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 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
NCT ID:
NCT04765566
Eligibility Criteria:
Inclusion Criteria:
* The FLUENCY® PLUS Vascular Stent Graft implantation procedure was for the purpose of lesions in the iliac arteries.
* The FLUENCY® PLUS Vascular Stent Graft was placed between January 2010 and March 2020.
* Male or female ≥ 18 years old at the time of implantation.
* The subject provides written informed consent. The subject may be enrolled without informed consent for anonymous data collection if the responsible Ethics Committee has waived the requirement due to the retrospective study design, and written documentation about this decision is provided to the Investigator and the Sponsor.
Exclusion Criteria:
* The FLUENCY® PLUS Vascular Stent Graft was implanted in an anatomic location other than iliac arteries.
* Absence of a target lesion (i.e. diseased or damaged artery) in the area covered by the FLUENCY® PLUS Vascular Stent Graft.
* Subjects without any existing follow-up information after hospital discharge (This criterion does not apply to subjects who deceased during implantation/prior to discharge).
* The subject was identified with a medical condition, which, in the opinion of the Investigator, may cause him/her to be noncompliant with the protocol, or confound the data interpretation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04765566
Study Brief:
Protocol Section:
NCT04765566