Can a tiny implant seal large artery holes faster and safer?
NCT ID NCT07719244
First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time
Summary
This study tests a new device called the xDot Access Management System, designed to close large puncture sites in the femoral artery and vein after catheter-based procedures. The device delivers a small implant around the access site to stop bleeding. Researchers are measuring how quickly bleeding stops and whether major complications occur, aiming to see if the device is safe and effective for routine use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a device called the xDot Access Management System (AMS) that delivers an implant to close the puncture site in the femoral artery or vein
- What this could lead to
- If successful, this device could provide a faster, safer way to close large puncture sites after catheter procedures, reducing complications and recovery time.
- What could go wrong
- This is a pivotal study, but the device is still investigational. It may not work as intended or could cause complications like bleeding or infection at the access site.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 266 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 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: 1. femoral artery, as determined by pre-procedural computed tomography angiography (CTA) and confirmed by ultrasound at the time of procedure (arterial vessel sizing can be assessed by ultrasound at index procedure if pre-procedure CTA is not SOC). 2. femoral vein, as determined by ultrasound at the time of procedure. 6. Candidate for elective or planned (i.e., not emergent or urgent) percutaneous transcatheter interventional procedure through: 1. The common femoral artery using 8F to 22F devices or sheaths (max 26F OD; including, but not limited to TAVR and EVAR) 2. The common femoral vein using 8F to 26F devices or sheaths (max 30F OD; including, but not limited to transcatheter mitral/tricuspid valve repair/replacement and LAA occlusion) Exclusion Criteria: 1. If female, individuals who are pregnant, planning to become pregnant, or lactating 2. Immunocompromised or with pre-existing autoimmune disease 3. Active systemic infection or a local infection at or near the access site 4. Known or suspected COVID-19 infection 5. Significant anemia (hemoglobin \<10 g/dL, hematocrit \<30%) 6. Morbidly obese or cachectic (Body mass index \[BMI\] \>40 kg/m\^2 or \<20 kg/m\^2) 7. Severe co-existing co-morbidities which, in the opinion of the investigator, would clinically confound the study primary endpoints 8. Known bleeding disorder including thrombocytopenia (platelet count \<100,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease 9. Allergy to any device material, including polypropylene, NiTinol, or Titanium 10. Common femoral artery or vein with calcium, as determined by baseline CTA or angiogram, which, in the clinical judgment of the investigator, precludes safe access, or severe peripheral vascular disease as evidenced by severe claudication when ambulating \<100 feet, weak or absent pulses in the affected limb, or ankle-brachial index (ABI) \<0.5 at rest 11. Previous iliofemoral intervention in the region of the access site, including prior atherectomy, stenting, or surgical or grafting procedures 12. Use of an intra-aortic balloon pump through the access site within 30 days prior to the baseline evaluation 13. Continuous oral anticoagulation therapy that cannot be stopped for the peri-procedural period or international normalized ratio (INR) \>1.8 at the time of the procedure 14. Unable to be adequately anti-coagulated for the procedure 15. Unable to ambulate at baseline (e.g., wheelchair user or confined to bed) 16. ST-elevation myocardial infarction (MI) within 30 days prior to procedure or acute coronary syndrome (i.e., unstable angina or MI) ≤30 days before the catheterization procedure 17. New York Heart Association (NYHA) class IV heart failure 18. Left ventricular ejection fraction \<20% 19. Unilateral or bilateral lower extremity amputation 20. Renal insufficiency (serum creatinine \>2.5 mg/dl) or on dialysis therapy 21. Existing nerve damage in the ipsilateral leg 22. Additional planned endovascular procedure within the next 30 days 23. Currently participating in another clinical trial of an unapproved investigational device or drug that has not concluded the follow-up period 24. Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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