N/A
N=132
Study to Evaluate Cerebral AneurysmFlow Results in Occlusion
Intracranial Aneurysm
Bottom Line
View on ClinicalTrials.gov: NCT03663257 ↗Enrolled (actual)
132
Serious AEs
3.0%
Results posted
Sep 2025
Primary outcome: Primary: Prognostic Value of the MAFA (Mean Aneurysm Flow Amplitude) Ratio With Respect to Full Aneurysm Occlusion Within 12 Months — 0.540 probability
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- AneurysmFlow (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Philips Clinical & Medical Affairs Global
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prognostic Value of the MAFA (Mean Aneurysm Flow Amplitude) Ratio With Respect to Full Aneurysm Occlusion Within 12 Months |
0.540 | — |
| SECONDARY Prognostic Value of the MAFA Ratio With Respect to Full Aneurysm Occlusion Within 6 Months |
0.568 | — |
| SECONDARY Optimal MAFA Threshold |
NA | — |
| SECONDARY Serious Adverse Events |
6 | — |
Summary
AneurysmFlow R1.0 is an approved (i.e. CE labeled, 510k, Health Canada), software tool intended to provide relevant information on the blood flow in a cerebral aneurysm and its parent artery based on angiography. It calculates the Mean Aneurysm Flow Amplitude (MAFA) ratio to measure the volumetric flow rate quotient before and after Flow Diverter Stent (FDS) implantation in the region of interest.
The current study is a prospective, single arm, observational, multicenter cohort study to assess the prognostic value of the MAFA ratio for predicting full aneurysm occlusion 12 months after flow diverter placement.
Eligibility Criteria
Inclusion Criteria
- Subject with unruptured, ≥5mm saccular aneurysm(s) located in the anterior intracranial circulation and suitable for an endovascular treatment with a Flow Diverter Stent
- Subject is 18 years of age or older, or of legal age to give informed consent per state or national law.
- Subject is available for clinical follow-ups.
Exclusion Criteria
- Non-saccular brain aneurysm(s) (i.e. dissecting, fusiform, atherosclerotic, mycotic, bifurcational). Prior aneurysm treatment with either endovascular (stenting, coiling) or surgical (clipping) techniques.
- Endovascular treatment assisted with coils or intracranial stents
- Significant or severe allergy to intra-arterial contrast medium uncontrolled by pre-procedure medications.
- Severe kidney disease (Glomerular Filtration Rate < 60).
- Subjects not willing (or able) to attend post FDS insertion standard-of-care follow up clinic visits requiring DSA, head MRI or CTA imaging.
- Subject participates in a potentially confounding drug or device trial during the course of the study.
- Subject meets an exclusion criteria according to national law (e.g. age, pregnant woman, breast feeding woman).
Data sourced from ClinicalTrials.gov (NCT03663257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.