NCT00556309

Brief Summary

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

4.3 years

First QC Date

November 7, 2007

Last Update Submit

October 19, 2022

Conditions

Cerebral Aneurysm

Outcome Measures

Primary Outcomes (1)

  • Aneurysm Healing

    Optical Coherence Tomography Imaging

    up to 12 months

Study Arms (1)

Diagnostic Tool

Optical Coherence Tomography Imaging of Post Coil Aneurysm Healing.

Device: Optical Coherence Tomography

Interventions

Optical Coherence TomographyDEVICE

Optical Coherence Tomography Imaging of Post Coil Aneurysm Healing.

Also known as: Optical Coherence Tomography Imaging
Diagnostic Tool

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary care clinic

You may qualify if:

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

You may not qualify if:

  • Pregnant women
  • Age ≤ 18 years of age
  • Patient presenting emergently with acutely ruptured aneurysms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beckman Laser Institute,University of California, Irvine

Irvine, California, 92612, United States

Location

Neurosurgery department, University of California,Irvine

Irvine, California, 92612, United States

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Marlon Mathew, MD

    UCIMC

    PRINCIPAL INVESTIGATOR

  • Zhongping Chen, PhD

    Zhongping Chen, PhD, Assistant Professor, Beckman Laser Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Marlon Mathews, M.D., Department of neurosurgery

Study Record Dates

First Submitted

November 7, 2007

First Posted

November 9, 2007

Study Start

January 1, 2007

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

October 20, 2022

Record last verified: 2022-10

Locations

US(2)