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Safety and feasibility of absolute cerebral flow and microvascular resistance measurements by thermodilution using the PressurewireX

Safety and feasibility of absolute cerebral flow and microvascular resistance measurements by thermodilution using the PressurewireX - Evaluation of the cerebral microcirculation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57118
Enrollment
30
Registered
2024-11-25
Start date
2025-08-11
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Cerebral perfusion Microcirculation dysfunction

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age 18 years or older - Scheduled for diagnostic digital subtraction angiography (for the indication of Cerebral aneurysm, Tinnitus, Vasculitis, Follow-up after earlier embolization or neurosurgery) undergoing complete work-up of intracranial vessels (injection of at least left and right internal carotid artery) - Written informed consent obtained

Exclusion criteria

Exclusion criteria: - Any previous stroke or known neurological disorder associated with permanent structural brain abnormalities - An untreated arteriovenous malformation in the anterior cerebral circulation - Known history of: o connective tissue disease o significant stenosis of the common or internal carotid artery o dissection in the internal carotid artery - Hypercoagulability - Physical or psychiatric condition making it for the patient impossible or uncomfortable to lay still during the procedure - Visual pathology assessed during the diagnostic work-up that could interfere with the measurements.

Design outcomes

Primary

MeasureTime frame
Main parameters of interest are intracranial intra-arterial pressure, flow and resistance measurements of the left and right internal carotid, middle cerebral and vertebral arteries. Procedural safety outcomes will be documented.

Secondary

MeasureTime frame
The reproducibility (first vs. second measurement, and right vs. left), the influence of a different infusion rates of saline (low vs. high rate), and the influence of sensor position (distal vs. proximal) will be evaluated by linear regression analysis and with Bland-Altman plots. Hemodynamic data will be reported per case.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 11, 2026