Poland-Italy Aortic Research Bridge Real World Registry
Key facts
- Who runs it
- American Heart of Poland
- Where
- Castel Volturno, Catania, Pozzilli, Reggio Emilia, and San Donato Milanese, ItalySee the 5 sitesAlso in 1 other country, 21 sites
- Trial code
- Status
- Recruiting
- People taking part
- 200 people, planned
- Started
- 1 Mar 2026
- Expected to end
- 31 Mar 2030
- Type of study
- Observational
- Record updated
- 20 March 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 22 criteriaShow less
Who cannot take part
- Internal iliac artery aneurysms (unless pre-treated)
- Subject has a known contraindication dual antiplatelets therapy or contrast media,
- Previous aortoiliac surgery or EVAR
- Selected patients with chronic kidney failure (CKF) can undergo EVAR using standard contrast or CO2 as contrast agent
- Recent stroke/MI (< 3 months)
- Allergy to device materials
- 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
Other criteria
- Anatomical Inclusion Criteria (as per IFU):
- Morphologically suitable aneurysm
- Neck length ≥ 10 mm
- Neck diameter suitable for 20-36 mm body (considering 10-20% of oversizing)
- Neck angle: infrarenal ≤ 75°
- Distal seal zone ≥ 10 mm
- Iliac arteries 8-20 mm diameter; Patient Inclusion Criteria:
- Age >18 years
- Signed informed consent
- Pregnancy test for premenopausal women
Where in Italy
Also in 1 other country, 21 sites
- Clinica Pineta GrandeCastel Volturno, ItalyContact: Rosario Mancusi, DrNot yet recruiting
- Centro Cuore MorgagniCatania, ItalyContact: Vincenzo Monaca, DrNot yet recruiting
- IRCCS Neuromed - Istituto Neurologico MediterraneoPozzilli, ItalyContact: Enrico Cappello, DrNot yet recruiting
- Arcispedale Santa Maria NuovaReggio Emilia, ItalyContact: Nicola Tusini, DrNot yet recruiting
- Policlinico San DonatoSan Donato Milanese, ItalyContact: Giovanni Nano, Prof.Not yet recruiting
About the trial
What the trial wants to find out
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.
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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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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)
- Record updated
- 20 March 2026