Vascular Closure Devices
Conditions
Keywords
Large bore femoral-arterial access site closure, Large bore femoral-venous access site closure, Hemostasis, Percutaneous catheter-based interventional procedures
Brief 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.
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.
Interventions
The xDot AMS is designed to deliver the xDot Implant Unit in the anterior wall of the target vessel to close the puncture site.
Sponsors
xDot Medical, Inc
Bright Research Partners
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 computed tomography angiography (CTA) 2. femoral vein, as determined by ultrasound or angiogram. 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; e.g., TAVR, EVAR) 2. 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
1. 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/m2 or \<20 kg/m2) 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) Intraprocedural
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from major complications of the target access site | 30 days post-procedure | — |
| Time to hemostasis (TTH) | 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). |
Countries
United States
Contacts
CONTACTVirginia Kirby
CONTACTBen Smith
STUDY_DIRECTORBen Smith, PhD
Bright Research, Inc.
Outcome results
None listed