Condition: Abdominal Aortic Aneurysm · Sponsor: American Heart of Poland
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.
This description comes directly from the study's public registry record.
Przemysław Nowakowski, MD, PhD, Prof · (+48) 32 758 69 01 · nowakowski.mcsn@gmail.com
Always discuss trial participation with your own doctor first.
| Clinica Pineta Grande | Castel Volturno, Italy | Not Yet Recruiting |
| Centro Cuore Morgagni | Catania, Italy | Not Yet Recruiting |
| IRCCS Neuromed - Istituto Neurologico Mediterraneo | Pozzilli, Italy | Not Yet Recruiting |
| Arcispedale Santa Maria Nuova | Reggio Emilia, Italy | Not Yet Recruiting |
| Policlinico San Donato | San Donato Milanese, Italy | Not Yet Recruiting |
| Uniwersytecki Szpital Kliniczny w Białymstoku | Bialystok, Poland | Recruiting |
| Szpital Wojewódzki w Bielsku-Białej | Bielsko-Biala, Poland | Recruiting |
| Wojewódzki Szpital Specjalistyczny nr 4 | Bytom, Poland | Recruiting |
| Małopolska Cardiovascular Center, Polish-American Heart Clinic in Chrzanów | Chrzanów, Poland | Recruiting |
| 118 Szpital Wojskowy z Przychodnią SPZOZ | Ełk, Poland | Recruiting |
| Szpital im. Św. Wincentego a Paulo | Gdynia, Poland | Recruiting |
| Wojewódzki Szpital Zespolony | Kielce, Poland | Recruiting |
+ 14 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07476196