Vascular Closure DevicesNCT07719244
xDot Access Management System Pivotal Study
A study testing xDot Access Management System (AMS) in people with Vascular Closure Devices, run by xDot Medical, Inc.
Trial summary
The objective of this study is to establish reasonable assurance of safety and effectiveness for the xDot Access Management System (AMS) when used as indicated for femoral-arterial and femoral-venous closure. 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
- 266 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2027
- 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 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).
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- femoral vein, as determined by ultrasound at the time of procedure.
- 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; including, but not limited to TAVR and EVAR)
- 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)
Who cannot join
- If female, 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/m^2 or <20 kg/m^2)
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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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: xDot Access Management System Pivotal Study for Closure of Large Bore Femoral-Arterial & Venous-Access Sites
The objective of this study is to establish reasonable assurance of safety and effectiveness for the xDot Access Management System (AMS) when used as indicated for femoral-arterial and femoral-venous closure. Additionally, this study will provide preliminary evidence on the impact on health outcomes for patients undergoing interventional catheterization procedures when the xDot AMS is used for vascular closure.
Read the detailed description
The study is a prospective, multicenter, dual-cohort, single-arm, open-label IDE pivotal trial enrolling patients undergoing catheter-based interventional procedures requiring large bore femoral arterial or femoral venous access, comprising:
- A single-arm Femoral Arterial cohort for evaluation of the xDot AMS for closure of femoral arterial access sites ("Femoral Arterial cohort"), and
- A single-arm Femoral Venous cohort for evaluation of the xDot AMS for closure of femoral venous access sites ("Femoral Venous cohort")
The study includes a roll-in cohort consisting of treatment-only subjects, which will be analyzed and presented separately and will not contribute to the pivotal analysis populations.
- 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 around the access site on 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 for Femoral Arterial cohort
Measured: 30 days post-procedure
Time to hemostasis (TTH) for Femoral Arterial cohort
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
Freedom from major complications of the target access site for Femoral Venous cohort
Measured: 30 days post-procedure
Time to hemostasis (TTH) for Femoral Venous cohort
Defined as the elapsed time from procedural sheath removal to the first observed cessation of common femoral vein bleeding (excluding cutaneous or subcutaneous oozing at the access site).
Measured: During procedure
Secondary outcomes (2)
Time-to-ambulation (TTA) for Femoral Arterial cohort
Defined as the elapsed time from final procedural sheath removal to time when the subject stands and walks at least 20 feet without re-bleeding.
Measured: 48 hours post-procedure
Time-to-ambulation (TTA) for Femoral Venous cohort
Defined as the elapsed time from final procedural sheath removal to time when the subject stands and walks at least 20 feet without re-bleeding.
Measured: 48 hours post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (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
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- xDot Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bright Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Ben Smith, PhD, Study director, Bright Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719244
- Sponsor's protocol ID
- xDOT-CL-5100
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- xDot Access Management System Pivotal Study for Closure of Large Bore Femoral-Arterial & Venous-Access Sites
- ClinicalTrials.gov ID
- NCT07719244
- Acronym / sponsor ID
- xDOT-CL-5100
- 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
- Not yet recruiting
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- xDot Medical, IncIndustry (pharma, biotech, devices)
- Collaborators
- Bright Research, Inc.
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 22 Jul 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 establish reasonable assurance of safety and effectiveness for the xDot Access Management System (AMS) when used as indicated for femoral-arterial and femoral-venous closure. Additionally, this study will provide preliminary evidence on the impact on health outcomes for patients undergoing interventional catheterization procedures when the xDot AMS is used for vascular closure.
Detailed description
The study is a prospective, multicenter, dual-cohort, single-arm, open-label IDE pivotal trial enrolling patients undergoing catheter-based interventional procedures requiring large bore femoral arterial or femoral venous access, comprising:
- A single-arm Femoral Arterial cohort for evaluation of the xDot AMS for closure of femoral arterial access sites ("Femoral Arterial cohort"), and
- A single-arm Femoral Venous cohort for evaluation of the xDot AMS for closure of femoral venous access sites ("Femoral Venous cohort")
The study includes a roll-in cohort consisting of treatment-only subjects, which will be analyzed and presented separately and will not contribute to the pivotal analysis populations.
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 (24 listed)
- If female, 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 around the access site on the target vessel to close the puncture site. | Device | xDot Access Management System |
Primary outcome
Freedom from major complications of the target access site for Femoral Arterial cohort
Time frame: 30 days post-procedure
Time to hemostasis (TTH) for Femoral Arterial cohort
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)
Freedom from major complications of the target access site for Femoral Venous cohort
Time frame: 30 days post-procedure
Time to hemostasis (TTH) for Femoral Venous cohort
Time frame: During procedure
Defined as the elapsed time from procedural sheath removal to the first observed cessation of common femoral vein bleeding (excluding cutaneous or subcutaneous oozing at the access site).
2 secondary outcomes
Time-to-ambulation (TTA) for Femoral Arterial cohort
Time frame: 48 hours post-procedure
Time-to-ambulation (TTA) for Femoral Venous cohort
Time frame: 48 hours post-procedure
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 22 Jul 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
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.
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 24 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: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 (Ginny) 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 for Femoral Arterial cohort (time frame: 30 days post-procedure). The study lists 4 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 22 Jul 2026.