[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581528":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":29,"responsibleParty":109,"collaborators":11,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":113,"sex":119,"minAge":120,"maxAge":11,"enrollmentInfo":121,"targetDuration":11,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":11,"overallStatus":32,"whyStopped":11,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"Ladera Medical","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"The Ladera LBC System will be used in all participants enrolled in the study","EXPERIMENTAL",null,[13],"Device: Ladera LBC System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","Ladera LBC System","Use of the Ladera LBC System to close the femoral arteriotomy",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Sarah L Canio","CONTACT","408-316-5575","sarah.canio@laderamedical.com",{"name":27,"role":23,"phone":11,"phoneExt":11,"email":28},"Keri Y Ng","keri@inventure.group",[30,48,60,72,85,98],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Jessie McPherson Private Hospital","RECRUITING","Clayton","Clayton VIC","3168","Australia","AU",{"type":39,"coordinates":40},"Point",[41,42],145.11667,-37.91667,{"lat":42,"lon":41},[45],{"name":46,"role":47,"phone":11,"phoneExt":11,"email":11},"Liam McCormick, MD","PRINCIPAL_INVESTIGATOR",{"facility":49,"status":32,"city":50,"state":51,"zip":11,"country":36,"countryCode":37,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Macquarie University","Sydney","New South Wales",{"type":39,"coordinates":53},[54,55],151.20732,-33.86785,{"lat":55,"lon":54},[58],{"name":59,"role":47,"phone":11,"phoneExt":11,"email":11},"Martin Ng, Professor",{"facility":61,"status":32,"city":62,"state":63,"zip":11,"country":36,"countryCode":37,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Monash Health, Victoria Heart Hospital","Melbourne","Victoria",{"type":39,"coordinates":65},[66,67],144.96332,-37.814,{"lat":67,"lon":66},[70],{"name":71,"role":47,"phone":11,"phoneExt":11,"email":11},"Robert Gooley, A\u002FProf",{"facility":73,"status":32,"city":74,"state":11,"zip":11,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"AZ Sint-Jan Brugge AV","Bruges","Belgium","BE",{"type":39,"coordinates":78},[79,80],3.22424,51.20892,{"lat":80,"lon":79},[83],{"name":84,"role":47,"phone":11,"phoneExt":11,"email":11},"Jan Van der Heyden, MD, PhD",{"facility":86,"status":32,"city":87,"state":11,"zip":11,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"OLVG Amsterdam","Amsterdam","Netherlands","NL",{"type":39,"coordinates":91},[92,93],4.88969,52.37403,{"lat":93,"lon":92},[96],{"name":97,"role":47,"phone":11,"phoneExt":11,"email":11},"Giovanni Amoroso, MD",{"facility":99,"status":32,"city":100,"state":11,"zip":11,"country":88,"countryCode":89,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Erasmus University Medical Center","Rotterdam",{"type":39,"coordinates":102},[103,104],4.47917,51.9225,{"lat":104,"lon":103},[107],{"name":108,"role":47,"phone":11,"phoneExt":11,"email":11},"Nicolas Van Mieghem, Prof. Dr.",{"type":110,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100581528","the-ladera-suture-mediated-large-bore-closure-study-100581528",false,"NCT06851481","The Ladera Suture-Mediated Large Bore Closure Study","A Prospective, Multi-Center, Single-Arm Study to Evaluate the Safety and Performance of the Ladera Medical Suture-Mediated Closure System When Used to Achieve Hemostasis of Common Femoral Arteriotomies in Patients Undergoing Percutaneous Catheter-Based Interventional Procedures (the FASTEN Study)","FASTEN","Inclusion Criteria:\n\n1. Patient is ≥ 18 years old\n2. Patient 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, PEVAR, TEVAR)\n3. Patient is able to undergo emergent vascular surgery if a complication related to the vascular closure necessitates such surgery\n4. Patient is willing and able to complete follow-up requirements\n5. Patient 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\nPatients must be EXCLUDED from participation in this study if ANY of the following criteria are met:\n\nScreening \u002F Baseline\n\n1. Prior intra-aortic balloon pump at access site within 30 days of baseline evaluation\n2. Patients 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\n3. Common femoral artery and iliac lumen diameter is \\\u003C 6 mm as confirmed with prior standard of care CT Imaging\n4. Common femoral artery calcium at the arteriotomy site (i.e., target access site), which is visible with prior CT Imaging\n5. Marked tortuosity (at the investigator's discretion) of the femoral or external iliac artery in the target leg based on prior CT Imaging\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. Patients receiving glycoprotein IIb\u002FIIIa inhibitors within 24 hours prior to, during, or within 48 hours after the catheterization procedure\n10. Patients with significant anemia (Hgb \\\u003C 9 g\u002FdL, Hct \\\u003C 30%)\n11. Patient 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. Patient 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 index procedure\n19. Patients 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. Patient 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. Patient 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. Patient has other medical, social or psychological problem that in the opinion of the Investigator precludes them from participating\n27. Patient is mentally incompetent or a prisoner\n28. Patient 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. Patients who have already participated in this Investigational study\n34. Patients who are currently participating in any other investigational studies Intra-Procedure\n35. Patient 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\n36. Access site above the most inferior border of the IEA and\u002For above the inguinal ligament based upon bony landmarks\n37. Access site in the profunda femoris or superficial femoral arteries, or the bifurcation of these vessels\n38. Ipsilateral femoral venous sheath during the catheterization procedure\n39. Patient in which there is difficulty inserting the introducer sheath or need for greater than 2 ipsilateral arterial punctures at the start of the catheterization procedure\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. Angiographic evidence of arterial laceration, dissection, or stenosis in the femoral artery that would preclude use of the investigational device\n43. Index procedural sheath \\\u003C 10 Fr or \\> 24 Fr\n44. Activated clotting time (ACT) greater than 250 seconds, unless protamine has been administered, immediately prior to index procedure sheath removal and planned vascular closure\n45. 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":122,"type":123},55,"ESTIMATED","INTERVENTIONAL",[126],"NA","This study evaluates the safety and performance of the Ladera Medical suture-mediated large bore closure (LBC) system in gaining post procedure hemostasis in subjects undergoing interventional catheterization procedures using a large-bore procedure sheath.",[129,130],"Vascular Closure","Femoral Arteriotomy Closure","2025-12-12",{"date":133,"type":134},"2025-12-15","ACTUAL",{"date":136,"type":134},"2025-08-18",{"date":138,"type":123},"2025-12-31",{"name":5,"class":6},6]