[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100124068":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":11,"locations":24,"responsibleParty":37,"collaborators":11,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":41,"sex":47,"minAge":48,"maxAge":11,"enrollmentInfo":49,"targetDuration":11,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":69,"whyStopped":11,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Abbott Medical Devices","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Xience V®","EXPERIMENTAL",null,[13],"Device: Xience V®",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DEVICE","Placement of a Xience V® stent within a restenosed bare metal stent.",[9],[20],{"name":21,"affiliation":22,"role":23},"Didier Carrie, MD","HOPITAL DE RANGUEIL - CHU","PRINCIPAL_INVESTIGATOR",[25],{"facility":26,"status":11,"city":27,"state":11,"zip":28,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":11},"Hopital de Rangueil - Chu","Toulouse","31403","France","FR",{"type":32,"coordinates":33},"Point",[34,35],1.44367,43.60426,{"lat":35,"lon":34},{"type":38,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100124068","phase-3-clinical-evaluation-of-patients-with-everolimus-eluting-stent-xience-v-implanted-in-the-treatment-of-restenosis-in-non-coated-metallic-stent-bms-in-stent-restenosis-during-a-2-year-clinical-follow-up-period-100124068",false,"NCT00882219","Clinical Evaluation of Patients With Everolimus-eluting Stent Xience V® Implanted in the Treatment of Restenosis in Non-coated Metallic Stent (BMS In-stent Restenosis) During a 2 Year Clinical Follow-up Period","XERES Trial: Clinical Evaluation of Patients With Everolimus-eluting Stent \" Xience V® \" Implanted in the Treatment of Restenosis in Non-coated Metallic Stent (BMS In-stent Restenosis) During a 2 Year Clinical Follow-up Period","XERES","Inclusion Criteria:\n\n* Patients 18 years of age or older\n* Patients affiliated to a social security or equivalent regimen\n* Patients agreeing to participate in the study (Patient with signed informed consent )\n* Patients with evidence of myocardial ischemia (stable or unstable angina, silent ischemia, positive functional exploration or a reversible modification in the ECG consistent with ischemia).\n* Patient acceptable candidate for CABG surgery\n* Patient agreeing to undergo all protocol scheduled follow-up examinations.\n* Patients who tolerate the association Aspirin (dosed 75 to 160 mg\u002Fday) and Clopidogrel at 75 mg\u002Fday for at least 6 months\n\nAngiographic inclusion criteria:\n\n* Patient with de novo and sole in-stent restenosis (focal, diffuse or proliferative) in a non-coated metallic stent with or without any other coronary lesions.\n* Patient with target reference vessel diameter between 2.5 and 4 mm by visual estimate\n* Patient with a target lesion ≤ 22mm by visual estimate\n* Patient with a target lesion in an artery with a visual estimate of the restenosis between 50 and 99% and a TIMI flow grade \\> 1\n* Patient with multiple lesions, the other lesions have been treated with success\n\nExclusion Criteria:\n\n* Patient in emergency\n* Patient pregnant\n* Patient nursing\n* Patient unable to give informed consent personally.\n* Patient with myocardial infarction within the previous 72 hours.\n* Patient with limited life expectancy (lesser than 1 year post-inclusion)\n* Patient with unstable arrhythmia\n* Patient with left ventricular ejection fraction (LVEF) lesser than 30%\n* Patient receiver of a cardiac or any other organ transplantation or candidate to an organ transplant\n* Patient who receive or scheduled to receive chemo- or radio- therapy within the 30 days prior to any protocol-related procedure.\n* Patient treated with immunosuppressives or for known immunodepressive or auto-immune pathologies\n* Patient receiving chronically anticoagulant therapy with an INR greater than 2.5\n* Patient with known hypersensitivity or contraindications to anti-platelet drugs, everolimus, heparin, chromium cobalt alloys, nickel, tungsten, acrylic- or fluoro- polymers or sensitivity to angiographic contrast agents.\n* Patient with planned elective surgery requiring the interruption or discontinuation of anti-platelet therapy.\n* Patient with platelet count \\\u003C100 000\u002F mm3 or \\>700 000mm3 ; WBC counts \\\u003C3 000\u002Fmm3 or known or suspected liver disease\n* Patient with severe renal insufficiency (creatinine clearance rate \\\u003C 30 ml\u002Fmin), or under dialysis\n* Patient with an history of coagulopathy refusing blood transfusion\n* Patient who had a stroke\u002Fcerebrovascular accident or transient cerebrovascular ischemia in the preceding 6 months\n* Patient with urinary or gastro-intestinal bleed in the preceding 6 months\n* Patient with other known serious medical illness or known history of substance abuse (alcohol, drugs) that might result in non-compliance to the investigational plan, or interfere with the results or diminish the life expectancy to less than a year.\n* Patient enrolled in an interventional study with another medical device or drug Angiographic exclusion criteria\n* Patient with in-stent restenosis located on the left main on the coronary by-pass\n* Patient with a lesion of the in-stent restenosis located in a bifurcation including a lateral branch of diameter \\> 1.5mm\n* Patient with the target vessel totally occluded\n* Patient with a lesion of the restenosis previously treated with another device (with the exception of balloon-tipped catheter) such as a cutting balloon, an atherectomy, laser, brachytherapy or any another medicated stent.\n* Patient with thrombus in the target vessel\n* Patient with aorto-ostiale lesions\n* Patient with previous failures of multiple lesions treated by angioplasty.","ALL","18 Years",{"count":50,"type":51},102,"ACTUAL","INTERVENTIONAL",[54],"PHASE3","Interventional, prospective, non-randomized, non-comparative, open and multicentric study of patients with everolimus-eluting stent \" Xience V® \" implanted in the treatment of restenosis in non-coated metallic stent (BMS in-stent restenosis) during a 2 year clinical follow-up period.",[57],"Coronary Restenosis",[59,60,61,62,63,64,65,66,67,68,57],"Drug eluting stent","Stents","Angioplasty","Chronic coronary occlusion","Stent thrombosis","Vascular disease","Myocardial ischemia","Coronary artery stenosis","Coronary Disease","Coronary Artery Disease","COMPLETED","2012-09-05",{"date":72,"type":73},"2012-09-06","ESTIMATED",{"date":75,"type":11},"2009-03",{"date":77,"type":51},"2012-07",{"name":5,"class":6},1]