xDot Access Management System Pivotal Study (NCT07719244) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
xDot Access Management System Pivotal Study
266 participantsStarted 2026-09
Plain-language summary
The objective of this study is to establish reasonable assurance of safety and effectiveness for the xDot Access Management System (AMS) when used as indicated for femoral-arterial and femoral-venous closure. Additionally, this study will provide preliminary evidence on the impact on health outcomes for patients undergoing interventional catheterization procedures when the xDot AMS is used for vascular closure.
Who can participate
Age range
18 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 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:
. femoral artery, as determined by pre-procedural computed tomography angiography (CTA) and confirmed by ultrasound at the time of procedure (arterial vessel sizing can be assessed by ultrasound at index procedure if pre-procedure CTA is not SOC).
. femoral vein, as determined by ultrasound at the time of procedure.
. Candidate for elective or planned (i.e., not emergent or urgent) percutaneous transcatheter interventional procedure through:
Exclusion criteria
. If female, 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 for Femoral Arterial cohort
Timeframe: 30 days post-procedure
2
Time to hemostasis (TTH) for Femoral Arterial cohort
Timeframe: During procedure
3
Freedom from major complications of the target access site for Femoral Venous cohort
Timeframe: 30 days post-procedure
4
Time to hemostasis (TTH) for Femoral Venous cohort