Doppler Flow Wires in Cerebral Angiography
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|ClinicalTrials.gov Identifier: NCT03145701|
Recruitment Status : Completed
First Posted : May 9, 2017
Last Update Posted : October 1, 2020
|Condition or disease|
|Aneurysm Cerebral Aneurysm|
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|
|Actual Enrollment :||117 participants|
|Official Title:||Predicting Cerebral Aneurysm Recurrence Using Doppler Guidewire Measurements|
|Actual Study Start Date :||June 1, 2020|
|Actual Primary Completion Date :||June 1, 2020|
|Actual Study Completion Date :||June 1, 2020|
- 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
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): NCT03145701
|United States, Washington|
|Harborview Medical Center|
|Seattle, Washington, United States, 98104|
|Principal Investigator:||Louis J Kim, MD||University of Washington Department of Neurological Surgery|