View clinical trials related to Aortic Aneurysm, Thoracic.
Filter by: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.
Thoracic aortic aneurysms (TAA) are considered "silent killers" because they scarcely display any symptomatology, but are correlated with significant mortality and morbidity. Current guidelines regard aortic aneurysm disease as a coronary artery disease equivalent and suggest aspirin and statin use to reduce the progression of atherosclerosis, as well as beta-blocker (BB) therapy. No therapy, however, is effective at limiting aneurysm expansion and preventing rupture, even in large trials. TAA has emerged as an inflammation-mediated disorder. Angiotensin-converting enzyme inhibitors (ACEIs) can reduce the wall shear stress and inflammation, both of which play vital roles in the expansion of the aneurysm. The study will be a randomized, double-blind trial. Patients will be randomized into one of two parallel arms, receiving captopril or atenolol. The doses of captopril and atenolol will be 25 mg daily for the first 15 days, rising to 100 mg according to clinical tolerance and BP estimates. The sample size will be set at 424 subjects (212 per group). The primary end-point will be the rate of change in the absolute diameter of the aortic root and ascending aorta on MRI of the aorta after 36 months of therapy with captopril vs. atenolol. BBs have not been precisely found to decrease aneurysm growth rates. ACEIs could lead to the prevention of aneurysm degeneration through their antihypertensive and anti-inflammatory properties. The results of this trial will clarify that ACEIs are superior to BB therapy in reducing the growth rate of TAAs, the rate of change in aortic insufficiency, the time to aortic rupture or dissection, the need for aortic surgery or intervention, and death.
Thoracic aneurysm incidence is estimated to 4.5 cases per 100 000. The manifestation as well as natural history of thoracic aneurysm depend on many factors such as its localisation, its diameter, presence of collagen disease and family history. For the ascendant aortic aneurysm, it is often linked to a degeneration of the media arterial layer of the arterial wall. The media degeneration is cause by the degeneration of the elastic fibres, which lead to a weakening of the arterial wall accompanied with dilation. This process is often due to age and is accelerated by high blood pressure. Amongst the numerous factors causing the aneurysm, the investigators find: hypertension, aortic bicuspid valve, smoking, atherosclerosis, trauma and genetic predisposition. The average growth rate of thoracic aneurysm is 0.1-0.2 cm/year. The risk of rupture is associated to the size of the aneurysm as well as patient's symptoms. The ruptures and dissections rates are accounted for 2-3/year for thoracic aneurysm between 5.5-6.0 cm in diameter. The patients are often limited in their daily life activities considering their concern and risk of rupture and/or dissect. The effects of exercise on the progression of the aneurysm dilation in patients with thoracic ascendant aortic aneurysm are unknown. It is well known that high blood pressure is a risk factor for rupture of the aortic aneurysm. Many studies have demonstrated the benefits of physical exercise regarding the lowering impact of blood pressure in a cardiac hypertensive population. At 3 and 6 months of the intervention, the subjects in the exercise group will have: 1) a lowered blood pressure at rest and during exercise, 2) maintenance/ improvement of muscle strength, 3) improvement of aerobic exercise capacity (VO2max), and 4) aortic dilation that remained stable or comparable to the control group. The research objective is to measure and compare to a control group, the effects of an exercise program on the following parameters: blood pressure response at rest and during exercise, as well as the VO2max at 3 and 6 months time of the intervention. This randomised and prospective study will take place at the " Institut Universitaire de Cardiologie et de Pneumologie du Québec (IUCPQ) " and will include patients who have a non-surgical ascendant thoracic aortic aneurysm (ATAA). The selected subjects will be randomised into two groups: 1) exercise group (n=15), and 2) control group (n=15). Both groups will be met prior to the intervention (baseline) and at 3 and 6 months time of the intervention, and measures described below will be recorded.
Pre-market, single-arm, prospective, open-label, multi-center clinical trial aimed at assessing the safety and the performance of the Medyria TrackCath system in patients undergoing endovascular intervention.
EndoAnchors (Heli-FX device, Medtronic, Santa Rosa) have beed described to improve fixation (mimicking an open surgical anastomosis) during or after EVAR/TEVAR. The investigators want to describe the outcomes of all consecutive patients treated with this device (retrospective and prospective data - observational study)
Patients with bicuspid aortic valve-related aortopathy are at increased risk of aortic dilatation, dissection and rupture. Currently, risk stratification is largely based on aortic diameter measurements, with those deemed high risk referred for aortic replacement surgery. This approach is imperfect, and potentially exposes many patients to unnecessary high-risk aortic surgery, or fails to identify those at risk of dissection or rupture with smaller diameters. In patients with abdominal aortic aneurysms, the investigators recently demonstrated that uptake of 18F-sodium fluoride predicts disease progression and clinical events independent of aneurysm diameter and standard clinical risk factors. Based on the investigators preliminary data, a study was proposed to look at 18F-sodium fluoride uptake in patients with bicuspid aortic valve-related aortopathy. The proposed study will shed light on the underlying pathological processes involved in aortic complications of this disease as well as potentially providing an important risk marker to predict disease progression and guide the need for major aortic surgery.
The primary objective of this study is to assess the use of the thoracic bifurcation and the visceral manifold devices in the repair thoracoabdominal aortic aneurysms in patients with appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device. Additionally, the study will assess technical success and treatment success at each follow-up interval.
Thoracic endovascular repair (TEVAR) and transcatheter aortic valve implantation (TAVI) are standard of care procedures to treat thoracic aortic aneurysm or severe aortic stenosis, respectively. Both procedures have a high risk of stroke and silent infarction. Gas has been detected in the cerebral vasculature during these procedures and associated with DWI positive lesions on MRI. The hypothesis is that air emboli contribute to stroke and silent infarction. The investigators propose addressing air emboli by flushing the device with carbon dioxide prior to flushing with saline. This is a pilot study comparing standard saline flush alone to carbon dioxide flushing with saline flush.
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.
Thoracic endovascular aortic repair (TEVAR) for disease involving the aortic arch remains complex and challenging due the angulation and tortuosity of the arch and its peculiar biomechanical environment. Currently, TEVAR planning is based on the analysis of anatomical features by means of static imaging protocols. Such an approach, however, disregards the impact of pulsatile forces that are transmitted as migration forces on the terminal fixation sites of the endograft, and may jeopardize the long-term clinical success of the procedure. Hence,the investigators aim to assess the migration forces acting on different proximal landing zones of the aortic arch by computational modeling, and develop in silico patient-specific simulations that can provide a quantitative evaluation of the stent-graft performance. Study's results are expected to provide valuable insights for proper proximal landing zone and stent-graft selection during TEVAR planning, and ultimately improve postoperative outcome.