Study to Evaluate Cerebral AneurysmFlow Results in Occlusion

NCT03663257 | Completed Results DMC FDA Device

• 1 other identifier: XCY610-130253
• Study Type: observational
• Target: 132
• Locations: 3 countries
• Sites: 4

Brief 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.

Conditions

Intracranial Aneurysm

Keywords

Interventional Neurology; Aneurysm; Neurology; Radiology; AneurysmFlow

Outcome Measures

Primary Outcomes (1)

• Prognostic Value of the MAFA (Mean Aneurysm Flow Amplitude) Ratio With Respect to Full Aneurysm Occlusion Within 12 Months

  To assess the prognostic value (i.e. c-statistic including confidence intervals) of the MAFA ratio with respect to full aneurysm occlusion (i.e. using the Raymond-Roy Occlusion Classification I on standard-of-care head imaging) 12 months after Flow Diverter Stent placement. The objective was evaluated using logistic regression analysis to evaluate the univariate predictive association between the index test (i.e., the MAFA ratio) and complete aneurysm occlusion (i.e., complete occlusion yes/no) at 12 months. The primary endpoint was presented using a Receiver Operating Characteristic (ROC) curve including the c-statistic (also known as the Area Under the Curve (AUC) of the ROC curve) and confidence intervals.

  12 months

Secondary Outcomes (3)

• Prognostic Value of the MAFA Ratio With Respect to Full Aneurysm Occlusion Within 6 Months

  6 months

• Optimal MAFA Threshold

  12 months

• Serious Adverse Events

  12 months

Study Arms (1)

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.

Device: AneurysmFlow

Interventions

AneurysmFlow DEVICE

AneurysmFlow R1.0 is an approved (CE labeled, cleared in US, Canada and Argentina), software tool intended to provide relevant information on the blood flow in a cerebral aneurysm and its parent artery based on angiography. It provides color coded and vector field representation of a digital subtraction angiography (DSA). It can quantify blood flow rates in the artery based on DSA and 3-D Rotational Angiogram (3DRA) data. It can visualize blood flow patterns in an aneurysm based on DSA data. Specifically, 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. It is manufactured by Philips Medical Systems B.V., a Philips Healthcare company.

AneurysmFlow Observational Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with age 18 or older, of both genders and all races. Patients are considered to be enrolled in the study after they have signed the informed consent form.

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.

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (4)

Baptist Health

Jacksonville, Florida, 32207, United States

Location

UMass Medical Center

Worcester, Massachusetts, 01655, United States

Location

ENERI

Buenos Aires, C1428 CABA, Argentina

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Intracranial Aneurysm; Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Joris de Groot
• Organization: Philips Medical Systems Nederland B.V.

joris.ah.de.groot@philips.com

+31621949619

Study Officials

• Ricardo Hanel, MD, PhD

  Baptist Medical Center Jacksonville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 10, 2018
• Study Start: October 4, 2018
• Primary Completion: November 27, 2023
• Study Completion: November 27, 2023
• Last Updated: September 26, 2025
• Results First Posted: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (1); AR (1)