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| Descriptive Information Fields | |||||
| Brief Title † | Optical Coherence Tomography (OCT) Imaging of Post Coil Aneurysm Healing. | ||||
| Official Title † | Optical Coherence Tomography (OCT) Imaging of Post Coil Aneurysm Healing. | ||||
| Brief Summary | At Beckman Laser Institute, University of California, Irvine, we have developed diagnostic device call 'Optical Coherence tomography (OCT)'. OCT is an imaging technique capable of performing high-resolution,cross-sectional imaging. OCT enables real-time, in situ visualization of tissue microstructure without the need to excise and process the specimen as required for conventional biopsy and histopathology. OCT is analogous to ultrasound except that imaging is performed with light instead of acoustic waves. OCT measures light reflected from turbid structures. Consequently, OCT is a powerful method to image biological tissue in-vivo at high resolution. The objective of the study is to demonstrate a healing response in coiled aneurysms using OCT imaging at three months. The healing process constitutes fibrosis, and organization of the coiled aneurysm as well as re-endothelization. |
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| Detailed Description | Subjects presenting with subarachnoid hemorrhage secondary to ruptured cerebral aneurysms as well as subjects with unruptured aneurysms that are being treated using endovascular coiling will be included in the study. An image will be acquired by the Optical Coherence Tomography (OCT) at the rime of initial angiography in subjects with unruptured aneurysms, and at the three month follow up catheter angiogram for all subjects. Patients with acutely ruptured aneurysms will not be investigated with OCT at the initial intervention. Images obtained at three month follow up will be analyzed for aneurysm healing based on the presence of a membranous covering or endothelization. Endovascular therapeutic coiling is a widely used procedure in the management of aneurysms, which is an angiogram . Following therapeutic coiling of the aneurysm the 6F endocatheter and the microcatheter used for the coiling procedure will be left in place in the internal carotid artery and parent artery lumen respectively. The OCT fiber will be inserted through the lumen of the tube on which the images will be obtained. |
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| Study Phase | |||||
| Study Type † | Observational | ||||
| Study Design † | Case-Only, Prospective | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Aneurysm | ||||
| Intervention † | Device: OCT | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Enrolling by invitation | ||||
| Enrollment † | 40 | ||||
| Start Date † | January 2007 | ||||
| Completion Date | July 2012 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00556309 | ||||
| Organization ID | RR-01192;NIH-NCRR | ||||
| Secondary IDs †† | NIH-LAMMP | ||||
| Study Sponsor † | University of California, Irvine | ||||
| Collaborators †† | Beckman Laser Institute Medical Clinic Neurosurgery department,University of California,Irvine, Orange. |
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| Investigators † |
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| Information Provided By | University of California, Irvine | ||||
| Verification Date | May 2008 | ||||
| First Received Date † | November 7, 2007 | ||||
| Last Updated Date | May 22, 2008 | ||||
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