Invasive and non-invasive intracranial Flow velocity measurements in patients with UNruptured IntraCranial Aneurysms

Conditions: balloonlike dilatation of cerebral bloodvessels
intracranial aneurysms
10007963

Registration Number: NL-OMON31258

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

- Patients with untreated unruptured aneurysms in or near the circle of Willis, found incidentally, in screening populations or in patients with multiple aneurysms
- Planned for endovascular treatment at the AMC
- Age 18- 70 yrs
- Written informed consent

Exclusion Criteria

contrast allergy, impared renal function, contra-indications for MRI (pacemaker, claustrofobia, etc.)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study parameters:<br /><br>- measurement of flow velocities (in cm/s) in blood vessels proximal and distal<br /><br>of intracranial aneurysms as well as within the aneurysms. Flow velocities will<br /><br>be derived from invasive endovascular measurements using the ComboWire® and<br /><br>from non-invasive 4D phase-contrast MRA measurements.<br /><br>- measurements of pressure (mmHg) in blood vessels surrounding intracranial<br /><br>aneurysms and within the aneurysm, using ComboWire®.<br /><br><br /><br>Primary outcome:<br /><br>- Comparisons of flow velocity measurements in individual patients between<br /><br>invasive and non-invasive techniques to assess the accuracy of 4D<br /><br>phase-contrast MRA in measuring flow velocity.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters:<br /><br>- Measurement of the aneurysm wall displacement on 3DRA and 4D MRA images.<br /><br>- Visual scores and quantative measurements of aneurysm morphology by two<br /><br>neuroradiologists based on 3DRA imaging and Maximum Intensity Projection (MIP)<br /><br>MRA images.<br /><br><br /><br>Secondary outcome:<br /><br>- The construction of a computational model of aneurysm wall elasticity based<br /><br>on pressure measurements and aneurysm wall distensibility.<br /><br>- The determination of a relation between aneurysm morphology and its local<br /><br>flow velocity and pressure.<br /><br>- Modelling of local hemodynamics of intracranial aneurysms.</p><br>