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Aortic Aneurysm, Abdominal clinical trials

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NCT ID: NCT03320408 Completed - Clinical trials for Abdominal Aortic Aneurysm

Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers

PARIS
Start date: October 4, 2017
Phase:
Study type: Observational [Patient Registry]

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

NCT ID: NCT03320252 Recruiting - Clinical trials for AAA - Abdominal Aortic Aneurysm

Endurant CHevAr New Indication Trial: ENCHANT

ENCHANT
Start date: October 26, 2017
Phase:
Study type: Observational

The purpose of the post-market study is to assess the clinical outcomes, safety, and performance of the Endurant Chimney Graft Technique (Endurant Stent Graft Systems used with a balloon-expandable covered stent graft) for treatment of juxtarenal aortic aneurysms with a short infrarenal neck in a real world setting.

NCT ID: NCT03310710 Completed - Clinical trials for Aortic Aneurysm, Abdominal

VIABAHN BX Used in Fenestrated EVAR Study

Start date: February 13, 2017
Phase: N/A
Study type: Interventional

Fenestrated endovascular abdominal aortic aneurysm repair (FEVAR) is a procedure to treat abdominal aortic aneurysms which are not amenable to conventional repair or stenting. A stent is placed in the aorta and confines blood flow to a normal diameter lumen to remove pressure on the diseased aortic wall. Fenestrations (custom holes in the graft) are necessary to maintain blood flow to abdominal organs when the aneurysm sac extends to far proximally. These fenestrations are then typically aligned with their respective vessels using covered stents. These stents also help keep the arteries open. Unfortunately some of the stents currently used occlude either immediately or over time, which can lead to organ failure, morbidity and death. A recent advancement in stent design has heparin bonded to the stent surface which prevents clot from forming. This new design has been shown to help maintain stent patency in other parts of the body. The investigators believe it may do the same for FEVAR patients. The proposed study is a 20-patient pilot to assess the safety of substituting a heparin bonded stent graft for FEVAR branches over a period of one year. Patients who are deemed eligible for FEVAR by a UHN multidisciplinary vascular conference will be recruited to the study. All the branches in their FEVAR will use the Viabahn BX stent in place of the current standard of care stent. They will then be followed per the standard of care for one year. Adverse events will be recorded and the rate of occlusion will be assessed based on CT imaging. The investigators hypothesize that using heparin bonded stent grafts is safe and they will have a low rate of occlusion.

NCT ID: NCT03298477 Active, not recruiting - Clinical trials for Abdominal Aortic Aneurysm Without Rupture

EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study

EVAS2
Start date: December 1, 2017
Phase: N/A
Study type: Interventional

Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System.

NCT ID: NCT03296280 Completed - Heart Failure Clinical Trials

Evaluation of Implementation of a National Point-of-Care Ultrasound Training Program

Start date: October 3, 2016
Phase:
Study type: Observational

This VA QUERI Partnered Evaluation Initiative will evaluate the impact of an immersive Point-of-care Ultrasound (POCUS) Training Course on provider skill acquisition and retention; the frequency of POCUS use by trained providers; and the barriers/facilitators to POCUS in the VHA. Data sources include pre- and post-course assessment tools, medical coding data, and course evaluations. Providers that participate in the POCUS Training Course will be compared to control providers from wait-listed facilities. Additionally, participating facilities vs. wait-listed facilities for the POCUS Training Course will be compared. Findings from this project will guide ongoing efforts of the investigators' operating partners, VA Specialty Care Centers of Innovation (SCCI) and the VA Simulation Learning and Research Network (SimLEARN), to develop a national POCUS training program and facilitate implementation of POCUS use system-wide in the VA healthcare system.

