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Aneurysm clinical trials

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NCT ID: NCT05247944 Completed - Vascular Diseases Clinical Trials

F-BEVAR vs Open Surgery for Complex Abdominal Aortic Aneurysm

Start date: January 2010
Phase:
Study type: Observational

The aim of the present study was to investigate outcomes of a propensity matched series of patients treated with F-BEVAR and open surgery repair for complex abdominal aortic aneurysm in two aortic high-volume centres.

NCT ID: NCT05150873 Completed - Aortic Aneurysm Clinical Trials

Anatomical Feasibility of an Off-the-shelf Scalloped Stent-graft for Infrarenal Abdominal Aneurysm With a Hostile Neck

ReSTHoNe
Start date: January 1, 2022
Phase:
Study type: Observational

In clinical practice a lot of EVAR cases are performed IFU for adverse neck anatomy(6) with acceptable short- and mid-term outcomes, but the long-term durability is currently an issue (7). Neck length shorter than 15 mm and angulation are two of. neck charteristics. that contribute more to define an "hostile neck" (8). The issue linked to the anatomical not feasibility of standard EVAR in patients not eligible for OR can be solved with custom made devices (CMD), but they were limited by high production costs and long time for creations (10-12 weeks)1. Nowadays no one off-the-shelf device aimed to overcome neck hostility in AAA is available on the market. The present study aims at evaluating the anatomical applicability of an off-the-shelf scalloped stent-graft to treat infrarenal AAA with a short and/or angulated neck.

NCT ID: NCT05148988 Completed - Clinical trials for Abdominal Aortic Aneurysm

Ultrasound Velocimetry in the Abdominal Aorta Before and After Endovascular Aneurysm Repair

EchoPIV in AAA
Start date: July 6, 2022
Phase:
Study type: Observational

Rationale: An abdominal aortic aneurysm (AAA) is a common vascular disease with a high mortality in case of rupture. The underlying processes initiating aneurysmal degeneration and driving aneurysmal growth remain poorly understood. Local hemodynamics might play a key role in the pathogenesis of AAA, as it is associated with aneurysmal growth, intraluminal thrombus formation and rupture risk. Visualizing and quantifying local blood flow profiles could eventually provide more insight in the underlying mechanisms of aneurysm progression as well as identify smaller AAA with increased vulnerability or larger AAA with low risk of rupture. Consequently, this may improve risk assessment and provide patient-specific therapy guidance. Nowadays, endovascular aneurysm repair (EVAR) is the preferred treatment modality in most patients with an infrarenal AAA. However, EVAR is associated with a relatively high reintervention rate. It is hypothesized that the placement of a stent graft may alter local hemodynamics and subsequent recirculations or flow stagnations promote the onset of thrombosis or micro-emboli. These unfavourable flow conditions might be related to various complications after EVAR, such as limb occlusion, renal dysfunction, and the persistence of type II endoleaks. Visualizing local blood flow profiles after EVAR might provide insight in these (un)favourable conditions. In vivo blood flow quantification is a great challenge, particularly in the abdomen. Advanced ultrasound based techniques, incorporating ultrasound contrast agents and plane wave imaging, proved to be feasible in quantifying aortoiliac blood flow patterns in healthy volunteers. Objective: The aim of this study is to determine the feasibility of ultrafast contrast-enhanced ultrasound particle image velocimetry (echoPIV) measurements to quantify spatiotemporal blood flow velocity profiles in the abdominal aorta of AAA patients before and after endovascular repair. Secondary objectives are to determine the correlation between echoPIV and phase-contrast MRI (PC MRI) based measurements to ultimately validate the spatiotemporal velocity profiles obtained with echoPIV. Furthermore, changes in blood flow velocity profiles after placement of a stent graft will be evaluated.

NCT ID: NCT05141123 Completed - Aneurysm Abdominal Clinical Trials

Registry of Patients Treated by Preloaded Fenestrated Stent-graft Designs for Complex Endovascular Aortic Procedures

Start date: October 30, 2022
Phase:
Study type: Observational

The aim of the study is to evaluate the outcomes of the preloaded stent-graft design (PLD) in the routine treatment of para-renal and thoraco-abdominal aneurysms. Results and postoperative events are reported in accordance with the current reporting standards for endovascular aortic repair prepared and revised by the Ad Hoc Committee for Standardized Reporting Practices in Vascular Surgery of The Society for Vascular Surgery/American Association for Vascular Surgery. The Registry will include approximately 300 patients treated from January 2015 to May 2021 (retrospective arm) and June 2021 to June 2023 (perspective arm) for the routine treatment of para-renal and thoraco-abdominal aneurysms. To reach 300 patients, the enrollments can be extended until June 2026.

NCT ID: NCT05055102 Completed - Clinical trials for Aneurysms or Occlusive Disease of the Abdominal Aorta

Post-Market Clinical Follow-up of WOVEX (Wovex® Polyester Vascular Prostheses) Bifurcated Prostheses From LEMAITRE VASCULAR Society in the Treatment of Aneurysms or Occlusive Diseases of the Abdominal Aorta.

WOBIF
Start date: January 16, 2021
Phase:
Study type: Observational

The Wovex bifurcated dacron vascular prostheses have been available on the French market since 2008. They are mainly used to treat aneurysmal or occlusive aortic diseases. To date, they have not been the subject of a specific clinical efficacy/safety study, unlike other Dacron prostheses used in the same field. We purpose a monocentric, retrospective, consecutive study based on medical data, including all the patients operated for aneurysms or occlusive disease of the abdominal aorta at Dijon Bourgogne University Hospital between 2013 and 2017 and who received a WOVEX bifurcated prosthesis (Wovex® Polyester Vascular Protheses). The objective is to explore the safety (short-term postoperative morbidity and mortality at 5 years) and efficacy (primary permeability, secondary permeability and dilatation of the prosthesis at 5 years) of the WOVEX prosthesis.

