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

This study has been completed.
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00556309
First received: November 7, 2007
Last updated: June 10, 2015
Last verified: June 2015
  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 University of California, Irvine:

Primary Outcome Measures:
  • Aneurysm Healing [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 7, 2007
Last Updated: June 10, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Aneurysm
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 02, 2015