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CTRI Number  CTRI/2021/07/034719 [Registered on: 09/07/2021] Trial Registered Prospectively
Last Modified On: 30/04/2024
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Other 
Public Title of Study   Prospective Registry for Assessment of Acute Ischemic Stroke Patients 
Scientific Title of Study   Prospective Registry for Assessment of Acute Ischemic Stroke Patients Treated with Neurothrombectomy Devices in India 
Trial Acronym  PRAAN 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vinay Rajan 
Designation  Senior Manger Clinical and Medical Affairs 
Affiliation  India Medtronic Pvt Ltd 
Address  India Medtronic Pvt Ltd Solitaire Corporate Park Building Number 12 6th Floor Andheri Ghatkopar Link Road Andheri East 400093
India Medtronic Pvt Ltd Solitaire Corporate Park Building Number 12 6th Floor Andheri Ghatkopar Link Road Andheri East 400093
Mumbai
MAHARASHTRA
400093
India 
Phone  00919619332703   
Fax    
Email  vinay.rajan@medtronic.com  
 
Details of Contact Person
Scientific Query  
Name  Vinay Rajan 
Designation  Senior Manger Clinical and Medical Affairs 
Affiliation  India Medtronic Pvt Ltd 
Address  India Medtronic Pvt Ltd Solitaire Corporate Park Building Number 12 6th Floor Andheri Ghatkopar Link Road Andheri East 400093
India Medtronic Pvt Ltd Solitaire Corporate Park Building Number 12 6th Floor Andheri Ghatkopar Link Road Andheri East 400093
Mumbai
MAHARASHTRA
400093
India 
Phone  00919619332703   
Fax    
Email  vinay.rajan@medtronic.com  
 
Details of Contact Person
Public Query  
Name  Vinay Rajan 
Designation  Senior Manger Clinical and Medical Affairs 
Affiliation  India Medtronic Pvt Ltd 
Address  India Medtronic Pvt Ltd Solitaire Corporate Park Building Number 12 6th Floor Andheri Ghatkopar Link Road Andheri East 400093
India Medtronic Pvt Ltd Solitaire Corporate Park Building Number 12 6th Floor Andheri Ghatkopar Link Road Andheri East 400093
Mumbai
MAHARASHTRA
400093
India 
Phone  00919619332703   
Fax    
Email  vinay.rajan@medtronic.com  
 
Source of Monetary or Material Support  
India Medtronic Pvt Ltd Solitaire Corporate Park Building Number 12 6th Floor Andheri Ghatkopar Link Road Andheri East-400093 
 
Primary Sponsor
Modification(s)  
Name  India Medtronic Pvt Ltd 
Address  Solitaire Corporate Park Bldg No 12 6th Floor Andheri Ghatkopar Link Road Andheri (e) Mumbai Maharashtra 400093  
Type of Sponsor  Other [Medical Device ] 
 
Details of Secondary Sponsor
Modification(s)  
Name  Address 
India Medtronic Pvt Ltd  Solitaire Corporate Park Bldg No 12 6th Floor Andheri Ghatkopar Link Road Andheri (e) Mumbai Maharashtra 400093 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 15  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shailesh Gaikwad   All India Institute of Medical Sciences  All India Institute of Medical Sciences, Department of Neuroscience, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI 		 9971237573

sgaikwad_63@yahoo.com 
Dr Vipul Gupta  Artemis Hospital  Artemis Hospital, Department of Neuroscience, Sector 51,Gurugram 122001 Haryana, India"
Gurgaon
HARYANA 		 9810542372

drvipulgupta25@gmail.com 
Dr Anil Panduranga Karapurkar  Breach Candy Hospital Trust  Breach Candy Hospital Trust, Departmnet of Neuroscience, 60 A Bhulabhai Desai Road, Mumbai : 400026, India"
Mumbai
MAHARASHTRA 		 9820643170

anilkarapurkar@gmail.com 
Dr Jeyaraj D Pandian  CHRISTIAN MEDICAL COLLEGE AND HOSPITAL  PRINCIPAL (Dean), PROFESSOR, DEPARTMENT OF NEUROLOGY, CHRISTIAN MEDICAL COLLEGE AND HOSPITAL
Ludhiana
PUNJAB 		 9915784750

jeyarajpandian@hotmail.com 
Dr Mathew Cherian  Kovai Medical Center & Hospital  Kovai Medical Center & Hospital, Department of Neuroscience, 99, Avanashi Road, Coimbatore-641014,
Coimbatore
TAMIL NADU 		 9600900373

dr.mathewcherian@gmail.com 
Dr Gaurav Goel  Medanta – The Medicity  Medanta – The Medicity Department of Neuroscience, CH Baktawar Singh Rd, near Olympus, Medicity, Medicity, Islampur Colony, Sector 38 Gurugram, Haryana- 122001. India
Gurgaon
HARYANA 		 9650789820

drgauravgoel1@rediffmail.com 
Dr Vikram Huded  Narayana Hrudayalaya  Narayana Hrudayalaya Institute of Neurosciences, Basant Health Centre Building, No-1 18th main Opp.HSR Club Sector 3 HSR Layout Bangalore Karnataka 560102
Bangalore
KARNATAKA 		 9900002101

