Poland-Italy Aortic Research Bridge Real World Registry
This trial has no sites in United States.
It has sites in 2 countries. Choose a country to see its 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 doctorTrial details
- Who runs it
- American Heart of Poland
- Trial code
- NCT07476196
- Record updated
- 20 March 2026
- Original description
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.Read full original descriptionShow less
A Pragmatic, Observational, Multicenter Registry on the Implantation of the Tri Modular PERCUTEK Tycheseal™ Endograft System for the Treatment of Abdominal Aortic Aneurysm (AAA)
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.
Exclusion: 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.
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.