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.
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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.
Timeframe: 12 months
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.
Timeframe: 12 month
Freedom from type I or III endoleaks, confirmed by Doppler ultrasound or angio CT at the 6- and 12-month follow-ups.
Timeframe: 6 and 12 months
Freedom from aneurysm rupture during the 12-month follow-up period.
Timeframe: 12 months
Freedom from stent-graft migration resulting in a serious adverse event or requiring secondary intervention.
Timeframe: 12 months
Freedom from any stent-graft occlusion at 12 months.
Timeframe: 12 months
Przemysław Nowakowski, MD, PhD, Prof