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Doppler Flow Wires in Cerebral Angiography

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03145701
Recruitment Status : Not yet recruiting
First Posted : May 9, 2017
Last Update Posted : January 30, 2019
Information provided by (Responsible Party):
Louis Kim, University of Washington

Brief Summary:
The purpose of this study is to use a wire with a Doppler tip to measure blood flow in vessels in the brain and determine hemodynamic factors associated with treatment success or failure. Many neurological diseases cause abnormal blood flow in the brain in specific vessels. The special wire used in this study is place into brain blood vessels during standard of care procedure to treat such diseases, and blood flow parameters (such as velocity and pressure) are measured to gain better understanding of these neurological diseases.

Condition or disease
Aneurysm Cerebral Aneurysm

Detailed Description:

Current treatments of cerebral aneurysms are imperfect, and aneurysmal hemodynamics is an important factor in treatment failure. The identification of hemodynamic factors that influence treatment success could predict outcome. Published studies show that the hemodynamic environment of aneurysms changes after treatment, and there is limited retrospective evidence that the degree of change affects treatment success. However, previous hemodynamic calculations did not have access to patient-specific measurements of blood flow, which substantially reduced their accuracy. In addition, no prospective studies of the predictive value of post-treatment aneurysm hemodynamics have been done.

Methods: Prospectively test new aneurysm patients for hemodynamic predictors of treatment outcome based upon the hypothesis long-term aneurysm treatment outcome can be prospectively predicted by measuring the immediate hemodynamic effects of aneurysm treatment with novel patient-specific modeling techniques. Task 1: In a new cohort of patients undergoing aneurysm treatment, the investigators will again use Doppler guidewire measurements to create patient-specific hemodynamic models of treatment effects. By prospectively applying the knowledge of crucial hemodynamic changes the investigators will use immediate post-treatment hemodynamics to predict long-term treatment outcome.

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predicting Cerebral Aneurysm Recurrence Using Doppler Guidewire Measurements
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Primary Outcome Measures :
  1. Treatment Prediction [ Time Frame: May 2017- July 2019 ]
    The results of this prospective aim have the potential to substantially influence aneurysm management by predicting long-term outcome at the time of initial treatment. The investigators will determine how well the prospective test predicts long-term treatment success as applied at the time of treatment, using computational fluid dynamics modeling of hemodynamic factors with the incorporation of patient-specific measurements obtained by the Doppler guidewire

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be eligible for this aim if they were not previously enrolled in the study, as this phase seeks to prospectively apply the tests generated by the previous retrospective cohort. Selection criteria will be similar in which a patient with an unruptured intracranial aneurysm ≥ 5mm in size undergoes endovascular treatment and subsequent angiographic follow-up.

Inclusion Criteria:

  • Patient with an unruptured intracranial aneurysm ≥ 5mm in size undergoes endovascular treatment and subsequent angiographic follow-up

Exclusion Criteria:

-previously enrolled in the study

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 identifier (NCT number): NCT03145701

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Contact: Cory Kelly, BS 206-685-4043

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United States, Washington
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Cory Kelly, BS    206-685-3043      
Sponsors and Collaborators
University of Washington
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Principal Investigator: Louis J Kim, MD University of Washington Department of Neurological Surgery

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Responsible Party: Louis Kim, Professor, Neurological Surgery, University of Washington Identifier: NCT03145701     History of Changes
Other Study ID Numbers: STUDY00002026
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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