Poland-Italy Aortic Research Bridge Real World Registry
ConditionAbdominal Aortic Aneurysm
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAmerican Heart of Poland
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Morphologically suitable aneurysm
Neck length ≥ 10 mm
Neck diameter suitable for 20-36 mm body (considering 10-20% of oversizing)
Neck angle: infrarenal ≤ 75°
Disqualifiers
Anatomical unsuitability
Subject has a life expectancy < 1 year
Circumferential thrombus in neck
Ruptured aneurysm
Trial population
Patients with abdominal aortic aneurysm
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Technical success of the PERCUTEK Tycheseal™ stent-graft implantation, defined as successful deployment at the intended site with the absence of immediate type I or III endoleaks and no requirement for unplanned conversion to open repair.
Time frame
12 months2
Freedom from aneurysm sac enlargement, defined as no increase ≥5 mm in the maximum transverse aortic aneurysm diameter at 12 months compared to baseline imaging.
Time frame
12 month3
Freedom from type I or III endoleaks, confirmed by Doppler ultrasound or angio CT at the 6- and 12-month follow-ups.
Time frame
6 and 12 months4
Freedom from aneurysm rupture during the 12-month follow-up period.
Time frame
12 monthsSecondary outcomes
1
Aneurysm-related mortality at 12 months
Time frame
12 months2
All-cause mortality
Time frame
30 days; 12 months3
Aneurysm sac regression >5 mm at 12 months compared to baseline.
Time frame
12 months4
Major adverse events (MAEs) at 30 days, 12 months, and 24 months, including: Myocardial infarction, Stroke or transient ischemic attack, New-onset renal failure or dialysis requirement.
Time frame
30 days; 12 months; 24 monthsOther outcomes
1
Device performance metrics as rated by implanting physicians (e.g., ease of use, trackability, radiopacity).
Time frame
24 months2
Medication adherence, particularly antiplatelet and anticoagulant regimens.
Time frame
24 monthsSponsors and contacts
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Source ClinicalTrials.gov