Not Yet RecruitingNot Applicable

xDot Access Management System Early Feasibility Study

30 participantsStarted 2026-04

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Age 18 to 80 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: a. femoral artery, as determined by computed tomography angiography (CTA) b. femoral vein, as determined by duplex ultrasound (DUS) or angiogram.
✓. Candidate for elective or planned (i.e., not emergent or urgent) percutaneous transcatheter interventional procedure through:
✓. The common femoral artery using 8F to 22F devices or sheaths (max 26F OD; e.g., TAVR, EVAR)
✓. The common femoral vein using 8F to 26F devices or sheaths (max 30F OD; e.g., transcatheter mitral/tricuspid valve repair/replacement and LAA occlusion)

Exclusion criteria

✕. Individuals who are pregnant, planning to become pregnant, or lactating
✕. Immunocompromised or with pre-existing autoimmune disease
✕. Active systemic infection or a local infection at or near the access site
✕. Known or suspected COVID-19 infection
✕. Significant anemia (hemoglobin \<10 g/dL, hematocrit \<30%)
✕. Morbidly obese or cachectic (Body mass index \[BMI\] \>40 kg/m2 or \<20 kg/m2)
✕. Severe co-existing co-morbidities which, in the opinion of the investigator, would clinically confound the study primary endpoints
✕. Known bleeding disorder including thrombocytopenia (platelet count \<100,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease

What they're measuring

Freedom from major complications of the target access site

Timeframe: 30 days post-procedure

Time to hemostasis (TTH)

Timeframe: During procedure

Trial details

NCT IDNCT07464353

SponsorxDot Medical, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08

Contact for this trial

Virginia Kirby

612-720-6255 ginny.kirby@xdotmedical.com

View on ClinicalTrials.gov More Vascular Closure Devices trials