View clinical trials related to Aneurysm.
Filter by:Protocol Short Title: POWER Study - PrehabilitatiOn Workshop and mentored Exercise programme in patients having elective aortic aneurysm Repair Population: Patients scheduled for elective repair of aortic aneurysm at St. Thomas' Hospital Screening and recruitment: Eligible participants will be identified by the vascular team; during the weekly multi-disciplinary team meeting, or via the clinical nurse specialist from tertiary referrals. Participant information leaflets will then be sent out to eligible patients 2 weeks before the outpatient appointment. Recruitment will be carried out during surgical outpatient appointments. Written informed consent will be obtained and participants will be randomised into three groups. This pilot study will help us to: 1. To assess feasibility of screening, recruitment and retention 2. To assess adherence to intervention and blinding. 3. To generate outcome data that may be used to power definitive clinical trials Primary objective To determine the feasibility of delivery of a randomised control trial. Secondary objective (s) To determine baseline outcome data that may be used to power a randomised control trial. Number of Subjects/Patients A convenience sample of 15 patients per group is planned, with a total of 45 patients recruited. At GSTT 200-250 aortic aneurysm operations are performed annually. We aim to recruit 40% of those eligible and screened. This would equate to 4-6 recruited per month. Trial Design Single-blinded, randomised, controlled pilot study. Patients will be allocated into the following groups: Control group: - Current standard practice, no prehabilitation workshop. Non-mentored group: - Prehabilitation workshop with no further patient contact. - Participants to be given a prehab 'pack' which includes advice and a diary card. Mentored group: - Prehabilitation workshop with addition of regular 'mentoring' for up to 8 weeks after the workshop. - Participants to be given a prehab 'pack' which includes advice and a diary card. Primary Endpoints: 1. Screening and recruitment 2. Retention, blinding and follow up procedures. 3. Adherence Secondary Endpoints: To determine baseline outcome data that may be used to power a randomised control trial by examining the following: 1. Composite of post-operative cardiac, respiratory and renal complications at 30 days 2. Mortality at 30 days following surgery. 3. Length of postoperative hospital stay 4. Quality of life (EQ-5DL)- post surgery. 5. Tests of activity and function Main Inclusion Criteria Inclusion: Elective all aortic aneurysm repair (Willingness to return after 8 weeks for re-assessment of secondary measures) Note: *COVID PANDEMIC ADJUSTMENT: Since March 2020, 1st national lockdown. Participants are no longer required to attend the 8 week follow up in person. The Quality of life questionnaires are done over the telephone by the research practitioner. The functional assessments are now done when the participant is admitted for their surgery Participants must have an e mail address. Exclusions: Urgent or emergency repair Contraindications to exercise (doesn't apply for short term illness) Severe musculoskeletal disorders preventing exercise
The objective of this retrospective study is to describe in real-life settings the clinical practice, utilization and the treated population outcomes at 1-year (12-16 months) follow-up at selected, representative centers in France.
