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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON31258
Enrollment
20
Registered
2007-10-05
Start date
2007-10-01
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

balloonlike dilatation of cerebral bloodvessels intracranial aneurysms

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)