Trial Outcomes & Findings for Study to Evaluate Cerebral AneurysmFlow Results in Occlusion (NCT NCT03663257)
NCT ID: NCT03663257
Last Updated: 2025-09-26
Results Overview
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.
COMPLETED
132 participants
12 months
2025-09-26
Participant Flow
Participant milestones
| Measure |
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.
AneurysmFlow: 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.
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|---|---|
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Overall Study
STARTED
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132
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Overall Study
COMPLETED
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106
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Overall Study
NOT COMPLETED
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26
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate Cerebral AneurysmFlow Results in Occlusion
Baseline characteristics by cohort
| Measure |
AneurysmFlow Observational Cohort
n=106 Participants
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.
AneurysmFlow: 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.
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|---|---|
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Age, Continuous
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57.0 years
STANDARD_DEVIATION 13.0 • n=5 Participants
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Sex: Female, Male
Female
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96 Participants
n=5 Participants
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Sex: Female, Male
Male
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10 Participants
n=5 Participants
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Race/Ethnicity, Customized
Self-reported Race · American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race/Ethnicity, Customized
Self-reported Race · Asian
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2 Participants
n=5 Participants
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Race/Ethnicity, Customized
Self-reported Race · Black or African American
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8 Participants
n=5 Participants
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Race/Ethnicity, Customized
Self-reported Race · White
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93 Participants
n=5 Participants
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Race/Ethnicity, Customized
Self-reported Race · Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race/Ethnicity, Customized
Self-reported Race · Unknown
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3 Participants
n=5 Participants
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Region of Enrollment
Canada
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14 participants
n=5 Participants
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Region of Enrollment
Argentina
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55 participants
n=5 Participants
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Region of Enrollment
United States
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37 participants
n=5 Participants
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Smoking history
Never smoked or has not smoked within the last 10 years
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33 Participants
n=5 Participants
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Smoking history
Not a current smoker, but has smoked within the past 10 years
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17 Participants
n=5 Participants
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Smoking history
Current smoker, less than one pack per day
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11 Participants
n=5 Participants
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Smoking history
Current smoker, greater than or equal to one pack per day
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3 Participants
n=5 Participants
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Smoking history
Unknown
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42 Participants
n=5 Participants
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Medical history
Hyperlipidemia
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18 participants
n=5 Participants
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Medical history
Hypertension
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44 participants
n=5 Participants
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Medical history
Migraines
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22 participants
n=5 Participants
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Type of presentation
Incidental
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80 Participants
n=5 Participants
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Type of presentation
Symptomatic
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26 Participants
n=5 Participants
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Aneurysm measurements
Aneurysm maximum height
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6.3 mm
STANDARD_DEVIATION 4.3 • n=5 Participants
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Aneurysm measurements
Aneurysm neck diameter
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4.6 mm
STANDARD_DEVIATION 2.2 • n=5 Participants
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Aneurysm location in Internal Carotid Artery segment
C1 (Cervical Segment)
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1 Participants
n=5 Participants
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Aneurysm location in Internal Carotid Artery segment
C2 (Petrous Segment)
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1 Participants
n=5 Participants
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Aneurysm location in Internal Carotid Artery segment
C3 (Lacerum Segment)
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0 Participants
n=5 Participants
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Aneurysm location in Internal Carotid Artery segment
C4 (Cavernous Segment)
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16 Participants
n=5 Participants
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Aneurysm location in Internal Carotid Artery segment
C5 (Clinoid Segment)
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14 Participants
n=5 Participants
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Aneurysm location in Internal Carotid Artery segment
C6 (Ophthalmic Segment)
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52 Participants
n=5 Participants
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Aneurysm location in Internal Carotid Artery segment
C7 (Communicating Segment)
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19 Participants
n=5 Participants
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Aneurysm location in Internal Carotid Artery segment
Unknown
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3 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 12 monthsPopulation: The Analysis Population is defined as all enrolled subjects that met the eligibility criteria, have the AneurysmFlow measurements recorded pre and post Flow Diverter Stent placement, and have the aneurysm occlusion state (Scale of Roy) available for the 6 month and/or 12 month follow up visit.
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.
Outcome measures
| Measure |
AneurysmFlow Observational Cohort
n=106 Participants
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.
