[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ceric Sàrl\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":248},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,41,77,103,139,167,192,219],{"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":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100640561","expand-management-of-blood-pressure-with-renal-denervation-in-patients-undergoing-staged-pci-for-advanced-coronary-artery-disease-100640561",false,"NCT07602790","Expand Management of Blood Pressure With Renal Denervation in Patients Undergoing Staged PCI for Advanced Coronary Artery diseasE","Expand Management of Blood Pressure With Renal Denervation in Patients Undergoing Staged PCI for Advanced Coronary Artery Disease","EMBRACE","Inclusion Criteria:\n\n* Subject with multi-vessel disease\n* Having successful index PCI and planned staged procedure within 1-6 weeks to complete revascularization\n* Subjects ≥21 years of age\n* Office systolic blood pressure at index procedure and\u002For staged procedure (systolic blood pressure \\>140 mmHg) while taking 2 or more antihypertensive drugs\n* Subject agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study prior to staged procedure\n\nExclusion Criteria:\n\n* \\- Contraindication for RDN outlined by IFU\n* Acute MI at time of the staged PCI procedure (AMI at time of the index PCI is allowed)\n* Subject has undergone prior renal denervation.\n* Subject has renal artery anatomy that is ineligible for RDN treatment per Symplicity Spyral™ IFU\n* Known secondary cause (e.g., renal artery stenosis, primary aldosteronism, pheochromocytoma, Cushing's syndrome, or other identifiable etiologies).\n* Severe renal failure (eGFR \\\u003C30 ml\u002Fmin\u002F1.73 m²)\n* Known LVEF \\\u003C30%\n* Known history of polycystic kidney disease, unilateral kidney, or undergone renal transplant\n* Mechanical circulatory support during PCI\n* Subject is under judicial protection, tutorship or curatorship\n* Failure of index procedure\n* Acute MI, severe renal failure, need for mechanical circulatory support, or legal incapacity between the index and staged procedures resulting in loss of eligibility.","ALL","21 Years",{"count":20,"type":21},1000,"ESTIMATED","INTERVENTIONAL",[24],"NA","EMBRACE is a randomized, controlled, multicenter clinical study evaluating the effect of renal denervation on clinical adverse events in hypertensive patients undergoing staged percutaneous coronary intervention (PCI) for multivessel coronary artery disease.",[27,28],"Multivessel Coronary Artery Disease","Hypertension Resistant to Conventional Therapy","NOT_YET_RECRUITING","2026-05-18",{"date":32,"type":33},"2026-05-22","ACTUAL",{"date":35,"type":21},"2026-11",{"date":37,"type":21},"2033-11",{"name":39,"class":40},"Ceric Sàrl","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":52,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":62,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":4},"100638696","pascal-precision-gdmt-registry-100638696","NCT07578129","PASCAL Precision-GDMT Registry","Improvement in Guideline-Directed Medical Therapy After Tricuspid Transcatheter Edge-to-Edge Repair in Participants With Reduced Left Ventricular Function","PASCAL","Inclusion Criteria:\n\n* Participants of age ≥ 18 years\n* ≥ severe tricuspid regurgitation\n* LVEF \\\u003C 50%\n* Written informed consent of the patient or her\u002Fhis legal representative\n* Patient understands the purpose, the potential risks as well as benefits of the trial and is willing to participate in all parts of the follow-up\n* Planned follow-up within a dedicated heart failure clinic as part of routine care.\n\nExclusion Criteria:\n\n* Anatomy unsuitable for TEER as determined by local heart team\n* severe mitral regurgitation (defined as an EROA\\>40 mm2) treated (surgically or percutaneously) less than 3 months prior\n* severe left ventricular dysfunction (defined as an LVEF \\\u003C20%)\n* systolic pulmonary artery pressure \\>70 mmHg (right heart catheterization)\n* prior tricuspid valve intervention\n* severe leaflet degeneration or tricuspid valve anatomy precluding successful device placement\n* primary tricuspid valve disease\n* COPD requiring home oxygen therapy\n* active endocarditis, or recent episode within 4 weeks of discontinuation of antibiotic therapy\n* participants with unstable hemodynamic condition\n* significant co-morbidities resulting in an expected less than 12-month life expectancy\n* The presence of other anatomic or comorbid conditions or other medical, social or psychological conditions that in the investigators' opinion could limit the subject's ability to participate in the clinical study and its follow-up.