Castel Volturno

Researchers are evaluating the use of the PERCUTEK Tycheseal21 stent-graft system for repairing abdominal aortic aneurysms (AAA) in a real-world setting across multiple centers in Italy and Poland. This observational registry study aims to collect detailed patient, procedural, and outcome data to assess the technical success, safety, and mid-term performance of this tri-modular endograft system. The study focuses on patients with infrarenal AAA, a condition where the abdominal aorta is abnormally enlarged and at risk of rupture, which can be life-threatening without timely treatment. The PERCUTEK Tycheseal21 system consists of a main body and two iliac limb components designed for precise placement and adaptability to challenging anatomical features such as varying neck diameters and angles. The device is delivered through a low-profile system and includes features to enhance visibility and durability. Throughout the study, participants will receive endovascular repair using this device, with data collected on procedure details and device performance. Follow-up assessments occur at discharge, 1 month, 12 months, and 24 months after implantation to monitor outcomes. Participants will undergo regular evaluations including imaging studies such as Doppler ultrasound and angio CT to monitor for complications like endoleaks, aneurysm sac changes, stent-graft migration, occlusion, or rupture. The study measures technical success defined by correct device deployment without immediate complications and tracks freedom from adverse events over 12 months. Data are entered into standardized forms and monitored for quality. The total enrollment is expected to be 120-200 patients over 18 months, with follow-up continuing up to 24 months post-implantation.

The VISTA Nova Study investigates the safety, performance, and long-term durability of the Navitor valve in patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR). This global post-market study aims to assess these outcomes in a real-world clinical setting, focusing on patients eligible for the Navitor TAVI procedure based on current approved indications. Participants will receive the Navitor Transcatheter Aortic Valve, delivered using the FlexNav Delivery System and the Navitor Loading System. The study follows patients who undergo the TAVR procedure with this device, monitoring their outcomes to evaluate device performance and safety. During the study, participants will be observed for key outcomes including all-cause mortality and the occurrence of moderate or greater paravalvular leak at 30 days after the TAVI procedure. Patients are expected to return for all required post-procedure follow-up visits to monitor these outcomes, with safety and performance data collected throughout the study duration.

Researchers are evaluating the TES HT100 device to see how accurately and safely it can detect brain abnormalities in adults who come to the emergency department with mild head injuries or certain neurological symptoms that are not immediately life-threatening. The study aims to compare TES HT100 results with standard head CT scans, which are the current reference for diagnosing such conditions. It also explores whether TES HT100 could improve patient triage and optimize hospital resource use in emergency settings. This is a prospective, multicenter clinical investigation conducted in Italy and Poland. The TES HT100 device is a non-invasive screening tool that uses very low-power, non-ionizing electromagnetic waves to detect intracranial abnormalities. The examination takes about 5 minutes and is performed by trained personnel in addition to the usual clinical assessment and head CT scan. TES HT100 results provide a simple positive or negative indication of brain abnormalities. To avoid bias, the device exam is done within 24 hours before or after the CT scan, and the personnel performing the test do not have access to CT results. The study plans to enroll about 850 participants across three centers over 30 months. Participants will receive their usual clinical care along with the TES HT100 examination. Researchers will monitor for any device-related side effects throughout the study, which lasts about one year per participant. The main outcomes measured are how well TES HT100 detects brain abnormalities compared to CT and the rate of any device-related adverse events. The investigation will also assess the potential usefulness of TES HT100 in emergency triage and resource management, aiming to provide evidence on its diagnostic performance and safety.