Pulsatility Aneurysmal Evaluation Process by Cerebral Dynamic CTA (Computed Tomography Angiography) (PULSAN)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03535181|
Recruitment Status : Enrolling by invitation
First Posted : May 24, 2018
Last Update Posted : February 14, 2020
Intracranial aneurysm are frequent with a prevalence estimated over 2-5% in the general population. These are focal dilatations occuring in the cerebral vessels. They usually remain silent until complications occur. Complications associated with intracranial aneurysms include mass effect on adjacent structures and rupture. Rupture is the most severe complication with a mortality rate of 35-50% and a high rate of morbidity including long-term disability. It incidence is estimated about 1% per year for aneurysm smaller than 1 cm.
However, preventative treatments have their own risk of complication and morbi-mortality rate including stroke and hemorrhage. Actual guidelines for treatment planning are mainly designed with the size, the location and the age of the patient. This is why working on the identification of imaging markers of aneurysmal instability is relevant.
Dynamic CTA (Computed Tomography Angiography) acquisition allow to study the variation of metrics such as dome height, dome length, ostium width, ostium area, and volume during the cardiac cycle. The goal of this study is to assess different aneurysmal metrics to determine those which may vary the most during the cardiac cycle and to assess it as an imaging marker of aneurysmal instability.
|Condition or disease|
|Aneurysm, 4D CT Scan|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Pulsatility Aneurysmal Evaluation Process by Cerebral Dynamic CTA (Computed Tomography Angiography)|
|Actual Study Start Date :||April 20, 2018|
|Estimated Primary Completion Date :||December 15, 2021|
|Estimated Study Completion Date :||December 15, 2021|
- Assess the variation of different aneurysmal metrics (dome height, dome length, ostium width, ostium area, and volume) during the cardiac cycle. [ Time Frame: 6months ]Is there a difference between the maximum and the minimum values ? Measurements are realised with a 4D computed tomography angiography.
- Evaluate among different aneurysmal metrics (dome height, dome length, ostium width, ostium area, and volume) the most relevant ones. [ Time Frame: 6months ]Evaluate among different aneurysmal metrics (dome height, dome length, ostium width, ostium area, and volume) for a composite endpoint including those which may vary the most during the cardiac cycle (maximum minus minium values) and which have the best reproducibilities over one (intrareader agreement) and multiples cardiac cycles.
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): NCT03535181
|CHRU de Brest|
|Brest, France, 29609|