\n* Participants under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision\n* Participation in another trial, which would lead to deviations in the preparation or performance of the intervention or the post-implantation management from this protocol","18 Years",{"count":51,"type":21},50,"12 Months","OBSERVATIONAL","The goal of this observational study is to demonstrate that successful tricuspid valve repair with the PASCAL Precision System in participants with at least severe tricuspid insufficiency and left ventricular dysfunction will be associated with an improvement in up-titration of guideline-directed medical therapy (GDMT). The main question it aims to answer is:\n\nDoes the tricuspid insufficiency repair with the Pascal Precision System increases the dose of the medications used for heart failure therapy in the study population 12 months after tricuspid repair, as compared to the dose taken at baseline.\n\nParticipants undergoing tricuspid repair and fulfilling all inclusion\u002Fexclusion criteria will be asked to answer heart failure assessment as well as quality of life questionnaires at baseline and at 12 months post intervention. Medication monitoring will be performed throughout the study.",[56,57,58,59,60,61],"Tricuspid Insufficiency","Tricuspid Regurgitation (TR)","Left Ventricular Cardiac Dysfunction","Left Ventricular (LV) Systolic Dysfunction","Left Ventricular Dysfunction","Left Ventricular Ejection Fraction",[63,64,65,66,67,68],"T-TEER","Severe Tricuspid regurgitation","left ventricular dysfunction","GDMT score","NHYA","KCCQ","2026-05-11",{"date":71,"type":33},"2026-05-13",{"date":73,"type":21},"2026-08-01",{"date":75,"type":21},"2027-08-31",{"name":39,"class":40},{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100582288","surgical-vs-transcatheter-aortic-valve-replacement-in-young-patients-100582288","NCT06861361","Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients","Surgical Bioprosthesis Aortic Valve Replacement Vs. Myval Balloon-Expandable THV Series in Patients Aged 65 to 75 With Symptomatic Severe Aortic Stenosis Judged Eligible by Heart Team","START YOUNG","Inclusion Criteria:\n\nParticipant will be included if all the following criteria are met:\n\n1. Patients aged ≥65 and ≤75\n2. Symptomatic severe aortic stenosis (mean gradient≥40mmHg, and or peak velocity\\>4m\u002Fsec).\n3. Patients with symptomatic heart disease due to severe native calcific aortic stenosis, as judged by a multidisciplinary heart team (including a cardiac surgeon), for whom SAVR or transfemoral TAVR is deemed feasible and approved by the local heart team.Signed informed consent for participation in the clinical investigation\n\nExclusion Criteria:\n\nParticipant will not be included if any one of the following conditions exists:\n\n1. Unable to understand and follow clinical investigation-related instructions or unable to comply with the clinical investigation protocol\n2. Life expectancy less than 1 year\n3. Known hypersensitivity or allergy to aspirin, clopidogrel or any Device frame components.\n4. Under judicial protection, tutorship, or curatorship\n5. Participation in another trial before the primary endpoint","65 Years","75 Years",{"count":88,"type":21},1180,[24],"The study objective is to demonstrate that the clinical outcomes of the Myval balloon-expandable THV series are non-inferior to those of SAVR in patients with symptomatic severe aortic stenosis aged 65 to 75 years.",[92],"Symptomatic Severe Aortic Stenosis","RECRUITING","2026-05-07",{"date":96,"type":33},"2026-05-12",{"date":98,"type":33},"2025-05-15",{"date":100,"type":21},"2037-09",{"name":39,"class":40},49,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":115,"conditions":116,"keywords":121,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},"100595896","leave-nothing-behind-study-which-compares-dcb-with-bail-out-brs-versus-brs-strategy-alone-100595896","NCT07038408","Leave Nothing Behind Study Which Compares DCB With Bail Out BRS Versus BRS Strategy