View clinical trials related to Aortic Aneurysm.
Filter by:The objective of this clinical investigation is to evaluate, in a controlled setting, the safety and performance of the BeGraft Peripheral (BGP) balloon expandable covered stent Graft System (Bentley InnoMed, Hechingen, Germany) implanted as bridging stent in FEVAR (fenestrated endovascular aortic repair) for complex aortic aneurysms.
There is a relationship between aerobic fitness and survival both with and without surgery. Some patients can improve their aerobic fitness with a structured exercise programme but currently it is not know how much this could change predicted survival for patients with an abdominal aortic aneurysm, or how long this change can be maintained. Survival can be predicted after planned abdominal aortic aneurysm (AAA) surgery using physical fitness measured with a cardiopulmonary exercise test. The researchers have validated this in a published peer reviewed multicentre study. In this study the patient's fitness will be measured before and after a structured exercise programme and assess if there is any change in their predicted survival. The primary objective of the study is to measure the change in predicted survival for abdominal aortic aneurysm surgery after a structured exercise programme. In addition the patients are asked to complete the following questionnaires:- EQ-5D-5L, Hospital Anxiety and Depression Scale (HADS) before and after the exercise programme.
The objective of this clinical investigation is to evaluate, in a controlled setting, the safety and performance of the BGP+ balloon expandable covered stent Graft System (Bentley InnoMed, Hechingen, Germany) implanted as bridging stent in BEVAR (branched endovascular aortic repair) for complex aortic aneurysms.
Abdominal aortic aneurysm (AAA) is an aortic dilatation superior or equal to 30 mm with an estimated prevalence at 8% in men over 65 year-old. It evolves with no clinical signal until the rupture of the aortic wall with dramatic outcomes. The pathophysiological mechanisms include extracellular matrix remodeling, smooth muscle cells apoptosis, aggregation and activation of inflammatory cells in the aortic wall and heredity. The initiating and regulatory processes are complex and not fully elucidated. They encompass local aortic environment (flux, thrombus, wall shear stress, pressure and adipose tissue) and patient-dependent genetic (de)regulation. This project follows the previous prospective ACTA study that aimed at identifying clinical criteria, circulating biomarkers or imaging data for thoracic aneurysm prognosis in an AAA population. The preliminary results showed that 1) a low wall shear stress index and the luminal volume are more predictive values for a rapid AAA growth and an intraluminal thrombus than the maximal aortic diameter 2) three thoracic aortic phenotypes (normal, dilated, aneurysmal) stratify the disease extent 3) the age and the female gender are associated to an extended disease. During this study we created a biobank in which blood samples of AAA patients were collected at the time of their inclusion (T1). This new ACTA-miRNA study aims at correlating circulating biomarkers to the anatomical and biomechanical markers previously highlighted for a rapid aneurysmal growth. Circulating miRNA are involved in parietal remodeling and constitute promising targets for estimating patients-specific aortic risk. From the literature, we thus selected 18 miRNA described to be involved in AAA biology: inflammation, remodeling, cellular homeostasis and wall shear stress. As control, we select non-AAA patients presenting with peripheral arterial obstructive disease (PAOD) matched in age, BMI, tobacco consumption, diabetes, cholesterol level and blood pressure with AAA patients enrolled in the ACTA study. During their follow-up, these ACTA patients are solicited to continue the program research and can participate to the ACTA-miRNA study. A third time analysis is performed for them (T3): we collect imaging data of total aorta required by their standard follow-up, as well as a blood sample. Differential analysis of the miRNA panel will be conducted between 1) AAA patients (T1) vs PAOD patients 2) fast-growing AAA vs slow-growing AAA 3) AAA & AAT patient group vs AAA alone and/or AAA & dilatation of thoracic aorta. 110 patients from the ACTA study are eligible to be included into the ACTA mi-RNA study. Inclusion of PAOD controls will be conducted until the number of 165 cases is reached (1:1.5 ratio). Our primary objective is to validate a circulating-miRNA signature specific for abdominal aortic aneurysm.
The purpose of the BSET-CLEVAR Registry is to collect device-specific performance outcomes of the GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL System (EXCC device) in routine clinical treatment of patients with abdominal aortic aneurysm in the UK. The novel EXCC device is an evolution of an established device allowing active shaping to conform to the specific patient aortic neck anatomy, with more accurate deployment, potentially greater neck coverage and better long term fixation/sealing. This may translate to improved effectiveness of this device over time, reducing the need for any further procedures. The primary aim of this study is to assess the degree of neck coverage by the EXCC device. The British Society of Endovascular Therapy (BSET) has received funds from the stent manufacturer (W.L. Gore & Associates, Inc.) to conduct this study. BSET and the Sponsor (Imperial College London) have full responsibility for the design, conduct, analysis and reporting of the study.
INITIATION is a postmarket clinical follow-up study in China. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of Incraft in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 120 subjects will be enrolled and followed through 1-years postprocedure. Up to 20 sites in China may participate.
The study was created to evaluate the theoretical anatomical feasibility of the new E-nside Multibranch Stent Graft System (JOTEC GmbH, Hechingen) in patients with thoracoabdominal and para-renal aortic aneurysms based on retrospective review of pre-operative imaging studies of the patients treated with other techniques for this pathology in the vascular Unit of San Raffaele Hospital, in the past ten years. With this study, investigators want to analyze in how many cases the new prosthesis would be usable. E-nside Multibranch Stent Graft System (JOTEC GmbH, Hechingen) is in the pre-CE marking stage. At present, the certifying organism is evaluating the documentation for the release the CE mark certification and Declaration of Conformity.
The sudy purpose is to investigate efficacy and safety of percutaneous endovascular aortic aneurysm repair using INCRAFT stent graft for Korean patients with abdominal aortic aneurysm. This study is designed as an investigator-initiated, multi-center, single-arm, prospective registry study. A total of 100 patients who meet all inclusion criteria, but none of exclusion criteria will be enrolled after the implantation of INCRAFT stent graft. The primary efficacy outcome is technical success defined as successful deployment of the stent-graft with no type I/III endoleak, unintentional coverage of visceral aortic branches or internal iliac arteries at the end of the procedure, and with successful removal of the delivery system. The primary safety outcome is major vascular complications at 30 days including. The study subjects will be followed for 12 months.
Background and rationale of the study: Patients undergoing non-cardiac major surgery show a perioperative cardiac risk and postoperative complications, that can be stratified based on parameters linked to patient's conditions and to surgery types. An accurate identification of this risk could offer numerous advantages for these patients, who's 30-day mortality is around 2%. The identification of the correct risk could lead to a better pre- and postoperative management, that could guarantee a better surgery outcome and a faster postoperative recovery. To this day there is no perfect method to correctly estimate this risk. Various studies show that high BNP levels are linked to cardiac events at 30 and 180 days. Further investigations identify different groups, at low, intermediate and high risk, based on BNP levels. BNP is released by ventricular myocytes in response to a wall distress, due to an increased volume, pressure or myocardial ischemia. So BNP plasma levels could be used as a prognostic and diagnostic marker, improving the cardiac risk stratification in patients undergoing surgery and a much more precise management. This study is determined to do an evaluation of the correlations between pre- and postoperative BNP levels and the incidence of cardiac events in patients undergoing major vascular surgery.
The study is non-randomized, multicenter international safety, performance and clinical benefit outcome assessment of ANEUFIX to treat patients with isolated type II endoleak in the presence of a growing AAA-sac following an EVAR procedure more than 6 months ago.