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Desjardins",{"facility":73,"status":40,"city":74,"state":10,"zip":10,"country":30,"countryCode":31,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Hôpital d'instruction des Armées Sainte Anne","Toulon",{"type":33,"coordinates":76},[77,78],5.92836,43.12442,{"lat":78,"lon":77},[81],{"name":82,"role":22,"phone":10,"phoneExt":10,"email":10},"Fabien Beranger",{"facility":84,"status":40,"city":74,"state":10,"zip":10,"country":30,"countryCode":31,"cosmosGeoPoint":85,"geoPoint":87,"contacts":88},"Hôpital Privé Toulon Hyeres St. Jean",{"type":33,"coordinates":86},[77,78],{"lat":78,"lon":77},[89],{"name":90,"role":22,"phone":10,"phoneExt":10,"email":10},"Pierre Sarradon",{"type":92,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100508630","investigating-the-safety-and-clinical-performance-of-eight-ivascular-devices-for-endovascular-intervention-in-renal-iliac-or-femoral-arteries-100508630",false,"NCT05902923","Investigating the Safety and Clinical Performance of Eight iVascular Devices for Endovascular Intervention in Renal, Iliac or Femoral Arteries","A Prospective PMCF Study Investigating the Safety and Clinical Performance of the Oceanus 18 and Oceanus 35 Balloon Dilatation Catheters, the Luminor 18 and Luminor 35 Drug Coated Balloons, the Restorer Peripheral Stent System, the iVolution Pro Peripheral Self-Expanding Stent System, the iCover Covered Peripheral Stent System and the Sergeant Peripheral Support Catheter for Endovascular Interventions.","Inclusion Criteria:\n\n* Corresponding to the CE-mark indications\u002Fcontra-indications and according to the IFU of the device.\n* Patient is \\>18 years old.\n* Patient understands the nature of the procedure and provides written informed consent prior to enrollment in the study.\n* Target lesion(s) is\u002Fare located in renal, iliac or femoral arteries.\n* Patient is eligible for treatment with the Oceanus 18 Balloon Dilatation Catheter and\u002For the Oceanus 35 Balloon Dilatation Catheter and\u002For the Luminor 18 Drug Coated Balloon and\u002For the Luminor 35 Drug Coated Balloon and\u002For the Restorer Peripheral Stent System and\u002For the iVolution pro Peripheral Self-Expanding Stent System and\u002For the iCover Covered Peripheral Stent System and\u002For the Sergeant Peripheral Support Catheter as described in IFU for each device.\n\nExclusion Criteria:\n\n* Anatomy or size of vessels that will not allow appropriate usage of the investigational devices, following IFU of the investigational devices.\n* Known contraindication and\u002For allergy to (a component of) an investigational device.\n* Pregnant women and women with childbearing potential not taking adequate contraceptives or currently breastfeeding.\n* Life expectancy of less than 12 months.\n* Any planned surgical intervention\u002Fprocedure within 30 days after the study procedure.\n* Any patient considered to be hemodynamically unstable at onset of the procedure.","ALL","18 Years",{"count":103,"type":104},209,"ESTIMATED","OBSERVATIONAL","The rationale of this study is to confirm and support the clinical safety and performance of any of these products in a real-world population of 209 patients who underwent an endovascular intervention within standard-of-care of the iliacofemoral artery and renal artery, using at least one of the investigational products from iVascular.",[108],"Artery Disease","2024-05-06",{"date":111,"type":112},"2024-05-08","ACTUAL",{"date":114,"type":112},"2023-08-01",{"date":116,"type":104},"2027-08",{"name":5,"class":6},6]