Ignite Creation Date:
2024-05-06 @ 9:16 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02948504
Status:
UNKNOWN
Last Update Posted:
2016-11-15
First Post:
2016-10-26
Brief Title:
Chinese Small Intracranial Aneurysm Study CSIAS
Sponsor:
RenJi Hospital
Organization:
RenJi Hospital
Study Overview
Official Title:
Treatment of Small Unruptured Intracranial Aneurysms Based on Clinical Characteristics Morphology and Hemodynamic Features
Status:
UNKNOWN
Status Verified Date:
2016-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Intracranial aneurysms are common in the general population The overall prevalence of unruptured intracranial aneurysms UIAs is estimated of 23-32 in the population without specific risk factors for SAH As noninvasive imaging modalities are more commonly used than before UIAs are increasingly being detected Most patients with small aneurysms less than 5mm are incidentally found in clinical practice Some studies indicate that the majority of patients with UIAs particularly with small aneurysms 7mm have a low risk of rupture and others have found that small ruptured aneurysms have a high proportion in patients with SAH Therefore there is a lot of controversy regarding which small aneurysms can be left untreated or which aneurysms are needed to be treated with clipping or coiling
The prevalence varies widely among different detection methods raceethnicity or patients with other inherited diseases Although a wealth of data is available for the natural history of UIAs the true natural history remains unknown because case selection bias occur in almost all studies However data on Chinese UIA is unknown Using the MR angiography MRA to detect aneurysms the prevalence is 7 of selected adult population in China Therefore small UIAs are very common and are increasingly being detected in clinical practice Conservative treatment surgical clipping and endovascular coiling are the three treatment options for UIAs The optimal treatment remains controversial particularly for small aneurysms less than 7mm To date no clinical trials have compared the safety and efficacy between conservative treatment and surgical clipping or endovascular coiling for UIAs It may be impossible to conduct the randomized controlled study considering aneurysm ruptured as a devastating event However surgical clipping or endovascular treatment itself carries a risk of immediate morbidity or mortality Therefore a substantial variability widely exists in treatment decision-making for UIAs and this may lead to a great variability in clinical recommendations
Our study is a prospective observational study to identify the incidence of rupture of small aneurysms in the first year after the diagnosis of the aneurysm which is left untreated Meanwhile we determine the differences of outcomes procedural complications and rates of retreatment between surgical clipping and endovascular coiling for small UIAs in China
The prevalence varies widely among different detection methods raceethnicity or patients with other inherited diseases Although a wealth of data is available for the natural history of UIAs the true natural history remains unknown because case selection bias occur in almost all studies However data on Chinese UIA is unknown Using the MR angiography MRA to detect aneurysms the prevalence is 7 of selected adult population in China Therefore small UIAs are very common and are increasingly being detected in clinical practice Conservative treatment surgical clipping and endovascular coiling are the three treatment options for UIAs The optimal treatment remains controversial particularly for small aneurysms less than 7mm To date no clinical trials have compared the safety and efficacy between conservative treatment and surgical clipping or endovascular coiling for UIAs It may be impossible to conduct the randomized controlled study considering aneurysm ruptured as a devastating event However surgical clipping or endovascular treatment itself carries a risk of immediate morbidity or mortality Therefore a substantial variability widely exists in treatment decision-making for UIAs and this may lead to a great variability in clinical recommendations
Our study is a prospective observational study to identify the incidence of rupture of small aneurysms in the first year after the diagnosis of the aneurysm which is left untreated Meanwhile we determine the differences of outcomes procedural complications and rates of retreatment between surgical clipping and endovascular coiling for small UIAs in China
Detailed Description:
1 Background There is a lot of controversy regarding which aneurysms can be left untreated or which aneurysms are needed to be treated with clipping or coiling To date no clinical trials have compared the safety and efficacy between conservative treatment and surgical clipping or endovascular coiling for small UIAs
2 Study design A multicenter prospective observation registry study This study is undertaken to conform to the study protocol Patients will be recruited between December 2016 and December 2018 Patients are eligible for the study if they meet the inclusion criteria and they are not eligible if any of the following exclusion criteria are met
3 Procedures All patients were interviewed by a multidisciplinary team that consisted of vascular neurosurgeons interventional neuroradiologists and anesthetists If patients meet all of the inclusion criteria an unruptured aneurysms 5mm are enrolled and then followed up at 6 and12 months Clinical observation surgical clipping and endovascular coiling are the three treatment options for UIAs In general when an UIA is detected it should be needed to quit smoking to aggressively manage hypertension and to control alcohol use When an aggressive treatment is considered treatment risks should be balanced against the risk of rupture
2 Study design A multicenter prospective observation registry study This study is undertaken to conform to the study protocol Patients will be recruited between December 2016 and December 2018 Patients are eligible for the study if they meet the inclusion criteria and they are not eligible if any of the following exclusion criteria are met
3 Procedures All patients were interviewed by a multidisciplinary team that consisted of vascular neurosurgeons interventional neuroradiologists and anesthetists If patients meet all of the inclusion criteria an unruptured aneurysms 5mm are enrolled and then followed up at 6 and12 months Clinical observation surgical clipping and endovascular coiling are the three treatment options for UIAs In general when an UIA is detected it should be needed to quit smoking to aggressively manage hypertension and to control alcohol use When an aggressive treatment is considered treatment risks should be balanced against the risk of rupture
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None