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Clinical Trials/CTRI/2019/04/018743
CTRI/2019/04/018743
Not yet recruiting
未知

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

Philips0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: G938- Other specified disorders of brain

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: G938- Other specified disorders of brain
Sponsor
Philips
Status
Not yet recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Observational

Investigators

Sponsor
Philips

Eligibility Criteria

Inclusion Criteria

  • •1\. Subject with unruptured, 5rnm saccular aneurysm(s) located in the anterior intracranial
  • •circulation and suitable for an endovascular treatment with a Flow Diverter Stent
  • •2\. Subject is 18 years of age or older, or of legal age to give informed consent per state or national law
  • •3\. Subject is available for clinical follow\-ups

Exclusion Criteria

  • •1\. Non\-saccular brain aneurysm(s) (i.e., dissecting, fusiform, atherosclerotic, mycotic, bifurcational)
  • •2\. Prior aneurysm treatment with either endovascular (stenting, coiling) or surgical (clipping) techniques
  • •3\. Endovascular treatment assisted with coils or intracranial stents
  • •4\. Significant or severe allergy to intra\-arterial contrast medium uncontrolled by pre\-procedure medications
  • •5\. Severe kidney disease (e\-GFR \< 60\)
  • •6\. Subjects not willing (or able) to attend post FDS insertion standard\-of\-care follow up clinic visits requiring DSA, head MRI or CTA imaging
  • •7\. Subject participates in a potentially confounding drug or device trial during the course of the study.
  • •8\. Subject meets an exclusion criteria according to national law (e.g. age, pregnant woman, breastfeeding woman)

Outcomes

Primary Outcomes

Not specified

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