An observational study in Abdominal Aortic Aneurysm, sponsored by American Heart of Poland. Recruiting at 26 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-20.
Sponsored by American Heart of Poland · Observational
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.
Background and Rationale
Abdominal Aortic Aneurysm (AAA): Clinical Burden and Unmet Needs Abdominal aortic aneurysm (AAA) is a progressive and potentially fatal vascular disease defined as a localized dilatation of the abdominal aorta exceeding 1.5 times its normal diameter, typically ≥3.0 cm. The pathophysiology of AAA involves complex interplay between genetic predisposition, chronic inflammation, extracellular matrix degradation, and biomechanical wall stress. Risk factors for AAA include advanced age, male sex, smoking, hypertension, dyslipidemia, and family history. Notably, population based screening studies have shown that up to 5-8% of men over the age of 65 harbor asymptomatic AAAs, many of which are at risk of expansion and eventual rupture if left untreated. The clinical importance of timely diagnosis and treatment of AAA lies in its natural history: once the aneurysm reaches a critical threshold-commonly 5.5 cm in diameter in men or 5.0 cm in women-the risk of rupture increases substantially. Aneurysm rupture is associated with extremely high mortality, with up to 90% of patients dying before reaching the hospital or during emergency intervention. Consequently, elective repair is indicated in appropriately selected patients based on aneurysm size, growth rate, symptomatology, and anatomical feasibility.
Advances and Challenges in Endovascular Aneurysm Repair (EVAR) Over the past two decades, endovascular aneurysm repair (EVAR) has largely supplanted open surgical repair (OSR) as the preferred modality for treating infrarenal AAA in anatomically suitable patients. EVAR offers several perioperative advantages, including reduced operative blood loss, shorter procedure times, lower 30-day mortality rates, and faster postoperative recovery. These benefits make EVAR especially attractive for elderly patients and those with significant comorbidities who may not tolerate open surgery.
Despite these advantages, EVAR is not without limitations. Long-term surveillance is required due to risks of late complications such as graft migration, endoleak formation (particularly types I and III), aneurysm sac expansion, and device thrombosis. These complications may necessitate secondary interventions and contribute to long-term morbidity. Additionally, anatomical constraints such as short or highly angulated necks, calcification, thrombus burden, and tortuous iliac arteries may preclude the safeuse of some endograft systems. As a result, device selection plays a crucial role in procedural success and long-term outcomes.
The Poland-Italy Aortic Research Bridge Real World Registry (POWER) is a pragmatic, observational, multicenter registry designed to systematically collect real-world data on the use of the PERCUTEK Tycheseal™Tri-Modular Endograft System in patients undergoing endovascular repair of abdominal aortic aneurysms (AAA).
Study Type This is a non-randomized, open-label, post-market physician-initiated clinical investigation. It does not involve experimental treatments or random allocation of interventions, and no comparator arm is included.
Objectives
Participating Countries and Sites
Estimated Enrollment
Each subject will be followed for up to 24 months post-implantation, with assessments at baseline, discharge, 1 month, 12 months and 24 months.
The PERCUTEK Tycheseal™Endograft System: Design Rationale The PERCUTEK Tycheseal™ system is a tri-modular stent graft platform designed for the treatment of infrarenal AAA. It consists of a main body and two iliac limb components, each optimized for precision deployment, modular adaptability, and enhanced seal zone conformity. The device is intended to address common anatomical challenges by accommodating a wide range of aortic neck diameters (main body proximal graft diameters: 20-36 mm, with 10-20% of oversizing), tolerating moderate angulation (up to 75°), and facilitating reliable fixation and sealing even in anatomically complex patients.
The PERCUTEK Tycheseal™ system features a low-profile delivery system, radiopaque markers for fluoroscopic visibility, and graft materials engineered for biocompatibility and durability. Early use in single-center case series and preliminary feasibility studies suggests that the device offers favorable deliverability, short procedure duration, and high technical success. However, robust, pragmatic, multicenter data in real-world settings are still lacking, which limits broader confidence in its long-term safety and performance.
Rationale for the POWER Registry The Poland-Italy Aortic Research Bridge Real World Registry (POWER) has been established to pragmatically evaluate the use of the PERCUTEK Tycheseal™ stent graft system in a real-world clinical environment across multiple high-volume European centers. This physician-initiated registry aims to fill a critical evidence gap by generating longitudinal, patient-level data on technical feasibility, clinical outcomes, and device-related complications over a 12-24- month period.
Several compelling factors justify the need for this registry:
Through detailed documentation of implantation success, early and mid-term complications, and follow-up imaging, the POWER Registry will support an evidencebased understanding of the PERCUTEK Tycheseal™system's performance. The use of standardized paper CRFs, centralized data coordination, and optional site-level aggregate submissions ensures a flexible yet rigorous data capture approach. Ultimately, the POWER Registry aligns with contemporary regulatory and clinical imperatives for post-market device surveillance, and its findings are expected to directly contribute to the refinement of EVAR indications, device iteration, and patient centered care in AAA management.
473 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 100 are open to participants now.
This study's planned enrollment of 200 is above the median of 166 across 220 observational studies indexed under Aortic Aneurysm, Abdominal.
Browse Aortic Aneurysm, Abdominal studies →American Heart of Poland is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with abdominal aortic aneurysm
Anatomical Inclusion Criteria (as per IFU):
Patient Inclusion Criteria:
Exclusion Criteria:
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 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.
Time frame: 12 month
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 months
Freedom from aneurysm rupture during the 12-month follow-up period.
Time frame: 12 months
Freedom from stent-graft migration resulting in a serious adverse event or requiring secondary intervention.
Time frame: 12 months
Freedom from any stent-graft occlusion at 12 months.
Time frame: 12 months
Aneurysm-related mortality at 12 months
Time frame: 12 months
All-cause mortality
Time frame: 30 days; 12 months
Aneurysm sac regression >5 mm at 12 months compared to baseline.
Time frame: 12 months
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 months
All endoleaks (types I, II, III, or undefined origin) detected at 30 days, 12 months, and 24 months.
Time frame: 30 days; 12 month; 24 months
Reinterventions, categorized as: For treatment of endoleaks, For stent-graft thrombosis or occlusion.
Time frame: 24 months
Serious adverse device effects (SADEs) throughout the study period.
Time frame: 24 months
Device performance metrics as rated by implanting physicians (e.g., ease of use, trackability, radiopacity).
Time frame: 24 months
Medication adherence, particularly antiplatelet and anticoagulant regimens.
Time frame: 24 months
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American Heart of Poland