xDot Access Management System Early Feasibility Study

Part of paid clinical trials in Saint Cloud, Minnesota.

Sponsor
xDot Medical, Inc
Study ID
NCT07464353
Status
Recruiting
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Conditions

  • Vascular Closure Devices

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • xDot Access Management System (AMS) — DEVICE
    The xDot AMS is designed to deliver the xDot Implant Unit in the anterior wall of the target vessel to close the puncture site.

Study Details

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.

Key Dates

Start date
Jun 16, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: xDot Access Management System

Primary Outcome Measure

Freedom from major complications of the target access site [ Time Frame: 30 days post-procedure ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
CentraCare Heart and Vascular CenterSaint CloudMinnesota56303
Thom Dahle, MD (PRINCIPAL_INVESTIGATOR)
Oklahoma Heart InstituteTulsaOklahoma74104
Kamran Muhammad, MD (PRINCIPAL_INVESTIGATOR)
North Central HeartSioux FallsSouth Dakota57108
J. Michael Bacharach, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Saint Cloud, MN

By research site
CentraCare Heart and Vascular Center· Saint Cloud, MNOklahoma Heart Institute· Tulsa, OKNorth Central Heart· Sioux Falls, SD