xDot Access Management System Pivotal Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vascular Closure Devices
• Intervention / Treatment: Device: xDot Access Management System (AMS)

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 Type: Interventional
• Enrollment (Estimated): 266
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Virginia (Ginny) Kirby; Phone Number: 612-720-6255; Email: ginny.kirby@xdotmedical.com
• Study Contact Backup: Name: Ben Smith, PhD; Phone Number: 312-972-3949; Email: ben.smith@brightresearch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: xDot Access Management System	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from major complications of the target access site for Femoral Arterial cohort		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)	During procedure
Freedom from major complications of the target access site for Femoral Venous cohort		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).	During procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	48 hours post-procedure

Collaborators and Investigators

• Sponsor: xDot Medical, Inc
• Collaborators: Bright Research, Inc.
• Investigators: Study Director: Ben Smith, PhD, Bright Research

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: July 15, 2026
• First Submitted That Met QC Criteria: July 17, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Hemostasis; Large bore femoral-arterial access site closure; Large bore femoral-venous access site closure; Percutaneous catheter-based interventional procedures
• Other Study ID Numbers: xDOT-CL-5100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes