View clinical trials related to Aortic Aneurysm, Abdominal.
Filter by:The purpose of the study is to describe Sodium Fluoride uptake (using Positron Emission Tomography-Computed Tomography - PET-CT) following Endovascular Aneurysm Repair (EVAR) and to determine whether Sodium Fluoride PET-CT can predict the development of endoleaks.
Nurea wants to set-up a pivotal phase clinical study for its software PRAEVAorta, a decision-making support for diagnosis and follow-up of abdominal aorta aneurysm. This study is a comparative study. Its purpose is to demonstrate the adequacy of PRAEVAorta to the current Gold Standard in the care of patients with abdominal aortic aneurysm. The currently benchmark methods are the maximal diameter method (Hand-held measurement of maximum diameter on scan images) and the segmentation method for the aneurysm volume (manual segmentation of scan images, then calculation of the AAA volume by counting the pixels). The hypothesis is that 90% of the segmented patients have a volume ratio and a diameter ration equal to or greater than 90%.
Ten percent of the population above 60 years develops an aortic abdominal aneurysm. In case of rupture, this pathology leads to death in more than 70% of the cases. Over the past ten years, Endovascular Aortic Aneurysm Repair (EVAR) has been the most used technique for elective treatment for abdominal aortic aneurysms (AAA) in patients with a favorable anatomy. But despite excellent postoperative results with a significant reduction of mortality , a close follow-up of these patients is mandatory to detect any potential endoleaks particularly in patients with a long-life expectancy. Failed Endovascular Infrarenal Aortic Aneurysm Repair (EVAR) with development of a proximal endoleak exposes the patient to the risk of rupture and must be treated. This type of endoleaks are often related to dilatation of the proximal neck of the AAA, and of the suprarenal aorta, making the use of any aortic fixation system, or uncovered stent ineffective. In these cases, open surgical conversion with stent graft removal is possible but at the price of a significant morbidity and mortality. The alternative is the use of a fenestrated or branched stent graft (F/BEVAR) extending the proximal sealing zone to a non-diseased aorta. The goal of this study was to evaluate the technical feasibility, early and midterm outcomes of (F/BEVAR) in patients with a proximal endoleak following a standard EVAR. The investigators performed a multicentre study between January 2010 and December 2019 in 8 French University Centres which included 85 patients with 3 years of post operative follow-up.
The primary objective of this study is to assess the use of a physician-modified Cook Alpha Thoracic Endovascular Graft in the repair of complex aortic aneurysms and thoracoabdominal aortic aneurysms and aneurysms secondary to aortic dissections in high-risk patients having appropriate anatomy. The primary intent of the study is to assess the safety and preliminary effectiveness of the device. Additionally, the study will assess renal function, radiation exposure, and quality of life.
BACKGROUND - Major blood loss is frequent in open repair of ruptured and intact abdominal aortic aneurysm (AAA) as well as in aorto-bifurcated prosthesis insertion due to aortoiliac occlusive disease. - Major blood loss is associated with death, post-operative complications and coagulopathy. - Data from randomized trials in trauma patients indicate that a high plasma to red blood cell (RBC) transfusion ratio reduces 30-day mortality. - No randomized trial data are available for the AAA population. - Observational data demonstrate, that a high plasma:RBC transfusion ratio associates to a lower 30 day mortality. However, the reports are based on small cohorts of 78-165 patients, short term outcomes and lack information on major adverse events such as cardiac and respiratory. - The Danish Vascular Registry (DVR), covering 1996-2018, contains data on approx. 4,400 ruptured and 8,200 intact (elective/symptomatic) AAA repairs, and 5,400 open aortoiliac repairs due to occlusive disease. Expected total count 1997-2018: 17,000. - The Danish Transfusion Database (DTDB), covering approx. 1997-2018, contains information on units of RBCs, plasma and platelets transfused. A unique patient identification number (CPR) allows merging of all data set. OBJECTIVE To identify whether resuscitation with a high plasma to RBC ratio associates to improves survival in open abdominal aortic surgery as compared to a low plasma to RBC-ratio. PICO - Population: Open abdominal aortic surgery - Intervention: "High FFP": FFP to RBC unit ratio of 2:3 to 3:3 (0.7 - 1.0) - Comparison: "Low FFP": FFP to RBC unit ratio of 0:3 to 1:3 (0.0 - 0.3) - Outcome: All-cause mortality 90 days following surgery. DATA SOURCES CPR, Danish Civil Registration System. DNPR, Danish National Patient registry. DVR, Danish Vascular registry. DPDB, The Danish national Prescription DataBase.
The aim of this randomized study is to compare the safety and performance of EndoVascular Aneurysm Repair with ESAR using Endurant + Heli-FX™ EndoAnchor™ system and FEVAR using customizable grafts from Cook (Zenith Fenestrated Graft) and Terumo (Fenestrated Anaconda Graft) for the treatment of aortic aneurysms with short aortic neck (4 to 15mm).
Deep learning applied to plain abdominal radiographic surveillance after Endovascular Aneurysm Repair (EVAR) of Abdominal Aortic Aneurysm (AAA).
In this research, the investigators are looking at the effects of a drug called metformin may have on the growth of abdominal aortic aneurysm (AAA)s. AAA is an abnormal enlargement of the aorta, which is the large artery in the abdomen (stomach area). The enlargement of the aorta carries a risk that it will rupture and cause life-threatening bleeding in the abdomen (belly). In this study the investigators hope to learn how metformin is associated with the enlargement or change in size of the AAA in study participants. Smaller studies have suggested that metformin may reduce the rate at which aortic aneurysms enlarge. This study will test this question: does metformin prevent AAAs from growing larger?
This will be a non-randomized, prospective, observational multi-center research study. Its purpose will be to assess the mortality and outcome of EVAR in patients with rAAA. As mentioned in the introduction, EVAR approach for ruptured bdominal aortic aneurysms is nowdays common clinical practice in many vascular centers , and the main treatment option in Hippokrateio General hospital. The same applies in all future participating vascular centers.
Endovascular aneurysm repair (EVAR) has lower short-term morbidity and mortality than open surgery. Intra-arterial contrast agents are an important component of successful EVAR as the tool of choice for preoperative evaluation of aortic aneurysm morphology as well as precise sizing and intraoperative visualization of the ostia of the renal and hypogastric arteries for graft replacement. Although iodinated contrast (IC) is overwhelmingly the most common contrast agent, the perioperative use of IC agents is not recommended in patients with renal dysfunction or allergies to IC The aim of this study was to evaluate feasibility, efficacy and safety of carbon dioxide (CO2) digital subtraction angiography (DSA) to guide endovascular aneurysm repair (EVAR) in a cohort of patients with abdominal aortic aneurysm