Study to Evaluate Cerebral AneurysmFlow Results in Occlusion
Key facts
- Who runs it
- Philips Clinical & Medical Affairs Global
- Where
- Jacksonville and Worcester, United StatesSee the 2 sitesAlso in 2 other countries, 2 sites
- Trial code
- Status
- Completed
- People taking part
- 132 people enrolled
- Started
- 4 Oct 2018
- Ended
- 27 Nov 2023
- Type of study
- Observational
- Treatments tested
- AneurysmFlow
- Record updated
- 26 September 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- Non-saccular brain aneurysm(s) (i.e. dissecting, fusiform, atherosclerotic, mycotic, bifurcational). Prior aneurysm treatment with either endovascular (stenting, coiling) or surgical (clipping) techniques
- Subject participates in a potentially confounding drug or device trial during the course of the study
- Significant or severe allergy to intra-arterial contrast medium uncontrolled by pre-procedure medications
- Severe kidney disease (Glomerular Filtration Rate < 60)
- Subject meets an exclusion criteria according to national law (e.g. age, pregnant woman, breast feeding woman)
- Endovascular treatment assisted with coils or intracranial stents
- Subjects not willing (or able) to attend post FDS insertion standard-of-care follow up clinic visits requiring DSA, head MRI or CTA imaging
Where in United States
Also in 2 other countries, 2 sites
- Baptist HealthJacksonville, United States
- UMASS medical centerWorcester, United States
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The group in the trial
- AneurysmFlow Observational Cohort
Subjects with unruptured, \>5mm saccular aneurysm(s) located in the anterior intracranial circulation and suitable for an endovascular treatment with a Flow Diverter Stent enrolled at the centers participating in this CARO study.
Treatment: AneurysmFlow
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Multicenter Observational Cohort Study to Evaluate Cerebral AneurysmFlow Results in Occlusion
- Record updated
- 26 September 2025