drvikramhuded@gmail.com 
Dr Kaushik Sunder  Rabindranath Tagore International Institute of Cardiac Sciences  Rabindranath Tagore International Institute of Cardiac Sciences, Department of Neuroscience, 124, Eastern Metropolitan Bypass, Premises No: 1489, Mukundapur
Kolkata
WEST BENGAL 		 9585515234

skaushik85@gmail.com 
Dr Manish Chugh  Sir Ganga Ram Hospital  Department of Neurology, Sir Ganga Ram Hospital Marg, Rajinder Nagar,New Delhi, Delhi 110060
New Delhi
DELHI 		 9810983027

drchugh02@gmail.com 
Dr Nishant Aditya  Sir H N Reliance Foundation Hospital and Research Centre  Prarthana Samaj, Raja Rammohan Roy Rd Mumbai : 400007, India.
Mumbai
MAHARASHTRA 		 9769636049

nishantaditya@yahoo.com 
Dr Sylaja PN  Sree Chitra Tirunal Institute for Medical Sciences and Technology  Professor of Neurology, Department of Neuroscience, Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Thiruvananthapuram, Kerala, India
Thiruvananthapuram
KERALA 		 9446566287

sylajapn@sctimst.ac.in 
Dr Sabarish SS  Sri Ramachandra Institute of Higher Education and Research  1, Mount Poonamallee Rd, Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116, India
Chennai
TAMIL NADU 		 9994270566

sabarish.ss.dr@gmail.com 
Dr Hiren F Patel  Sterling Hospital  Sterling Hospital Rd,Near Maharaja Agrasen Vidhyalaya, L.K Society,Nilmani Society, Memnagar, Ahmedabad,Gujarat 380052, India
Ahmadabad
GUJARAT 		 9974062120

patelhirendr@gmail.com 
Dr Arvinda HR  The National Institute of Mental Health and Neuro-Sciences  368, 8th Main Rd, 2nd Block, Someshwara Nagar, Jayanagar, Bengaluru, Karnataka 560029, India
Bangalore
KARNATAKA 		 9900487180

aravind.radiology@gmail.com 
Dr Suresh Girgani  Yashoda Hospital  Behind Hari Harakala Bhavan, SP Road, Secunderabad, Telangana - 500003, India.
Hyderabad
TELANGANA 		 8501950088

suresh8g@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 14  
Name of Committee  Approval Status 
Narayana Health Medical Ethics Committee  Approved 
Artemis Health Science Institutional Ethics Committee  Approved 
Ethics Committee, Breach Candy Hospital Trust  Approved 
Institute Ethics Committee, AIIMS  Not Applicable 
Institutional Ethics Committee Christian Medical College and Hospital  Approved 
Institutional Ethics Committee of the NIMHANS Hospital  Approved 
Institutional Ethics Committee of the Sir H N Reliance Foundation Hospital and Research Centre  Approved 
Institutional Ethics Committee Sree Chitra Tirunal Institute for Medical Sciences and Technology  Approved 
Institutional Ethics Committee Yashoda Academy of Medical Education and Research  Approved 
Institutional Ethics Committee, Sir Ganga Ram Hospital  Approved 
Kovai Medical Center and Hospital Ethics Committee  Approved 
Medanta Institutional Ethics Committee  Approved 
NH Rabindranath Tagore International Institute of Cardiac Sciences Ethics Committee  Approved 
Sterling Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Notified 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I633||Cerebral infarction due to thrombosis of cerebral arteries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Subject/subject’s legally authorized representative has given Informed Consent according to country regulations, and/or EC requirements
2.Subject is 18 years of age or older
3. Subject has experienced an Acute Ischemic Stroke due to large intracranial vessel
occlusion in at least one of the following intracranial vessels: internal carotid artery (ICA), M1and M2 segments of the middle cerebral artery (MCA), basilar, and vertebral arteries
4.Subject has been or will be treated with a Medtronic market‐released neuro thrombectomy
device as the initial device used to remove the thrombus
5.Subject is willing to participate in a 90‐day follow‐up visit
6.Treatment within 8 hours of last known well
7.Pre-Stroke Modified Rankin Scale (mRS) score ≤1 (immediately) prior to stroke onset
8.Pre-treatment National Institutes of Health Stroke Scale (NIHSS) ≥ 6 and ≤ 30
 
 
ExclusionCriteria 
Details  Patient must not meet any of the following general exclusion criteria:
1. Concurrent participation in another mechanical neuro thrombectomy device trial or any other
clinical trial with an active treatment arm or where the study procedure or treatment might
confound the study analysis
2.Patients meeting the contraindication as mention in the IFU of devices
3.Patients identified with active COVID-19 infection at the time of enrollment
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
mTICI score
NIHSS
mRS score 		 Enrolment, Discharge and 90 days 
 
Secondary Outcome  
Outcome  TimePoints 
Cost effectiveness,
mRS, NIHSS
 		 Discharge and 90 day follow up
 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   30/07/2021 
Date of Study Completion (India) 31/01/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="6"
Days="30" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The purpose of this registry is to assess clinical outcomes and different factors that may affect these clinical outcomes that are associated with the use of Medtronic market-released neurothrombectomy devices SolitaireTM and/or ReactTM Aspiration catheters family of devices intended to restore blood flow in patients experiencing acute ischemic stroke due to large intracranial vessel occlusion. A post‐market registry designed to collect real world data associated with the use of Medtronic market‐released neurothrombectomy devices in acute ischemic stroke (AIS) patients from India. 
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