[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600492":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":19,"responsibleParty":35,"collaborators":19,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":39,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":19,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":60,"overallStatus":67,"whyStopped":19,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":19},{"fullName":5,"class":6},"Poly Medicure Limited","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"RisoR Crest Everolimus Eluting Coronary Stent System","OTHER","The RisoR Crest Everolimus Eluting Coronary Stent System is coated with a drug and biodegradable polymer coating formulation consisting of Everolimus drug, the active ingredient, and biodegradable polymers.\n\nThis is intended to supply continuous release of Everolimus drug after stent implantation over an extended period of time. The unique ultrasonic atomization drug technology is combined with acoustic activation and carrier stream technologies.",[13],"Device: Coronary Stent",[15],{"type":16,"name":17,"description":9,"armGroupLabels":18,"otherNames":19},"DEVICE","Coronary Stent",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Dr. Praveen Chandra, DM Cardiology","Medanta-The Medicity, Gurugram, Haryana, India","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Dinesh Rajendra Patil","CONTACT","+91-8149037128","dinesh.patil@polymedicure.com",{"name":32,"role":28,"phone":33,"phoneExt":19,"email":34},"Priyadarshini Arambam","+91-9910990347","regulatory@clicebo.com",{"type":36,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100600492","to-evaluate-the-performance-and-safety-of-risor-crest-everolimus-eluting-coronary-stent-system-100600492",false,"NCT07098195","To Evaluate the Performance and Safety of RisoR Crest Everolimus Eluting Coronary Stent System","An OPen-label, Multicentre, Single Arm, Clinical InvestigatIon to Evaluate PerFormance and Safety of RIsoR Crest EveRolimus Eluting Coronary Stent System","PACIFIER","Inclusion Criteria:\n\n1. Age more than 18 years\n2. All Genders (Males, Females, Transgenders, Non binary)\n3. Patient or legally authorized representative (LAR) agrees to participate by signing the informed consent form.\n4. Patient with coronary artery disease eligible for percutaneous coronary intervention (PCI) as per regional or hospital's standard practices guidelines for PCI (For Europe, as per ESC guidelines)\n5. Patient with coronary artery disease having one or more de novo or in - stent stenosis lesions in native coronary artery with a visually estimated diameter stenosis ≥70%.\n6. Patients with Reference vessel diameter of 2.0 to 4.5 mm\n7. Patients with lesion length less than 48 mm\n\nExclusion Criteria:\n\n1. Pregnant and lactating females\n2. Candidates for emergency bypass Surgery\n3. Patients corresponding to the criteria of a vulnerable population (Vulnerable subjects, including patients who are unable to fully understand all aspects of the investigation, patients who could be manipulated or unduly influenced, patients lacking capacity in the informed consent procedure and patients with dementia and cognitive impairment, patients under social security, imprisonment etc.)\n4. Known congestive heart failure (NYHA IV) or left ventricular ejection fraction (LVEF) less than 30 Percent\n5. Patients with known hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, Everolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media\n6. Current medical condition with a life expectancy of less than 12 months\n7. Patient who have current unstable arrhythmias\n8. Patient previously undergone CABG.\n9. Left Main Coronary Artery lesion\n10. Patients with Cardiogenic shock, systemic bleeding and coagulation disorders, intracranial bleeding, Renal insufficiency requiring dialysis, Acute or chronic renal dysfunction (serum creatinine \\>2.0mg\u002Fdl or 150 μmol\u002FL), peripheral vascular diseases, cancer, etc. and patients who are planning to undergo surgery within 360 days of the index procedure\n11. Patients with platelet count \\\u003C100,000 cells\u002Fmm3 or \\>700,000 cells\u002Fmm3 or a WBC \\\u003C3,000 cells\u002Fmm3","ALL","18 Years","99 Years",{"count":49,"type":50},2000,"ESTIMATED","INTERVENTIONAL",[53],"NA","The study will evaluate the performance and safety of RisoR Crest Everolimus Eluting Coronary Stent System. A total of 2000 participants will be included in the study from India and Italy.",[56,57,58,59],"Coronary Artery Disease","Coronary Artery Stenosis","Percutaneous Coronary Intervention","de Novo Lesions in Native Coronary Arteries",[61,62,63,64,65,66],"RisoR Crest","Everolimus Eluting Stent","Poly Medicure Private Limited","Drug Eluting Stent","Biodegradable Polymer","Pacifier","NOT_YET_RECRUITING","2025-07-29",{"date":70,"type":71},"2025-08-01","ACTUAL",{"date":73,"type":50},"2025-08-18",{"date":75,"type":50},"2028-01-17",{"name":5,"class":6}]