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Optical Coherence Tomography Imaging of Post Coil Aneurysm Healing. (OCT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00556309
First Posted: November 9, 2007
Last Update Posted: February 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
  Purpose
The purpose of this study is to identify the healing of aneurysms in three month use Optical Coherence Tomography image to measure outcomes in post coiled aneurysms. Endovascular therapeutic coiling is a widely used procedure in the management of aneurysms, which is an angiogram .

Condition Intervention
Cerebral Aneurysm Device: Optical Coherence Tomography

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Optical Coherence Tomography Imaging of Post Coil Aneurysm Healing.

Resource links provided by NLM:


Further study details as provided by Beckman Laser Institute and Medical Center, University of California, Irvine:

Primary Outcome Measures:
  • Aneurysm Healing [ Time Frame: up to 12 months ]
    Optical Coherence Tomography Imaging


Enrollment: 3
Study Start Date: January 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Diagnostic Tool
Optical Coherence Tomography Imaging of Post Coil Aneurysm Healing.
Device: Optical Coherence Tomography
Optical Coherence Tomography Imaging of Post Coil Aneurysm Healing.
Other Name: Optical Coherence Tomography Imaging

Detailed Description:

Subarachnoid hemorrhage secondary to ruptured cerebral aneurysms, unruptured aneurysms that are being treated using endovascular coiling. The researcher can use Optical Coherence Tomography image at the rime of initial angiography with unruptured aneurysms, and at the three month follow up catheter angiogram.

Optical Coherence Tomography image can follow the therapeutic coiling of the aneurysm, the 6F endocatheter and the microcatheter used for the coiling procedure place in the internal carotid artery and parent artery lumen follow with Optical Coherence Tomography fiber insert through the lumen of the tube on which the image can obtain.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary care clinic
Criteria

Inclusion Criteria:

  • Age ≥ 18 years of age
  • Subject diagnosis of aneurysm and undergoing endovascular coiling

Exclusion Criteria:

  • Pregnant women
  • Age ≤ 18 years of age
  • Patient presenting emergently with acutely ruptured aneurysms
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00556309


Locations
United States, California
Beckman Laser Institute,University of California, Irvine
Irvine, California, United States, 92612
Neurosurgery department, University of California,Irvine
Irvine, California, United States, 92612
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Marlon Mathew, MD UCIMC
Principal Investigator: Zhongping Chen, PhD Zhongping Chen, PhD, Assistant Professor, Beckman Laser Institute
  More Information

Responsible Party: Beckman Laser Institute and Medical Center, Marlon Mathews, M.D., Department of neurosurgery, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00556309     History of Changes
Other Study ID Numbers: NIH-LAMMP-2006-5031
First Submitted: November 7, 2007
First Posted: November 9, 2007
Last Update Posted: February 10, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases