PMCF Study in Patients With Acute or Chronic Aortic Dissection or Aortic Aneurysm Treated With E-vita...
Vascular AneurysmThe NEOS-APAC post-market clinical follow-up study is undertaken to demonstrate the safety and clinical performance of E-vita OPEN NEO in the treatment of aneurysm or dissection in the ascending aorta, aortic arch and descending thoracic aorta.
A Study in Patients With a Descending TAA or PAU Treated With the E-nya Thoracic Stent Graft System...
Vascular AneurysmThe CONFORM-TAA post-market clinical follow-up study is undertaken to evaluate the prevention of death related to a descending aortic aneurysm or PAU when treated by the E-nya Thoracic Stent Graft System. The secondary objective is to evaluate the safety and clinical performance of the device.
Coated Mongolian Aneurysm Treatment Study 1
Intracranial AneurysmAneurysm1 moreThe purpose of this study is to assess safety and effectiveness of the p64 MW HPC or p48 MW HPC Flow Modulation Device under Dual Antiplatelet Medication.
Terumo Aortic Global Endovascular Registry
Abdominal Aortic AneurysmThoracic Aortic Aneurysm1 moreMulti-arm, multi-center, open label, prospective observational registry designed to obtain safety and performance data on the use of CE marked and custom Terumo Aortic endovascular grafts.
Zenith® Fenestrated+ Clinical Study
Aortic AneurysmAbdominal3 moreThe Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) for the treatment of patients with aortic aneurysms involving one or more of the major visceral arteries.
Clinical Effectiveness of an Off-the-shelf Single REnal Scalloped sTent-graft for HOstile NEck Infrarenal...
Abdominal Aortic AneurysmThe goal of this multicenter, observational cohort study is to evaluates the clinical effectiveness of a single-renal scallop custom-made stent-graft (TREO, Terumo Aortic, Sunrise, FL) to treat "hostile" AAA with mismatched renal arteries as actual standard of care in this Vascular Unit The main question it aims to answer are: if a dedicated devices could improve the results in the endovascular treatment of patients suffering to infrarenal abdominal aortic aneurism with a mismatched takeoff of the renal arteries. Participants responding to inclusion criteria will be treated as best clinical practice with a custom made device with a single scallop for the renal artery. The minimum follow-up requested, as standard clinical practice, was: 3-months, 12-18 months- and 5-years CTA; clinical and DUS examination at 6- and 12- and 36-months after the intervention and yearly thereafter. No comparison group was present.
Evaluation of the Valiant Captivia Physician Fenestrated Stent Graft System in Aortic Arch and Descending...
Penetrating Ulcer of AortaAneurysm Aortic2 moreThe study objectives are to assess safety and effectiveness, measured acutely and at the 30-day visit after implantation of the Valiant Captivia physician fenestrated Stent Graft. Clinical utility measures throughout the procedure and until discharge will be assessed
Optimizing CO2 Injection Technique for EVAR
Abdominal Aortic AneurysmEndovascular Aortic RepairAutomated carbon dioxide (CO2) angiography is considered a safe diagnostic alternative to standard iodinated contrast medium (ICM) for endovascular aortic repair (EVAR) of abdominal aortic aneurysm (AAA), especially in patients with preoperative renal function impairment. Recent literature experiences describe the use of automated CO2 angiography in EVAR. One of the main issues of CO2 angiography is the inability to detect the origin of the lowest renal artery (proximal neck visualization) that was estimated up to 38%. In these experiences, the CO2 automated angiography is usually performed by a 5F pigtail catheter placed at renal arteries level. The aim of the study is to evaluate the efficacy of a new automated CO2 injection technique by a 5F introducer (single hole catheter) positioned at the distal level of the proximal neck in detecting both renal arteries in the first diagnostic and completion angiographies.
Zenith Thoracic Alpha (ZTA) Post-Market Data Collection
Thoracic Aortic AneurysmPenetrating Aortic UlcerThis study aims to gather real-world clinical data demonstrating the continued safety and performance of the a marketed stent graft (Zenith® Alpha Thoracic Endovascular Graft [ZTA]) and collect longer term follow-up to better understand clinical outcomes associated with the expected lifetime of the device.
Comparison of a Full Automatic Software With Standard Methods of Vessels Analysis
Abdominal Aortic AneurysmThe treatment of aortic aneurysms is today based on different indicators (diameters, lengths, angles, volumes of the arteries) measured on CT scan images. Several indicators are time consuming and complicatated to measure. They demand training and practice. Nurea is developing a software for automatic measurement of these indicators, PRAEVAorta® 2, to facilitate and assist the physician in his clinical routine. The purpose of this study is to compare the analysis realised by the software PRAEVAorta® 2 with the analysis realised by the healthcare professional on retrospective CT scan images. Contrasted and non-contrasted, pre-operation or post-operation CT scans from 50 patients will be analysed. The main objectif is to validate the accuracy of the software by demonstrating its adequacy to the standard method of analysis. The second objectives are the following: Evaluate the security of the software PRAEVAorta® 2 Evaluate the unanticipated risks related to the use of the software Validate the accessory PRAEVAorta® Web We make the following assumption : 90% of the patients show 90% of adequacy to the healthcare professional analysis