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Karola Marcinkowskiego","Zielona Góra",{"type":26,"coordinates":318},[319,320],15.50643,51.93548,{"lat":320,"lon":319},[323],{"name":324,"role":15,"phone":7,"phoneExt":7,"email":325},"Łukasz Dzieciuchowicz, Prof.","L.Dzieciuchowicz@inm.uz.zgora.pl",{"type":11,"investigatorFullName":327,"investigatorTitle":328,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"Przemysław Nowakowski","M.D., PhD, Professor","100629555","poland-italy-aortic-research-bridge-real-world-registry-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":340,"type":341},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.",[346],"Abdominal Aortic Aneurysm",[348,349,350,351,352],"Abdominal aortic aneurysm","Endovascular Aneurysm Repair","PERCUTEK Tycheseal™","vascular disease","stent graft","2026-03-18",{"date":355,"type":356},"2026-03-20","ACTUAL",{"date":358,"type":356},"2026-03-01",{"date":360,"type":341},"2030-03-31",{"name":5,"class":6},26]