Zenith® Low Profile AAA Endovascular Graft

• Zenith Low Profile AAA Endovascular Graft and ancillary components (Device): Treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms having morphology suitable for endovascular repair

Primary outcomes

• Number of Patients Without Major Adverse Events Within 30 Days [30 days]: Major adverse events include all-cause death, Q-wave MI, renal failure requiring dialysis, paralysis, stroke, bowel ischemia, re-intubation
• Number of Patients With Device Success [12 months]: Device success will be measured with none of the following: type I or III endoleaks requiring re-intervention, graft limb occlusion, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Subject has at least one of the following

  * Aortic or aortoiliac aneurysm
  * Iliac aneurysm
  * Aneurysm with a history of growth

Exclusion Criteria:

* Less than 18 years of age
* Inability or refusal to give informed consent
* Disease considerations that would compromise patient safety or study outcomes
* Pregnant of breastfeeding or planning on becoming pregnant with 60 months
* Unwilling to comply with the follow-up schedule

Participant flow

Outcome results

• Number of Patients Without Major Adverse Events Within 30 Days (Primary), Count of participants, Participants: Endovascular Graft 62
• Number of Patients With Device Success (Primary), Count of participants, Participants: Endovascular Graft 57

Adverse events

Time frame: 5 years

Serious adverse events by term

10 more terms not shown.

Other adverse events by term

• Study Protocol and Statistical Analysis Plan: version 6 (PDF, 2013-11-06)
• Study Protocol and Statistical Analysis Plan: version 7 (PDF, 2014-04-15)