A Pragmatic, Observational, Multicenter Registry on the Implantation of the Tri Modular PERCUTEK Tycheseal™ Endograft System for the Treatment of Abdominal Aortic Aneurysm (AAA)

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).