Alone","Multi-center, Open-label, Prospective, Randomized Study to Show Long-term Efficacy of DCB Treatment With Bail-out BRS in Comparison to BRS Treatment of De-novo Native Coronary Artery Lesions in a Relatively Young PCI Population.","LNB","Inclusion Criteria:\n\n* Patients aged ≥ 18 years ≤ 68 years\n* Single vessel or multivessel disease with low to moderate complex de-novo native coronary artery lesions up to 30 mm length and reference vessel diameter 2.75-4.0 mm\n* Maximum of 3 target lesions\n* Maximal cumulative lesion length of all treated lesions 80 mm\n* Signed informed consent for participation in the study\n\nExclusion Criteria:\n\n* ST-segment Elevation Myocardial Infarction (STEMI) treatment at index or in the previous 48 hours\n* Severe calcified lesions\n* Bifurcations lesions with planned 2 device strategy\n* Left-Main (LM) disease ≥ 50% diameter stenosis\n* More than 3 target lesions\n* Renal insufficiency with Glomerular Filtration Rate (GFR) \\\u003C 45 ml\u002Fmin\n* Life expectancy less than 1 year\n* Known hypersensitivity or allergy to aspirin or P2Y12 receptor inhibitors\n* Incapable of providing written informed consent\n* Pregnant or breastfeeding women\n* Under judicial protection, tutorship, or curatorship\n* Participation in another trial","68 Years",{"count":113,"type":21},2256,[24],"The goal of this study is to investigate the equivalence in early and long-term efficacy between the two \"Leave nothing behind strategies\" (Drug-Coated Baloon \\[DCB\\] strategy with bail-out BioResorbable Scaffold \\[BRS\\] versus BRS strategy) of de-novo native coronary artery lesions in a relatively young Percutaneous Coronary Intervention (PCI) population, to be more specific, Patients with Chronic Coronary Syndromes (CCS) and Acute Coronary Syndrome (ACS) (Non-ST-segment Elevation Myocardial Infarction \\[NSTEMI\\] and Unstable angina) between 18-68 years of age scheduled for PCI. The main questions aim to answer are:\n\nDCB strategy with bail-out BRS implantation has equivalent clinical outcomes at 12 months compared to BRS strategy? DCB strategy with bail-out BRS implantation has noninferior angiographic in-segment net gain at 13 months compared to BRS strategy? DCB strategy with bail-out BRS implantation has equivalent clinical outcomes at 60 months compared to BRS strategy?\n\nParticipants will be followed at:\n\n1. st FU visit - 1 month (in hospital)\n2. nd FU visit - 6 months (telephone)\n3. rd FU visit - 365 days±15 days (telephone) - 1Y Primary efficacy endpoint\n4. th FU visit - 395 days±15 days (in hospital) co-primary efficacy endpoint for the angiographic substudy\n5. th FU visit - 730 days±30 days (telephone call) - 2Y\n6. th FU visit - 1095 days±30 days (telephone call) - 3Y\n7. th FU visit - 1460 days±30 days (telephone call) - 4Y\n8. th FU visit- 1825 days±30 days (telephone call) - 5Y",[117,118,119,120],"Drug Coated Balloon","Bioresorbable Scaffold","Percutaneous Coronary Intervention (PCI)","Acute Coronary Syndrome (ACS)",[122,123,124,125,126,127,128,129],"MULTI-CENTER","OPEN-LABEL","PROSPECTIVE","RANDOMIZED STUDY","LONG-TERM EFFICACY OF DCB TREATMENT WITH BAIL-OUT BRS","BRS TREATMENT","DE-NOVO NATIVE CORONARY ARTERY LESIONS","YOUNG PCI POPULATION","2026-04-27",{"date":132,"type":33},"2026-04-30",{"date":134,"type":33},"2026-04-24",{"date":136,"type":21},"2032-03",{"name":39,"class":40},1,{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":86,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":148,"briefSummary":149,"conditions":150,"keywords":152,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":138},"100584290","tactic-coronary-thrombus-aspiration-with-cath-rx-in-anterior-myocardial-infarction-a-randomized-control-trial-100584290","NCT06887413","TACTIC Coronary Thrombus Aspiration With Cath Rx In Anterior Myocardial Infarction: A Randomized Control Trial.","TACTIC","INCLUSION CRITERIA\n\n1. Age \\>18 and \\\u003C75 years old\n2. Acute anterior STEMI with ≥2 mm in two (2) or more contiguous anterior leads or ≥4 mm total ST-segment deviation sum in the anterior leads V1-V4 AND anterior wall motion abnormality noted on a diagnostic quality left ventriculogram or echocardiogram\n3. Culprit lesion proximal or mid LAD at coronary angiography\n4. TIMI thrombus grading \\> 3 or TIMI flow 0 after guidewire crossing the lesion.