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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT02209194
Eligibility Criteria:
Inclusion Criteria:
* Patients must comply with the indications for use
* Unilateral or bilateral common iliac aneurysm diameter equal or greater 25mm
* Unsuitable distal sealing site within the common iliac artery for traditional EVAR
Exclusion Criteria:
* Patients with a stenotic internal iliac ostium of \< 4mm in diameter
* Patients with severe internal iliac atherosclerosis
* Patients that do not have a suitable landing area in the main stem of the IIA
* Patients with pseudoaneurysms
* Patients with symptomatic and ruptured iliac aneurysms
* Patients with one of the contraindications as indicated in the instructions for use
* Patients pretreated with a bifurcated vascular graft
* Patient with thrombocytopenia
* Patient with creatinine \>2.4 mg/dl immediately before the intervention
* Patient with malignancy needing chemotherapy or radiation
* Patients who are enrolled in another clinical study
* Patients with life expectancy of less than 36 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02209194
Study Brief:
Protocol Section:
NCT02209194