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

A Pragmatic, Observational, Multicenter Registry on the Implantation of the Tri Modular PERCUTEK Tycheseal™ Endograft System for the Treatment of Abdominal Aortic Aneurysm (AAA)

Observational American Heart of Poland · NCT07476196

This registry will see how well the PERCUTEK Tycheseal stent-graft works and how safe it is for adults having endovascular repair of abdominal aortic aneurysms.

Quick facts

Study typeObservational
Enrollment200 (estimated)
Ages18 Years and up
SexAll
SponsorAmerican Heart of Poland Academic / other
Locations26 sites (Castel Volturno and 25 other locations)
Trial IDNCT07476196 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (age >18) with abdominal aortic aneurysm who meet the device anatomic criteria (for example adequate neck length and diameters per IFU), can consent, and can complete follow-up are ideal candidates.

Not a fit: Patients with anatomically unsuitable aneurysms, ruptured aneurysm, life expectancy under one year, contraindications to device materials or required therapies, recent stroke/MI, prior aortoiliac surgery or EVAR, or other exclusion criteria are unlikely to benefit from inclusion.

Why it matters

Potential benefit: If successful, the registry could provide real-world evidence on the safety and mid-term effectiveness of the PERCUTEK Tycheseal device to help clinicians select patients and refine procedural technique.

How similar studies have performed: Endovascular stent-grafts are an established treatment for AAA and multiple registries and trials of comparable devices have shown favorable outcomes, but real-world data specific to the PERCUTEK Tycheseal system are currently limited.

Eligibility criteria

Show full inclusion / exclusion 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

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 this trial is running

Castel Volturno and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Abdominal Aortic AneurysmAbdominal aortic aneurysmEndovascular Aneurysm RepairPERCUTEK Tycheseal™vascular diseasestent graft
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.