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 @ 7:33 PM
Ignite Modification Date:
2025-12-24 @ 7:33 PM
NCT ID:
NCT01911403
Eligibility Criteria:
Inclusion Criteria:
* Patient ≥ 18 years Interventional Radiology procedures with Femoral Artery puncture (4 French - 8 French Introducers)
* Patient available for follow-up at 2 weeks
* Patients who are willing to participate and have signed an Ethic Committee approved patient informed consent.
Exclusion Criteria:
* Access unsuitable for use of Angio-Sea
* Presence of calcification at the puncture site
* Presence of visible hematoma at the end of the procedure
* Patients who are unable to comply with the follow-up schedule based on their geographic location or for any reason.
* Patients who are pregnant.
* Patients currently participating in a clinical investigation that includes an active treatment arm.
* Contraindication for ambulation at 2 hours after the end of the procedure
* Patients with a life expectancy of less then 1 month.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01911403
Study Brief:
Protocol Section:
NCT01911403