FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/04/018743 [Registered on: 24/04/2019] Trial Registered Prospectively
Last Modified On: 18/04/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   The value of flow measurements in brain Aneurysms 
Scientific Title of Study   Multicenter observational cohort study to evaluate Cerebral AneurysmFlow Results in Occlusion (CARO) 
Trial Acronym  CARO 
Secondary IDs if Any  
Secondary ID  Identifier 
NCT03663257  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Santhosh Joseph 
Designation  PI CARO Study Chennai 
Affiliation  Professor&Head Dept. of Neuro-Radiology and Div. of Interventional Radiology  
Address  Sri Ramachandra Medical Center Department of Neuro-Radiology No.1 Ramachandra Nagar Porur Chennai Tamil Nadu India 600 116

Chennai
TAMIL NADU
600116
India 
Phone    
Fax    
Email  santhoshjo@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Santhosh Joseph 
Designation  PI CARO Study Chennai 
Affiliation  Professor&Head Dept. of Neuro-Radiology and Div. of Interventional Radiology  
Address  Sri Ramachandra Medical Center Department of Neuro-Radiology No.1 Ramachandra Nagar Porur Chennai Tamil Nadu India 600 116

Chennai
TAMIL NADU
600116
India 
Phone    
Fax    
Email  santhoshjo@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Santhosh Joseph 
Designation  PI CARO Study Chennai 
Affiliation  Professor&Head Dept. of Neuro-Radiology and Div. of Interventional Radiology  
Address  Sri Ramachandra Medical Center Department of Neuro-Radiology No.1 Ramachandra Nagar Porur Chennai Tamil Nadu India 600 116

Chennai
TAMIL NADU
600116
India 
Phone    
Fax    
Email  santhoshjo@gmail.com  
 
Source of Monetary or Material Support  
Philips Veenpluis 6 5684PC Best The Netherlands 
 
Primary Sponsor  
Name  Philips 
Address  Veenpluis 6 5684PC Best The Netherlands 
Type of Sponsor  Other [Medical Device Company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Canada
India
United States of America  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Santhosh Joseph  Sri Ramachandra Medical College and Research Institute  Sri Ramachandra Medical Center Department of Neuro-Radiology No.1 Ramachandra Nagar Porur Chennai Tamil Nadu India 600 116
Chennai
TAMIL NADU 		 044-45928653

santhoshjo@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Ramachandra Medical College and Research Inistitute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G938||Other specified disorders of brain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Male 
Details  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 
 
ExclusionCriteria 
Details  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) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Full aneurysm occlusion 12
months after flow diverter placement 		 12 months after flow diverter placement 
 
Secondary Outcome  
Outcome  TimePoints 
Full aneurysm occlusion 6
months after flow diverter placement 		 6 months after flow diverter placement 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="25" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/05/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/10/2018 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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.
 
Close