Risk Factors for Intracranial Aneurysm Recanalization After Endovascular Treatment.
Intracranial AneurysmEndovascular treatment is now the first line treatment for the management of intracranial aneurysms. However aneurysm recanalization is an important limitation to this treatment. Several factors seems to be associated with aneurysm recanalization including medical history of the patient, aneurysm status (ruptured or unruptured), aneurysm size and location, modalities of treatment, immediate post-operative occlusion of the aneurysm. A precise knowledge of factors increasing the risk of aneurysm recanalization is quite important to optimize strategy of treatment and reduce the recanalization rate. No large, prospective, multicenter trial dealing with this question has been published in the literature.
TransForm™ Occlusion Balloon Catheter Registry
Intracranial AneurysmsThe primary objective of this registry is to collect real world data on the safety and performance of the TransForm™ Occlusion Balloon Catheter when used in current neurointerventional procedures
Post-Approval Study of the Ovation™/Ovation Prime™ Abdominal Stent Graft System
Aortic AneurysmAbdominalThe Post-Approval Study (PAS) will evaluate the "real world" data on the Ovation™/Ovation Prime™ Abdominal Stent Graft System along with the long-term data collected from the IDE cohort to monitor the long-term safety and effectiveness of the device.
X-chromosome Inactivation, Epigenetics and the Transcriptome
Turner SyndromeKlinefelter Syndrome3 moreThe human genetic material consists of 46 chromosomes of which two are sex chromosomes. The sex-chromosome from the mother is the X and from the father the Y-chromosome. Hence a male consist of one Y and one X chromosome and a female of 2 X-chromosomes. Alterations in the number of sex-chromosomes and in particular the X-chromosome is fundamental to the development of numerous syndromes such as Turner syndrome (45,X), Klinefelter syndrome (47,XXY), triple X syndrome (47,XXX) and double Y syndrome (47,XYY). Despite the obvious association between the X-chromosome and disease only one gene has been shown to be of significance, namely the short stature homeobox gene (SHOX). Turner syndrome is the most well characterized and the typical diseases affecting the syndrome are: An Increased risk of diseases where one's own immune system reacts against one's own body (autoimmune diseases) and where the cause of this is not known; For example diabetes and hypothyroidism. Increased risk of abortion and death in uteri Underdeveloped ovaries with the inability to produce sex hormones and being infertile. Congenital malformations of the major arteries and the heart of unknown origin. Alterations in the development of the brain, especially with respect to the social and cognitive dimensions. Increased incidence obesity, hypertension, diabetes and osteoporosis. In healthy women with to normal X-chromosomes, the one of the X-chromosomes is switched off (silenced). The X-chromosome which is silenced varies from cell to cell. The silencing is controlled by a part of the X-chromosome designated XIC (X-inactivation center). The inactivation/silencing of the X-chromosome is initiated by a gene named Xist-gene (the X inactivation specific transcript).This gene encodes specific structures so called lincRNAs (long intervening specific transcripts) which are very similar to our genetic material (DNA) but which is not coding for proteins. The final result is that women are X-chromosome mosaics with one X-chromosome from the mother and the other X from the father. However, numerous genes on the X-chromosome escape this silencing process by an unknown mechanism. Approximately two third of the genes are silenced, 15 % avoid silencing and 20 percent are silenced or escape depending on the tissue of origin. The aforementioned long non-protein-coding parts of our genetic material (LincRNAs) are abundant and produced in large quantities but their wole as respect to health and disease need further clarification. Studies indicate that these LincRNAs interact with the protein coding part of our genetic material modifying which genes are translated into proteins and which are not. During this re-modelling there is left foot prints on the genetic material which can indicate if it is a modification that results in silencing or translation of the gene. It is possible to map these foot prints along the entire X-chromosome using molecular techniques like ChIP (Chromatin immunoprecipitation) and ChIP-seq (deep sequencing). The understanding achieved so far as to the interplay between our genetic material and disease has arisen from genetic syndromes which as the X-chromosome syndromes are relatively frequent and show clear manifestations of disease giving the researcher a possibility to identify genetic material linked to the disease. Turner and Klinefelter syndrome are, as the remaining sex chromosome syndromes, excellent human disease models and can as such help to elaborate on processes contributing to the development of diseases like diabetes, hypothyroidism, main artery dilation and ischemic heart disease. The purpose of the study is to: Define the changes in the non-coding part of the X-chromosome. Identify the transcriptome (non-coding part of the X-chromosome)as respect to the RNA generated from the X-chromosome. Identify changes in the coding and non-coding parts of the X-chromosome which are specific in relation to Turner syndrome and which can explain the diseases seen in Turner syndrome. Study tissue affected by disease in order to look for changes in the X-chromosome with respect to both the coding and non-coding part of the chromosome. 6. Determine if certain genes escape X-chromosome silencing and to establish if this is associated with the parent of origin.
