Poland–Italy Aortic Bridge Registry: PERCUTEK Tycheseal for Abdominal Aortic Aneurysm

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a pragmatic, observational multicenter registry collecting patient-level clinical, anatomical, procedural, and follow-up data from participating centers in Italy and Poland on use of the PERCUTEK Tycheseal stent-graft. Sites will record information on standardized paper case report forms and follow data entry timelines and quality-control checks. The projected enrollment is 120–200 patients over an approximately 18-month inclusion period, with inclusion guided by the device instructions-for-use (anatomic and clinical criteria). The registry focuses on technical success, device-related safety events, and mid-term clinical and imaging outcomes in routine practice.

Why it matters

Who can join: the full rules

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

Exclusion Criteria:

* 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's running

• 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

Study contacts

• Principal investigator: Przemysław Nowakowski, MD,PhD, Prof — American Heart of Poland
• Study coordinator: Przemysław Nowakowski, MD, PhD, Prof
• Email: nowakowski.mcsn@gmail.com
• Phone: (+48) 32 758 69 01

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.