[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"calcific-coronary-arteriosclerosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:calcific-coronary-arteriosclerosis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,87,114],{"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":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100642157","evaluation-of-calcified-coronary-lesion-preparation-with-the-naviscore-scoring-balloon-100642157",false,"NCT07650578","Evaluation of Calcified Coronary Lesion Preparation With the Naviscore Scoring Balloon","MILOU: Minimize Intra Luminal Obstructive Underexpansion: A Prospective, Multi-Center Randomized Trial for the Evaluation of Calcified Coronary Lesion Preparation With the Naviscore Scoring Balloon","MILOU","Inclusion Criteria:\n\n* Patient written consent is given, ≥18 years.\n* A de novo lesion to be treated in a vessel between 2.5 and 4.0 mm.\n* Moderate to heavily calcified lesions detected by coronary angiography on two orthogonal views, and confirmed by IVUS if the lesion can be crossed with the catheter.\n\nExclusion Criteria:\n\n* Patient \\\u003C18 years old.\n* Pregnant female.\n* Contraindication to dual antiplatelet therapy.\n* Thrombocytopenia (under 100 000).\n* Major surgical intervention planned within one year.\n* Significant left main lesion.\n* Chronic total occlusion.\n* Lesion in a graft.\n* In-stent restenosis lesion.\n* Lesion responsible of a ST elevated Myocardial Infarction (STEMI)","ALL","18 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this clinical study is to evaluate the effectiveness and safety of a specialized medical device, the Naviscore scoring balloon, in preparing calcified coronary artery narrowings before the implantation of a drug-eluting stent. During percutaneous coronary interventions, the presence of calcified plaques in the heart arteries represents a major challenge because it can prevent stents from expanding fully. When a stent remains under-expanded, it significantly increases the long-term risk of arterial re-narrowing or blood clot formation. To optimize stent expansion, appropriate preparation of the diseased vessel section before stent insertion is a critical phase.\n\nThis study is a prospective, multi-center randomized trial designed to test the hypothesis that treating calcified coronary lesions with the Naviscore scoring balloon will achieve a better stent expansion and a larger final minimal stent area compared to standard lesion preparation using regular non-compliant balloons. Eligible participants will be randomized in a one-to-one ratio to one of these two lesion preparation strategies. For all included patients, standard drug-eluting stents will be deployed. The study will use intravascular ultrasound imaging to evaluate the final minimum area of the stent directly inside the treated artery at the site of the highest initial calcium burden. Participant health and clinical outcomes will be monitored for up to twelve months following the procedure.",[27,28],"Coronary Arterial Disease (CAD)","Calcific Coronary Arteriosclerosis",[30,31,32,33,34,35],"Percutaneous Coronary Intervention","Lesion Preparation","Scoring Balloon","Intravascular Ultrasound","Stent Expansion","Coronary Artery Calcification","NOT_YET_RECRUITING","2026-06-10",{"date":39,"type":40},"2026-06-16","ACTUAL",{"date":42,"type":21},"2026-07",{"date":44,"type":21},"2028-06",{"name":46,"class":47},"University of Mons","OTHER",14,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":58,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":66,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"100636493","overviewing-real-world-outcomes-to-boost-interventional-management-of-calcified-coronary-lesions-the-orobica-registry-100636493","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.",{"count":57,"type":21},3000,"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.",[62,28,63,64,65,33,30],"Coronary Artery Disease (CAD)","Intravascular Lithotripsy; Rotational Atherectomy; OFDI","Orbital Atherectomy","Optical Coherence Tomography (OCT)",[67,68,69,70,71,72,73,74,75,76],"Coronary calcifications","coronary artery disease","percutaneous coronary intervention","intravascular imaging","atherectomy","intravascular lithotripsy","rotational