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:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT00706394
Eligibility Criteria:
Inclusion Criteria:
* 18 years old or older
* Informed consent understood and signed
* Will comply with protocol follow-up requirements
* Candidate for conventional open surgical repair
* Aneurysm outer diameter is one or more of the following:
* greater than or equal to 4.0cm
* greater than or equal to 3.0cm (saccular aneurysm)
* greater than or equal to twice the normal aortic outer diameter
* rapidly growing (greater than or equal to 5mm over 6 months)
* Proximal non-aneurysmal aortic neck fixation length greater than or equal to 1.5cm between the renal arteries and the aneurysm
* Non-aneurysmal proximal aortic neck inner diameter between 23 and 32mm
* Iliac artery internal diameter greater than or equal to 8 mm
Exclusion Criteria:
* Life expectancy \<2 years
* Participating in another clinical study
* Pregnant or lactating women
* Acutely ruptured/leaking aneurysm
* Traumatic vascular injury
* Other medical or psychiatric problems
* Contraindication to non-ionic contrast media or anticoagulants
* Coagulopathy or bleeding disorder
* Active systemic or localized groin infection
* Indispensable inferior mesenteric artery
* Connective tissue disease (e.g., Marfan's Syndrome)
* Creatinine level \>1.7 mg/dl
* Renal transplant patient
* Proximal attachment site \>60º angle to the aneurysm body
* Iliac arteries \>90º angle
* \<1.5 cm of non-aneurysmal common iliac artery above the iliac bifurcation on both sides \[One internal iliac artery is required to remain patent\]
* Thrombus \>30% at implantation site
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00706394
Study Brief:
Protocol Section:
NCT00706394