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
To assess technical success and safety outcomes associated with the use of the
PERCUTEK Tycheseal™system.
To evaluate mid-term clinical outcomes, including aneurysm sac behavior, endoleak
rates, and device-related complications over a follow-up period of up to 24 months.
Participating Countries and Sites
Multicenter registry with sites in Poland and Italy.
Sites must demonstrate documented experience in aortic endovascular repair.
Each participating center must have local ethics approval and assign a trained data
manager and a site principal investigator, unless a general (e.g. national or
regional) ethics committee approval is applicable.
Estimated Enrollment
• A total of 120-200 patients will be enrolled consecutively over approximately 18
months.
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:
Real-World Generalizability: Unlike tightly controlled randomized trials, the POWER
Registry reflects actual clinical practice, encompassing diverse operator experience
levels, institutional protocols, and patient anatomies.
Post-Market Surveillance: As the PERCUTEK Tycheseal™ system expands into routine
use, structured post-market follow-up becomes essential to detect rare adverse
events and performance trends.
Multinational Collaboration: By including centers from both Poland and Italy, the
registry promotes transnational harmonization of endovascular standards and
facilitates benchmarking of regional clinical outcomes.
Clinical Decision Support: The findings from this registry will provide procedural
insights and safety benchmarks that can inform clinical decision-making, guideline
development, and payer evaluations.
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.