NCT ID: NCT05049564 Completed - Clinical trials for Intracranial Aneurysm

Comparison of Clipping Via Keyhole Versus Traditional Approaches and Coiling for Ruptured Aneurysms

Start date: January 1, 2013
Phase: N/A
Study type: Interventional

Endovascular coiling has become a strategy of choice of intracranial aneurysms due to its minimally invasiveness. However, there has few prospective randomized controlled studies on the comparison of therapeutic effect between endovascular coiling and microsurgical clipping, especially the latter via keyhole approaches, which has been widely used in recent years. Based on the data of a single center, a randomized controlled study was conducted on patients with ruptured anterior circulation aneurysms suitable for both endovascular and extravascular treatment, including endovascular coiling, microsurgical clipping via conventional craniotomy and keyhole approaches, in order to compare the efficacy of the above strategies and provide more objective basis for treatment selection for operators.

NCT ID: NCT05031195 Completed - Clinical trials for Abdominal Aortic Aneurysm

Prognostic Impact of NLR, PLR, and MPV in Patients Undergoing AAA Open Repair

Start date: January 11, 2020
Phase:
Study type: Observational

Abdominal aortic aneurysm (AAA) is a multifactorial degenerative disorder, which if untreated might lead to catastrophic complications. The treatment for AAA includes open and endovascular repair, both of which carry a significant degree of risk. Thus, researchers have performed several studies addressing simple and readily available risk stratification markers, such as complete blood count in patients undergoing open AAA repair. The neutrophil to lymphocyte ratio (NLR) has been frequently used as a marker of systemic inflammatory response, which reflects neutrophilia and lymphopenia. The primary pathophysiology of AAA involves chronic inflammation in the aortic wall and atherosclerosis, accompanied with thrombosis. NLR was proposed as a fair indicator for poor prognosis in patients with AAA. The mean platelet volume (MPV) is the marker of platelet activation and an indicator of the activation of thrombus formation. Moreover, it is reportedly associated with the prognosis of patients with cardiovascular diseases. Moreover, the platelet to lymphocyte ratio (PLR) suggests thrombosis and inflammation and indicates a high risk of cardiovascular events in various groups of patients. The PLR is associated with poor prognosis following AAA repair. Despite accumulating evidence for the prognostic value of white blood cell counts in abdominal aortic aneurysm, few studies have investigated the value of these parameters, including NLR, MPV, and PLR, in patients undergoing AAA open repair. The investigators aimed to investigate if preoperative neutrophil to lymphocyte ratio (NLR), platelet to lymphocyte ratio (PLR), or mean platelet volume (MPV) could be used to predict 1-year mortality in patients undergoing open abdominal aortic aneurysm (AAA) repair.

NCT ID: NCT05028400 Completed - Glioma Clinical Trials

Intraoperative Laser Speckle Contrast Imaging to Assess Blood Flow During Neurosurgery

LSCI-NSURG
Start date: February 1, 2022
Phase: N/A
Study type: Interventional

Cerebral blood flow (CBF) is of paramount importance to human brain function, as the brain relies on a continuous blood supply to meet its energy needs. Blockage of a cerebral blood vessel during neurosurgery, even if transient and short-lived, may result in irreversible brain tissue damage (i.e. stroke) and loss of cortical function, if not identified quickly enough. Laser speckle contrast imaging (LSCI) has been demonstrated to provide the ability to visualize flow in vessels in real time and continuously without the need for contrast agents. In LSCI, the tissue of interest is illuminated with low power laser light at red or near infrared wavelengths and the light reflected from the tissue surface is imaged onto a camera. The resulting images are laser speckle patterns and a computer processes the images to produce speckle contrast images, which are images of the motion within the field of view (ie, blood flow). The purpose of this clinical investigation is to assess the usefulness and accuracy of LSCI compared to ICGA and/or FA during neurovascular surgery. LSCI videos will be recorded automatically intraoperatively in each patient before, during, and after ICGA and/or FA in the same surgical field of view to guarantee comparability of the methods.

NCT ID: NCT04963933 Completed - Cerebral Aneurysm Clinical Trials

A Medical Device to Treat Brain Aneurysms

Start date: March 17, 2021
Phase: N/A
Study type: Interventional

An aneurysm is a bulge in a blood vessel caused by a weakness in the blood vessel wall, usually where it branches. As blood passes through the weakened blood vessel, the blood pressure causes a small area to bulge outwards like a balloon. Most brain aneurysms only cause noticeable symptoms if they burst (rupture). This leads to an extremely serious condition known as a subarachnoid hemorrhage, where bleeding caused by the ruptured aneurysm can cause extensive brain damage and symptoms. The study aims to evaluate the safety and effectiveness of a medical device to treat brain aneurysms.

NCT ID: NCT04935268 Completed - Clinical trials for Aortic Aneurysm, Abdominal

Demographic Differences in Patients With Abdominal Aortic Aneurysm and Surgical Features of Treatment

Start date: May 1, 2021
Phase:
Study type: Observational [Patient Registry]

The study of demographics and risk factors for abdominal aortic aneurysms, allows to individualize treatment approaches. Determining of the results of treatment of patients who requires a late open conversion after EVAR will allow to develop the surgical approach and the selection of the optimal type of surgical treatment. Determination of genetic polymorphisms will reduce the number of postoperative complications by predicting of possible complications in the long term period.