[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lithotripsy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lithotripsy":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,59],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":39,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":5},"100617275","optimal-strategy-to-correct-stent-underexpansion-in-resistant-lesions-100617275",false,"NCT07316504","Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions","OSCAR","Inclusion criteria :\n\n* Patient who have undergone coronary angiography with ISR, defined as ≥50% reduction of the diameter of the intrastent lumen occurring ≥ 6 months after stent implantation\n* And with a suspicion of stent under-expansion on angiography, possibly assisted by a stent enhancement technique\n* The reference diameter of the target vessel must be ≥2.5 mm and ≤5.0 mm.\n* Coronary flow must be TIMI 3\n* Ability to cross the lesion with the OCT catheter (possibly after predilatation with a balloon up to 2 mm)\n* Patient affiliated to the French National Health Insurance\n\nExclusion criteria :\n\n* Heart failure with NYHA III or IV (or cardiogenic shock)\n* LVEF \\\u003C20%\n* Chronic renal failure with clearance \\\u003C30mL\u002Fmn according to CKD\n* Pregnant or breast-feeding women\n* Patient with a condition\u002Fcomorbidity that could reduce compliance with the protocol, including pre-specified study follow-up\n* Patient participating in another ongoing medical study evaluating a pharmacological or biological agent or medical device, unless authorized by the concomitant protocol.\n* Patient unable to tolerate double antiaggregation (i.e., aspirin and clopidogrel or prasugrel or ticagrelor) for at least 6 months.\n* Possible or defined thrombus (by angiography or endovascular imaging) in the target vessel.","ALL","18 Years",{"count":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23],"NA","Percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) accounts for 5-10% of PCI. ISR may be linked to mechanical complications mainly under-expansion (UE), neointimal hyperplasia and\u002For neoatherosclerosis. International guidelines recommends non-compliant and very-high-pressure balloons, which lead to sub-optimal angiographic and clinical results. Recently, observational studies have suggested the feasibility and safety of intravascular lithotripsy (IVL) in UE treatment. There are no prospective randomised controlled studies comparing intravascular lithotripsy with balloons in ISR with UE.",[26,27,28,29,30,31,32,33,34,35,36,37,38],"Coronary Angioplasty","Restenosis","Lithotripsy","Restenosis of Coronary Artery Stent","Angioplasty, Transluminal, Percutaneous Coronary","Percutaneous Coronary Intervention (PCI)","OCT Angiography","Optical Coherence Tomography (OCT)","Intravascular Lithotripsy; Rotational Atherectomy; OFDI","Intravascular Lithotripsy","Coronary Artery Disease","Coronary Artery Disease (CAD)","Coronary Stent Restenosis",[40,41,42,43,44,45,46],"restenosis","underexpansion","intrastent restenosis","randomized clinical trial","intravascular lithotripsy","baloon PCI","Percutaneous coronary intervention","RECRUITING","2025-12-18",{"date":50,"type":51},"2026-01-05","ACTUAL",{"date":53,"type":51},"2025-10-22",{"date":55,"type":20},"2031-09",{"name":57,"class":58},"University Hospital, Clermont-Ferrand","OTHER",{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":21,"phases":68,"briefSummary":69,"conditions":70,"keywords":74,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},"100563450","virtual-reality-to-reduce-pain-and-anxiety-during-extracorporeal-shock-wave-lithotripsy-100563450","NCT06616324","Virtual Reality to Reduce Pain and Anxiety During Extracorporeal Shock Wave Lithotripsy","Virtual Reality: An Innovative Approach to Reduce Pain and Anxiety During Extracorporeal Shock Wave Lithotripsy - A Randomized Controlled Trial","Inclusion Criteria:\n\n* Scheduled for ESWL at Region Zealand\n* Age of 18 or above\n* Ability to understand the trial protocol, risks, and benefits and provide signed informed consent\n\nExclusion Criteria:\n\n* Inability to read and understand Danish.\n* Uncooperativeness (as judged by investigators)\n* Claustrophobia or fear of small spaces\n* Disorders that prevent the person from wearing a VR device\n* Highly visually or auditive impaired",{"count":67,"type":20},72,[23],"The objective of this study is to evaluate the impact of intraprocedural Virtual Reality (VR) as a non-pharmacological intervention for mitigating anxiety and pain during Extracorporeal Shock Wave Lithotripsy (ESWL). The hypothesis is that VR can effectively reduce both pain and anxiety levels in patients by diverting their cognitive focus, potentially leading to a decrease in pharmacological intervention requirements.\n\nThe primary outcome is pain at energy level 900 during ESWL for the intervention and the control group.\n\nThe secondary outcomes are as follows:\n\n* Type and dose of analgesia\n* Conductance scores\u002Fvalues\n* Anxiety levels\n* Patient satisfaction\n* Procedure duration\n* Adverse events\n\nParticipants will be randomized into either the intervention or control group. Both groups will undergo ESWL according to standard treatment; however, the intervention group will wear a Virtual Reality headset and noise-cancelling headphones during the procedure, while the control group will not",[71,72,73,28],"Anxiety","Pain","Virtual Reality",[73,72,71,75,76,77,28,78],"VR","ESWL","Extracorporeal Shock Wave Lithotripsy","Non-pharmacological","2025-09-22",{"date":81,"type":51},"2025-09-23",{"date":83,"type":51},"2024-10-24",{"date":85,"type":20},"2025-10-01",{"name":87,"class":58},"Zealand University Hospital",1]