Poland-Italy Aortic Research Bridge Real World Registry
A Pragmatic, Observational, Multicenter Registry on the Implantation of the Tri Modular PERCUTEK Tycheseal™ Endograft System for the Treatment of Abdominal Aortic Aneurysm (AAA)
American Heart of Poland
200 participants
Mar 1, 2026
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria9
- 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
- Age \>18 years
- Signed informed consent
- Pregnancy test for premenopausal women
Exclusion Criteria12
- 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
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Locations(26)
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NCT07476196