The uncertainty regarding the management of Unruptured Intracranial Aneurysms (UIAs) has not progressed in the last 30 years. The fundamental ethical basis for this study is that physicians should only offer a risky preventive treatment when it has been shown to be beneficial. Before that, such treatment should be offered as an RCT. The CAM trial offers a comprehensive framework, so that all patients confronted with the clinical dilemma can be offered participation. The prinicpal questions to be addressed are : 1. do patients with UIAs, considered for curative treatments, have a better long-term clinical outcome with active treatment or conservative management? 2. when patients are considered ineligible for conservative management, and surgical and endovascular management are both judged reasonable, do patients with UIAs have a better long-term clinical outcome with surgical or endovascular management? The primary hypothesis for patients allocated to at least 2 options, one of which is conservative management is: the 10 year combined neurological morbidity and mortality (mRS>2) will be reduced from 24% to 16% (beta 80%; alpha 0.048; sample size 961 patients (836 plus 15% losses to FU and cross-overs) with active treatment. This study is designed as a pragmatic, comprehensive way to address the unruptured aneurysm clinical dilemma, combining large simple RCTs whenever patients are judged eligible for more than one management option, or otherwise a registry of each option. All patients with one or more UIAs will be eligible for participation in either a registry or one of the trials. Patients will be followed for 10 years according to a standard of car follow-up schedule. The primary outcome is survival without neurological dependency (mRS<3) at 10 years. The secondary outcomes are: 1. the incidence of SAH during follow-up and related morbidity and mortality; 2. the morbidity and mortality related to endovascular or surgical treatment of the UIA at one year; 3. overall mortality at 1, 5 and 10 years; 4. overall morbidity (mRS>2) at 1, 5 and 10 years; 5. length of hospitalization; 6. discharge to location other than home
Abdominal aortic aneurysm (AAA) is an abnormal dilatation of the aorta in the abdomen due to a wall weakening caused by atherosclerosis. While indications for a rupture intervention are based on AAA maximal diameter (MaxD) (5 cm), 23% of ruptured AAAs are less than 5 cm and in large AAAs, rupture rate could be lower than expected. We propose to expand and validate our vascular ultrasound elastography software to 3D. Strain maps generated from radiofrequency (RF) data acquired from 30 AAA patients with a matrix-array 3D probe will be registered to conventional CT (phase 1) and validated to a biomechanical for characterization of AAA wall, assessing vulnerability and influence of surrounding tissues (phase 2). At the end of the project, we will have analyzed 3D strain maps to improve patient selection before surgery.
This study was designed to identify whether there is a measurable reduction in inflammation in walls of intracranial aneurysms with oral atorvastatin.
The objective of this study is to explore the effects of Sirolimus on the underlying molecular alterations of cerebral aneurysms.
The objective of this study is to demonstrate the safety and efficacy of the Penumbra SMART COIL® System, including the WAVE™ Extra Soft Coils (WAVE) as a fill and finish coil, in the treatment of intracranial aneurysms. Imaging will be analyzed by an independent core lab to assess aneurysm occlusion rates and perform a comparative analysis between imaging modalities.
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)
Both abdominal aortic aneurysm (AAA) and carotid artery stenosis (CAS) are frequent clinical entities, with major morbidity and mortality. This project obtains robust data on the prevalence of AAA and CAS in the Brussels Capital Region. Using duplex ultrasound, a low invasive examination, we want to obtain information on a vast sample of men and women of the Brussels capital region, starting at the age of 60. With these data we can have a far better view on the Belgian situation of these two main vascular clinical entities. The data can provide insights on if, and how, Belgian public health policy can be improved concerning AAA and CAS.
Abdominal Aortic Aneurysm (AAA) is a known vascular entity that may be life threatening condition .The most common treatment approach nowadays is the endovascular approach, a procedure known as endovascular aortic repair (EVAR). The most common procedure related complication is the expansion of the aneurysm from a "feeding vessel", usually a lumbar or intercostal artery. Another known complication is an endoleak from the stentgraft.Today, accepted EVAR follow up protocol consists of one multiple multiphasic CT angiography (CTA) scan, one month after the procedure and ultrasound exams there after . Ultrasonography is a useful method for detection and evaluation of AAA, has no ionizing radiation and is useful for the dynamic estimation of the aortic width in patients post EVAR. However, the sensitivity of ultrasonography solely for detection of endoleaks in post EVAR patients is not high.In recent years, the development of "fusion" applications allows the dual modality merge between ultrasound and CT scans that can be used as follow up examinations of known imaging findings on CT .Another application that had been developed for ultrasound machines is the ability to generate a 3 dimensional (3D) reconstruction which allows more precision. In the recent year the usage of intravenous contrast agent for ultrasonography based on microbubbles (BRACO SONOVIEW) has been approved by the Israeli ministry of health. This contrast agent is not nephrotoxic and the risk for allergic reaction is very low statistically similar to Gadolinium.A 3D contrast enhanced ultrasonography "fused" together with CTA may be a helpfull addition , which lacks radiation and odine contrast reactions and nephrotoxicity ,in the follow up in post EVAR patients , by means of identifing endoleaks at an earlier stage than by ultrasound alone. The purpose of our research is to evaluate the combined modality (fusion of CTA with CEUS) mentioned above in identifing early endoleaks in post EVAR patients and thus enabilng early intervention when needed