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46 active trials for Abdominal Aortic Aneurysm

Safety and Efficacy of Allogeneic MSCs in Promoting T-regulatory Cells in Patients With Small Abdominal Aortic Aneurysms

This project is to determine the safety and explore the effectiveness of allogeneic (not cells of the participant but those of another human) mesenchymal stromal cells (MSCs) in decreasing inflammation and possible enlargement of the participants' abdominal aortic aneurysm. Participants will be selected as a possible subject because of an abdominal aortic aneurysm discovered on the ultrasound or computed tomographic ("CT") scan requested by the participants' doctor. The purpose of this study is to collect information that will be used to determine if MSCs can be used to decrease inflammation and possibly slow down enlargement of the participants' aneurysm. The investigators will also be collecting blood samples to study special inflammatory cells that cause aneurysms as well as asking participants to have a "PET" (positron emission tomography) scan that can measure inflammation directly in the participants' aneurysm.

Start: December 2016

Carbon Dioxide Guided Angiography in Endovascular Abdominal Aortic Aneurysm Repair

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

Start: November 2019

Terumo Aortic Global Endovascular Registry

Multi-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.

Start: December 2019

Global Fenestrated Anaconda Clinical sTudy

This study is a prospective non-interventional, multi-centre study of the Vascutek Fenestrated Anaconda™ system, and is essentially a post-market study. The Vascutek Fenestrated Anaconda™ system is a custom made device used for the treatment of Abdominal Aortic Aneurysm.

Start: September 2017

Detecting Abdominal Aortic Aneurysms in First Degree Relatives (Adult Offsprings) to AAA Patients (DAAAD)

The 8-12 fold higher risk for sisters and brothers of patients with Abdominal Aortic Aneurysms (AAA) to develop AAA compared to persons in the population is well known in the scientific community. Recently the value of the screening program for siblings has been analyzed and is shown to be highly cost-efficient, similar to the population based screening of 65-year old men for AAA. Most importantly detection of siblings also adresses and includes women at risk. The adult offsprings to AAA patient would hypothetically bear the same risk of AAA as siblings. This has never been evaluated scientifically due to the practical difficulties in tracking the offspring and inviting them to screening at an age when they are at risk of AAA-disease. In Sweden, the unique multigeneration registry exists which could support such detection, with the possibility to track adult offspring to patients, and investigate the true contemporary prevalence in them. The DAAAD project aims at investigating the prevalence in adult offspring parallel to developing a model for such a selective screening program

Start: October 2020

Contrast Enhanced Ultrasound Endoleak Identification and Classification

Surgery for abdominal aortic pathology usually occurs in the setting of advanced cardiovascular disease. The repair can be relatively simple or complex with multiple steps including open repair, placing a stent with a catheter, and placing a complicated stent that allows for crossing vessels without occluding them. All these repairs require imaging follow up. The most commonly accepted tool for follow up is Computed Tomography (CT) scan which involves ionizing radiation and potentially nephrotoxic iodinated contrast. Recommendations for the time interval for follow up, as well the radiology imaging technique vary. Routine ultrasound with Doppler, CT, and MRI has all been employed utilizing various imaging protocols. Clinicians use non-contrast CT, arterial phase and delayed phase CT, ultrasound, and various combinations based on personal experience and patient pathology. Concerns over cost, potential nephrotoxicity of contrast agents and repeated radiation exposure has led to investigation of alternate imaging modalities such as contrast-enhanced ultrasound (CEUS). CEUS represents an improvement of ultrasound imaging but comparisons against CT report widely varying results, likely due to technical factors of CEUS and limitations of single-phase CTA. Contrast ultrasound has been used effectively to diagnose leaks in the aorta post repair and is without the radiation and potential nephrotoxicity of iodinated contrast. Of yet, no large prospective studies have compared CT and contrast US and no studies have looked at the more complicated staged or fenestrated repairs. This study proposes to perform a contrast ultrasound at the same time as a contrast CT using a standardized protocol. This protocol would include a non-contrast CT, angiographic CT, and a CT in a delayed phase in all patients as standard of care. We will compare the results of a contrast US with the various data derived from a three phase CT.

Start: December 2020

Tonometry(1) and Duplex Ultrasound(2) to Predict CV Events in to be Treated Patients With an AAA

Abdominal aortic aneurysm (AAA) is a common vascular disease and associated with risk of rupture, but also with a high cardiovascular (CV) event rate. A key difficulty in AAA is predicting these life-threatening complications, which are strongly linked to vascular health. In 2013, the SMART risk score was developed to calculate the risk of the patients for recurrent vascular events based on clinical characteristics. Recently, a novel, easy to perform, non-invasive test of endothelial function (the carotid artery reactivity (CAR) test), reflecting target organ damage, has been introduced. The CAR is a simple, quick (5-min), non-invasive test that uses ultrasound to examine the carotid artery in response to sympathetic stimulation by placing one hand in cold water. This test shows strong agreement with both coronary and aortic responses to sympathetic stimulation and predicted CV-events in patients with peripheral arterial disease. The aim of this prospective 2-year follow-up study is to investigate the predictive capacity of the CAR-test for development of CV-events after elective AAA repair in comparison to the SMART risk score. Secondary objectives are to investigate the predictive capacity of arterial stiffness measurements and the post-operative CAR-test for development of CV-events and to evaluate health status scores to provide insight if these scores can support clinical decision making.

