The value of flow measurements in brain Aneurysms

Not yet recruiting

• Conditions: Other specified disorders of brain,

• Registration Number: CTRI/2019/04/018743
• Lead Sponsor: Philips

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-05
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Male
• Target Recruitment: 120

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 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

• 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.
• Subject meets an exclusion criteria according to national law (e.g. age, pregnant woman, breastfeeding woman).

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
months after flow diverter placement	12 months after flow diverter placement
Full aneurysm occlusion 12	12 months after flow diverter placement

Secondary Outcome Measures

Name	Time	Method
Full aneurysm occlusion 6	months after flow diverter placement

Trial Locations

Locations (1)

Sri Ramachandra Medical College and Research Institute; 🇮🇳 Chennai, TAMIL NADU, India

Sri Ramachandra Medical College and Research Institute

🇮🇳Chennai, TAMIL NADU, India

Dr Santhosh Joseph

Principal investigator

044-45928653

santhoshjo@gmail.com