[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"orbital-atherectomy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:orbital-atherectomy":28},{"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":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":32,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100636493","overviewing-real-world-outcomes-to-boost-interventional-management-of-calcified-coronary-lesions-the-orobica-registry-100636493",false,"NCT07566403","Overviewing Real-World Outcomes to Boost Interventional Management of CAlcified Coronary Lesions: the OROBICA Registry.","OROBICA","Inclusion Criteria:\n\n* Patients undergoing percutaneous coronary intervention (PCI) for severely calcified coronary lesions, angiographically defined as radiopacities noted without cardiac motion before contrast injection, generally involving both sides of the arterial wall.\n* Patients undergoing PCI for calcified coronary lesions with intracoronary optical coherence tomography (OCT) showing at least one of the following features:\n\n  * calcium arc ≥180°\n  * calcium thickness ≥0.3 mm\n  * calcium length ≥3 mm\n  * presence of calcified nodules\n* Patients undergoing PCI for calcified coronary lesions with intravascular ultrasound (IVUS) showing at least one of the following features:\n\n  * calcium arc ≥180°\n  * concentric or superficial calcium with extensive acoustic shadowing\n  * presence of calcified nodules\n\nExclusion Criteria:\n\n* Lack of availability of essential clinical or procedural data.\n* Refusal or withdrawal of informed consent for the prospective component of the registry, when applicable.\n* Exercise of the right to object to data processing, according to applicable data protection regulations.","ALL","18 Years",{"count":19,"type":20},3000,"ESTIMATED","5 Years","OBSERVATIONAL","The OROBICA (Overviewing Real-World Outcomes to Boost Interventional Management of CAlcified Coronary Lesions) Registry is a multicenter, ambispective, real-world observational study designed to evaluate clinical, procedural, imaging, and economic outcomes of patients undergoing percutaneous coronary intervention (PCI) for severely calcified coronary artery disease.\n\nCoronary artery calcification represents one of the main determinants of procedural complexity and adverse outcomes in contemporary interventional cardiology. Despite the increasing availability of advanced calcium-modification technologies and intracoronary imaging techniques, evidence regarding the optimal treatment strategy in real-world clinical practice remains limited, particularly among high-risk and complex patients often underrepresented in randomized trials.\n\nThe OROBICA Registry aims to systematically collect longitudinal data from all-comer patients treated for severely calcified coronary lesions using contemporary PCI strategies, including intracoronary imaging guidance (IVUS\u002FOCT), rotational atherectomy, orbital atherectomy, intravascular lithotripsy, specialty balloons, and combined calcium-modification approaches.\n\nThe primary objective is to assess clinical and procedural outcomes, with particular focus on target vessel failure (TVF). Secondary and exploratory objectives include evaluation of procedural success, imaging findings, predictors of adverse outcomes, healthcare resource utilization, and economic impact associated with the treatment of calcified coronary lesions.\n\nThe registry is designed as a flexible research platform intended to support future hypothesis-generating analyses and provide real-world evidence to improve personalized management strategies for calcified coronary artery disease.",[25,26,27,28,29,30,31],"Coronary Artery Disease (CAD)","Calcific Coronary Arteriosclerosis","Intravascular Lithotripsy; Rotational Atherectomy; OFDI","Orbital Atherectomy","Optical Coherence Tomography (OCT)","Intravascular Ultrasound","Percutaneous Coronary Intervention",[33,34,35,36,37,38,39,40,41,42],"Coronary calcifications","coronary artery disease","percutaneous coronary intervention","intravascular imaging","atherectomy","intravascular lithotripsy","rotational atherectomy","orbital atherectomy","cutting balloon","target vessel failure","NOT_YET_RECRUITING","2026-05-04",{"date":46,"type":47},"2026-05-06","ACTUAL",{"date":49,"type":20},"2026-06-30",{"date":51,"type":20},"2036-06-30",{"name":53,"class":54},"Papa Giovanni XXIII Hospital","OTHER",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":78,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100572699","orbital-atherectomy-vs-intravascular-lithotripsy-for-the-treatment-of-calcified-coronary-nodules-orbit-shock-100572699","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.",{"count":65,"type":20},50,"INTERVENTIONAL",[68],"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.",[71,72,73,28,74,29,75,76,77],"Coronary