NCT ID: NCT03277781 Completed - Clinical trials for Abdominal Aortic Aneurysm

Female Aneurysm Screening STudy

FAST
Start date: November 1, 2016
Phase:
Study type: Observational

An abdominal aortic aneurysm (AAA) is a swelling of the main blood vessel (aorta) in the abdomen. If the swelling gets too large the aorta can burst and this is usually fatal. In order to prevent rupture, AAA can be surgically repaired. This is usually carried out when the size of the AAA is more than 5.5cm in diameter as below this size, the risk of rupture is lower than the risk of surgery. AAA are usually asymptomatic before rupture but can easily and safely be diagnosed by ultrasound scanning. There is currently a national screening programme for men, but not women. Women are not screened for AAA on the basis that the disease is less common in females. However, 33.6% of all deaths caused by ruptured AAA in England and Wales are in females (1109 female deaths)1. Death rates due to ruptured AAA in men have nearly halved over the last decade but the reduction in female deaths over the same time period is less than one third. Females with AAA are also 4-times more likely to rupture their aneurysm and have higher rates of complications and death after emergency surgery than men. There are groups of females such as smokers, who are at high risk of AAA. The investigators have identified risk factors that are easily identifiable from general practice databases that may be able to identify women at high risk of AAA. In this research it will be determined whether it is feasible to select women for AAA screening using these risk factors, how many women in these high-risk groups attend if they are invited for AAA screening, and screen women to determine the numbers in the different risk groups who have AAA. This will allow the assessment of whether screening women for AAA could be clinically or cost effective and who would benefit the most. The investigators will also investigate if the siblings of patients with AAAs are at higher risk of disease by inviting them for screening too.

NCT ID: NCT03231397 Terminated - Clinical trials for Abdominal Aortic Aneurysm (AAA)

Predictors of AAA Expansion and/or Rupture

Start date: August 1, 2017
Phase: Phase 4
Study type: Interventional

Eligible subjects in this study will have either a known abdominal aortic aneurysm (AAA) or because they do not have an AAA (control group). The purpose of this research study is to further study, through FEA, changes that occur in the mechanical properties of the aortic wall. The investigator will compare two radiotracers, 18F-FDG and 11C-PBR28 to determine if one provides more useful and reliable information about inflammation. 18F-FDG and 11C-PBR28 are radioactive drugs that will be used for imaging during the PET-CT scan. The investigator will also compare the results describing the mechanical properties of the AAA wall to the degree of inflammation in that wall as determined by PET-CT imaging to define new and better predictors of AAA growth and/or rupture.

NCT ID: NCT03208920 Completed - Clinical trials for Abdominal Aortic Aneurysm

Use of Fish Oil to Reduce Inflammation During Endovascular Abdominal Aortic Repair

Omega-EVAR
Start date: December 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if high-dose PUFA supplementation in patients undergoing EVAR for infra-renal AAA reduces the peri-operative inflammation.

NCT ID: NCT03188341 Completed - Clinical trials for Peripheral Arterial Disease

Cardiac Complication After Vascular Surgery

CCVS
Start date: December 2010
Phase: N/A
Study type: Observational

The vascular surgery is a highest risk procedure when considering postoperative complications associated with the cardiovascular system. The leading clinical presentation is acute hemodynamic decompensation. However, one of the possible pathomechanisms might be repolarization disturbances. Many of perioperative risk factors of cardiac complications are modifiable. The identification may help in the global perioperative risk reduction. Aim: The aim of the study was an identification of the factors which may release clinically overt repolarization disturbances. Methods: The study group consisted of 100 patients, diagnosed with abdominal subrenal aortic aneurysms or peripheral arterial disease scheduled for an elective "open" vascular surgery procedure. The authors investigated whether age, gender, comorbidities or some perioperative factors (including hemodynamic, metabolic or genetic) were related to the occurrence of clinically concealed repolarization disturbances or clinically disclosed cardiac complications in postoperative time up to 30 day and one year after vascular surgery procedure.

NCT ID: NCT03187522 Terminated - Clinical trials for Aortic Aneurysm, Abdominal

An European Union (EU) Post-Approval Registry of the TREO® Stent-Graft

Start date: June 22, 2017
Phase: N/A
Study type: Interventional

This is an EU sponsored trial and independent of the US trial registered under Clinicaltrials.gov ID NCT02009644. The purpose of this registry is to gather clinical data on the safety and performance of the TREO Stent-Graft in patients with infrarenal abdominal aortic aneurysms. The registry is part of TREO's EU post-market surveillance plan providing long-term systematic clinical follow-up.