Vascular Closure DevicesNCT07464353
xDot Access Management System Early Feasibility Study
A study testing xDot Access Management System (AMS) in people with Vascular Closure Devices, run by xDot Medical, Inc at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Closure Devices
- What is being tested?
- xDot Access Management System (AMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- 16 Jun 2026to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 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:
- femoral artery, as determined by computed tomography angiography (CTA)
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- femoral vein, as determined by ultrasound 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)
Who cannot join
- 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)
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- 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
- Allergy to any device material, including polypropylene, NiTinol, or Titanium
- 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
- Previous iliofemoral intervention in the region of the access site, including prior atherectomy, stenting, or surgical or grafting procedures
- Use of an intra-aortic balloon pump through the access site within 30 days prior to the baseline evaluation
- 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
- Unable to be adequately anti-coagulated for the procedure
- Unable to ambulate at baseline (e.g., wheelchair user or confined to bed)
- 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
- New York Heart Association (NYHA) class IV heart failure
- Left ventricular ejection fraction <20%
- Unilateral or bilateral lower extremity amputation
- Renal insufficiency (serum creatinine >2.5 mg/dl) or on dialysis therapy
- Existing nerve damage in the ipsilateral leg
- Additional planned endovascular procedure within the next 30 days
- Currently participating in another clinical trial of an unapproved investigational device or drug that has not concluded the follow-up period
- Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)
- Intraprocedural Exclusion Criteria
- Patients will be excluded from participating in this trial if any of the following exclusion criteria occur at the time of the procedure, prior to introduction of the xDot AMS into the patient:
- Hypertension with blood pressure (BP) ≥180/110 mm Hg at the initial time of the procedure that cannot adequately be controlled.
- Presence of the following at the target access site (arterial or venous): i) hematoma, ii) AV fistula, iii) pseudoaneurysm, or iv) thrombus
- Puncture site scenarios for the femoral artery or vein:
- Sites in target groin within the prior 14 days
- Sites in the target that have not healed
- Puncture is through the posterior wall or if there are multiple punctures in the same access site
- Access site above the most inferior border of the inferior epigastric artery/vein and/or above the inguinal ligament based upon bony landmarks
- Access site is below the femoral artery/vein bifurcation
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
Mahesh Raju, MD
- Recruiting
Aurora St. Luke's
Milwaukee, Wisconsin, 53215
Suhail Allaqaband, MD
- Recruiting
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota, 56303
Thom Dahle, MD
- Recruiting
North Central Heart
Sioux Falls, South Dakota, 57108
J. Michael Bacharach, MD
- Recruiting
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104
Kamran Muhammad, MD
About this study
Official title: xDot Access Management System Early Feasibility Study for Closure of Large Bore Femoral-Arterial & Venous-Access Sites
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.
Read the detailed 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.
- Conditions
- Vascular Closure Devices
- Being tested
- xDot Access Management System (AMS)
- Keywords
- Large bore femoral-arterial access site closure, Large bore femoral-venous access site closure, Hemostasis, Percutaneous catheter-based interventional procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| xDot Access Management System | Experimental | Not described Receives: Device: xDot Access Management System (AMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from major complications of the target access site
Measured: 30 days post-procedure
Time to hemostasis (TTH)
Defined as the elapsed time from procedural sheath removal to the first observed cessation of common femoral artery bleeding (excluding cutaneous or subcutaneous oozing at the access site).
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start16 Jun 2026
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Closure DevicesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- xDot Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bright Research Partners
- Responsible party
- Sponsor
- Investigators
- Ben Smith, PhD, Study director, Bright Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464353
- Sponsor's protocol ID
- xDOT-CL-5000
- Status last verified
- Aug 2026
- First submitted
- 6 Mar 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- xDot Access Management System Early Feasibility Study for Closure of Large Bore Femoral-Arterial & Venous-Access Sites
- ClinicalTrials.gov ID
- NCT07464353
- Acronym / sponsor ID
- xDOT-CL-5000
- Conditions
- Vascular Closure Devices
- Keywords
- Large bore femoral-arterial access site closure, Large bore femoral-venous access site closure, Hemostasis, Percutaneous catheter-based interventional procedures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- xDot Medical, IncIndustry (pharma, biotech, devices)
- Collaborators
- Bright Research Partners
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| xDot Access Management System | Experimental | Device: xDot Access Management System (AMS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 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:
Key exclusion criteria (34 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| xDot 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. | Device | xDot Access Management System |
Primary outcome
Freedom from major complications of the target access site
Time frame: 30 days post-procedure
Time to hemostasis (TTH)
Time frame: During procedure
Defined as the elapsed time from procedural sheath removal to the first observed cessation of common femoral artery bleeding (excluding cutaneous or subcutaneous oozing at the access site).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ben Smith, PhD study director
Bright Research, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing xDot Access Management System (AMS) in people with Vascular Closure Devices, run by xDot Medical, Inc at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Virginia Kirby (612-720-6255, ginny.kirby@xdotmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from major complications of the target access site (time frame: 30 days post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.