Doppler Flow Wires in Cerebral Angiography

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Brief Title

Doppler Flow Wires in Cerebral Angiography

Official Title

Predicting Cerebral Aneurysm Recurrence Using Doppler Guidewire Measurements

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.
    

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.
    


Study Type

Observational


Primary Outcome

Treatment Prediction


Condition

Aneurysm



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

117

Start Date

June 1, 2020

Completion Date

June 1, 2020

Primary Completion Date

June 1, 2020

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Louis J Kim, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03145701

Organization ID

STUDY00002026


Responsible Party

Principal Investigator

Study Sponsor

University of Washington


Study Sponsor

Louis J Kim, MD, Principal Investigator, University of Washington Department of Neurological Surgery


Verification Date

September 2020