Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-24 @ 10:57 PM
NCT ID:
NCT00615069
Eligibility Criteria:
Inclusion Criteria:
* Infrarenal AAA \> or equal to 4.5 cm in diameter
* Proximal infrarenal aortic neck length \> or equal 15mm
* Anatomy meets 31mm EXCLUDER specification criteria
* Access vessel able to receive 20 Fr. introducer sheath
* Life expectancy \>2 years
* Surgical candidate
* ASA Class I, II, III, or IV
* NYHA Class I, II, III
* 21 years of age or older
* Male or infertile female
* Ability to comply with protocol requirements including follow-up
* Signed Informed Consent Form
Exclusion Criteria:
* Mycotic or ruptured aneurysm
* Participating in another investigational device or drug study within 1 year
* Documented history of drug abuse within 6 months
* Coexisting thoracic aortic aneurysm (50% larger than proximal aorta)
* Myocardial infarction or cerebral vascular accident within 6 weeks
* Pulmonary insufficiency requiring chronic home oxygen therapy or inability to ambulate due to pulmonary function
* Renal insufficiency (Creatinine \> 2.5 mg/dL) without dialysis
* Iliac anatomy that would require occlusion of both internal iliac arteries
* "Planned" occlusion or reimplantation of significant mesenteric or renal arteries
* "Planned" concomitant surgical procedure or previous major surgery within 30 days
* Previous prosthesis placement in the same position of the aorta or iliac arteries
* Degenerative connective tissue disease, e.g., Marfans and Ehlers Danlos Syndrome
* Proximal neck angulation \> 60 degrees
* Presence of significant thrombus at arterial implantation sites
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT00615069
Study Brief:
Protocol Section:
NCT00615069