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Poland-Italy Aortic Research Bridge Real World Registry
Sponsor: American Heart of Poland
Summary
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. Study 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. The target enrollment is 120-200 patients across all participating sites.
Official title: A Pragmatic, Observational, Multicenter Registry on the Implantation of the Tri Modular PERCUTEK Tycheseal™ Endograft System for the Treatment of Abdominal Aortic Aneurysm (AAA)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2026-03-01
Completion Date
2030-03-31
Last Updated
2026-03-20
Healthy Volunteers
No
Conditions
Locations (26)
Clinica Pineta Grande
Castel Volturno, Italy
Centro Cuore Morgagni
Catania, Italy
IRCCS Neuromed - Istituto Neurologico Mediterraneo
Pozzilli, Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, Italy
Policlinico San Donato
San Donato Milanese, Italy
Uniwersytecki Szpital Kliniczny w Białymstoku
Bialystok, Poland
Szpital Wojewódzki w Bielsku-Białej
Bielsko-Biala, Poland
Wojewódzki Szpital Specjalistyczny nr 4
Bytom, Poland
Małopolska Cardiovascular Center, Polish-American Heart Clinic in Chrzanów
Chrzanów, Poland
118 Szpital Wojskowy z Przychodnią SPZOZ
Ełk, Poland
Szpital im. Św. Wincentego a Paulo
Gdynia, Poland
Wojewódzki Szpital Zespolony
Kielce, Poland
Bonifraterskie Centrum Medyczne
Krakow, Poland
Krakowski Szpital Specjalistyczny im. JPII
Krakow, Poland
Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego
Lublin, Poland
Uniwersytecki Szpital Kliniczny Nr 4
Lublin, Poland
Wojewódzki Szpital Specjalistyczny w Lublinie
Lublin, Poland
Uniwersytecki Szpital Kliniczny w Opolu
Opole, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Poland
Wojewódzki Szpital im. Św. Ojca Pio
Przemyśl, Poland
Uniwersytecki Szpital Kliniczny Nr 2 PUM
Szczecin, Poland
Mazowiecki Szpital Bródnowski
Warsaw, Poland
Narodowy Instytut Kardiologii
Warsaw, Poland
Uniwersyteckie Centrum Kliniczne WUM
Warsaw, Poland
Wodzisławskie Centrum Medyczne
Wodzisław Śląski, Poland
Szpital Uniwersytecki im. Karola Marcinkowskiego
Zielona Góra, Poland