endologix Fenestrated Proximal Extension Stent must have the ability to overlap the bifurcated stent graft by at least 3cm.
  -  Aortic diameter at the most caudal renal artery of 18 to 36mm
  Exclusion Criteria:
  -  Life expectancy <2 years as judged by the investigator;
  -  Psychiatric or other condition that may interfere with the study;
  -  Participating in the enrollment or 30-day follow-up phase of another clinical study;
  -  Known allergy to any device component;
  -  Coagulopathy or uncontrolled bleeding disorder;
  -  Contraindication to contrast media or anticoagulants;
  -  Ruptured, leaking, or mycotic aneurysm;
  -  Aortic dissection
  -  Serum creatinine (S-Cr) level >2.0 mg/dL;
  -  Traumatic vascular injury;
  -  Active systemic or localized groin infection;
  -  Connective tissue disease (e.g., Marfan's Syndrome);
  -  Recent (within prior three months) cerebrovascular accident or myocardial infarction;
  -  Prior renal transplant;
  -  Length of either renal artery to be stented <13mm;
  -  Significant occlusive disease of either renal artery (>70% stenosis);
  -  An essential accessory renal artery;
  -  Indispensable inferior mesenteric artery;
  -  Aneurysmal disease of the descending thoracic aorta;
  -  Clinically significant mural thrombus circumferentially in the suprarenal segment;
  -  Prior iliac artery stent implanted that may interfere with delivery system introduction;
  -  Unsuitable vascular anatomy;
  -  Pregnancy (female patient of childbearing potential only)
  -  Existing renal stent;
  -  Pre-planned need for concomitant procedure (e.g. surgical conduit for vascular access, hypogastric artery embolization/coil, renal artery angioplasty)

Relevance to patient case: not relevant