[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Biosensors Europe SA\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":99},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100578837","inflate-study-investigation-of-the-safety-and-performance-of-a-novel-ptv-balloon-in-patients-undergoing-tavi-for-severe-aortic-stenosis-100578837",false,"NCT06816485","INFLATE Study: Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis","Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis","Inclusion Criteria:\n\n1. Symptomatic severe calcific stenosis of a native aortic valve with an AVA ≤1.0 cm2 (or AVA index ≤0.6 cm2\u002Fm2) AND mean aortic pressure gradient ≥ 40mmHg OR maximal transaortic velocity ≥4.0m\u002Fs OR Doppler velocity index ≤0.25 on site-reported echocardiography\n2. Local multi-disciplinary Heart Team agrees on indication and eligibility for TAVI\n3. Age ≥18 years\n4. Patient has signed the Patient Informed Consent Form\n5. Patient is willing and able to comply with requirements of the study\n6. Patients planned for trans-femoral procedure\n\nExclusion Criteria:\n\n1. Mean aortic annulus diameter as measured by pre-procedural CT or internal diameter of the bioprosthesis is \\\u003C16 mm or \\>30 mm\n2. Echocardiographic evidence of intracardiac thrombus, mass or vegetation (site-reported)\n3. Significant disease of the aorta that would preclude safe advancement of the TAVI system\n4. Severe ilio-femoral vessel disease that would preclude safe performance of the TAVI procedure\n5. Severe tricuspid regurgitation and\u002For failing right heart (site-reported)\n6. Severe left ventricular dysfunction with ejection fraction (EF) \\\u003C20% (site-reported)\n7. Evidence of active endocarditis or other acute infections\n8. Renal failure requiring continuous renal replacement therapy\n9. Untreated clinically significant coronary artery disease requiring revascularization\n10. Acute MI ≤30 days prior to the index procedure\n11. Symptomatic carotid or vertebral artery disease requiring intervention or carotid\u002Fvertebral intervention within the preceding 45 days\n12. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) ≤6 months or prior CVA with moderate or severe disability (e.g. modified Rankin scale score \\>2)\n13. History of bleeding diathesis or coagulopathy; acute blood dyscrasias as defined: thrombocytopenia (platelets \\\u003C80,000\u002Fµl), acute anemia (hemoglobin \\\u003C10 g\u002Fdl), leukopenia (WBC \\\u003C3000\u002F µl)\n14. Severe (greater than 3+) mitral insufficiency (site-reported)\n15. Known hypersensitivity to contrast media, which cannot be adequately pre-medicated or contraindication to anticoagulant or anti-platelet medication or to nitinol alloy or to bovine tissue\n16. Currently participating in another investigational drug or device study\n17. Pregnancy or intend to become pregnant during study participation\n18. Unicuspid aortic valve\n19. Non-calcified aortic stenosis\n20. Identified high risk of coronary occlusion due to Sinus of Valsalva anatomy and\u002For bulky calcified aortic valve leaflets in close proximity to coronary ostia\n21. Isolated Aortic Insufficiency\n22. Patients with a permanent pacemaker\n23. Patients with pre-existing LBBB, RBBB and AV block 2 and 3","ALL","18 Years",{"count":19,"type":20},93,"ESTIMATED","INTERVENTIONAL",[23],"NA","This clinical investigation is being done to evaluate the safety and effectiveness of a new device, a PTV Balloon, that will be used to open up an area in the heart (the valve) before and potentially after placing a new valve in patients requiring a new heart valve.\n\nThe main question it aims to answer is:\n\nWhat percentage of patients develop new heart conduction problems after using the investigational PTV Balloon for pre-dilatation?\n\nParticipants will:\n\n1. Undergo a TAVI procedure, where the PTV Balloon will be used for pre-dilatation and may also be used for post-dilatation.