atherectomy","orbital atherectomy","cutting balloon","target vessel failure","2026-05-04",{"date":79,"type":40},"2026-05-06",{"date":81,"type":21},"2026-06-30",{"date":83,"type":21},"2036-06-30",{"name":85,"class":47},"Papa Giovanni XXIII Hospital",1,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":95,"targetDuration":97,"studyType":59,"phases":4,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":86},"100630702","brazilian-prospective-registry-of-the-inspiron-evo-drug-eluting-stent-in-complex-coronary-lesions-100630702","NCT07491107","Brazilian Prospective Registry of the Inspiron EVO Drug-Eluting Stent in Complex Coronary Lesions","National Prospective Registry of the Inspiron EVO Drug-Eluting Stent in Complex Coronary Lesions","PCI EVOlution","Inclusion Criteria:\n\n* Individuals aged 18 years or older presenting with complex coronary lesions requiring percutaneous coronary intervention (PCI).\n* Individuals who provide consent and are willing to comply with the follow-up protocol.\n* Individuals who received treatment with the Inspiron™ EVO Stent.\n* Individuals with lesions ≥ 30 mm in length (Subprotocol 1).\n* Individuals with significantly calcified coronary lesions (moderate to severe according to the ACC\u002FAHA classification B1, B2, or C), with or without indication for lesion preparation techniques (Subprotocol 2).\n* Individuals with multivessel coronary artery disease (≥2 affected coronary vessels, with at least one vessel of small diameter ≤2.5 mm) (Subprotocol 3).\n* Individuals included in Subprotocol 1, 2, or 3. The evaluated segment must be accessible to the IVUS (Intravascular Ultrasound) catheter (Subprotocol 4).\n\nExclusion Criteria:\n\n* Lesions in saphenous vein grafts or internal mammary grafts.\n* Contraindication to the use of a drug-eluting stent.\n* Individuals who were treated during the index procedure with any stent other than the Inspiron™ EVO Stent.",{"count":96,"type":21},2000,"12 Months","The objective is to evaluate the efficacy and safety of the Inspiron™ EVO drug-eluting stent in complex coronary lesions in a real-world population. Patients with symptomatic ischemic heart disease due to lesions in native coronary arteries and restenotic lesions will be treated with the Inspiron™ EVO drug-eluting stent.",[62,100,101,102,28,103],"Stenosis Coronary","Small Vessel Ischemic Disease","Multivessel Coronary Artery Disease","Complex Coronary Lesions","2026-03-24",{"date":106,"type":40},"2026-03-30",{"date":108,"type":21},"2026-04-30",{"date":110,"type":21},"2030-04-30",{"name":112,"class":113},"Scitech Produtos Medicos SA","INDUSTRY",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":86},"100465849","the-value-of-ivl-compared-to-opn-non-compliant-balloons-for-treatment-of-refractory-coronary-lesions-victory-trial-100465849","NCT05346068","The Value of IVL Compared To OPN Non-Compliant Balloons for Treatment of RefractorY Coronary Lesions (VICTORY) Trial","The Value of IVL Compared To OPN Non-Compliant Balloons for Treatment of RefractorY Coronary Lesions (VICTORY) Trial - A Randomized, Multicenter, Non-inferiority Comparison of Shockwave Intravascular Lithotripsy (IVL) and the OPN Non-compliant Balloon for Treatment of Calcified and Refractory Coronary Lesions","VICTORY","Clinical inclusion criteria:\n\n* Age ≥18 years and consentable;\n* Acute or chronic coronary artery disease with ischemia related symptoms (e.g. angina) and\u002For evidence of myocardial ischemia (e.g. FFR\u002F iFR, CMR, SPECT or PET-CT);\n* Angiographically-proven coronary artery disease;\n* Lesions in non-target vessels requiring PCI may be treated either\n\n  * prior to the study procedure if the procedure was unsuccessful or complicated; or\n  * in the same session if feasible and safe for the patient, otherwise a staged PCI procedure for non-target vessels may be considered;\n* Informed Consent signed by the subject.