[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Robocath\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100604183","first-in-human-trial-of-r-star-a-novel-robotic-system-for-minimally-invasive-coronary-artery-procedures-100604183",false,"NCT07146204","First in Human Trial of R-Star: A Novel Robotic System for Minimally Invasive Coronary Artery Procedures.","First in Human Evaluation of the R-Star, a Novel Robotic-assisted Percutaneous Coronary Intervention System","R-STAR-FIH","Inclusion Criteria:\n\n* Subjects eligible for inclusion in this study must meet all of the following inclusion criteria:\n* Patient ≥ 18 years old;\n* Patient with confirmed CAD, with indication for elective PCI;\n* Patient with CAD presenting the following specifications:\n\n  * de novo native coronary artery lesion (i.e. a coronary lesion not previously treated)\n  * Study reference vessel diameter is between 2.5 mm and 4.0 mm by visual estimate\n  * Study lesion diameter showing stenosis of at least 50% by visual estimate.\n* Subject deemed appropriate for robotic-assisted PCI with R-Two system used per its intended use; based on the investigator's judgment;\n* The patient provides written informed consent as approved by the applicable Ethics Committee and is willing to comply with all study requirements including 30 day follow-up;\n* The patient is affiliated with a social security system.\n* Female subjects must be of non-child bearing potential, or if able to bear children, have a negative urinary pregnancy test within 7 days prior to the intended index procedure.\n\nExclusion Criteria:\n\n* Planned PCI or coronary artery bypass graft (CABG) within 30 days after the study procedure.\n* Acute myocardial infarction within 72 hours before the study procedure.\n* Left ventricular ejection fraction \\\u003C 30%.\n* Recent PCI within 72 hours, or PCI within the past 30 days with a major adverse cardiac event.\n* Known allergy or contraindication to study-related medications or materials (aspirin, heparin, P2Y12 inhibitors, stainless steel, cobalt chromium, contrast media) not manageable with premedication.\n* Significant blood count abnormalities (platelets \\\u003C 100,000\u002Fmm³ or \\> 700,000\u002Fmm³; WBC \\\u003C 3,000\u002Fmm³).\n* Severe renal impairment (serum creatinine \\> 2.0 mg\u002FdL or eGFR \\\u003C 30 mL\u002Fmin).\n* Stroke within 30 days before the procedure.\n* Hemodynamic instability or acute pulmonary edema.\n* Significant active bleeding or high bleeding risk (recent GI bleeding, bleeding disorders, refusal of transfusion).\n* Pregnancy, breastfeeding, or planning pregnancy before study completion.\n* Current participation in another investigational study without completed follow-up.\n* Angiographic exclusions: total occlusion, intraluminal thrombus, need for atherectomy or other non-balloon devices before stenting, unprotected left main stenosis \\> 50%, or certain bypass graft lesions.","ALL","18 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn if the R-Star robotic system can be used safely and effectively to perform percutaneous coronary intervention (PCI) in adults with coronary artery disease who are scheduled for an elective PCI.\n\nThe main questions it aims to answer are:\n\n* Can PCI be completed with the robotic system without needing to switch fully to manual operation because of a technical issue or system limitation?\n* Is the treated artery adequately opened without complications during the procedure?\n\nParticipants will:\n\n* Have selection tests, including a medical exam, lab tests, ECG, and a review of their medical history.\n* Undergo PCI using the R-Star robotic system, with angiography before and after the procedure.\n* Have checkups before leaving the hospital and about 30 days later to monitor recovery and collect study data.",[27],"Coronary Artery Disease",[29,30,31],"coronary artery disease","percutaneous coronary intervention","Robotic-assisted percutaneous coronary intervention","NOT_YET_RECRUITING","2025-08-21",{"date":35,"type":36},"2025-08-28","ACTUAL",{"date":38,"type":21},"2026-01",{"date":40,"type":21},"2026-02",{"name":42,"class":43},"Robocath","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":55,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100504829","change-history-and-adopt-a-robotic-solution-for-angioplasty-procedure-100504829","NCT05853419","Change History and Adopt a Robotic SolutioN for anGioplasty procedurE","CHANGE","Inclusion Criteria:\n\n* 1\\. Age ≥ 18 years;\n* 2.Subjects with coronary artery disease with clinical indication for PCI;\n* 3.Subject deemed appropriate for robotic-assisted PCI; and\n* 4.The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.\n\nExclusion Criteria:\n\n* 1.Failure\u002Finability\u002Funwillingness to provide informed consent, unless the ethic committee has waived informed consent; or\n* 2.The Investigator determines that the subject or the coronary anatomy is not suitable for robotic-assisted PCI.\n* 3.STEMI\n* 4.Cardiogenic shock\n* 5.Subjects will not be included if they are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision.","120 Years",{"count":54,"type":21},500,"1 Day","OBSERVATIONAL","The main objective of the CHANGE registry is the evaluation of the real-world performance and safety profile of the R-One System in PCI.",[59],"Coronary Disease","RECRUITING","2025-08-14",{"date":63,"type":36},"2025-08-20",{"date":65,"type":36},"2023-06-20",{"date":67,"type":21},"2026-06",{"name":42,"class":43},8,""]