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

Clinical trial: Post-Approval Trial of the Talent™ Abdominal Stent Graft to Treat Aortic Aneurysms

Summary: The purpose of this study is to examine, through the endpoints established in this protocol, the long-term safety and effectiveness of the Talent Abdominal Stent Graft System, in a post-approval environment.

Detailed description: The Talent Abdominal Stent Graft System is a next-generation modular system for endovascular repair of Abdominal Aortic Aneurysm (AAA). The system was designed with the following enhancements: a suprarenal wire frame to provide migration resistance, and improved flexibility designed to treat difficult anatomies.
  Medtronic Vascular submitted a Pre-Market Application (PMA) to the Food and Drug Administration (FDA) on October 17, 2007, and received market approval for the Talent Abdominal Stent Graft System on April 15th, 2008. As a condition of approval, the FDA has requested a post-approval study. Medtronic has therefore designed a post-approval study, in collaboration with FDA, to document the performance of the Talent Abdominal Stent Graft System under market conditions.

Eligibility: Inclusion Criteria:
  -  Subject must have an abdominal aortic aneurysm, with or without iliac involvement.
  -  Iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories;
  -  A proximal aortic neck length of ≥ 10mm;
  -  Proximal aortic neck angulation ≤ 60°;
  -  Distal iliac artery fixation length of ≥ 15mm;
  -  An aortic neck diameter of 18-32mm and iliac artery diameters of 8-22mm; and
  -  Vessel morphology suitable for endovascular repair.
  Exclusion Criteria:
  -  Are less than 18 years of age
  -  Are pregnant or lactating
  -  Have a dominant patent inferior mesenteric artery and an occluded or stenotic celiac and/or superior mesenteric artery
  -  Have aneurysmal involvement or occlusion (surgically performed or naturally occurring) of the bilateral internal iliac arteries
  -  Have vessels and/or aneurysm dimensions that cannot accommodate the Talent Abdominal Stent Graft as per the indications in Section 3.
  -  Have no distal vascular bed (one vessel lower extremity run-off required)
  -  Have contraindications for use of contrast medium or anticoagulation drugs
  -  Have an uncorrectable coagulopathy
  -  Have an SVS/AAVS score greater than 2
  -  Have a mycotic aneurysm
  -  Have circumferential mural thrombus in the proximal aortic neck
  -  Have had a recent (within 3 months) myocardial infarction (MI), cerebral vascular accident (CVA), or major surgical intervention
  -  Have traumatic aortic injury
  -  Have leaking, pending rupture or ruptured aneurysms
  -  Have pseudoaneurysms resulting from previous graft placement
  -  Require a revision to previously placed endovascular stent grafts.
  -  Have genetic connective tissue disease (e.g., Marfan's or Ehlers-Danlos' Syndromes)
  -  Have concomitant thoracic aortic or thoracoabdominal aneurysms
  -  Are patients with active systemic infections
  -  Are patients who have a condition that threatens to infect the graft.
  -  Are patients with sensitivities or allergies to the device materials.
  -  Have access vessels (as determined by treating physician) that preclude safe insertion of the delivery system. NOTE: Iliac conduits may be used to ensure the safe insertion of the delivery system.

Relevance to patient case: not relevant