Prevalence of Intracranial Aneurysm in Hong Kong Chinese
Intracranial AneurysmIntracranial aneurysm (localized dilatation in weakened blood vessel wall) rupture is a catastrophic disease, with half of the victims died and many of the survivors disabled. There is currently no data in the literature for the Chinese population concerning the prevalence, characteristics (location and size) and risk of harboring an unruptured intracranial aneurysm. In this study, the investigators aim to study the population prevalence and characteristics (location and size) of intracranial aneurysm in Hong Kong Chinese, and its cost-effectiveness. The screening is carried out using magnetic resonance angiography (MRA), with a 3-T magnetic resonance system, which is a well-established non-invasive method for intracranial aneurysm detection.
The Canadian UnRuptured Endovascular Versus Surgery Trial (CURES)
Intracranial AneurysmsPurpose: Phase 1: (Pilot Phase) To compare the treatment efficacy of surgical clipping and endovascular coiling for unruptured intracranial aneurysms. To obtain better estimates of morbidity and mortality related to a surgical or endovascular treatment strategy at one year within the context of an RCT. To show that an RCT comparing the morbidity and mortality of a surgical management strategy to an endovascular management strategy is feasible. Phase 2: To compare the results of surgical and endovascular management strategies, in terms of: Overall mortality and morbidity at 1 and 5 years. The clinical efficacy and safety of a surgical or endovascular management strategy at 1 and 5 years Hypotheses: Phase 1 Hypotheses: Surgical clipping of intradural, saccular, unruptured intracranial aneurysms is superior to endovascular management in terms of a lesser number of patients experiencing treatment failure. An RCT comparing the clinical outcomes of a surgical versus endovascular management strategy is feasible. Phase 1 Primary End-points: • Treatment failure, hereby defined as having occurred when either: the intended initial modality (surgical or endovascular) fails to occlude the aneurysm, a "major" (saccular) angiographic aneurysm recurrence is found, or an intracranial hemorrhagic event occurs during the 1-year follow-up period. Phase 1 Secondary End-points: Overall morbidity and mortality at one year. Occurrence of morbidity (mRS >2) or mortality following treatment. Occurrence of failure of aneurysm occlusion using the initial intended treatment modality. Occurrence of a "major" (saccular) angiographic aneurysm recurrence. Occurrence of an intracranial hemorrhage following treatment. Peri-treatment hospitalization lasting more than 5 days Discharge following treatment to a location other than home Treatment: Trial feasibility, or the capacity for patient recruitment, would require enrollment of at least 8 patients per actively recruiting center per year. Phase 2 Hypotheses: It may be too early to explicitly define the primary hypothesis of Phase 2, however, the intent of Phase 2 can be expressed as: One management strategy is superior to the other in terms of clinical outcome at five years. One management strategy is superior to the other in terms of clinical efficacy at five years.
Enterprise Stent Aneurysm Treatment (ESAT) Study - France
Intracranial AneurysmThe purpose of this study is to evaluate the morbidity, mortality, and efficacy of use of the Enterprise(TM) stent for the treatment of (ruptured or non-ruptured) intracranial aneurysms.
Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment
Intracranial AneurysmThis is a prospective observational multicenter registry to evaluate safety and efficacy data on Neuroform3TM stenting for treatment with endovascular coiling of wide neck aneurysms on an intent to treat basis. The objectives of this study are: Assessment of morbidity-mortality at 1 month and 12-18 months following the treatment of the intracranial aneurysm with Neuroform3TM stent and endovascular coiling using the modified Rankin scale (mRS). to evaluate adverse events. Angiographic assessment at 12-18 months compared to the initial post-treatment assessment via the modified Raymond scale and same/better/worse scale.
Hypothalamo-, Pituitary-, Adrenal Axis Dysfunction in Subarachnoid Hemorrhage
Subarachnoid HemorrhageCerebral AneurysmSubarachnoid haemorrhage (SAH) may cause damage to the hypotalamo-pituitary-adrenal axis (HPA) thus disturbing the hormonal response of these structures. The aim of our study is to characterize the function of HPA-axis acutely and over time up to three months in patients with SAH.
Familial Intracranial Aneurysm Study II
Intracranial AneurysmSubarachnoid HemorrhageThe purposes of this study are to identify possible genes that may increase the risk of aneurysm development in the brain, and to determine the effect of environmental factors such as cigarette smoking and high blood pressure on the expression of these genes.