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Clinical Trials/CTRI/2019/04/018743
CTRI/2019/04/018743Not yet recruitingNot Applicable

Multicenter observational cohort study to evaluateCerebral AneurysmFlow Results in Occlusion (CARO)

Philips1 site in 1 country120 target enrollmentStarted: January 5, 2019Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Philips
Enrollment
120
Locations
1
Primary Endpoint
months after flow diverter placement
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This is a prospectively planned, single arm, observational, multicenter cohort study to assess the prognostic value of the MAFA ratio using AneurysmFlow (i.e. an approved software tool from Philips intended to provide relevant information on the blood flow in a cerebral aneurysm and its parent artery based on angiography 2D flow measurement) for predicting full aneurysm occlusion 12 months after flow diverter placement.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 99.00 Year(s) (—)
Sex
Male

Inclusion Criteria

  • •Subject with unruptured, 5rnm 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 (e-GFR < 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, breastfeeding woman).

Outcomes

Primary Outcomes

months after flow diverter placement

Time Frame: 12 months after flow diverter placement

Full aneurysm occlusion 12

Time Frame: 12 months after flow diverter placement

Secondary Outcomes

  • Full aneurysm occlusion 6(months after flow diverter placement)

Investigators

Sponsor
Philips
Sponsor Class
Other [Medical Device Company]

Study Sites (1)

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