\n2. Will be followed up until discharge or up to 7 days, whichever happens first.",[26],"Aortic Diseases",[28,29,30,31],"PTV Balloon","TAVI","Aortic Valve Stenosis","Balloon Aortic Valvuloplasty","RECRUITING","2026-04-15",{"date":35,"type":36},"2026-04-16","ACTUAL",{"date":38,"type":36},"2025-12-15",{"date":40,"type":20},"2026-08",{"name":42,"class":43},"Biosensors Europe SA","INDUSTRY",9,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":54,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100478127","eultra-10k---biofreedom-ultra-100478127","NCT05505929","eUltra 10k - Biofreedom Ultra","A Post-Market Registry of the BioFreedom Ultra CoCr Biolimus A9 Coated Coronary Stent System","Inclusion Criteria:\n\n* According to the current version of Instructions of Use (IFU)\n* Patient is at least 18 years old\n* Patient provides a signed informed consent\n\nExclusion Criteria:\n\n* According to current version of IFU\n* Patients will be excluded as per Medical Device Regulation (MDR) (Article 65: \"Clinical investigations on minors\" and article 66: \"Clinical investigations on pregnant or breastfeeding women\"\n* Patients will be excluded if they are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision",{"count":53,"type":20},10000,"12 Months","OBSERVATIONAL","This registry captures data on BioFreedomTM Ultra CoCr DCS in standard clinical practice (real world population) and serves as Post Market Clinical Follow up (PMCF) as part of the Post-Market Surveillance.",[58],"Post Market Clinical Follow up (PMCF)",[60,61,62,63],"PMCF","Registry","Biofreedom Ultra","eUltra","2026-03-02",{"date":66,"type":36},"2026-03-04",{"date":68,"type":36},"2023-06-15",{"date":70,"type":20},"2029-03-30",{"name":42,"class":43},10,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100566603","leaders-free-iv-rct-biofreedom-ultra-vs-biofreedom-in-hbr-patients-100566603","NCT06657326","LEADERS FREE IV (RCT): BioFreedom™ Ultra vs BioFreedom™ in HBR Patients","Evaluation of the Efficacy (QCA) and Safety of the BioFreedom™ Ultra Drug Coated Stent in Patients With High Bleeding Risk and Coronary Artery Disease Undergoing Percutaneous Coronary Intervention","Inclusion Criteria:\n\n1. Patients at high bleeding risk (HBR) with an indication for PCI who can tolerate at least one month of DAPT. This includes patients with stable angina, silent ischemia, acute coronary syndromes (ACS) (STEMI and NSTEMI), de novo lesions in native arteries with diameter stenosis \\>70% by visual estimation and evidence of ischemia in the territory of the target vessel(s).\n2. Patients meet ARC-HBR definition i.e at least 1 major or 2 minor criteria.\n\nExclusion Criteria:\n\n1. Pregnant and breastfeeding women\n2. Age \\\u003C18 years old\n3. Patients lacking capacity (i.e. patients suffering from dementia and others) to provide informed consent\n4. Patients expected not to comply with 1 month DAPT\n5. Active bleeding at the time of inclusion\n6. Procedure requires the use of non-study stents, or alternative therapeutic options not followed by stent implantation (angioplasty only, atherectomy only)\n7. Number of target lesions \\>2\n8. Patient requires a stent of diameter \\\u003C2.25mm\n9. Patient requires a stent of diameter \\>4.0mm\n10. Isolated ostial lesions within 3 mm of the origin of LAD or LCx (left main lesions involving the ostia of the LAD and\u002For LCx are eligible)\n11. Patient has known left ventricular ejection fraction (LVEF) \\\u003C30% (LVEF may be obtained at the time of the index procedure if the value is unknown and the investigator believes it is necessary)\n12. Patient with chronic total occlusion(s) as target lesion(s)\n13. Severe calcification that might prevent sufficient expansion of the DES, unless pre-treated with a plaque modification device such as cutting balloon, scoring balloon or intravascular lithotripsy.\n\n    Note: Use of rotational or orbital atherectomy is also permitted.\n14. Cardiogenic shock\n15. Compliance with long-term single anti-platelet therapy unlikely\n16. Known hypersensitivity or contraindication to aspirin, clopidogrel (or to any other P2Y12 inhibitor if applicable), cobalt chromium, stainless steel, zinc, Biolimus A9™ or a sensitivity to contrast media, which cannot be adequately pre-medicated\n17. Any PCI during the previous 12 months\n18. Participation in another clinical study (12 months after index procedure)\n19. Patients with a life expectancy of \\\u003C12 months",{"count":81,"type":20},444,[23],"This study aims to demonstrate that the BioFreedom™ Ultra Drug Coated Stent (DCS) is non-inferior to the BioFreedom™ DCS, with respect to in-stent late lumen loss, and that it has safety characteristics similar to the BioFreedom™ DCS.",[85,86,87,88,89],"Coronary Artery Disease","Chronic Stable Angina","Unstable Angina","Silent Ischemia","Acute Coronary Syndrome","2025-06-03",{"date":92,"type":36},"2025-06-05",{"date":94,"type":36},"2024-12-18",{"date":96,"type":20},"2030-12",{"name":42,"class":43},6,""]