Poland-Italy Aortic Research Bridge Real World Registry

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.

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