AneurysmFlow: 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.
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Prognostic Value of the MAFA (Mean Aneurysm Flow Amplitude) Ratio With Respect to Full Aneurysm Occlusion Within 12 Months
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0.540 probability
Interval 0.4 to 0.68
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SECONDARY outcome
Timeframe: 6 monthsPopulation: The Analysis Population is defined as all enrolled subjects that met the eligibility criteria, have the AneurysmFlow measurements recorded pre and post Flow Diverter Stent placement, and have the aneurysm occlusion state (Scale of Roy) available for the 6 month and/or 12 month follow up visit.
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) 6 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 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.
Outcome measures
| Measure |
AneurysmFlow Observational Cohort
n=106 Participants
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.
AneurysmFlow: 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.
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|---|---|
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Prognostic Value of the MAFA Ratio With Respect to Full Aneurysm Occlusion Within 6 Months
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0.568 probability
Interval 0.45 to 0.68
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SECONDARY outcome
Timeframe: 12 monthsPopulation: The Analysis Population is defined as all enrolled subjects that met the eligibility criteria, have the AneurysmFlow measurements recorded pre and post Flow Diverter Stent (FDS) placement, and have the aneurysm occlusion state (Scale of Roy) available for the 6 month and/or 12 month follow up visit.
To determine the optimal threshold for the MAFA ratio (to predict full aneurysm occlusion within 12 months), ROC analysis will be performed in combination with net-benefit analysis. Net benefit incorporates estimates of prevalence and misclassification costs, and it is clinically interpretable since it reflects changes in correct and incorrect diagnoses when a new diagnostic test is introduced. The optimal MAFA ratio threshold for clinical decision making is defined as the MAFA ratio where the net benefit is maximized. MAFA (Mean Aneurysm Flow Amplitude) = (mean aneurysm flow post / mean aneurysm flow pre) \* (mean arterial flow pre / mean arterial flow post)
Outcome measures
| Measure |
AneurysmFlow Observational Cohort
n=106 Participants
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.
AneurysmFlow: 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.
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Optimal MAFA Threshold
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NA MAFA ratio
Based on ROC analysis the net benefit curve does not show a maximum for any MAFA ratio and therefore the optimal MAFA ratio threshold for clinical decision making cannot be determined. This is due to an insufficient number of participants with non-occluded aneurysms, along with the fact that the data from occluded and non-occluded cases were too similar to establish the threshold.
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SECONDARY outcome
Timeframe: 12 monthsTo register serious adverse events (i.e. re-operations, ruptures and deaths).
Outcome measures
| Measure |
AneurysmFlow Observational Cohort
n=132 Participants
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.
AneurysmFlow: 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.
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Serious Adverse Events
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6 serious adverse events
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Adverse Events
AneurysmFlow Observational Cohort
Serious adverse events
| Measure |
AneurysmFlow Observational Cohort
n=132 participants at risk
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.
AneurysmFlow: 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.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
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0.76%
1/132 • Number of events 1 • 12 months follow up
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Nervous system disorders
Cerebrovascular accident
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0.76%
1/132 • Number of events 1 • 12 months follow up
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Product Issues
Device occlusion
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0.76%
1/132 • Number of events 1 • 12 months follow up
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Injury, poisoning and procedural complications
Head injury
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0.76%
1/132 • Number of events 1 • 12 months follow up
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Injury, poisoning and procedural complications
Fall
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0.76%
1/132 • Number of events 1 • 12 months follow up
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Nervous system disorders
Headache
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0.76%
1/132 • Number of events 1 • 12 months follow up
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Other adverse events
| Measure |
AneurysmFlow Observational Cohort
n=132 participants at risk
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.
AneurysmFlow: 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.
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|---|---|
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Cardiac disorders
Chest pain
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0.76%
1/132 • Number of events 1 • 12 months follow up
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Musculoskeletal and connective tissue disorders
Muscle weakness
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0.76%
1/132 • Number of events 1 • 12 months follow up
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General disorders
Stent stenosis
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0.76%
1/132 • Number of events 1 • 12 months follow up
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Eye disorders
Diplopia
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0.76%
1/132 • Number of events 1 • 12 months follow up
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Eye disorders
Visual impairment
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0.76%
1/132 • Number of events 1 • 12 months follow up
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place