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

Sponsor

University Hospital, Brest (Other)

Overall Status

Completed

CT.gov ID

NCT03535181

Collaborator

(none)

Enrollment

Location

31.9

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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	Intervention/Treatment	Phase
Aneurysm, 4D CT Scan

Study Design

Study Type:

Observational

Actual Enrollment :

11 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Apr 20, 2018

Actual Primary Completion Date :

Dec 15, 2020

Actual Study Completion Date :

Dec 15, 2020

Outcome Measures

Primary Outcome Measures

Assess the variation of different aneurysmal metrics (dome height, dome length, ostium width, ostium area, and volume) during the cardiac cycle. [6months]
Is there a difference between the maximum and the minimum values ? Measurements are realised with a 4D computed tomography angiography.

Secondary Outcome Measures

Evaluate among different aneurysmal metrics (dome height, dome length, ostium width, ostium area, and volume) the most relevant ones. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Patient with an intracranial aneurysm assessed with a 4D CTA

Exclusion Criteria:

Minor
Refusal to participate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHRU de Brest	Brest		France	29609

Sponsors and Collaborators

University Hospital, Brest

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Brest

ClinicalTrials.gov Identifier:

NCT03535181

Other Study ID Numbers:

PULSAN (29BRC18.0073)

First Posted:

May 24, 2018

Last Update Posted:

Jun 29, 2021

Last Verified:

Jan 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Aneurysm

Study Results

No Results Posted as of Jun 29, 2021