\n5. Patient presents to the hospital between 1 - 6 hours of ischemic pain onset\n6. Patient indicated for primary percutaneous coronary intervention (PPCI)\n\nEXCLUSION CRITERIA\n\n1. Unable to give Informed consent.\n2. Life expectancy \\\u003C 1 year.\n3. Contraindication to PCI\n4. STEMI due to stent thrombosis\n5. Spontaneous coronary aretery dissection\n6. Patient undergone any kind of maneuvers to restore flow before randomization\n7. Unwitnessed cardiac arrest OR ≥30 minutes of cardiopulmonary resuscitation (CPR) prior to enrolment OR any cardiac arrest with impairment in mental status, cognition or any global or focal neurological deficit\n8. New onset of stroke symptoms and NIHSS \\>2, prior to index procedure\n9. Known intolerance to aspirin, clopidogrel, ticagrelor, heparin, contrast media.\n10. Active severe bleeding\n11. Severe hepatic\u002Fkidney impairment\n12. Administration of fibrinolytic therapy within 24 hours prior to enrolment\n13. Cardiogenic shock defined as systemic hypotension (systolic BP \\\u003C90 mmHg or the need for inotropes\u002Fpressors to maintain a systolic BP \\>90 mmHg), plus one (1) of the following: any requirement for pressors \u002F inotropes prior to arrival at the catheterization laboratory, clinical evidence of end-organ hypoperfusion, or use of IABP or any other mechanical circulatory support device\n14. Inferior STEMI or suspected right ventricular failure\n15. Severe valvulopathy\n16. Acute cardiac mechanical complication: LV-free wall rupture OR interventricular septum rupture OR acute mitral regurgitation\n\nMedical Conditions \\& History:\n\n1. Suspected or known pregnancy\n2. Suspected systemic active infection\n3. History or known hepatic insufficiency prior to catheterization\n4. Undergoing a renal replacement therapy\n5. Chronic obstructive pulmonary disease (COPD) with home oxygen therapy or on chronic steroid therapy\n6. Contraindication to perform MRI or use gadolinium \\[creatinine clearance (CrCl) \\\u003C30 mL\u002Fmin, non-compatible implant, claustrophobia\\]\n\nCardiovascular history\n\n1. Known or evidence of prior MI, including pathologic Q-waves in non-anterior leads\n2. Prior coronary artery bypass graft surgery (CABG) or LAD PCI\n3. History of heart failure (documented history of EF \\\u003C40% or documented hospitalization for HF within 1 year prior to screening\n4. Prior aortic valve surgery or TAVR\n5. Left bundle branch block (new or old)\n6. History of stroke\u002FTIA within 3 months prior to screening",{"count":147,"type":21},140,[24],"The aim of this study is to evaluate the impact of sustained thrombectomy with INDIGO ASPIRATION SYSTEM using CAT RX versus no thrombectomy during primary percutaneous coronary intervention (PPCI) on microvascular obstruction and infarct size, as measured by cardiovascular magnetic resonance (CMR) between 3 and 5 days post PPCI, in patients with anterior STEMI",[151],"Anterior Myocardial Infarction",[153,154,155,156,157,158],"STEMI","thromboaspiration","anterior myocardial infarction","INDIGO CAT RX","indigo system","HEART ATTACK","2026-04-16",{"date":161,"type":33},"2026-04-21",{"date":163,"type":33},"2026-02-18",{"date":165,"type":21},"2027-05-31",{"name":39,"class":40},{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":176,"conditions":177,"keywords":180,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":189,"leadSponsor":191,"locationsCount":4},"100619724","coronary-laser-atherectomy-registry-from-an-international-taskforce-100619724","NCT07348341","Coronary Laser Atherectomy Registry From an International Taskforce","CLARIT","Inclusion Criteria:\n\nSubjects will be included if all the following criteria are met:\n\n1. Age 18 years or over\n2. Patient willing to be included in the registry\n3. Patients with stable coronary artery disease or acute coronary syndromes with de-novo or intra-stent restenosis (ISR) coronary lesions suitable to be treated with ELCA\n\n   * Non-Crossable with ICI catheter or:\n   * Crossable with ICI catheter with significant calcium score suggesting need for calcium modification based on IVUS or OCT criteria and\u002For\n   * Non-Dilatable with 1:1 NC balloon\n4. Mandated use of ICI:\n\n   * Attempted before use of ELCA or\n   * Following ELCA and any other calcium modification strategy utilized (to evaluate whether the additional modification demonstrates significant additional modification of the calcium on ICI)\n   * Final