[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vascular-closure-device\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vascular-closure-device":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100634557","the-ladera-suture-mediated-large-bore-closure-pivotal-study-100634557",false,"NCT07541235","The Ladera Suture-Mediated Large Bore Closure Pivotal Study","A Prospective, Multi-Center, Single-Arm Pivotal Study to Evaluate the Safety and Efficacy of the Ladera Medical Suture-Mediated Large Bore Closure System When Used to Achieve Hemostasis of Common Femoral Arteriotomies in Patients Undergoing Percutaneous Catheter-Based Interventional Procedures (FASTEN II)","FASTEN II","Inclusion Criteria:\n\n1. Participant is ≥ 18 years old\n2. Participant is scheduled for elective or planned (i.e., not emergent or urgent) percutaneous interventional catheterization procedures involving access through the common femoral artery using 10 to 24 Fr introducer sheaths (i.e., BAV, TAVR\u002FTAVI, EVAR, TEVAR)\n3. Participant is able to undergo emergent vascular surgery if a complication related to the vascular closure necessitates such surgery\n4. Participant is willing and able to complete follow-up requirements\n5. Participant has the mental capacity to consent for themselves (i.e., does not require the use of a Legally Authorized Representative), and signs a written Informed Consent Form (ICF) prior participating in the study\n\nExclusion Criteria:\n\n1. Prior intra-aortic balloon pump at access site within 30 days of baseline evaluation\n2. Participants with severe inflow disease (iliac artery diameter stenosis \\> 50%) and\u002For severe peripheral arterial disease (Rutherford Classification 5 or 6), as confirmed with prior standard of care Computed Tomography (CT) Imaging, and\u002For DUS\n3. Common femoral artery and iliac lumen diameter is \\\u003C 6 mm as confirmed with prior standard of care CT Imaging, angiography, and\u002For DUS\n4. Common femoral artery calcium at the arteriotomy site (i.e., target access site), which is visible with prior CT Imaging and\u002For DUS\n5. Marked tortuosity (at the Investigator's discretion) of the femoral or external iliac artery in the target leg based on prior CT Imaging, angiography, and\u002For DUS\n6. In opinion of the Investigator, significant scarring of the target access site which would preclude use of the device in accordance with the IFU\n7. Prior target artery closure with any closure device \\\u003C 90 days, or closure with manual compression ≤ 30 days prior to index procedure\n8. Prior atherectomy, vascular surgery, vascular graft, or stent in region of access site\n9. Participants receiving glycoprotein IIb\u002FIIIa inhibitors within 24 hours prior to, during, or within 48 hours after the catheterization procedure\n10. Participants with significant anemia (Hgb \\\u003C 9 g\u002FdL, Hct \\\u003C 30%)\n11. Participant with known bleeding disorder including thrombocytopenia (platelet count \\\u003C 100,000), thrombasthenia, hemophilia or Von Willebrand's disease or known Type II heparin-induced thrombocytopenia\n12. Participant with renal insufficiency (serum creatinine level \\> 221 μmol\u002FL or 2.5 mg\u002FdL), on dialysis therapy, or with renal transplant\n13. Known severe allergy to contrast reagent that cannot be managed with premedication\n14. Inability to tolerate aspirin and\u002For other anticoagulation\u002Fantiplatelet treatment\n15. Planned anticoagulation therapy post-procedure such that ACT is expected to be elevated above 250 seconds for more than 24 hours after the procedure\n16. Connective tissue disease (e.g., Marfan's Syndrome)\n17. Thrombolytics (e.g., Tissue Plasminogen Activator (t-PA), streptokinase, urokinase), Angiomax (bivalirudin) or other thrombin-specific anticoagulants ≤ 24 hours prior to the index procedure\n18. Recent (within 8 weeks) cerebrovascular accident or Q-wave myocardial infarction or acute coronary syndrome (i.e., unstable angina or myocardial infarction) within 48 hours of the primary procedure\n19. Participants who are morbidly obese (Body Mass Index (BMI) \\> 40 kg\u002Fm2) or cachectic (BMI \\\u003C 20 kg\u002Fm2)\n20. Planned major intervention or surgery, including planned interventional catheterization procedure in the target leg, within 30 days following the interventional procedure\n21. Participant unable to ambulate at baseline (i.e., confined to wheelchair or bed)\n22. Currently participating in a clinical study of an investigational device or drug that has not completed its primary study endpoint\n23. Known allergy to any of the materials used in the investigation device (refer to IFU)\n24. Participant is known or suspected to be pregnant or lactating or planning to become pregnant within 30 days following the index procedure\n25. Evidence of active systemic or local groin infection\n26. Participant has other medical, social or psychological problem that in the opinion of the Investigator precludes them from participating\n27. Participant is mentally incompetent or a prisoner\n28. Participant would refuse blood transfusion if it were to be needed\n29. New York Heart Association (NYHA) Class IV heart failure that is uncontrolled and requires treatment in the Intensive Care Unit within 24 hours prior to the index procedure\n30. Left Ventricular Ejection Fraction (LVEF) \\\u003C 20%\n31. Unilateral or bilateral lower extremity amputation\n32. Known existing nerve damage in the target leg\n33. Participants who have already participated in this Investigational Device Exemption (IDE) study Intra-Procedure\n34. Participant has a tissue tract (i.e., estimated distance from skin entry point to arterial anterior surface at arteriotomy) expected to be greater than 8 cm\n35. Access site in the external