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 @ 2:46 PM
Ignite Modification Date:
2025-12-24 @ 2:46 PM
NCT ID:
NCT00507559
Eligibility Criteria:
Inclusion Criteria:
* Infrarenal AAA with a maximum diameter ≥ 4.5 cm.
* Infrarenal AAA with at least 12 mm length of non-aneurysmal proximal neck.
* Infrarenal AAA with a proximal neck internal diameter between 19-29 mm.
* Infrarenal AAA with an internal diameter at the aortic bifurcation ≥ 18 mm.
* Infrarenal AAA with an angle of ≤ 60° relative to the long axis of the aneurysm.
* Bilateral iliac artery distal fixation sites ≥ 10 mm in length.
* Bilateral iliac arteries with an internal diameter between 9 and 20 mm.
* Bilateral femoral/iliac arteries with morphology compatible with standard vascular access techniques and vessel size must accommodate a 16F (5.3 mm) or 18F (6.0 mm) delivery system.
Exclusion Criteria:
* Myocardial infarction within past 10 weeks.
* Active systemic infection.
* Ruptured or leaking AAA.
* Mycotic or inflammatory AAA.
* Genetic connective tissue disorders (e.g., Marfans or Ehlers-Danlos Syndromes).
* Concomitant TAA or thoracoabdominal aortic aneurysms.
* Requires emergent AAA surgery.
* Previous AAA repair.
* Patients with a body habitus that would prevent imaging required by the study.
* Patient has significant comorbid conditions that pose undue risk of general anesthesia or endovascular surgery.
* Patient requires additional planned major procedure at the time of AAA repair or within 30 days before or after AAA repair.
* Dialysis dependent renal failure or creatinine \> 2.5 mg/dL.
* Allergy to or intolerance of radiopaque contrast agents.
* Patients with a known sensitivity or allergy to implant materials.
* Patients who cannot discontinue oral anticoagulation or antiplatelet therapy at the time of the study procedure.
* Patients with history of bleeding diathesis or hypercoagulable condition.
* Patients with thrombus, calcification, and/or plaque ≥ 2mm in thickness and/or ≥ 50% (180°) continuous coverage of the vessel circumference in the intended seal zone.
* Patients with irregular shaped calcification and/or plaque that may compromise the fixation and sealing at the proximal or distal implantation sites.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT00507559
Study Brief:
Protocol Section:
NCT00507559