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Study to Evaluate Cerebral AneurysmFlow Results in Occlusion (CARO)

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ClinicalTrials.gov Identifier: NCT03663257
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Philips Healthcare

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.


Condition or disease Intervention/treatment
Intracranial Aneurysm Device: AneurysmFlow

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Observational Cohort Study to Evaluate Cerebral AneurysmFlow Results in Occlusion
Actual Study Start Date : October 4, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Group/Cohort Intervention/treatment
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
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.




Primary Outcome Measures :
  1. Prognostic value of the MAFA ratio with respect to full aneurysm occlusion within 12 months [ Time Frame: 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.


Secondary Outcome Measures :
  1. Prognostic value of the MAFA ratio with respect to full aneurysm occlusion within 6 months [ Time Frame: 6 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) 6 months after Flow Diverter Stent placement.

  2. Optimal MAFA threshold [ Time Frame: 12 months ]
    To determine the optimal MAFA ratio threshold to predict full aneurysm occlusion within 12 months

  3. Adverse events [ Time Frame: 12 months ]
    To register (serious) adverse events (i.e. re-operations, ruptures and deaths).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663257


Contacts
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Contact: Joris de Groot +316 116 45 166 joris.ah.de.groot@philips.com
Contact: Ricardo Hanel, MD, PhD

Locations
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United States, Florida
Baptist Health Recruiting
Jacksonville, Florida, United States, 32207
Contact: Nancy Ebreo    904-202-7063    Nancy.Ebreo@bmcjax.com   
United States, Massachusetts
UMass Medical Center Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Mary Howk    774-441-8442    mary.howk@umassmed.edu   
Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Alex Kostynskyy    416-603-5800 ext 4806    alex.kostynskyy@uhn.ca   
Sponsors and Collaborators
Philips Healthcare
Investigators
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Principal Investigator: Ricardo Hanel, MD, PhD Baptist Medical Center Jacksonville

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Responsible Party: Philips Healthcare
ClinicalTrials.gov Identifier: NCT03663257     History of Changes
Other Study ID Numbers: XCY610-130253
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Philips Healthcare:
Interventional Neurology
Aneurysm
Neurology
Radiology
AneurysmFlow

Additional relevant MeSH terms:
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Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases