Aortic Aneurysm

The purpose of this research is to assess safety and preliminary effectiveness of the Physician-Modified Terumo Treo Abdominal Stent-Graft System.

The Goal of this Clinical Study is to evaluate the safety and effectiveness of the Rapidlink device in the repair or replacement of the supra-aortic vessels during open surgical repair of aortic disease affecting the thoracic aorta. This study will collect information on patients who are already having surgery to repair their aorta and who will have Rapidlink device implanted into one or more of the aortic arch vessels. The first 32 subjects enrolled will undergo left subclavian artery repair or replacement, only, with the Rapidlink device. After the 32nd subject, enrollment will proceed to include subjects undergoing any supra-aortic vessel (i.e., left subclavian artery, left common carotid artery, and/or innominate artery) repair or replacement with the Rapidlink device in a planned surgery. After the 32nd subject is enrolled in the main group, up to 30 subjects will undergo supra-aortic vessel (i.e., left subclavian artery, left common carotid artery, and/or innominate artery) repair or replacement with the Rapidlink device in an emergency setting. Data will be collected before, during and after surgery including recovery at discharge, 30 days, 6 months, 1 and 2 years after the surgery.

This is a prospective, randomized, unblinded, multi-center study. Sites were selected from different geographies (EU and US) with different clinical practice to ensure the results are more generalizable. Primary objective is to demonstrate that the average procedure fluoroscopy time using LumiGuide is lower compared to conventional fluoroscopy guidance in Fenestrated Endovascular Aortic Repair (FEVAR)

The purpose of this research is to assess safety and preliminary effectiveness of the Physician-Modified Terumo Treo Abdominal Stent-Graft System.

The purpose of this study is to evaluate whether the application of soft foam dressings can reduce the occurrence of surgery-related pressure injuries among patients undergoing cardiac surgery. Specifically, this research aims to investigate differences in pressure injury outcomes before and after the intervention, and to assess the preventive effectiveness of soft foam dressings as an adjunctive skin-protection strategy.

Kinocardiography (KCG) is a portable measurement technique developed to estimate cardiac mechanical performance by studying the vibrations produced by myocardial contraction during each heartbeat and transmitted to the body surface. The goal of this observational study is to learn about kinocardiography in patients with aortic valve disease (AVD) or thoracic aortic aneurysm (TAA). The investigators believe that this technology will enable to diagnose aortic valve disease and aortic aneurysm. In patients with AVD of different severities or TAA, the investigators will collect informations from echocardiography and/or cardiac magnetic resonance imaging, KCG recordings, phonocardiography (PCG) recordings, and video recordings. Researchers will also compare subjects without any AVD nor TAA to better understand these effects on KCG, PCG and video signal.

The goal of this project is to establish a biobank of clinical information, DNA, plasma, and aortic tissue samples from patients with cardiovascular disease as well as healthy controls.

The primary clinical objective of this study is to evaluate the safety and effectiveness of a physician-modified, fenestrated and branched aortic endoprosthesis for the treatment of thoracoabdominal aortic aneurysms (TAAAs). The goal of the primary analysis is to demonstrate both the safety and effectiveness of using a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft as compared to previously published results of open surgical replacement of the aneurysmal aorta.

This is a single-center, prospective, randomized, open-label, parallel-controlled clinical study to evaluate the effectiveness of a large language model (LLM)-based intelligent health management assistant in the life-cycle health management of patients after cardiac surgery. A total of 500 adult patients who undergo cardiac surgery (including coronary artery bypass grafting, heart valve surgery, great vessel surgery, congenital heart disease correction, and other cardiac procedures) at Beijing Anzhen Hospital will be randomly assigned in a 1:1 ratio to an intervention group or a control group, stratified by age (\<65 vs ≥65 years) and surgery type. The intervention group will use the LLM-based mobile health management application in addition to standard postoperative care, while the control group will receive standard postoperative care alone. The application integrates multimodal clinical data into a personalized health profile and provides surgery-type-specific postoperative management recommendations, medication adherence reminders, complication early warning, and cardiac rehabilitation guidance. The primary outcome is the composite endpoint of major adverse cardiac and cerebrovascular events (MACCE), defined as all-cause death, non-fatal myocardial infarction, non-fatal stroke, or unplanned cardiovascular reoperation/reintervention, within 12 months after randomization. Secondary outcomes include health-related quality of life (EQ-5D-5L), cardiovascular rehospitalization rate, medication adherence (MMAS-8), postoperative complication rate, and cardiac rehabilitation achievement rate. Follow-up visits are scheduled at 1, 3, 6, 9, and 12 months post-randomization.

This study will test how well an artificial intelligence (AI) software called Aorta AIM measures the size of the aorta (the body's main blood vessel) from CT scans. The aorta can become enlarged over time, which may lead to serious health problems. Doctors need to measure the aorta accurately to monitor patients and decide on treatment. Currently, doctors measure the aorta manually on CT scans, which takes time and can vary between different doctors. Aorta AIM is designed to measure the aorta automatically and consistently. In this study, researchers will compare Aorta AIM's measurements to those made by experienced radiologists or cardiologists (doctors who specialize in reading medical images). The study will use CT scans that have already been taken as part of routine medical care - no additional scans or procedures are needed. The study will include approximately 250 participants across multiple hospitals in Brazil and the United States. Participants will be adults who have had a chest or abdominal CT scan that shows their aorta. The main goals are to: * Check if Aorta AIM measures the aorta as accurately as radiologists * See if Aorta AIM can help doctors work more efficiently * Evaluate if the software works well in different hospital settings and with different types of patients This research may help improve how doctors monitor aortic disease and make treatment decisions in the future. There are no risks to participants since the study only uses existing medical images.

Using 3D printing technology to create personalized models of diseased heart and aortic blood vessels, surgeons can perform preoperative planning and evaluate relevant indicators.

Surgical indication in patients suffering from Ascending aorta aneurysm is currently based mainly on the maximum diameter of the aortic dilatation and on the yearly growth rate. Several clinical preoperative patients characteristics have been, potentially, correlated to impaired mechanical characteristics of aortic wall, and therefore to an increased risk of rupture and or dissection. On other hands, such suppositions have been never confirmed, as a full characterization of the mechanical behaviour of the ascending aortic tissue, especially in case of aneurysm, has not been fully clarified yet. Objective of this observational study is to better elucidate, using direct in vivo evaluation, the mechanical characteristics of the aortic wall in patients with ascending aorta diseases. Our study will have a further peculiar characteristic as we have the intention of compare such mechanical characteristics to those of patients, without known aortic diseases, undergoing heart transplantation. Potential correlation between, directly measured mechanical characteristics of the aortic wall, and preoperative parameters (anagraphic patients characteristics, clinical data and diagnostic tests) will be also investigated.

The Montalcino Aortic Consortium (MAC) will provide the infrastructure to assemble large cohorts of patients with mutations in known heritable thoracic aortic disease (H-TAD) genes, define the phenotype associated with these genes, and determine genetic and environmental modifiers of H-TAD.

Aortic aneurysm patients benefit from exercise yet patients and physicians do not know a safe level. Cardiac MRI (CMR) is the most comprehensive imaging modality for phenotypic evaluation of patients with cardiac disease but it has not been used to study aneurysm patients. The purpose of this project is use exercise CMR to understand regional aortic function and quantify aortic elasticity in these populations while exercising. This project will correlate the exercise CMR data with the biomechanical properties of the patient's aortic tissue, including epiaortic ultrasound and TEE performed during aortic repair, and explanted aortic specimens subjected to ex vivo uniaxial tensile testing. Correlating this data with aortic response to exercise will allow us to understand how aortic size, in vivo circumferential strain values, ex vivo aortic efficiency and mechanical failure all relate to exercise physiology.

This international, observational multi-centre observational study of the devices BeFlared FEVAR Stent Graft System (BeFlared), BeGraft Stent Graft System (BeGraft), and BeGraft Plus Stent Graft System (BeGraft Plus) will monitor technical success of the implantation, data regarding clinical performance, clinical benefit, as well as potential unknown side effects for the use as bridging stent grafts in combination with fenestrated aortic endovascular grafts.

Prospective, non-randomized, multi-center clinical investigation of the NEXUS™ Aortic Arch Stent Graft System (NEXUSTM) for the treatment of thoracic aortic lesions involving the aortic arch with a proximal landing zone, native or previously implanted surgical graft, in the ascending aorta and with a brachiocephalic trunk native landing zone.

