Study to Evaluate Cerebral AneurysmFlow Results in Occlusion

Completed

Conditions studied: Intracranial Aneurysm

In brief

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.

Key facts

Study ID

NCT03663257

Run by

Philips Clinical & Medical Affairs Global

People needed

132

Starts

2018-10-04

Expected to finish

2023-11-27

Last updated by the study team

2025-09-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Baptist Health — Jacksonville, Florida, United States
• UMass Medical Center — Worcester, Massachusetts, United States
• ENERI — Buenos Aires, Argentina
• Toronto Western Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.