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 @ 6:30 PM
Ignite Modification Date:
2025-12-24 @ 6:30 PM
NCT ID:
NCT02948257
Eligibility Criteria:
Inclusion Criteria:
* Acceptable candidate for post-procedural manual compression
* Able to ambulate at least 20 feet, with or without assistance
Exclusion Criteria:
* Active systemic or cutaneous infection or inflammation
* Ipsilateral femoral arteriotomy with any of the following conditions: a) access within \< or = 10 days; b) any residual hematoma, significant bruising, or known associated vascular complications; or c) within \< or = 90 days, use of an intra-vascular closure device (i.e., Angioseal)
* Previous vascular grafts or surgery at the target vessel access site
* Major amputation of ipsilateral lower extremity - previous history of, or planned within next 30 days prior to study exit
* Extreme morbid obesity (BMI greater than 4 kg/m2) or underweight (BMI less than 20 kg/m2)
* Femoral arterial diameter \< 6 mm at access site
* Antegrade arterial access site is a side stick and/or is not a single anterior wall femoral puncture
* Length of tissue tract, the distance between the anterior arterial wall and skin, is \< 2.5 cm.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02948257
Study Brief:
Protocol Section:
NCT02948257