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 @ 3:17 AM
Ignite Modification Date:
2025-12-25 @ 3:17 AM
NCT ID:
NCT02345005
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or older
* Provided written informed consent for data release
* Elective procedure; Indication for aorto-iliac endovascular stent graft repair, as determined by the treating physician
Exclusion Criteria:
* Patient is participating in another clinical study (RCT; interfering with endpoints)
* Patient's life expectancy \<2 years as judged by the investigator
* Patient has a psychiatric or other condition that may interfere with the study
* Patient has a known allergy to any device component (ePTFE, FEP, nitinol)
* Patients with a systemic infection who may be at increased risk of endovascular graft infection
* Patient has a coagulopathy or uncontrolled bleeding disorder
* Patient has a ruptured, leaking, or mycotic aneurysm
* Patient had a CVA or an MI within the prior three months
* Patient is pregnant (Female patients of childbearing potential only)
* Other stents placed in CIA or hypogastric arteries than the Gore® EXCLUDER® iliac branch Endoprosthesis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02345005
Study Brief:
Protocol Section:
NCT02345005