after DES implantation or prior to use of DCB\n5. Declared PCI strategy (planned use of ELCA, need for IVL\u002Fspecialty balloons\u002Falternative atherectomy and stent strategy) prior to PCI procedure\n\nExclusion Criteria:\n\n1. Pregnant or breast feeding\n2. Unable to give informed consent\n3. PCI performed without IVCI attempt\n4. No ELCA use\n5. Allergy to clopidogrel, prasugrel or ticagrelor or non-compliance\n6. Post- cardiac arrest or haemodynamic instability\n7. Participation in another trial.",{"count":175,"type":21},500,"This study is a prospective, investigator-initiated, multi-center, single arm, observational registry of performance of Excimer Laser Coronary Atherectomy (ELCA) in standard use cases of percutaneous coronary intervention (PCI).",[178,179],"Stable Coronary Artery Disease","Acute Coronary Syndromes",[181,182,172,183,184],"excimer laser coronary atherectomy","ELCA","coronary artery disease","acute coronary syndromes","2026-01-08",{"date":187,"type":33},"2026-01-16",{"date":132,"type":21},{"date":190,"type":21},"2029-07-30",{"name":39,"class":40},{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":22,"phases":202,"briefSummary":203,"conditions":204,"keywords":207,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":4},"100579286","the-european-bifurcation-club-randomized-trial-of-stepwise-provisional-stenting-versus-drug-coated-balloon-therapy-for-non-left-main-true-coronary-bifurcations-100579286","NCT06822322","The European Bifurcation Club Randomized Trial of Stepwise Provisional Stenting Versus Drug Coated Balloon Therapy for Non-left Main True Coronary Bifurcations","The European Bifurcation Club Randomized Trial of Stepwise Provisional Stenting Versus Drug Coated Balloon Therapy for Non-left Main True Coronary Bifurcations - EBC DCB Study","EBC DCB","Inclusion Criteria:\n\n* True non-left main bifurcation disease with both MV and SB involvement (i.e Medina 1\u002F1\u002F1, 1\u002F0\u002F1, 0\u002F1\u002F1)\n* Bifurcation lesion responsible for an acute or chronic coronary syndrome with at least one of the following:\n\n  * ≥70% angiographic MV and SB diameter stenosis\n  * Positive non-invasive testing for ischaemia\n  * Positive coronary physiology for ischaemia\n* Significant SB as described by diameter stenosis ≥50% and all of the following:\n\n  * SB length ≥73mm\n  * SB diameter ≥2.5mm\n  * Absence of another SB emerging distally from the MV\n  * Non-dominant circumflex artery, if SB is a diagonal branch.\n\nExclusion criteria\n\n* Patients \\\u003C18 years old\n* STEMI \\\u003C48 hours\n* Cardiogenic shock\n* Chronic total occlusion involving target bifurcation vessels\n* In-stent restenosis\n* Patient life expectancy \\\u003C12 months\n* \\>2 other coronary lesions (target or non-target) planned for treatment\n* SYNTAX score \\>32\n* Platelet count ≤50x109\u002Fmm3\n* Left ventricular ejection fraction ≤20%\n* Participation in another investigational drug or device study\n* Patient unable to give informed consent",{"count":201,"type":21},750,[24],"Clinical outcomes are worse in patients with coronary artery bifurcation lesions, even if commonly encountered in clinical practice. The use of drug coated balloons within bifurcation lesions offers the acute advantage of a more straightforward procedure, without recrossing and deformation of a stent. Thus, the primary objective of this study is to determine if Drug Coated Balloon treatment of non-left main true coronary artery bifurcation lesions is non-inferior (similar) to a provisional strategy with Drug Eluted Stent deployment.",[205,206],"Coronary Artery Disease (non-left Main)","Coronary Bifurcation Lesion",[208,209,210],"non-left coronary bifurcation","drug coated balloon","drug eluted stent","2025-02-13",{"date":213,"type":33},"2025-02-14",{"date":215,"type":21},"2025-05",{"date":217,"type":21},"2035-08",{"name":39,"class":40},{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":22,"phases":228,"briefSummary":229,"conditions":230,"keywords":235,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":247},"100476082","evaluation-of-the-valiant-captivia-physician-fenestrated-stent-graft-system-in-aortic-arch-and-descending-thoracic-aorta-pathologies-100476082","NCT05479305","Evaluation of the Valiant Captivia Physician Fenestrated Stent Graft System in Aortic Arch and Descending Thoracic Aorta Pathologies","EVERGREEN","Inclusion Criteria:\n\nTAA\u002FPAU (Thoracic Aortic Aneurysms and Penetrating Ulcers):\n\n1. Subject is at least 18 years of age.