Doppler Flow Wires in Cerebral Angiography

• ClinicalTrials.gov Identifier: NCT03145701
• Recruitment Status: Completed
• First Posted: May 9, 2017
• Last Update Posted: October 1, 2020
• Sponsor: University of Washington
• Information provided by (Responsible Party): Louis Kim, University of Washington

Tracking Information

• First Submitted Date: April 6, 2017
• First Posted Date: May 9, 2017
• Last Update Posted Date: October 1, 2020
• Actual Study Start Date: June 1, 2020
• Actual Primary Completion Date: June 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 4, 2017)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Aneurysm
• Cerebral Aneurysm

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 29, 2020): 117
• Original Estimated Enrollment (submitted: May 4, 2017): 90
• Actual Study Completion Date: June 1, 2020
• Actual Primary Completion Date: June 1, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03145701
• Other Study ID Numbers: STUDY00002026
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Louis Kim, University of Washington
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Washington
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Washington
• Verification Date: September 2020