xDot Access Management System Early Feasibility Study for Closure of Large Bore Femoral-Arterial & Venous-Access Sites
xDot Medical, Inc
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.
Description
The investigation is a prospective, multi-center, single-arm early feasibility study composed of two (2) distinct cohorts: femoral-arterial and femoral-venous. The purpose of this study is to demonstrate the safety and assess the effectiveness of the xDot AMS for closing the access sites of the femoral artery (femoral-arterial cohort) and femoral vein (femoral-venous cohort). This is a treatment-only early feasibility study (EFS) intended to capture and characterize outcomes, especially safety outcomes, with the xDot AMS.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
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, \<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. 6. Candidate for elective or…
Interventions
- DevicexDot Access Management System (AMS)
The xDot AMS is designed to deliver the xDot Implant Unit in the anterior wall of the target vessel to close the puncture site.
Locations (3)
- CentraCare Heart and Vascular CenterSaint Cloud, Minnesota
- Oklahoma Heart InstituteTulsa, Oklahoma
- North Central HeartSioux Falls, South Dakota