← Back to all trials
Recruiting
NCT07464353
xDot Access Management System Early Feasibility Study
Conditions: Vascular Closure Devices
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: xDot Medical, Inc
Location: CentraCare Heart and Vascular Center Saint Cloud Minnesota
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.
Eligibility Criteria
Inclusion Criteria:
1. Age 18 to 80 years
2. Willing and able to provide written informed consent prior to initiation of study procedures
3. Willing and able to comply with the protocol-specified procedures and assessments
4. Investigator opinion suitable for xDot AMS for femoral closure (arterial or venous, as applicable)
5. Minimum vessel diameter of 5.5 mm and vessel depth ≥1.5 cm and ≤5.0 cm, \
Source: ClinicalTrials.gov (NCT07464353). StuddyBuddy aggregates publicly available trial information.