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| Sponsor: | Montana Compton |
|---|---|
| Collaborators: |
Beckman Laser Institute University of California Irvine University of California, Irvine |
| Information provided by (Responsible Party): | Montana Compton, University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00556309 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Aneurysm |
Device: OCT |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Optical Coherence Tomography (OCT) Imaging of Post Coil Aneurysm Healing. |
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
diagnostic
imaging
|
Device: OCT
OCT image during angiogram procedure
|
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 time 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Primary care clinic
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Neurosurgery department, University of California,Irvine | |
| Irvine, California, United States, 92612 | |
| Beckman Laser Institute,University of California, Irvine | |
| Irvine, California, United States, 92612 | |
| Principal Investigator: | Marlon Mathew, MD | UCIMC |
More Information
| Responsible Party: | Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00556309 History of Changes |
| Other Study ID Numbers: | NIH-OCT EB-093-07 |
| Study First Received: | November 7, 2007 |
| Last Updated: | October 28, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Aneurysm Vascular Diseases Cardiovascular Diseases |