\n\nAngiographic inclusion criteria:\n\n* Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches) with\\*:\n\n  * Stenosis of ≥70%;\n  * Stenosis ≥50% and \\\u003C70% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve value ≤0.80, or iFR \\\u003C0.90 or IVUS minimum lumen area ≤4.0 mm²;\n* The target vessel reference diameter must be ≥2.5 mm \\& ≤4.5mm;\n* AND AT LEAST ONE OF THE FOLLOWING CRITERIA:\n\n  * Evidence of calcification at the lesion site by angiography (Grade 3), with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location and total length of calcium of at least 15 mm and extending partially into the target lesion,\n  * AND\u002F OR by OCT, with presence of ≥270° calcium;\n  * AND\u002F OR Prior attempt at PCI with inability to expand a balloon in target lesion.\n\nAnnotation: Only one lesion and vessel per randomized patient may be treated according to protocol and considered for the purpose of this study. The lesion considered for the study should represent the most calcified one.\n\nThe presence of any one of the following exclusion criteria will lead to the exclusion of the subject:\n\nExclusion criteria:\n\n* Patient experienced an acute STEMI or cardiogenic shock related to an acute MI within 2 days prior to index procedure;\n* Any comorbidity or condition which may reduce compliance with this protocol, including follow-up calls\u002F visits (e.g. advanced dementia);\n* Any medical, geographic, and\u002For social factor making study participation impractical or precluding required follow-up.\n* Patient is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment);\n* Unable to take a P2Y12 inhibitor (i.e. clopidogrel, prasugrel, or ticagrelor) for at least 6 months;\n* Patient has an allergy to imaging contrast media which cannot be adequately pre-medicated;\n* Renal failure with an eGFR \\\u003C30ml\u002Fmin1.73m2;\n* History of a stroke or transient ischemic attack (TIA) within 7 days, or any prior intracranial hemorrhage;\n* Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months;\n* Untreated pre-procedural hemoglobin \\\u003C10g\u002FdL or intention to refuse blood transfusions if one should become necessary;\n* Patient has an allergy or intolerance to cobalt-chromium and\u002F or everolimus.\n* Life expectancy of less than 1 year.\n\nAngiographic exclusion criteria:\n\n* Anatomy where the device or OCT catheter are unlikely to be delivered due to tortuosity or other characteristics;\n* Target lesion is in a coronary artery bypass graft;\n* Target lesion is an in-stent restenosis (ISR);\n* Flow limiting target vessel thrombus (evident on angiography or OCT);\n* Definite or possible thrombus (by angiography or intravascular imaging) in the target vessel;\n* Evidence of aneurysm in target vessel within 10 mm of the target lesion.\n\nOf note, only qualified physicians who are investigators or a sub-investigators for the trial will assess each individual´s eligibility criteria and take the final decision to include the subject in the trial (ICH GCP 4.3.1). This decision will be documented prior to the subject receiving the first intervention.",{"count":123,"type":21},280,[24],"Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation has become the dominant treatment strategy for patients with acute and chronic coronary artery disease (CAD) requiring revascularization. Nonetheless, PCI with stent implantation has some limitations and especially patients with severely calcified coronary lesions (approximately 10-20% of all patients with CAD) have an elevated risk for adverse outcomes, including target lesion failure (TLF) and stent thrombosis (ST).\n\nSeveral dedicated PCI devices have been developed for treatment of severely calcified lesions. Whereas especially two of them have shown promising results in smaller, prospective studies. First, the super high-pressure NC PCI balloon (OPN™ NC, SIS Medical AG, Frauenfeld, Switzerland) has been shown to represent an effective and safe device for lesion preparation. Second, the lately introduced Shockwave intravascular lithotripsy (IVL)™ balloon catheter (Shockwave Medical, Santa Clara, CA, USA) appears to be a safe and efficient alternative device for treatment of calcified coronary lesions. However, it remains unknown, if the OPN™ NC balloon is non-inferior to to IVL regarding lesion preparation and completeness of stent expansion in severely calcified lesions.",[127,128,28,129,35],"Coronary Disease","Coronary Artery Disease","Stent Restenosis","RECRUITING","2024-06-16",{"date":133,"type":40},"2024-06-18",{"date":135,"type":40},"2022-11-22",{"date":137,"type":21},"2028-05-30",{"name":139,"class":47},"Luzerner Kantonsspital"]