The primary objective of the clinical investigation "Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Complex Aortic Aneurysms" is to assess the use of the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms in high-risk subjects considered to be high risk candidates for open surgical repair, have limited or no other options for on label treatment with an FDA approved device, and having appropriate anatomy.

The goal of this retrospective observational study is to evaluate whether prophylactic mesh reinforcement during abdominal wall closure can prevent incisional hernias (IH) in patients undergoing open abdominal aortic aneurysm (AAA) repair. The main questions it aims to answer are: * Does mesh reinforcement reduce the incidence of incisional hernias? * What is the frequency of associated postoperative complications? Researchers will compare the outcomes of patients who underwent mesh-reinforced closures to literature-reported outcomes for non-mesh cases to assess differences in IH incidence and complications. Participants will: * Undergo clinical follow-ups and abdominal ultrasounds to detect IH. * Complete quality-of-life questionnaires (EQ-5D and PROMIS).

This clinical study aims to evaluate the effectiveness and safety of using NE'X Glue R-eco to seal suture lines. The adhesive will be applied to reduce the risk of suture line bleeding in cardiac or vascular repair surgeries, a prosthetic or biologic graft, patch, or allograft. The effectiveness of the adhesive will be assessed after restoring blood flow.

The goal of this prospective observational cohort study is to compare health related quality of life in patients with abdominal aortic aneurysms treated by either standard or complex EVAR (endovascular aneurysm repair) devices. The main questions it aims to answer are: * Compare differences between the physical scores from the preoperative to the postoperative settings between patients treated with standard EVAR vs non-standard endovascular aortic repair (F-/BEVAR) * To compare long-term physical scores postoperatively between patients treated with standard EVAR vs non-standard endovascular aortic repair (F-/BEVAR) at one year. * To explore at which time points (if ever) patients treated with standard-EVAR and nonstandard endovascular aortic repair (F-/BEVAR) have restored or normalized physical scores measured by SF-12, measured at 30 days, 6 months, 1 and 3 years. Participants will be asked to fill out forms pre- and postoperatively with regards to health related quality of life. The different groups for comparison will be either standard EVAR for infrarenal aortic aneurysms or complex EVAR (fenestrated or branched) for paravisceral aortic aneurysms (PVAAA).

The goal of this clinical trial is to learn about a new device, named the LIFE device, to treat people with aneurysms (swellings) in the aorta (large, main blood vessel that delivers blood from the heart to the body). The main questions this trial aims to answer are: * If the LIFE device works to treat aortic aneurysms * What medical problems participants have when the LIFE device is used Participants will undergo treatment with the LIFE device and thereafter at 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years have their pulses checked, bloodwork to check kidney function (BUN and serum creatinine), and a CT scan of the aneurysm area.

This project is aiming at the integration of a biomechanical computer program with a guidance code to simulate the endovascular repair (EVAR) procedure of abdominal aortic aneurysm (AAA). The computational time associated with finite element simulation generally renders its usage impractical for real-time application. Based on data collected during clinical interventions and a priori knowledge of AAA and endovascular device mechanical modeling, the investigators are proposing a deformable registration between preoperative CT-scans and per-operative fluoroscopy that will take into account prior simulations of participant specific EVAR procedures. To avoid the computational cost of a full finite element simulation, the investigators propose a simplified and real-time compliant repetitive mechanical behaviour based on participant specific parameters. The results of this research will provide the Canadian industry with the first realistic deformable vascular geometry tool for live endovascular intervention guidance. The proposed biomechanical modeling can be translated to other vascular intervention procedure by adjusting the biomechanical parameters.

