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Aortic Aneurysm, Abdominal clinical trials

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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: 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: 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: NCT03157973 Completed - Aortic Aneurysm Clinical Trials

Modern Technology For Learning and Psychosocial Support In Patients With Abdominal Aortic Aneurysm

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

This study evaluates the effects of an eHealth tool and psychosocial support on anxiety, depression and health-related quality of life in patients undergoing surgical treatment for abdominal aortic aneurysm (AAA). Participants in the intervention group will receive access to the eHealth tool and structured follow-up with a contact nurse, the control group will receive standard of care.

NCT ID: NCT03116880 Completed - Clinical trials for Aortic Aneurysm, Abdominal

In Vivo Evaluation of Image Registration Techniques During Endovascular Repair

Start date: April 19, 2017
Phase:
Study type: Observational

Fluoroscopy is traditionally used for guidance of endovascular aortic repair (EVAR). In order to minimize exposure to radiation and nephrotoxic contrast medium, it is possible to generate a navigation road map by registering the intraoperative images with preoperative computed tomography angiograph (CTA). In modern hybrid operating rooms, several commercial solutions for this exists today (e.g. Siemens Syngo iPilot, Phillips Vesselnavigator). In order to register (fuse) the preoperative and intraoperative imaging to each other, a registration algorithm has to be applied. Sufficient accuracy of this algorithm is crucial, for if it fails the road map cannot be used for intraoperative navigation. The purpose of this study is therefore to evaluate two different 3D registration algorithms with regard to registration accuracy.

NCT ID: NCT03024554 Completed - Clinical trials for Aortic Aneurysm, Abdominal

Evaluation of Safety and Efficacy of the Bifurcated Multilayer Flow Modulator (BMFM®).

STREAMLINER
Start date: April 2014
Phase: N/A
Study type: Interventional

To determine the safety and efficacy of the BMFM® kit in the use for the endovascular treatment of aortic aneurysms involving iliac arteries. The BMFM® kit is an adaptation of the aortic MFM® to the aortoiliac bifurcation morphology. It should be noted that the aortic MFM® has CE mark approval for the aortic aneurysm treatment.

NCT ID: NCT02973308 Completed - Clinical trials for Abdominal Aortic Aneurysm

The Inter and Intra Reliability of Cardiopulmonary Exercise Testing in Abdominal Aortic Aneurysm Patients

CPEX
Start date: July 3, 2016
Phase: N/A
Study type: Interventional

Exercise testing is commonly being used in patients before surgery to test their overall fitness. One group it is being used in is patients who have an enlarged blood vessel in their stomach. This is known as an abdominal aortic aneurysm. The exercise test used is known as a cardiopulmonary exercise test as it looks at both heart and lung function at the same time. Whilst this test is commonly used there have been no studies (to date) which have looked at how reliable this test is; this means how well the investigators can obtain the same (or very similar) results after multiple tests. The investigators would like to test this reliability both between patients and the clinicians performing the testing.

NCT ID: NCT02949297 Completed - Clinical trials for Aortic Aneurysm, Abdominal

Expanding Patient Applicability With Polymer Sealing Ovation Alto Stent Graft Investigational Device Exemption (IDE) Study

ELEVATE
Start date: March 30, 2017
Phase: N/A
Study type: Interventional

A prospective clinical evaluation of the effectiveness of the Ovation Alto Abdominal Stent Graft System when used in the treatment of subjects with abdominal aortic aneurysm (AAA).