A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms
Condition: Abdominal Aortic Aneurysm
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
Intervention: TriVascular Stent-Graft System
Intervention description: TriVascular Stent-Graft System
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Abdominal Aortic Aneurysm; AAA; TriVascular Stent-Graft System; Stent-Graft

Summary:

      This study was a prospective observational study examined the safety of the TriVascular AAA
      Stent-Graft System in the elective treatment of patients with abdominal aortic aneurysms.
      Specifically, the study will evaluate the safety of the TriVascualr AAA Stent-Graft System,
      evaluate the ability to deliver the Tri-Vascular AAA Stent-Graft System to the desired
      location within the aorta, and evaluate the ability of the TriVascular AAA Stent-Graft to
      exclude the abdominal aortic aneurysm.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or infertile female

          -  Have signed an informed consent form.

          -  Are considered an appropriate candidate for open surgical repair of an abdominal
             aortic aneurysm.

          -  at least one of the following: Abdominal aortic aneurysm >= 4.5 cm in diameter;
             aneurysm has increased in size by 0.5cm in last 6 months; maximum diameter of aneurysm
             exceeds 1.5 times the transverse dimension of an adjacent normal aortic segment;
             saccular aneurysm larger than 3 cm.

          -  Have patent iliac or femoral arteries that allow endovascular access to the aneurysmal
             site with a 17F Delivery Catheter.

        Exclusion Criteria:

          -  A dissecting, acutely ruptured, or leaking aneurysm, or an acute vascular injury due
             to trauma.

          -  A need for emergent surgery.

          -  contraindication to undergoing angiography.

          -  A Thoracic aortic aneurysm that requires treatment.

          -  Presence of thrombus or atheroma in proximal aortic neck covering > 50% of the
             endoluminal surface.

          -  Presence of diffuse atherosclerotic disease in either common iliac artery that reduces
             the iliac artery diameter to <7mm.

          -  Congenital abnormalities in which the placement of the stent-graft will cause
             occlusion of major arterial flow. Such abnormalities should be evaluated(e.g.
             angiography or CT) prior to treatment.

          -  Unstable angina

          -  Morbid obesity or other clinical conditions that severely inhibit x-ray visualization
             of the aorta.

          -  Connective tissue disease (e.g., Marfan's or Ehlers-Danlos syndrome.)

          -  Hypercoagulable state.

          -  Contraindication for anticoagulation.

          -  Acute renal failure.

          -  Active systemic infection.

          -  less than 18 years of age.

          -  Life expectancy less than 1 year.

          -  Current, or anticipated participation within 1 year, in another research study
             involving an investigational device or new drug (with the exception of participation
             in the Lifeline Registry of Endovascular Therapy).

          -  Other medical, social, or psychological issues that in the opinion of the investigator
             preclude them from receiving this treatment, and the procedures and evaluations pre-
             and post-treatment.