xDot Access Management System Pivotal Study

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.

NCT Number	NCT07719244
Lead Sponsor	xDot Medical, Inc Collaborators: Bright Research, Inc.
Conditions	Vascular Closure Devices
Enrollment	266 participants
Start Date	2026-09
Primary Completion	2027-09 (estimated)
Study Completion	2027-09 (estimated)
Updated on ClinicalTrials.gov	2026-07-22