\n2. Subject understands and has signed an Informed Consent approved by the Sponsor for this study.\n3. Subject must be considered a candidate for revascularisation of BT, LCCA and LSA.\n4. Subject must be able to tolerate surgical revascularisation of BT, LCCA and LSA.\n5. Subject has a TAA\u002FPAU which is:\n\n   * a fusiform aneurysm with a diameter of ≥ 5.5 cm OR is \\> 2 times the diameter of the non-aneurysmal thoracic aorta; AND\u002FOR\n   * a saccular aneurysm or PAU (ulcer defined as ≥ 10 mm in depth and 20 mm in diameter, or symptomatic)\n6. Subject has a healthy, non-diseased aortic proximal seal zone of at least 20 mm\n7. Subject has no thrombus in the proximal neck\n8. Subject has a non-diseased aortic diameter between 25 mm and 42 mm and max diameter of the ascending aorta is ≤ 40 mm\n9. Subject has a non-diseased LSA which is eligible for stent-grafting\n10. Subject has sufficient landing zone within the LSA to accommodate the stent-graft without occlusion of any significant vessels\n11. Brachial, iliac or femoral artery access vessel morphology (diameter, calcification, tortuosity) that is compatible with vascular access techniques, the device, or accessories.\n12. Symptomatic patient who needs semi urgent repair; aptient is at high surgical risk and cannot wait for 6-8 weeks for a custom-made stent graft\n13. Subject is affiliated with the social security system\n\nInclusion criteria:\n\nTBAD(Type B Dissections) and Residual dissection after Type A repair:\n\n1. Subject is at least 18 years of age.\n2. Subject understands and has signed an Informed Consent approved by the Sponsor for this study.\n3. a) Subject has a degenerative aortic arch aneurysm which will require coverage of the LSA and extension of the proximal seal zone to zone 0 And\u002For b) Subject has a complicated TBAD (acute, subacute or chronic) which will require coverage of the LSA and extension of the proximal seal zone to zone 0 And\u002For c) Subject has a complicated residual dissection after replacement of the ascending aorta for type A aortic dissection which will require coverage of the LSA and extension of the proximal seal zone to zone 0\n4. Subject has a healthy, non-diseased (without thrombus) aortic proximal seal zone of at least 20 mm\n5. Subject has a healthy, non-diseased (without thrombus) aortic distal seal zone of at least 20 mm\n6. Subject has a maximum diameter of the distal ascending aorta just above the BT of 40 mm\n7. Subject has a non-diseased aortic diameter between 28 mm to 42 mm and the ascending aorta ≤ 40 m\n8. Subject has a no atheromatous lesions int the arch and the BT, LCCA and LSA\n9. Brachial, iliac or femoral artery access vessel morphology (diameter, calcification, tortuosity) that is compatible with vascular access techniques, the device, or accessories\n10. Symptomatic patient who needs semi urgent repair; aptient is at high surgical risk and cannot wait for 6-8 weeks for a custom-made stent graft\n11. Subject is affiliated with the social security system\n\nExclusion Criteria:\n\n(Thoracic Aortic Aneurysms and Penetrating Ulcers, TAA\u002FPAU):\n\n1. Subject has an aneurysmal, tortuous, or atherosclerotic LSA.\n2. Subject has an aneurysmal, tortuous, or atherosclerotic LCCA.\n3. Subject has an aneurysmal, tortuous, or atherosclerotic BT.\n4. Subject has an ascending aorta diameter \\> 40 mm\n5. Subject has thrombus in the proximal neck\n6. Subject has an emergent need of treatment of the aortic pathology\n7. Subject has prohibitive calcification, occlusive disease, or tortuosity of intended sealing sites\n8. Subject has circumferential calcification in the common femoral or external iliac artery or in the common iliac artery with an intraluminal diameter (ID) less than 9 mm at any point proximal to or at the access vessel site unless a surgical adjunctive procedure is planned.\n9. Subject has an aortic atheroma classified as grade IV or grade V.\n10. Subject has had previous endovascular repair of the ascending\n11. Subject has significant and\u002For circumferential aortic mural thrombus at either the proximal or distal attachment sites that would compromise sealing of the device.\n12. Subject is pregnant\n13. Subject has a known allergy or intolerance to the device components.