Pulsatility Aneurysmal Evaluation Process by Cerebral Dynamic CTA (Computed Tomography Angiography)

NCT ID: NCT03535181

Last Updated: 2021-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-20

Study Completion Date

2020-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aneurysm, 4D CT Scan

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient with an intracranial aneurysm assessed with a 4D CTA

Exclusion Criteria

* Minor
* Refusal to participate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHRU de Brest

Brest, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PULSAN (29BRC18.0073)

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Quantitative Pupillometry
NCT05386303 UNKNOWN
Functional MR Urography
NCT00301470 COMPLETED PHASE4