Actively Recruiting
Poland-Italy Aortic Research Bridge Real World Registry
Led by American Heart of Poland · Updated on 2026-03-20
200
Participants Needed
26
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Poland-Italy Aortic Research Bridge Real World Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Morphologically suitable aneurysm
- Neck length 9 10 mm
- Neck diameter suitable for 20-36 mm body with 10-20% oversizing
- Infrarenal neck angle 6 75 0
- Distal seal zone 9 10 mm
- Iliac arteries diameter 8-20 mm
- Age over 18 years
- Signed informed consent
- Pregnancy test for premenopausal women
You will not qualify if you...
- Anatomical unsuitability for the device
- Life expectancy less than 1 year
- Circumferential thrombus in neck
- Ruptured aneurysm
- Renal arteries originating from aneurysm sac
- Dominant inferior mesenteric artery with obstructed visceral vessels
- Internal iliac artery aneurysms unless pre-treated
- Known contraindication to dual antiplatelet therapy or contrast media
- Previous aortoiliac surgery or EVAR
- Stroke or myocardial infarction within the last 3 months
- Allergy to device materials
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 26 locations
1
Clinica Pineta Grande
Castel Volturno, Italy
Not Yet Recruiting
2
Centro Cuore Morgagni
Catania, Italy
Not Yet Recruiting
3
IRCCS Neuromed - Istituto Neurologico Mediterraneo
Pozzilli, Italy
Not Yet Recruiting
4
Arcispedale Santa Maria Nuova
Reggio Emilia, Italy
Not Yet Recruiting
5
Policlinico San Donato
San Donato Milanese, Italy
Not Yet Recruiting
6
Uniwersytecki Szpital Kliniczny w Białymstoku
Bialystok, Poland
Actively Recruiting
7
Szpital Wojewódzki w Bielsku-Białej
Bielsko-Biala, Poland
Actively Recruiting
8
Wojewódzki Szpital Specjalistyczny nr 4
Bytom, Poland
Actively Recruiting
9
Małopolska Cardiovascular Center, Polish-American Heart Clinic in Chrzanów
Chrzanów, Poland
Actively Recruiting
10
118 Szpital Wojskowy z Przychodnią SPZOZ
Ełk, Poland
Actively Recruiting
11
Szpital im. Św. Wincentego a Paulo
Gdynia, Poland
Actively Recruiting
12
Wojewódzki Szpital Zespolony
Kielce, Poland
Actively Recruiting
13
Bonifraterskie Centrum Medyczne
Krakow, Poland
Actively Recruiting
14
Krakowski Szpital Specjalistyczny im. JPII
Krakow, Poland
Actively Recruiting
15
Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego
Lublin, Poland
Actively Recruiting
16
Uniwersytecki Szpital Kliniczny Nr 4
Lublin, Poland
Actively Recruiting
17
Wojewódzki Szpital Specjalistyczny w Lublinie
Lublin, Poland
Actively Recruiting
18
Uniwersytecki Szpital Kliniczny w Opolu
Opole, Poland
Actively Recruiting
19
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Poland
Actively Recruiting
20
Wojewódzki Szpital im. Św. Ojca Pio
Przemyśl, Poland
Actively Recruiting
21
Uniwersytecki Szpital Kliniczny Nr 2 PUM
Szczecin, Poland
Actively Recruiting
22
Mazowiecki Szpital Bródnowski
Warsaw, Poland
Actively Recruiting
23
Narodowy Instytut Kardiologii
Warsaw, Poland
Actively Recruiting
24
Uniwersyteckie Centrum Kliniczne WUM
Warsaw, Poland
Actively Recruiting
25
Wodzisławskie Centrum Medyczne
Wodzisław Śląski, Poland
Actively Recruiting
26
Szpital Uniwersytecki im. Karola Marcinkowskiego
Zielona Góra, Poland
Actively Recruiting
Research Team
P
Przemysław Nowakowski, MD, PhD, Prof
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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