\n14. Subject is in acute renal failure\n15. Subject has a body habitus which prevents adequate visualisation of the aorta.\n16. Subject has coronary artery disease with unstable angina and who has not received treatment.\n17. Subject has a connective tissue disease (e.g. Marfan's syndrome, medial degeneration).\n18. Subject has active systemic infection and\u002For a mycotic aneurysm.\n19. Subject is currently participating in an investigational drug or device clinical trial that would interfere with the observations of this study.\n20. Subject has other medical, social, or psychological problems that, in the opinion of the investigator, will interfere with treatment and follow-up procedures.\n21. Subject has a life expectancy of less than 2 years year.\n22. Subject requires treatment of an infrarenal aneurysm at the time of the implantation.\n23. Subject has had previous surgical or endovascular treatment of an infra-renal aortic aneurysm \\\u003C30 days of implantation of investigational device.\n24. Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.\n25. Subject has had a cerebral vascular accident (CVA) within 3 months.\n26. Subject has had a myocardial infarction (MI) within 3 months.\n27. Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment\n\nExclusion criteria:\n\n(Type B Dissections, TBAD and residual dissection after Type A repair):\n\n1. Subject has an aneurysmal, tortuous, or atherosclerotic LCCA.\n2. Subject has an aneurysmal, tortuous, or atherosclerotic LSA.\n3. Subject has an aneurysmal, tortuous, or atherosclerotic BT.\n4. Subject has a dissected BT and or LCCA\n5. Subject has prohibitive calcification, occlusive disease, or tortuosity of intended sealing sites.\n6. Subject has circumferential calcification in the common femoral artery, external iliac artery or in the common iliac artery with an intraluminal diameter (ID) less than 9 mm at any point proximal to or at the access vessel site unless a surgical adjunctive procedure is planned.\n7. Subject has an aortic atheroma classified as grade IV or grade V.\n8. Subject has had previous endovascular repair of the ascending, arch\n9. Subject has significant and\u002For circumferential aortic mural thrombus at either the proximal or distal sealing sites that would compromise seal of the device\n10. Subject is pregnant\n11. Subject has a known allergy or intolerance to the device components\n12. Subject is in acute renal failure\n13. Subject has a body habitus which prevents adequate visualisation of the aorta.\n14. Subject has coronary artery disease with unstable angina and who has not received treatment.\n15. Subject has a connective tissue disease (e.g. Marfan's syndrome, medial degeneration).\n16. Subject has active systemic infection and\u002For a mycotic aneurysm.\n17. Subject is currently participating in an investigational drug or device clinical trial that would interfere with the observationsof this study\n18. Subject has other medical, social, or psychological problems that, in the opinion of the investigator, will interfere with treatment and follow-up procedures.\n19. Subject has a life expectancy of less than 2 years.\n20. Subject requires treatment of an infrarenal aneurysm at the time of the implantation.\n21. Subject has had previous surgical or endovascular treatment of an infra-renal aortic aneurysm \\\u003C30 days of implantation of investigational device.\n22. Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.\n23. Subject has had a cerebral vascular accident (CVA) within 3 months.\n24. Subject has had a myocardial infarction (MI) within 3 months.\n25. Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.\n\n    \\-",{"count":227,"type":21},30,[24],"The study objectives are to assess safety and effectiveness, measured acutely and at the 30-day visit after implantation of the Valiant Captivia physician fenestrated Stent Graft.\n\nClinical utility measures throughout the procedure and until discharge will be assessed",[231,232,233,234],"Penetrating Ulcer of Aorta","Aneurysm Aortic","Type B Aortic Dissection","Residual Dissection After Type A Repair",[236,237,238],"aortic arch","descending thoracic aorta","valiant captivia stent graft","2024-04-30",{"date":241,"type":33},"2024-05-01",{"date":243,"type":33},"2023-11-21",{"date":245,"type":21},"2027-10",{"name":39,"class":40},4,""]