[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100466454":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":55,"collaborators":24,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":24,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":41,"whyStopped":24,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Hospital Universitario La Paz","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Elective Rotational Atherectomy","ACTIVE_COMPARATOR","Operators can decide elective use of rotational atherectomy (RA) or conventional angioplasty according to the calcification patterns of the coronary lesion evaluated by Intravascular ultrasound (IVUS) or by angiography if the IVUS cannot cross the lesion.\n\nProcedure is performed with a Rotablator system, consisting of a rotating olive-shaped burr whose leading hemisphere is coated with microscopic diamond chips. The proximal end of the device has a housing unit containing the burr advancer, a fiberoptic tachometer cable, an irrigation port, and a nitrogen gas delivery hose, which permits the rapidly rotating of the burr. The RA catheter is introduced into the coronary artery over a stainless steel 0.09-inch wire to cross the lesion, then advanced with a slow pecking motion at a speed of 160,000 to 190,000 rpm with each ablation run \\\u003C15 seconds is performed. Burr size was with a burr\u002Fvessel ratio of 0.7. After RA, all patients received IVUS-guided percutaneous coronary intervention.",[13],"Device: Percutaneous coronary intervention (PCI)",{"label":15,"type":10,"description":16,"interventionNames":17},"Bailout Rotational Atherectomy","The operators began with conventional angioplasty (non-compliant balloon dilatation) regardless of the calcification patterns in the coronary lesion, and rotational atherectomy (RA) can be used only as a bailout.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Percutaneous coronary intervention (PCI)","Optimal stent expansion by IVUS-guided PCI.",[15,9],null,[26],{"name":27,"affiliation":28,"role":29},"Guillermo Galeote, PhD, MD","La Paz University Hospital","PRINCIPAL_INVESTIGATOR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":24,"email":34},"CONTACT","+34609024315","ggaleote1@gmail.com",{"name":36,"role":32,"phone":37,"phoneExt":24,"email":38},"Artemio García-Escobar, MD","+34608936547","dr_garciaescobar@hotmail.com",[40],{"facility":28,"status":41,"city":42,"state":24,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Madrid","28046","Spain","ES",{"type":47,"coordinates":48},"Point",[49,50],-3.70256,40.4165,{"lat":50,"lon":49},[53,54],{"name":27,"role":32,"phone":33,"phoneExt":24,"email":34},{"name":36,"role":32,"phone":37,"phoneExt":24,"email":38},{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Guillermo Galeote; MD, PhD","Principal Investigator","100466454","coronary-rotational-atherectomy-elective-vs-bailout-in-severely-calcified-lesions-and-chronic-renal-failure-100466454",false,"NCT05353946","Coronary Rotational Atherectomy Elective vs. Bailout in Severely Calcified Lesions and Chronic Renal Failure","CRATER Trial: Coronary Rotational Atherectomy Elective vs. Bailout in Patients With Severely Calcified Lesions and Chronic Renal Failure","CRATER","Inclusion Criteria:\n\n* Patients \\>18 years.\n* Glomerular filtration rate (GFR) \\\u003C60 mL\u002Fmin\u002F1.73 m2 for 3 months or more\n* Stenosis ≥70% in a coronary artery with a diameter ≥2,5 mm.\n* Severe angiographic calcification (affecting both sides of the arterial lumen)\n* Any clinical scenario except acute myocardial infarction in the first seven days of evolution.\n* Native coronary vessel or bypass graft.\n\nExclusion Criteria:\n\n* Absence of informed consent.\n* Acute myocardial infarction in the first 7 days of evolution.\n* Lesion in a single patent vessel.\n* Calcified lesions with an angulation \\>60º, dissections, lesions with thrombus, and degenerated saphenous vein grafts.\n* Hemodynamically unstable patients\n* Patients with allergy to iodinated contrast media\n* Patients with significant comorbidity and with a life expectancy of less than one year","ALL","18 Years","100 Years",{"count":71,"type":72},124,"ESTIMATED","INTERVENTIONAL",[75],"NA","The current role of the rotational atherectomy is for non-dilatable coronary lesions and for severely calcified lesions that may interfere with optimal stent expansion.\n\nSeverely calcified coronary lesions are associated with worse outcomes. In this regard, chronic kidney disease is associated with severely calcified coronary arteries.\n\nSome evidence suggests that elective rotational atherectomy used by experienced operators can be safe and effective, minimizing time and complications for patients with heavily calcified lesions.\n\nHowever, there is no direct randomized comparison between rotational atherectomy and angioplasty alone in the setting of chronic renal failure and with intravascular ultrasound assessment for detecting severely calcified coronary arteries.",[78,79],"Coronary Artery Disease","Chronic Renal Failure",[81,82,83,84,85],"Severely calcified coronary lesion","Rotational atherectomy","Chronic kidney disease","Intravascular ultrasound","Percutaneous coronary intervention","2022-04-25",{"date":88,"type":89},"2022-04-29","ACTUAL",{"date":91,"type":89},"2019-02-02",{"date":93,"type":72},"2023-12-04",{"name":57,"class":6},1]