Castel Volturno

Researchers are collecting and analyzing real-world data from multiple centers in Italy and Poland on the use of the PERCUTEK Tycheseal stent-graft system for repairing abdominal aortic aneurysms AAA. The study aims to evaluate the technical success, safety, and mid-term outcomes of this device in actual clinical practice. It focuses on patients with suitable anatomy undergoing this procedure, to provide evidence on the devices performance and related complications over time. This is an observational, physician-initiated registry enrolling 120 to 200 patients over about 18 months. Participants receive the PERCUTEK Tycheseal tri-modular endograft system, which includes a main body and two iliac limbs designed to fit a range of aortic anatomies. The device features a low-profile delivery system and radiopaque markers to aid placement. Data on the procedure and outcomes are collected without experimental treatments or randomization. Participants are followed for up to 24 months after device implantation with assessments at baseline, discharge, 1 month, 12 months, and 24 months. Study measures include technical success defined by proper device positioning and no immediate serious leaks, aneurysm size changes, endoleak presence, device migration or occlusion, and major adverse events. Data are collected using standardized forms, and safety outcomes are monitored throughout the study period to understand the devices mid-term clinical performance.

The VISTA Nova Study focuses on patients with aortic stenosis who are undergoing transcatheter aortic valve replacement TAVR. The goal is to assess the safety, performance, and long-term durability of the Navitor valve in a real-world setting. This observational study evaluates how well the device works and its impact on patient outcomes over time. Participants will receive the Navitor Transcatheter Aortic Valve using the FlexNav delivery system and the Navitor Loading System. The Navitor valve comes in five sizes to fit annulus diameters from 19 mm to 30 mm, and the delivery and loading systems are available in two sizes each. The procedure follows approved indications and involves specialized equipment to implant the valve. During the study, participants will be monitored at scheduled follow-up visits after their TAVI procedure to track outcomes such as overall survival and valve leakage. The primary outcomes measured include all-cause mortality and the presence of moderate or greater paravalvular leak at 30 days post-procedure. Participants are expected to return for all required follow-up visits to help researchers evaluate the valves long-term safety and effectiveness, with the study continuing through 2032.

Researchers are evaluating the TES HT100 device to see how accurately and safely it can detect intracranial abnormalities in adult patients who come to the emergency department with mild head trauma or neurological symptoms that are not related to trauma and are not immediately life-threatening. The study aims to understand how well TES HT100 compares to head CT, the standard method, and whether it can help improve patient triage and hospital resource use. Participants will receive the standard emergency department evaluation including a head CT scan as usual care. In addition, they will undergo a TES HT100 examination, which is a non-invasive test that uses ultra-low-power electromagnetic waves and takes about 5 minutes. This TES HT100 test is performed by trained personnel and provides a simple yesno result about the presence of brain abnormalities. The study is conducted at multiple centers using three TES HT100 devices over about 30 months, with the TES HT100 test done within 24 hours before or after the CT scan. During the study, participants will have routine clinical assessments, head CT scans, and the TES HT100 test. Researchers will compare TES HT100 results to CT reports to evaluate diagnostic accuracy and monitor any adverse events from TES HT100 use over an average of one year. They will also study how TES HT100 impacts screening time, procedures, and costs. The research aims to provide evidence on TES HT100s performance and safety as a quick, non-invasive screening tool in emergency care.