- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03145701
Doppler Flow Wires in Cerebral Angiography
Predicting Cerebral Aneurysm Recurrence Using Doppler Guidewire Measurements
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98104
- Harborview Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
May 2017- July 2019
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Louis J Kim, MD, University of Washington Department of Neurological Surgery
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00002026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aneurysm
-
University of BolognaCompletedThoracoabdominal Aortic Aneurysm | Ruptured Thoracic Aneurysm | Ruptured Aortic Aneurysm | Thoracoabdominal Aortic Aneurysm, RupturedItaly
-
University of North Carolina, Chapel HillCook Group Incorporated; UNC HospitalsEnrolling by invitationAortic Aneurysm, Abdominal | Aortic Arch Aneurysm | Ascending Aorta AneurysmUnited States
-
CEVARIIUniversity of Colorado, Denver; University of Copenhagen; University of Iowa; University... and other collaboratorsEnrolling by invitationComplex EVAR in Inflammatory and Infective Abdominal and Thoracoabdominal Aortic Aneurysms (CEVARII)Abdominal Aortic Aneurysm | Thoracoabdominal Aortic Aneurysm | Aneurysm, Infected | Inflammatory Abdominal Aortic Aneurysm | Aneurysm, MycoticUnited States
-
IRCCS San RaffaeleCompletedAneurysm Thoracic | Aneurysm Abdominal | Renal AneurysmUnited States, France, Italy, United Kingdom, Germany, Spain, Denmark, Sweden
-
Cook Research IncorporatedCompletedAbdominal Aortic Aneurysm (AAA) | Aorto-iliac Aneurysm | Juxtarenal AneurysmUnited States
-
IRCCS San RaffaeleCompletedAneurysm | Aneurysm Thoracic | Aneurysm Abdominal | Aneurysm, Thoracoabdominal AorticItaly
-
Gustavo OderichWilliam Cook AustraliaRecruitingThoracoabdominal Aortic Aneurysm | Aortic Arch Aneurysm | Complex Abdominal Aortic Aneurysm | Aortic Arch DissectionUnited States
-
JOTEC GmbHRecruiting
-
The Christ HospitalMedtronicRecruiting
-
University of California, San DiegoRecruitingJuxtarenal Aortic Aneurysm | Thoracoabdominal Aortic Aneurysm | Pararenal Aortic Aneurysm | Complex Abdominal Aortic AneurysmUnited States