[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07464353":3,"trial-entities:NCT07464353":114,"trial-summary:NCT07464353":118},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":39,"secondary_outcomes":47,"sex":48,"minimum_age":49,"maximum_age":50,"healthy_volunteers":15,"eligibility_criteria":51,"std_ages":55,"locations":58,"central_contacts":94,"overall_officials":104,"references":109,"see_also_links":110},"NCT07464353","xDOT-CL-5000","xDot Access Management System Early Feasibility Study","xDot Access Management System Early Feasibility Study for Closure of Large Bore Femoral-Arterial & Venous-Access Sites","RECRUITING","2026-08","2026-07","2026-07-06","2026-06-16","xDot Medical, Inc","INDUSTRY",false,"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.","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.",[19],"Vascular Closure Devices",[21,22,23,24],"Large bore femoral-arterial access site closure","Large bore femoral-venous access site closure","Hemostasis","Percutaneous catheter-based interventional procedures","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},30,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DEVICE","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.",[38],"xDot Access Management System",[40,43],{"measure":41,"timeFrame":42},"Freedom from major complications of the target access site","30 days post-procedure",{"measure":44,"description":45,"timeFrame":46},"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).","During procedure",[],"ALL","18 Years","80 Years",{"inclusion":52,"exclusion":53,"raw_text":54},[],[],"Inclusion Criteria:\n\n1. Age 18 to 80 years\n2. Willing and able to provide written informed consent prior to initiation of study procedures\n3. Willing and able to comply with the protocol-specified procedures and assessments\n4. Investigator opinion suitable for xDot AMS for femoral closure (arterial or venous, as applicable)\n5. Minimum vessel diameter of 5.5 mm and vessel depth ≥1.5 cm and ≤5.0 cm, \\\u003C50% stenosis for the: a. femoral artery, as determined by computed tomography angiography (CTA) b. femoral vein, as determined by duplex ultrasound (DUS) or angiogram.\n6. Candidate for elective or planned (i.e., not emergent or urgent) percutaneous transcatheter interventional procedure through:\n\n   1. The common femoral artery using 8F to 22F devices or sheaths (max 26F OD; e.g., TAVR, EVAR)\n   2. The common femoral vein using 8F to 26F devices or sheaths (max 30F OD; e.g., transcatheter mitral\u002Ftricuspid valve repair\u002Freplacement and LAA occlusion)\n\nExclusion Criteria:\n\n1. Individuals who are pregnant, planning to become pregnant, or lactating\n2. Immunocompromised or with pre-existing autoimmune disease\n3. Active systemic infection or a local infection at or near the access site\n4. Known or suspected COVID-19 infection\n5. Significant anemia (hemoglobin \\\u003C10 g\u002FdL, hematocrit \\\u003C30%)\n6. Morbidly obese or cachectic (Body mass index \\[BMI\\] \\>40 kg\u002Fm2 or \\\u003C20 kg\u002Fm2)\n7. Severe co-existing co-morbidities which, in the opinion of the investigator, would clinically confound the study primary endpoints\n8. Known bleeding disorder including thrombocytopenia (platelet count \\\u003C100,000 cells\u002FUL), thrombasthenia, hemophilia, or von Willebrand disease\n9. Allergy to any device material, including polypropylene, NiTinol, or Titanium\n10. 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 \\\u003C100 feet, weak or absent pulses in the affected limb, or ankle-brachial index (ABI) \\\u003C0.5 at rest\n11. Previous iliofemoral intervention in the region of the access site, including prior atherectomy, stenting, or surgical or grafting procedures\n12. Use of an intra-aortic balloon pump through the access site within 30 days prior to the baseline evaluation\n13. 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\n14. Unable to be adequately anti-coagulated for the procedure\n15. Unable to ambulate at baseline (e.g., wheelchair user or confined to bed)\n16. 