[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intravascular-lithotripsy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intravascular-lithotripsy":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,56,96],{"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":36,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100572699","orbital-atherectomy-vs-intravascular-lithotripsy-for-the-treatment-of-calcified-coronary-nodules-orbit-shock-100572699",false,"NCT06736665","Orbital Atherectomy vs Intravascular Lithotripsy for the Treatment of Calcified Coronary Nodules (ORBIT-SHOCK).","Comparative Efficacy of Orbital Atherectomy and Intravascular Lithotripsy in the Treatment of Calcified Coronary Nodules. The ORBIT-SHOCK Pilot Study.","ORBIT-SHOCK","Inclusion Criteria:\n\n1. Patients aged ≥ 18 years.\n2. Atherosclerotic coronary artery disease with calcified nodules identified by OCT in a native vessel, eligible for percutaneous coronary revascularization.\n3. Clinical presentation of chronic coronary syndrome or acute coronary syndrome without ST elevation\\*.\n4. Distal vessel reference diameters ≥ 2.5 mm and ≤ 4.0 mm. \\* Non-culprit lesions eligible for revascularization in a staged procedure following a ST-elevation myocardial infarction (STEMI) are considered for inclusion.\n\nExclusion Criteria:\n\n1. Culprit lesions in acute coronary syndrome with ST elevation.\n2. Left main disease.\n3. In-stent restenosis lesions.\n4. Critical stenoses where it is not possible to advance the OCT catheter across the lesion after predilation with a balloon of up to 2 mm in diameter.\n5. Lesion involving a bifurcation with a secondary branch diameter ≥2 mm.\n6. Cardiogenic shock.\n7. Patients requiring cardiac surgery or percutaneous valve intervention within three months before or after angioplasty.\n8. Pregnancy.\n9. Life expectancy of less than one year.\n10. Contraindication for the use of appropriate antiplatelet therapy post-revascularization.\n11. Coronary artery disease with an indication for surgical revascularization.\n12. Advanced chronic kidney disease or anatomical characteristics that contraindicate the use of optical coherence tomography.\n13. Inability to obtain informed consent.\n14. Allergy to eggs or soy, contraindicating the use of OA.","ALL","18 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"NA","The ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting calcified nodules (CN), identified by optical coherence tomography (OCT), causing significant angiographic stenosis and eligible for revascularization through percutaneous coronary intervention (PCI).\n\nPatients will be randomized in a 1:1 ratio to undergo lesion preparation with either orbital atherectomy (OA) or intravascular lithotripsy (IVL).\n\nThe ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting calcified nodules (CN), identified by optical coherence tomography (OCT), causing significant angiographic stenosis and eligible for revascularization through percutaneous coronary intervention (PCI). Patients will be randomized in a 1:1 ratio to undergo lesion preparation with either orbital atherectomy (OA) or intravascular lithotripsy (IVL).\n\nThe aim of this pilot trial is to compare PCI outcomes and the incidence of adverse events between both techniques.",[27,28,29,30,31,32,33,34,35],"Coronary Arterial Disease (CAD)","Coronary Calcification","Coronary Calcified Nodules","Orbital Atherectomy","Intravascular Lithotripsy","Optical Coherence Tomography (OCT)","Percutaneous Coronary Intervention (PCI)","Chronic Coronary Syndrome","Acute Coronary Syndrome (ACS)",[37,38,39,40,41,32,33,34,35,15,42],"Coronary arterial disease","Coronary calcification","Coronary calcified nodules","Orbital atherectomy","Intravascular lithotripsy","ORBIT SHOCK","RECRUITING","2026-04-26",{"date":46,"type":47},"2026-04-30","ACTUAL",{"date":49,"type":47},"2025-06-12",{"date":51,"type":21},"2027-12",{"name":53,"class":54},"Spanish Society of Cardiology","OTHER",6,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":66,"conditions":67,"keywords":78,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100617275","optimal-strategy-to-correct-stent-underexpansion-in-resistant-lesions-100617275","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.",{"count":64,"type":21},80,[24],"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.",[68,69,70,71,72,33,73,32,74,31,75,76,77],"Coronary Angioplasty","Restenosis","Lithotripsy","Restenosis of Coronary Artery Stent","Angioplasty, Transluminal, Percutaneous Coronary","OCT Angiography","Intravascular Lithotripsy; Rotational Atherectomy; OFDI","Coronary Artery Disease","Coronary Artery Disease (CAD)","Coronary Stent Restenosis",[79,80,81,82,83,84,85],"restenosis","underexpansion","intrastent restenosis","randomized clinical trial","intravascular lithotripsy","baloon PCI","Percutaneous coronary intervention","2025-12-18",{"date":88,"type":47},"2026-01-05",{"date":90,"type":47},"2025-10-22",{"date":92,"type":21},"2031-09",{"name":94,"class":54},"University Hospital, Clermont-Ferrand",2,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":4},"100556193","clinical-trial-on-the-treatment-of-stent-underexpansion-caused-by-calcification-using-intravascular-lithotripsy-100556193","NCT06521905","Clinical Trial on the Treatment of Stent Underexpansion Caused by Calcification Using Intravascular Lithotripsy","Prospective, Multicenter, Randomized Controlled Study on the Treatment of Stent Underexpansion Caused by Calcification Using Intravascular Lithotripsy","Inclusion Criteria:\n\n1. Age range: 18-80 years old, male or non pregnant female\n2. The patient or guardian can voluntarily sign and understand the informed consent form, and can accept follow-up\n3. Asymptomatic ischemic, stable or unstable angina or myocardial infarction (MI) (including ST segment elevation and non ST segment elevation MI) with chest pain onset to hospital admission time\\>24 hours, as well as old myocardial infarction patients\n4. Visually assess the target lesion with a reference vessel diameter of 2.5-4.0mm, diameter stenosis degree ≥ 70% or ≥ 50%, and evidence of ischemia\n5. The target lesion is the only lesion that requires treatment this time\n6. Patients suitable for percutaneous coronary stent implantation\n7. Confirmed by coronary angiography or IVUS testing that the target lesion is calcified, with any degree of calcification\n8. After surgical treatment for calcified lesions, IVUS testing confirmed that it meets the criteria for incomplete stent expansion\n\nExclusion Criteria:\n\nExclusion criteria for patient level:\n\n1. Individuals with abnormal coagulation function tests\n2. Patients with severe hemodynamic disorders\n3. Clinical manifestations of heart failure with LVEF\\\u003C30%\n4. I have experienced an acute myocardial infarction in the past week\n5. Patients allergic to heparin, contrast agents, antiplatelet drugs, anticoagulants, anesthetics, etc\n6. Patients with severe myocardial bridge\u002Fnegative remodeling or target vessel thrombosis\n7. Pregnant or lactating women\n8. Patients with malignant tumors or comorbidities with a life expectancy of less than 12 months\n9. History of active peptic ulcer or gastrointestinal bleeding within 6 months prior to enrollment\n10. Stroke occurred within 6 months prior to enrollment, excluding transient ischemic attack (TIA) and cerebral infarction\n11. Severe liver and kidney function impairment, transaminase levels exceeding the upper limit of normal by more than three times, creatinine levels greater than 2.5mg\u002FdL (221 μ moI\u002FL), or chronic renal failure requiring long-term dialysis\n12. Anti thrombotic therapy intolerance\n13. Severe anemia, thrombocytopenia, or leukopenia\n14. History of severe bleeding (intracranial, gastrointestinal)\n15. Also participating in other patients who have not completed clinical trials at the same time\n16. Patients with poor compliance and inability to complete the study on time\n17. Other situations deemed unsuitable by researchers to participate in this clinical study\n\nExclusion criteria for vascular level:\n\n1. Thrombotic lesion\n2. Bridge vascular disease\n3. Angiography shows tortuous vascular pathways, making it difficult for experimental instruments to reach the target position or retrieve them","80 Years",{"count":105,"type":21},222,[24],"Our aim is to investigate the efficacy and safety of intravascular lithotripsy(IVL) in the treatment of stent underexpansion caused by calcification through a prospective, multicenter, randomized controlled trial. Patients with inadequate stent expansion due to calcification detected by intravascular ultrasound(IVUS) were randomly divided into two groups. The experimental group received IVL in addition to high-pressure balloon post-dilation, while the control group only received high-pressure balloon post-dilation. Follow up for 1 year is conducted to determine the safety and efficacy of IVL application based on the primary efficacy endpoint, key secondary efficacy endpoint, other secondary efficacy endpoint, and safety endpoint.",[31],"NOT_YET_RECRUITING","2024-07-25",{"date":112,"type":47},"2024-07-29",{"date":114,"type":21},"2024-10-01",{"date":116,"type":21},"2026-10-01",{"name":118,"class":119},"China National Center for Cardiovascular Diseases","OTHER_GOV"]