[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572699":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":25,"centralContacts":38,"locations":48,"responsibleParty":142,"collaborators":145,"id":149,"slug":150,"hasResults":151,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":151,"sex":157,"minAge":158,"maxAge":25,"enrollmentInfo":159,"targetDuration":25,"studyType":162,"phases":163,"briefSummary":165,"conditions":166,"keywords":175,"overallStatus":51,"whyStopped":25,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":189},{"fullName":5,"class":6},"Spanish Society of Cardiology","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Orbital atherectomy","ACTIVE_COMPARATOR","The Diamondback-360 (OAS) (Abbott) device is used to perform this technique, consisting of a bidirectional, diamond-coated orbital crown that utilizes a combination of centrifugal force (creating elliptical orbits) and surface abrasion to modify the calcified plaque and increase distensibility. Additionally, the pulsatile impact of the crown at high speed can create microfractures in deep calcium. As a result, a single 1.25 mm crown can treat vessels ranging from 2.5 to 4 mm in diameter.",[13,14,15],"Device: Orbital atherectomy","Device: Optical Coherence Tomography (OCT)","Device: Percutaneous coronary intervention with stent implantation",{"label":17,"type":10,"description":18,"interventionNames":19},"Intravascular lithotripsy","The Shockwave Medical Intravascular Lithotripsy System (Shockwave Medical) is a balloon that emits pulsatile sonic waves capable of fracturing intracoronary calcium. This therapy is administered by advancing a catheter and inflating the balloon at low pressure to deliver sonic pulses.",[20,14,15],"Device: Intravascular lithotripsy",[22,26,30,34],{"type":23,"name":9,"description":11,"armGroupLabels":24,"otherNames":25},"DEVICE",[9],null,{"type":23,"name":17,"description":18,"armGroupLabels":27,"otherNames":28},[17],[29],"Shockwave",{"type":23,"name":31,"description":32,"armGroupLabels":33,"otherNames":25},"Optical Coherence Tomography (OCT)","Optical Coherence Tomography (OCT) is an intravascular imaging modality that uses near-infrared light to provide high-definition, cross-sectional and three-dimensional images of the vessel microstructure.\n\nThese images provide additional information on the degree and characteristics of coronary artery disease compared to angiography which doesn't delineate the composition of the coronary artery. With automated, highly accurate measurements, OCT can guide stent selection, placement, and deployment.",[17,9],{"type":23,"name":35,"description":36,"armGroupLabels":37,"otherNames":25},"Percutaneous coronary intervention with stent implantation","All patients will undergo percutaneous coronary intervention with drug-eluting stent implantation after plaque modification using the technique assigned by randomization.",[17,9],[39,44],{"name":40,"role":41,"phone":42,"phoneExt":25,"email":43},"Ángel Sánchez-Recalde, MD, PhD.","CONTACT","0034 676 59 95 32","asrecalde@hotmail.com",{"name":45,"role":41,"phone":46,"phoneExt":25,"email":47},"Luis Manuel Domínguez-Rodríguez, MD.","0034 639 82 56 65","luis-s-ma@hotmail.com",[49,69,84,98,113,128],{"facility":50,"status":51,"city":52,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Hospital Universitario General de Alicante","RECRUITING","Alicante","03010","Spain","ES",{"type":57,"coordinates":58},"Point",[59,60],-0.48149,38.34517,{"lat":60,"lon":59},[63,67],{"name":64,"role":41,"phone":65,"phoneExt":25,"email":66},"José Valencia-Martín, MD, PhD.","0034 699 43 83 76","jvalenciam@hotmail.com",{"name":64,"role":68,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"facility":70,"status":51,"city":71,"state":71,"zip":72,"country":54,"countryCode":55,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Hospital Universitario Lucus Augusti","Lugo","27003",{"type":57,"coordinates":74},[75,76],-7.55602,43.00992,{"lat":76,"lon":75},[79,83],{"name":80,"role":41,"phone":81,"phoneExt":25,"email":82},"Jeremías Bayón Lorenzo, MD, PhD.","0034 657 51 45 08","jerebayon@gmail.com",{"name":80,"role":68,"phone":25,"phoneExt":25,"email":25},{"facility":85,"status":51,"city":86,"state":86,"zip":87,"country":54,"countryCode":55,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Hospital Universitario Ramón y Cajal","Madrid","28034",{"type":57,"coordinates":89},[90,91],-3.70256,40.4165,{"lat":91,"lon":90},[94,95,96,97],{"name":40,"role":41,"phone":42,"phoneExt":25,"email":43},{"name":45,"role":41,"phone":46,"phoneExt":25,"email":47},{"name":40,"role":68,"phone":25,"phoneExt":25,"email":25},{"name":45,"role":68,"phone":25,"phoneExt":25,"email":25},{"facility":99,"status":51,"city":100,"state":100,"zip":101,"country":54,"countryCode":55,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Hospital Universitario de Salamanca","Salamanca","37007",{"type":57,"coordinates":103},[104,105],-5.66388,40.96882,{"lat":105,"lon":104},[108,112],{"name":109,"role":41,"phone":110,"phoneExt":25,"email":111},"Javier Martín-Moreiras, MD, PhD.","0034 629 25 31 16","jmmoreiras@gmail.com",{"name":109,"role":68,"phone":25,"phoneExt":25,"email":25},{"facility":114,"status":51,"city":115,"state":115,"zip":116,"country":54,"countryCode":55,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Hospital Clínico Universitario de Valladolid","Valladolid","47003",{"type":57,"coordinates":118},[119,120],-4.72353,41.65541,{"lat":120,"lon":119},[123,127],{"name":124,"role":41,"phone":125,"phoneExt":25,"email":126},"Jesús Ignacio Amat-Santos, MD, PhD.","0034 657 92 30 40","ijamat@gmail.com",{"name":124,"role":68,"phone":25,"phoneExt":25,"email":25},{"facility":129,"status":51,"city":130,"state":25,"zip":25,"country":54,"countryCode":55,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Hospital Universitario Reina Sofía de Córdoba","Córdoba",{"type":57,"coordinates":132},[133,134],-4.77275,37.89155,{"lat":134,"lon":133},[137,141],{"name":138,"role":41,"phone":139,"phoneExt":25,"email":140},"Manuel Pan, MD, PhD.","0034 676 99 91 44","manuelpanalvarez@gmail.com",{"name":138,"role":68,"phone":25,"phoneExt":25,"email":25},{"type":68,"investigatorFullName":143,"investigatorTitle":144,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Luis Manuel Domínguez Rodríguez","Interventional Cardiologist and Clinical Researcher",[146],{"name":147,"class":148},"Abbott","INDUSTRY","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":160,"type":161},50,"ESTIMATED","INTERVENTIONAL",[164],"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.",[167,168,169,170,171,31,172,173,174],"Coronary Arterial Disease (CAD)","Coronary Calcification","Coronary Calcified Nodules","Orbital Atherectomy","Intravascular Lithotripsy","Percutaneous Coronary Intervention (PCI)","Chronic Coronary Syndrome","Acute Coronary Syndrome (ACS)",[176,177,178,9,17,31,172,173,174,155,179],"Coronary arterial disease","Coronary calcification","Coronary calcified nodules","ORBIT SHOCK","2026-04-26",{"date":182,"type":183},"2026-04-30","ACTUAL",{"date":185,"type":183},"2025-06-12",{"date":187,"type":161},"2027-12",{"name":5,"class":6},6]