Arterial Disease (CAD)","Coronary Calcification","Coronary Calcified Nodules","Intravascular Lithotripsy","Percutaneous Coronary Intervention (PCI)","Chronic Coronary Syndrome","Acute Coronary Syndrome (ACS)",[79,80,81,82,83,29,75,76,77,62,84],"Coronary arterial disease","Coronary calcification","Coronary calcified nodules","Orbital atherectomy","Intravascular lithotripsy","ORBIT SHOCK","RECRUITING","2026-04-26",{"date":88,"type":47},"2026-04-30",{"date":90,"type":47},"2025-06-12",{"date":92,"type":20},"2027-12",{"name":94,"class":54},"Spanish Society of Cardiology",6,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":66,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":55},"100601087","trial-to-assess-non-inferiority-of-an-orbital-atherectomy-only-versus-a-calcium-tailored-debulking-approach-100601087","NCT07105930","Trial to Assess Non-inferiority of an Orbital Atherectomy Only Versus a Calcium-tailored Debulking Approach","A Randomized Controlled Multicentric Trial to Assess Non-inferiority of an Orbital Atherectomy Only Versus a Calcium-tailored Debulking Approach","OrFitA","Inclusion Criteria:\n\n* Age ≥ 18 Years\n* Chronic coronary syndrome with a clinical indication for percutaneous coronary intervention of a severely calcified lesion as defined by coronary computer tomography (CT; Agatston Score of target lesion ≥453 OR Calcium Arc \\>270°). The determination of calcification in the target lesion is based on native and contrast enhanced CT scans that are conducted as per clinical guidelines. The CT images must not be older than 6 months at the time of patient enrollment.\n* Signed informed consent\n* The patient is an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy\n\nExclusion Criteria:\n\n* Acute ST-Elevation Acute Coronary Syndrome (STE-ACS) within 48 hours\n* Cardiogenic shock\n* Chronic total occlusion of the target lesion\n* Glomerular filtration rate \\\u003C 30 ml\u002Fmin\u002F1.73 m2\n* Known presence, at the time of enrollment, of any contraindications listed in the Instructions for Use (IFU) of the investigational device:\n\n  * The OCT (optical coherence tomography) imaging catheter cannot cross\n  * The wire or imaging catheter cannot cross\n  * The target lesion is within a bypass graft or stent\n  * The patient is not an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy.\n  * The patient has angiographic evidence of thrombus\n  * The patient has only one open coronary vessel\n  * The patient has angiographic evidence of flow reducing dissection at the treatment site\n  * The patient has a known hypersensitivity to egg-, soy-, or peanut protein or to any of the active substances or excipients of the ViperSlide™ lubricant\n  * Pregnancy (assessed by clinical routine testing)\n* Participation in another interventional clinical trial",{"count":105,"type":20},310,[68],"Some patients with coronary artery disease have severely calcified vessels. In these cases, placing a stent - a small tube that helps keep the artery open - can be very difficult. Calcium build-up in the artery wall may prevent the stent from expanding properly, increasing the risk of complications or failure of the treatment.\n\nTo prepare these vessels before stenting, doctors use special techniques to modify or remove the calcium. These techniques are known as plaque modification strategies and can include devices such as atherectomy systems, scoring balloons, or intravascular lithotripsy. However, there is no clear standard as to which strategy is best.\n\nPurpose of the Study:\n\nThis study compares two different approaches to treating calcified coronary arteries before stenting:\n\n* A uniform approach using only the orbital atherectomy system (Diamondback 360®, Abbott), which sands away the calcium with a rotating crown\n* A tailored approach, where the operator chooses from various available methods (e.g., rotational atherectomy, scoring or cutting balloons, or shockwave therapy) based on the patient's specific type of calcium The goal is to determine whether the uniform orbital atherectomy approach is not worse (non-inferior) than the individualized method when it comes to how well the stent expands inside the artery.\n\nThis is a randomized, controlled clinical trial. Patients will be randomly assigned to one of the two groups.\n\nRandomization ensures fair comparison between both groups. The decision to implant a stent and to use additional techniques is at the discretion of the interventional cardiologist.",[28],"2026-03-23",{"date":111,"type":47},"2026-03-27",{"date":113,"type":47},"2025-10-30",{"date":115,"type":20},"2027-03",{"name":117,"class":54},"IHF GmbH - Institut für Herzinfarktforschung"]