The aim of the study is to investigate if iv iron formulation improve recovery after surgery with blood loss. Post-operative anaemia is a common debilitating condition after major surgery due to a combination of preoperative iron deficiency anaemia (IDA) and per-operative blood loss. Median blood loss following hepatopancreatobiliary (HPB) and complex aortic surgery typically range between 500-1000 ml. Bioavailability of iron may be a rate limiting factor in erythropoiesis in anaemia secondary to blood loss. For the IRIS trial, it is hypothesized that intravenously (iv) administered Ferric Carboxymaltose after a per-operative blood loss of 400-4000 ml, improves post-operative recovery and reduces the RBC transfusion. Patients scheduled for elective HPB surgery or complex aortic surgery will be screened for eligibility and recruited into the study. By the end of the surgical procedure, if blood loss is estimated to 400-4000 ml, the patient is randomized 1:1 to iv 1000 mg Ferric Carboxymaltose or placebo. The primary endpoint is a composite of death, number of RBC transfusions, post-operative severe anemia (Hb \<80 g/L) and FACT-An Quality of life (QoL) five weeks after surgery, assessed by win ratio. The trial will also examine effects on; a) levels of Hb; b) markers of erythropoiesis and iron bioavailability; c) post-operative complications; d) post-operative recovery; e) performance status; f) subgroups based on type of surgery and degree of anemia and iron deficiency; g) re-admissions; h) long term outcome based on patient medical records and i) how post-operative recovery differs between those with low (\<400 ml), high (400-4000 ml) and very high (\>4000 ml) per-operative blood loss. Recruitment will continue until 338 patients are randomized or 304 have completed the five week follow up The coordinating center of the trial is the Department of Surgery at Uppsala University Hospital. Participating sites are also Linköping University Hospital and Lund University Hospital, all in Sweden. Other sites may be added.

Abdominal aortic aneurysm (AAA), defined as a focal dilatation of the aorta, is a life-threatening condition and has become a serious public health challenge worldwide, associated with high rates of mortality and hospitalization. Endovascular aortic repair (EVAR) requires long-term surveillance by a multidisciplinary team to detect and treat post-operative complications.This international, multicentre, retrospective, observational study aims to use Artificial Intelligence-enhanced imaging analysis for the prediction of post-operative outcomes following EVAR. The primary aim is to identify predictive factors and build prediction models of post-operative outcomes following eligible EVAR. The secondary objective is to investigate morphological aortic changes and remodelling following EVAR . Screening for eligible patients will be done by a vascular specialist at each participating centers. Only subjects fulfilling all the inclusion and none of the exclusion criteria will be accepted in the study. Inclusion criteria from clinical characteristics may encompass the following: - patients who underwent elective EVAR for non-ruptured AAA for the first time, - patients who underwent non-complex EVAR procedure with commercially available endografts with CE mark, - patients with non-syndromic AAA or with non-infective AAA, - patients aged more than 18 years old. Inclusion criteria from CTA characteristics may encompass the following: - patients for whom one pre-operative and at least one post-operative CTA (within 1-year) can be collected in DICOM format. Detailed criteria for eligibility include the following: - Pre-operative CTA should be performed maximum 6 months before the intervention, - At least one post-operative CTA should be performed between 1 month and 12 months following the intervention, - CTA needs to be contrast-enhanced with at least injection at arterial and/or portal time, - CTA should have a spacing no more than 1 mm.Primary outcome will be EVAR-related complications including endoleaks, limb-occlusion and stent-graft migration. Secondary outcomes will include in-hospital length of stay post-intervention, re-interventions (with indication for re-intervention), and deaths (all-cause and aneurysm-related deaths). Outcomes will be investigated within 1 year and at the last follow-up of patients. Morphological changes following EVAR will be analyzed and compared based on pre-operative and post-operative CTA images. Images will be collected and analysed, using the PRAEVAorta 2 software (Nurea). Anatomic features measured include the measurement of aneurysm volume diameters and diameters (including AAA maximum diameter), measurement of intraluminal thrombus and calcifications, proximal and distal aneurysm neck lengths and diameters, suprarenal and infrarenal angulation, distal iliac landing zone length and diameter, and iliac tortuosity index. Based on the measurements, aneurysm sac will be classified into three categories: stable/ shrinkage/ expansion.The study will allow to identify predictive factors and develop predictive models of outcomes following eligible EVAR. By leveraging two approaches (traditional statistical analysis and AI-driven algorithms) and providing AI-enhanced detailed imaging analysis of the morphological characteristics of AAA, this study will allow a better understanding of pre-operative features predictive of the patients' outcomes.

The goal of this observational study is to determine the association of gastrointestinal dysfunction through the Gastrointestinal Dysfunction Scale (GIDS) tool and serum concentrations of citrulline and Intestinal fatty-acid binding protein (I-FABP) with primary \[calories received, protein received, parenteral nutrition requirement and 28-day mortality in the intensive care unit (ICU)\] and secondary (development of pneumonia, surgical and cardiovascular complications in the ICU, length of hospital and ICU stay, duration of mechanical ventilation) clinical outcomes in critically ill patients undergoing aortic surgery.