[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541093":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":15,"centralContacts":20,"locations":29,"responsibleParty":52,"collaborators":7,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":7,"enrollmentInfo":63,"targetDuration":7,"studyType":66,"phases":7,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":32,"whyStopped":7,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"University of Turin, Italy","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"DEVICE","Visceral aneurysm stenting","Flow diverter stenting",[14],"stent",[16],{"name":17,"affiliation":18,"role":19},"Marco Calandri, M.D.","University of Torino","PRINCIPAL_INVESTIGATOR",[21,26],{"name":22,"role":23,"phone":24,"phoneExt":7,"email":25},"Andrea Discalzi, M.D.","CONTACT","390116336311","adiscalzi@cittadellasalute.to.it",{"name":27,"role":23,"phone":24,"phoneExt":7,"email":28},"Bruno Ficara, Pharm.D.","bruno.ficara@unito.it",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"AOU Città della Salute e della Scienza di Torino","RECRUITING","Torino","TO","10126","Italy","IT",{"type":39,"coordinates":40},"Point",[41,42],11.99138,44.88856,{"lat":42,"lon":41},[45,49],{"name":46,"role":23,"phone":47,"phoneExt":7,"email":48},"Marco Prof. Calandri, MD","+390116336311","marco.calandri@unito.it",{"name":50,"role":51,"phone":7,"phoneExt":7,"email":7},"Andrea Dott. Discalzi, MD","SUB_INVESTIGATOR",{"type":53,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100541093","italian-multicentric-study-on-the-treatment-of-visceral-aneurysms-with-the-flow-diversion-stent-derivo-peripher-and-derivo-2-100541093",false,"NCT06325371","Italian Multicentric Study on the Treatment of Visceral Aneurysms With the Flow Diversion Stent Derivo Peripher and Derivo 2","DEDICATE","Inclusion criteria:\n\n* \\>18 years old\n* Visceral artery aneurysms, evaluated with computed tomography angiography-CTA- withindication for treatment according to 2020 SVS and 2024 SICVE\u002FSIRM and 2024 CIRSE guidelines. Specifically:\n\n  * Renal artery: \\>2 cm if fusiform morphology or all dimensions if sacculary or bifurcation morphology, if in fertile women or in hypertensive patients with renal stenosis\n  * Splenic artery: if \\>2 cm, or all dimensions in fertile women.\n  * Celiac tripod: if \\>2 cm.\n  * Hepatic artery: if \\>2 cm or growth greater than 0.5 cm\u002Fyear.\n  * Superior mesenteric artery, gastric or gastroepiploic artery, pancreaticoduodenal or gastroduodenal arteries, colic arteries, jejunal arteries, and ileal arteries: any size\n* anatomical characteristics compatible with the stent DED Instruction for Use (IFU). Specifically:\n\n  * the stent diameter should match the largest diameter of either the proximal or distal vessel of the aneurysm with an oversizing of 1-2 mm according to IFU.\n  * the stent length must allow for adequate proximal and distal landing, covering the neck of the aneurysm to 2.5 times the vessel's internal diameter and no less than 15 mm.\n* proper adherence to the anticoagulant and antiplatelet pharmacological protocol for the peri-procedural and post-procedural periods. Specifically:\n\n  * all patients should begin dual antiplatelet therapy (DAPT) before surgery (for at least 3 days before the procedure or with a loading dose pre-procedurally).\n  * all patients receive systemic anticoagulation during the procedure (Heparin 70 IU\u002Fkg to achieve an Activated Clot Time (ACT) \\> 250 s).\n  * after the procedure, the patient should continue DAPT (e.g., ASA 100 mg daily and Clopidogrel 75 mg daily) for at least 1 month, then continue with single antiplatelet therapy (e.g., ASA 100 mg) indefinitely.\n\nExclusion Criteria:\n\n* patients who are hemodynamically unstable or show CT signs of rupture or contained rupture of visceral aneurysm\n* pregnant or breastfeeding women\n* life expectancy less than 2 years","ALL","18 Years",{"count":64,"type":65},100,"ESTIMATED","OBSERVATIONAL","This is a multicentric voluntary observational study with a retrospective evaluation of prospectively collected data concerning the treatment of visceral aneurysms with flow diversion stent Derivo Peripher and Derivo 2 (DED, Acandis GmbH) Follow-up will include clinical and radiological (CT) evaluation at least 12 months after the intervention.\n\nThe enrollment period will be of 65 months (01\u002Fjan\u002F2020-30\u002Fjun\u002F2025). Sample size will be of 100 patients.",[69,70],"Aneurysm Abdominal","Arterial Aneurysm",[72,73,74],"flow diverter","visceral aneurysm","stenting","2025-02-17",{"date":77,"type":78},"2025-02-18","ACTUAL",{"date":80,"type":78},"2024-11-20",{"date":82,"type":65},"2026-06-30",{"name":5,"class":6},1]