Start: June 2020

Non-invasive Monitoring of Endovascular Repair of Abdominal Aortic Aneurysm (VBA)

This study evaluates a novel noninvasive method to dynamically monitor the effect of abdominal aortic aneurysm (AAA) and endovascular treatment of AAA (EVAR) on arterial pulse wave

Start: April 2018

Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices

The objective of this post-market trial is to evaluate Endologix AFX endovascular AAA system with anatomical fixation against other approved Endovascular systems with proximal fixation. Multiple U.S clinical centers will be involved in the trial to include a broad range of experience. Imaging data will be evaluated by an independent core lab.

Start: March 2015

Estimation of Biomechanical Aortic Wall Properties in Healthy and Aneurysmal Aortas Using Novel Imaging Techniques

The primary aim of this study is to establish the practicality of using two novel imaging modalities for the assessment of biomechanical properties of the aorta.

Start: August 2015

Metformin for Abdominal Aortic Aneurysm Growth Inhibition

A multi-centre population-based open-label randomized controlled trial with allocation concealment and blinded outcome assessment will examine if up to 2g metformin daily slows AAA growth in patients with small AAAs who do not have diabetes.

Start: February 2020

Deep Learning Applied to Plain Abdominal Radiographic Surveillance After Endovascular Aneurysm Repair (EVAR) of Abdominal Aortic Aneurysm (AAA)

Deep learning applied to plain abdominal radiographic surveillance after Endovascular Aneurysm Repair (EVAR) of Abdominal Aortic Aneurysm (AAA).

Start: October 2019

Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers

First aim: PARIS study The main aim of the current study is to determine the association between abdominal aortic aneurysm (AAA) progression and the evolution of proteases and cytokines levels.To achieve this aim, we will prospectively collect blood, aortic tissue, patient data, and imaging data. Aortic tissue will only be obtained when patients undergo conventional open repair. The other biomaterials will be collected during regular patient follow-up visits, with a maximum frequency of once per year. Second aim: Pearl AAA biobank For future research purposes, a new biobanking infrastructure will be created to collect and store additional blood and urine samples in a biobank. This biobank will be embedded within the infrastructure of the 'Parelsnoer Institute' (PSI) and will be called Pearl AAA. The Pearl AAA will be established in the extension of the PARIS study

Start: October 2017

Italian Multicenter Database for Open Conversions After EVAR

Late endovascular abdominal aneurysm repair (EVAR) complications not amenable to endovascular correction can undergo either late open conversion (LOC) or semi-conversion (SC). LOC is defined as a total or partial endograft explantation >30 days after the initial EVAR. SC is defined as open or laparoscopic surgery for endoleak (EL) correction with complete endograft preservation. The aim of this study is to collect in a prospective database the technical aspects of a multicenter experience of LOC and SC, and to analyse early and long-term outcomes of these two treatments.

Start: August 2020

Aneurysm Diameter and Surgical Outcome

Aneurysm diameter is an important risk for rupture and related death in affected patients. This study will evaluate whether aneurysms size may even influence post procedural outcomes both in open surgical repair and in end-vascular aneurysm repair. We will retrospectively review clinical data of operated patients with abdominal aortic aneurysm. We will consider both open surgical repair and endovascular aneurysm repair procedures in order to assess the influence of aneurysm size at the time of intervention.

Start: January 2020

Abdominal Aortic Aneurysm Surgery and Thrombosis

The aim of our study is to evaluate the incidence of post-operative thrombotic complications after abdominal aortic aneurysm surgery in the context of atherosclerosis or infectious aneurysm and its links with preoperative inflammation and hemostasis.

Start: March 2020

Safety and Efficacy of the SETA LATECBA Stent Graft for EVAR in Subjects With AAA

This is a Prospective, Open-label, Multicenter, and Non-randomized Clinical Study. The main purpose of this study is to establish the efficacy and safety of a medical device system, SETA LATECBA Stent Graft, intended for the treatment of EVAR of pararenal AAA (patients with complex anatomy, not eligible for other surgical procedure).Other objective is to evaluate the technical performance of the device SETA LATECBA Stent Graft.

Start: December 2019

Safety and Efficacy Study of Abdominal Aortic Aneurysm Stent Graft System

A prospective, multi-centre, objective performance criteria clinical trial to evaluate the safety and efficacy of Abdominal Aortic Aneurysm Stent Graft System manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for the infrarenal abdominal aortic aneurysm.

Start: September 2018

A Prospective Analysis on the Expansion Rates of Abdominal Aortic Aneurysms

Abdominal aortic aneurysm (AAA) disease is an abnormal bulging of the main abdominal artery, which is the called the abdominal aorta. The purpose of this observational study is to identify whether a blood biomarker protein RhoA can predict which small AAA patients may need surgery in the future. Participating patients will receive an ultrasound and blood draw. The patients will be divided into expanding and stable aorta groups after determining each patient's aortic expansion rate. The blood RhoA levels and aortic expansion rates between both groups would then be compared to look for any relationships.

Start: September 2015

Metformin Therapy in Non-diabetic AAA Patients

A prospective randomized, double blind, placebo-controlled, safety and efficacy study of metformin as add-on therapy in abdominal aortic aneurysm (AAA) OBJECTIVES Primary Objective To demonstrate treatment efficacy of metformin in AAA in comparison to placebo or active comparator, as measured by growth of the AAA maximum diameter at 12 months Secondary Objectives To asses inflammatory cytokines and parameters of neutrophil activation in AAA in response to metformin treatment by glucose insulin Interleukin-6 markers of neutrophil activation (MPO, elastase, NGAL)

Start: September 2018