iliac and\u002For above\u002Fthrough the inguinal ligament\n36. Access site in the profunda femoris or superficial femoral arteries, or the bifurcation of these vessels\n37. Ipsilateral femoral venous sheath during the catheterization procedure\n38. Common femoral artery calcium at the arteriotomy site (i.e., target access site), which is visible with Imaging and\u002For DUS\n39. Participant in which there is difficulty inserting the introducer sheath\n40. Difficulty in obtaining vascular access resulting in multiple arterial punctures and\u002For posterior arterial puncture\n41. Evidence of a hematoma (\\> 1.5 cm in diameter), arteriovenous fistula, pseudoaneurysm, or intraluminal thrombosis at the access site\n42. Marked tortuosity (at the Investigator's discretion) of the femoral or external iliac artery in the target leg based on angiography, and\u002For DUS\n43. Angiographic evidence of arterial laceration, dissection, or stenosis in the femoral artery that would preclude use of the investigational device\n44. Index procedural sheath \\\u003C 10 Fr or \\> 24 Fr\n45. Activated clotting time (ACT) greater than 250 seconds, unless protamine has been administered, immediately prior to index procedure sheath removal and planned vascular closure\n46. Uncontrolled hypertension (systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 110 mmHg) or hypotension (systolic blood pressure less than 90 mmHg) without pharmacological intervention at the time of index sheath removal and planned vascular closure","ALL","18 Years",{"count":20,"type":21},214,"ESTIMATED","INTERVENTIONAL",[24],"NA","The study objective is to demonstrate the safety and efficacy of the investigational device to achieve hemostasis of common femoral artery access sites in participants undergoing percutaneous interventional catheterization procedures utilizing 10 to 24 Fr introducer sheaths.",[27],"Vascular Closure Device","NOT_YET_RECRUITING","2026-04-14",{"date":31,"type":32},"2026-04-21","ACTUAL",{"date":34,"type":21},"2026-08",{"date":36,"type":21},"2027-10",{"name":38,"class":39},"Ladera Medical","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":40},"100614409","safety-and-effectiveness-of-the-vascular-closure-device-for-femoral-artery-hemostasis-in-patients-of-femoral-artery-puncture-100614409","NCT07279220","Safety and Effectiveness of the Vascular Closure Device for Femoral Artery Hemostasis in Patients of Femoral Artery Puncture","A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Safety and Effectiveness of the Vascular Closure Device for Femoral Artery Hemostasis in Patients of Femoral Artery Puncture","Inclusion Criteria:\n\n1. Age 18\\~80, male or non-pregnant female;\n2. Subjects undergoing interventional diagnostic or therapeutic procedures via femoral artery puncture;\n3. Subjects using 5F to 8F sheaths during the procedure (Note: Subjects using 5F-7F sheaths will enter the main randomized controlled cohort, while subjects using 8F sheaths will directly enter the single-arm observational cohort);\n4. Subjects or their legally authorized representatives can understand the purpose of the trial, voluntarily participate in the trial and sign informed consent form, and be able and willing to comply with follow-ups and related procedures.\n\nExclusion Criteria:\n\n1. Subjects with femoral artery occlusion or visually estimated lumen diameter \\\u003C5mm;\n2. Subjects with prior surgical procedures, percutaneous transluminal angioplasty (PTA), stent placement, or vascular grafts at the access site;\n3. Subjects with visible calcification at the access site, clinically significant peripheral vascular disease (requiring intervention), or stent implantation ≤1cm from the puncture site;\n4. Subjects whose puncture site is above the lowest edge of the inferior epigastric artery and\u002For above the inguinal ligament as identified by skeletal markers;\n5. Subjects with posterior wall vascular puncture or multiple femoral artery punctures due to difficulty in obtaining vascular access;\n6. Patients with pathological obesity (BMI \\>40 kg\u002Fm²);\n7. Subjects with pre-existing access site complications (hematoma, pseudoaneurysm, arteriovenous fistula, dissection, etc) or any procedure-related complications that may affect recovery, ambulation, or discharge timing;\n8. Subjects with acute ST-segment elevation myocardial infarction within 48 hours prior to the procedure;\n9. Subjects with uncontrolled hypertension during closure (Systolic BP \\>180 mmHg or Diastolic BP \\>110 mmHg);\n10. Subjects who are known to be contraindicated or allergic to iodine-containing contrast agents or polyethylene glycol materials;\n11. Subjects with severe thrombocytopenia (Platelet count \\\u003C30×10⁹\u002FL), hemophilia, von Willebrand disease, or severe anemia (Hemoglobin \\\u003C10 g\u002FdL, Hematocrit \\\u003C30%);\n12. International normalized ratio (INR) \\>1.5;\n13. Subjects with systemic infection or skin infection at the puncture site, or planned indwelling sheath;\n14. Subjects unable to ambulate 6 meters without assistance;\n15. Pregnant or lactating women;\n16. Subjects currently participating in other drug\u002Fdevice clinical trials;\n17. Other subjects deemed ineligible for this clinical trial by the investigator.","80 Years",{"count":50,"type":21},238,[24],"The purpose of this study is to verify the safety and effectiveness of the Vascular Closure Device manufactured by Shanghai Bomaian Medical Technology Co., Ltd. for femoral artery hemostasis in patients of femoral artery puncture.",[54,27,55],"Femoral Artery Puncture","Hemostasis","2025-11-30",{"date":58,"type":32},"2025-12-12",{"date":60,"type":21},"2025-12-29",{"date":62,"type":21},"2026-05-15",{"name":64,"class":39},"Shanghai Bomaian Medical Technology Co., Ltd"]