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AAA clinical trials

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NCT ID: NCT03762525 Recruiting - Angiography Clinical Trials

Iliac Branch Device Movement During Cardiac Cycle (IBD-dynamics)

Start date: October 5, 2016
Phase: N/A
Study type: Interventional

The incidence of isolated common iliac artery (CIA) aneurysms is low, but in combination with an abdominal aortic aneurysm (AAA) they are found in approximately 20-40% of cases. Basically, two different endovascular strategies can be applied to treat a CIA aneurysm with, including 1. the coverage and 2. the preservation of blood flow to the internal iliac artery (IIA). Coil and coverage of the IIA is related to ischemic complications, including buttock claudication, erectile dysfunction and the more severe spinal and colonic ischemia. Iliac branched devices (IBD) have been developed to exclude CIA aneurysms preserving the IIA and currently three alternatives are on the market. Clinical results of these devices are promising but loss of patency is not uncommon. The major difference between the two devices is the IIA component. The Cook IBD uses a -non-dedicated IIA component, while in the GORE® EXCLUDER® Iliac Branch Endoprosthesis (Gore IBE device) a dedicated self expanding stent is used. Stresses and forces exerted onto the endograft by aortic pulsatility may have an effect on the durability and functioning of the endograft. Intermittent hinchpoints could also have an effect on stent integrity and stenosis. By evaluating endograft movement during the cardiac cycle (ECG-gated CTA) it is possible to assess the stress and force exerted onto the endograft. This might help gain insight into mechanisms underlying potential endograft failure, and aid procedural planning and the development of future devices with long-term durability. The choice for device is not part of this study.

NCT ID: NCT03407664 Not yet recruiting - AAA Clinical Trials

NHS AAA Screening Programme Data Linkage With HES and ONS Datasets

Start date: April 1, 2018
Phase: N/A
Study type: Observational

An abdominal aortic aneurysm (AAA) is a dilation of the aorta, defined as an aortic diameter of ≥3cm. It is a significant cause of death internationally and in England each year causes c.4,000 deaths with 8,000 patients undergoing preventative surgery. AAA are often asymptomatic and there is a latent period between development and rupture. This represents an opportunity to screen by ultrasound which has been shown in trials to reduce AAA related mortality by half. In England this evidence is based on a randomised trial data from the late nineties, however, since these data were published the number of men identified with AAA has fallen to a current prevalence of just over 1%. Furthermore, similarly designed randomised trials in Western Australia demonstrated no meaningful differences in AAA or cardiovascular deaths. The first aim of our research is to follow men who have been screened for AAA in England in order to establish the medium (5 years) and long term (10+ years) impact of AAA screening on the risk of a AAA, cardiovascular and all-cause morbidity/mortality in a non-trial setting. Men with sub-aneurysms will be examined (Aorta=2.5-2.9cm) as several studies suggest this group is at risk of late rupture. The role of patient pathways to improve uptake of the screening programme will be examined. Current data suggests that the most 'deprived' men in England are the least likely to turn up for screening but the most likely to have an abdominal aneurysm. Outcomes in this group will be analysed including the benefit of a new patient pathway to improve uptake nationally. Lastly, several large studies have demonstrated that a larger aortic diameter may be associated with cardiovascular risk. The addition of aortic diameter to current risk prediction models could improve the accuracy of these models and will be examined.

NCT ID: NCT02843854 Not yet recruiting - Clinical trials for Peripheral Artery Disease

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

VIVAAA
Start date: October 2016
Phase: Phase 1
Study type: Interventional

This study will assess the safety and efficacy of systemic (IV) administration of escalating doses of allogeneic MSCs in modulating immune cell phenotypes and suppressing aortic inflammation in patients with small AAA. Subjects will be randomized in a 1:1:1 fashion to receive mesenchymal stromal cells (1 million or 3 million MSC/kg) intra-venously or placebo (Plasmalyte A).

NCT ID: NCT02692664 Recruiting - Iliac Aneurysm Clinical Trials

Prospective Multicenter Study for the Endovascular Treatment of Iliac Aneurysm With the Branched E-liac Stent Graft

TAILOR
Start date: April 2016
Phase: N/A
Study type: Observational

In this study, patients will be observed who receive an E-liac Stent Graft for treatment of isolated iliac aneurysms or an E-liac Stent Graft in combination with one of the following AAA stent grafts: E-tegra Stent Graft, Endurant AAA Stent Graft, Zenith AAA Endovascular Graft, Gore Excluder AAA Endoprosthesis for treatment of aorto-iliac aneurysms. Objectives of this post-market registry are: Primary: To prevent the risk of rupture and death by the treatment of common iliac aneurysm with an iliac branched stent graft (E-liac, JOTEC) Secondary: Evaluation of safety and feasibility of the E-liac Stent Graft System used in endovascular treatment of uni- or bilateral aorto-iliac or iliac aneurysm.

NCT ID: NCT02485496 Recruiting - Clinical trials for Abdominal Aortic Aneurysm

E-tegra Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms

SECURE
Start date: June 2015
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate clinical and technical success as well as safety and feasibility of the E-tegra Stent Graft System used in endovascular treatment of infrarenal aortic aneurysm.

NCT ID: NCT02461524 Active, not recruiting - Clinical trials for Abdominal Aortic Aneurysm

Endurant Evo International Clinical Trial

Start date: May 2015
Phase: N/A
Study type: Interventional

The purpose of this trial is to evaluate the safety and effectiveness of the Endurant Evo AAA (Abdominal Aortic Aneurysm) Stent graft system for endovascular treatment of subjects with infrarenal abdominal aortic or aortoiliac aneurysms.

NCT ID: NCT02393716 Active, not recruiting - Clinical trials for Abdominal Aortic Aneurysm

Endurant Evo US Clinical Trial

Start date: April 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate that the Endurant Evo AAA stent graft system is safe and effective for endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms.

NCT ID: NCT02179801 Recruiting - Clinical trials for Abdominal Aortic Aneurysm

Screening Cardiovascular Patients for Aortic aNeurysms (SCAN)

SCAN
Start date: March 2014
Phase: N/A
Study type: Observational

The aim of the cohort study SCAN (Screening Cardiovascular patients for Aortic aNeurysms) is to establish a screening programm for patients with a high risk for an AAA. Aortic aneurysms in these patients should be identified at an early stage and thereby AAA-associated mortality be decreased.