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Ojca Pio","Przemyśl",{"type":25,"coordinates":250},[251,252],22.76728,49.78498,{"lat":252,"lon":251},[255],{"name":256,"role":15,"phone":7,"phoneExt":7,"email":257},"Magdalena Biss-Mierzwińska, Dr","abiska55@gmail.com",{"facility":259,"status":89,"city":260,"state":7,"zip":7,"country":91,"cosmosGeoPoint":261,"geoPoint":265,"contacts":266},"Uniwersytecki Szpital Kliniczny Nr 2 PUM","Szczecin",{"type":25,"coordinates":262},[263,264],14.55302,53.42894,{"lat":264,"lon":263},[267],{"name":268,"role":15,"phone":7,"phoneExt":7,"email":269},"Arkadiusz Kazimierczak, Prof.","biker2000@wp.pl",{"facility":271,"status":89,"city":272,"state":7,"zip":7,"country":91,"cosmosGeoPoint":273,"geoPoint":277,"contacts":278},"Mazowiecki Szpital Bródnowski","Warsaw",{"type":25,"coordinates":274},[275,276],21.01178,52.22977,{"lat":276,"lon":275},[279],{"name":280,"role":15,"phone":7,"phoneExt":7,"email":281},"Piotr Myrcha, Prof.","piotrmyr@poczta.fm",{"facility":283,"status":89,"city":272,"state":7,"zip":7,"country":91,"cosmosGeoPoint":284,"geoPoint":286,"contacts":287},"Narodowy Instytut Kardiologii",{"type":25,"coordinates":285},[275,276],{"lat":276,"lon":275},[288],{"name":289,"role":15,"phone":7,"phoneExt":7,"email":290},"Piotr Szopiński, Prof.","petszop@wp.pl",{"facility":292,"status":89,"city":272,"state":7,"zip":7,"country":91,"cosmosGeoPoint":293,"geoPoint":295,"contacts":296},"Uniwersyteckie Centrum Kliniczne WUM",{"type":25,"coordinates":294},[275,276],{"lat":276,"lon":275},[297],{"name":298,"role":15,"phone":7,"phoneExt":7,"email":299},"Zbigniew Gałązka, Prof.","zbigniew.galazka@wum.edu.pl",{"facility":301,"status":89,"city":302,"state":7,"zip":7,"country":91,"cosmosGeoPoint":303,"geoPoint":307,"contacts":308},"Wodzisławskie Centrum Medyczne","Wodzisław Śląski",{"type":25,"coordinates":304},[305,306],18.47205,50.00377,{"lat":306,"lon":305},[309],{"name":310,"role":15,"phone":7,"phoneExt":7,"email":311},"Marek Kazibudzki, Dr","marekkaz@poczta.fm",{"facility":313,"status":89,"city":314,"state":7,"zip":7,"country":91,"cosmosGeoPoint":315,"geoPoint":319,"contacts":320},"Szpital Uniwersytecki im. Karola Marcinkowskiego","Zielona Góra",{"type":25,"coordinates":316},[317,318],15.50643,51.93548,{"lat":318,"lon":317},[321],{"name":322,"role":15,"phone":7,"phoneExt":7,"email":323},"Łukasz Dzieciuchowicz, Prof.","L.Dzieciuchowicz@inm.uz.zgora.pl",{"type":11,"investigatorFullName":325,"investigatorTitle":326,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"Przemysław Nowakowski","M.D., PhD, Professor","100629555",false,"NCT07476196","Poland-Italy Aortic Research Bridge Real World Registry","A Pragmatic, Observational, Multicenter Registry on the Implantation of the Tri Modular PERCUTEK Tycheseal™ Endograft System for the Treatment of Abdominal Aortic Aneurysm (AAA)","POWER","Anatomical Inclusion Criteria (as per IFU):\n\n* Morphologically suitable aneurysm\n* Neck length ≥ 10 mm\n* Neck diameter suitable for 20-36 mm body (considering 10-20% of oversizing)\n* Neck angle: infrarenal ≤ 75°\n* Distal seal zone ≥ 10 mm\n* Iliac arteries 8-20 mm diameter\n\nPatient Inclusion Criteria:\n\n* Age \\>18 years\n* Signed informed consent\n* Pregnancy test for premenopausal women\n\nExclusion Criteria:\n\n* Anatomical unsuitability\n* Subject has a life expectancy \\\u003C 1 year\n* Circumferential thrombus in neck\n* Ruptured aneurysm\n* Renal arteries from aneurysm sac\n* Dominant IMA with obstructed visceral vessels\n* Internal iliac artery aneurysms (unless pre-treated)\n* Subject has a known contraindication dual antiplatelets therapy or contrast media,\n* Selected patients with chronic kidney failure (CKF) can undergo EVAR using standard contrast or CO2 as contrast agent.\n* Previous aortoiliac surgery or EVAR\n* Recent stroke\u002FMI (\\\u003C 3 months)\n* Allergy to device materials","ALL","18 Years",{"count":337,"type":338},200,"ESTIMATED","24 Months","OBSERVATIONAL","Objective To pragmatically collect and analyze patient-level clinical, procedural, and outcome data from participating centers in Italy and Poland on the use of the PERCUTEK Tycheseal™ stent-graft system for the endovascular repair of abdominal aortic aneurysms. The study aims to generate high-quality, real-world evidence on the technical success, safety, and mid-term outcomes of the device.\n\nStudy Design This is a pragmatic, observational, multicenter physician-initiated registry that will collect patient-level data for all eligible patients undergoing PERCUTEK Tycheseal™ device implantation. Each site will enter data into a standardized paper case report form (CRF), including demographic, anatomical, procedural, and follow-up variables. Sites will be expected to comply with data entry timelines and quality control checks. The total projected enrollment is 120-200 patients across all sites over an expected 18 month inclusion period.\n\nThe target enrollment is 120-200 patients across all participating sites.",[343],"Abdominal Aortic Aneurysm",[345,346,347,348,349],"Abdominal aortic aneurysm","Endovascular Aneurysm Repair","PERCUTEK Tycheseal™","vascular disease","stent graft","2026-03-18",{"date":352,"type":353},"2026-03-20","ACTUAL",{"date":355,"type":353},"2026-03-01",{"date":357,"type":338},"2030-03-31",{"name":5,"class":6},26]