Poland-Italy Aortic Research Bridge Real World Registry
Recruiting now
Conditions studied: Abdominal Aortic Aneurysm
In brief
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.
Key facts
- Study ID
- NCT07476196
- Run by
- American Heart of Poland
- People needed
- 200
- Starts
- 2026-03-01
- Expected to finish
- 2030-03-31
- Last updated by the study team
- 2026-03-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Anatomical unsuitability
- Subject has a life expectancy < 1 year
- Circumferential thrombus in neck
- Ruptured aneurysm
- Renal arteries from aneurysm sac
- Dominant IMA with obstructed visceral vessels
- Internal iliac artery aneurysms (unless pre-treated)
- Subject has a known contraindication dual antiplatelets therapy or contrast media,
- Selected patients with chronic kidney failure (CKF) can undergo EVAR using standard contrast or CO2 as contrast agent.
- Previous aortoiliac surgery or EVAR
- Recent stroke/MI (< 3 months)
- Allergy to device materials
Where it is running
- Szpital Uniwersytecki im. Karola Marcinkowskiego — Zielona Góra, Poland (enrolling)
- Uniwersytecki Szpital Kliniczny Nr 2 PUM — Szczecin, Poland (enrolling)
- Mazowiecki Szpital Bródnowski — Warsaw, Poland (enrolling)
- Narodowy Instytut Kardiologii — Warsaw, Poland (enrolling)
- Uniwersyteckie Centrum Kliniczne WUM — Warsaw, Poland (enrolling)
- Wodzisławskie Centrum Medyczne — Wodzisław Śląski, Poland (enrolling)
- Uniwersytecki Szpital Kliniczny w Białymstoku — Bialystok, Poland (enrolling)
- Szpital Wojewódzki w Bielsku-Białej — Bielsko-Biala, Poland (enrolling)
- Wojewódzki Szpital Specjalistyczny nr 4 — Bytom, Poland (enrolling)
- Małopolska Cardiovascular Center, Polish-American Heart Clinic in Chrzanów — Chrzanów, Poland (enrolling)
- 118 Szpital Wojskowy z Przychodnią SPZOZ — Ełk, Poland (enrolling)
- Szpital im. Św. Wincentego a Paulo — Gdynia, Poland (enrolling)
- Wojewódzki Szpital Zespolony — Kielce, Poland (enrolling)
- Bonifraterskie Centrum Medyczne — Krakow, Poland (enrolling)
- Krakowski Szpital Specjalistyczny im. JPII — Krakow, Poland (enrolling)
- Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego — Lublin, Poland (enrolling)
- Uniwersytecki Szpital Kliniczny Nr 4 — Lublin, Poland (enrolling)
- Wojewódzki Szpital Specjalistyczny w Lublinie — Lublin, Poland (enrolling)
- Uniwersytecki Szpital Kliniczny w Opolu — Opole, Poland (enrolling)
- Uniwersytecki Szpital Kliniczny w Poznaniu — Poznan, Poland (enrolling)
- Wojewódzki Szpital im. Św. Ojca Pio — Przemyśl, Poland (enrolling)
- 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
Full record on ClinicalTrials.gov
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