xDot Access Management System Early Feasibility Study (NCT07464353) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
xDot Access Management System Early Feasibility Study
30 participantsStarted 2026-04
Plain-language summary
The objective of this study is to demonstrate safety and investigate effectiveness of the xDot Access Management System (AMS) for closure of large bore femoral-arterial and femoral-venous access sites.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18 to 80 years
. Willing and able to provide written informed consent prior to initiation of study procedures
. Willing and able to comply with the protocol-specified procedures and assessments
. Investigator opinion suitable for xDot AMS for femoral closure (arterial or venous, as applicable)
. Minimum vessel diameter of 5.5 mm and vessel depth ≥1.5 cm and ≤5.0 cm, \<50% stenosis for the: a. femoral artery, as determined by computed tomography angiography (CTA) b. femoral vein, as determined by duplex ultrasound (DUS) or angiogram.
. Candidate for elective or planned (i.e., not emergent or urgent) percutaneous transcatheter interventional procedure through:
. The common femoral artery using 8F to 22F devices or sheaths (max 26F OD; e.g., TAVR, EVAR)
. The common femoral vein using 8F to 26F devices or sheaths (max 30F OD; e.g., transcatheter mitral/tricuspid valve repair/replacement and LAA occlusion)
Exclusion criteria
. Individuals who are pregnant, planning to become pregnant, or lactating
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Freedom from major complications of the target access site