A Phase 4 interventional study of Surgical Clipping of Aneurysm in Brain Aneurysm, sponsored by Medical University of South Carolina. Completed at 10 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-03-24.
Sponsored by Medical University of South Carolina · Phase 4, Interventional, and Treatment
The purpose of this prospective registry is to determine if patients harboring intracranial aneurysms have any predictive markers between aneurysm wall tissue, cerebrospinal fluid and blood plasma.
To design a registry to evaluate the wall of intracranial aneurysms during open surgical clipping by direct photographic appearance, wall biopsy samples, CSF and blood plasma fluid collection (Interleukins; IL-8/ Matrix Metalloproteinase; MMP-9) for complete evaluation and comparison.
The focus of the registry will be to determine the presence of aneurysmal wall defects, mural clot, atherosclerotic and atheroma, wall permeability and delamination. These findings will then be correlated to the collected CSF and blood values to determine if there is any direct features of the aneurysm wall that would predict any of the reported post embolic syndromes. The collected data can also be correlated to the peroperative imaging, (MRI, CT and Angiogram).
427 studies on the registry are indexed under Intracranial Aneurysm; 115 are open to participants now.
This study's enrollment of 24 is below the median of 110 across 207 interventional studies indexed under Intracranial Aneurysm.
Browse Intracranial Aneurysm studies →Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Any patient presenting with any pre-treatment intracranial lesions
Procedure: Surgical Clipping of Aneurysm
Surgical clipping of intracranial aneurysm
Histological Change
To determine the relative and absolute differences in histological changes as seen in the tissue samples comparing this to the CSF and blood plasma samples. To also determine if there is any gene expressions that can be utilized as predictive markers in this cohort of patients.
Time frame: an average of 1 day after aneurysm treatment an analysis of the histological sample, CSF sample, and plasma samples will occur
Treatment related morbidity and mortality
Secondary analyses will be performed to compare treatment related morbidity and mortality,
Time frame: up to approximately 1 year post treatment
Clinical Outcome
clinical outcome at approximately 6 months after surgical clipping at routine follow up visit and approximately 12 months after clipping at routine follow up visit if indicated
Time frame: approximately clinical outcome at 6 months after surgical clipping at routine follow up visit and approximately 12 months after clipping at routine follow up visit if indicated
Bleeding Rate
bleeding rate post treatment.
Time frame: post treatment during approximate follow up periods 6mo and 12mo clinical follow up
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Medical University of South Carolina