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\n17. New York Heart Association (NYHA) class IV heart failure\n18. Left ventricular ejection fraction \\\u003C20%\n19. Unilateral or bilateral lower extremity amputation\n20. Renal insufficiency (serum creatinine \\>2.5 mg\u002Fdl) or on dialysis therapy\n21. Existing nerve damage in the ipsilateral leg\n22. Additional planned endovascular procedure within the next 30 days\n23. Currently participating in another clinical trial of an unapproved investigational device or drug that has not concluded the follow-up period\n24. Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)\n\nIntraprocedural Exclusion Criteria\n\nPatients 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:\n\n1. Hypertension with blood pressure (BP) ≥180\u002F110 mm Hg at the initial time of the procedure that cannot adequately be controlled.\n2. Presence of the following at the target access site (arterial or venous): i) hematoma, ii) AV fistula, iii) pseudoaneurysm, or iv) thrombus\n3. Puncture site scenarios for the femoral artery or vein:\n\n   1. Sites in target groin within the prior 14 days\n   2. Sites in the target that have not healed\n   3. Puncture is through the posterior wall or if there are multiple punctures in the same access site\n4. Access site above the most inferior border of the inferior epigastric artery\u002Fvein and\u002For above the inguinal ligament based upon bony landmarks\n5. Access site is below the femoral artery\u002Fvein bifurcation",[56,57],"ADULT","OLDER_ADULT",[59,72,83],{"facility":60,"status":8,"city":61,"state":62,"zip":63,"country":64,"contacts":65,"geoPoint":69},"CentraCare Heart and Vascular Center","Saint Cloud","Minnesota","56303","United States",[66],{"name":67,"role":68},"Thom Dahle, MD","PRINCIPAL_INVESTIGATOR",{"lat":70,"lon":71},45.5608,-94.16249,{"facility":73,"status":8,"city":74,"state":75,"zip":76,"country":64,"contacts":77,"geoPoint":80},"Oklahoma Heart Institute","Tulsa","Oklahoma","74104",[78],{"name":79,"role":68},"Kamran Muhammad, MD",{"lat":81,"lon":82},36.15398,-95.99277,{"facility":84,"status":8,"city":85,"state":86,"zip":87,"country":64,"contacts":88,"geoPoint":91},"North Central Heart","Sioux Falls","South Dakota","57108",[89],{"name":90,"role":68},"J. Michael Bacharach, MD",{"lat":92,"lon":93},43.54369,-96.72796,[95,100],{"name":96,"role":97,"phone":98,"email":99},"Virginia Kirby","CONTACT","612-720-6255","ginny.kirby@xdotmedical.com",{"name":101,"role":97,"phone":102,"email":103},"Ben Smith","612-345-4544","ben.smith@brightresearch.com",[105],{"name":106,"affiliation":107,"role":108},"Ben Smith, PhD","Bright Research, Inc.","STUDY_DIRECTOR",[],[111],{"label":112,"url":113},"Related Info","http:\u002F\u002Fxdotmedical.com",{"nct_id":4,"conditions":115,"biomarkers":117},[116],"Percutaneous Catheter-Based Interventional Procedures",[],{"nct_id":4,"found":119,"summary":120,"prompt_version":130},true,{"design":121,"status":122,"heading":123,"summary":124,"follow_up":125,"word_count":126,"commitments":127,"compensation":128,"drugs_mentioned":129},"This is an early feasibility study that will enroll 30 participants. It is a single-arm study, meaning all participants will receive the xDot Access Management System.","completed","xDot Access Management System Early Feasibility Study for Vascular Closure","This study is testing a new device called the xDot Access Management System (AMS). This system is designed to close the puncture site in a blood vessel after a medical procedure. Researchers want to see if the xDot AMS is safe and works well for closing large holes in the femoral artery (a major artery in your leg) and femoral vein (a major vein in your leg). They will measure how quickly bleeding stops and if there are any major problems at the access site within 30 days after the procedure. You might be able to join if you are between 18 and 80 years old, can give your consent, and your doctor thinks the xDot AMS is suitable for your femoral closure. The study aims to enroll 30 participants, but its current recruitment status is unclear.","Participants will be followed for 30 days after the procedure to check for major complications.",137,"Not specified in the trial record.","Not stated in the trial record.",[35],"v2"]