| CTRI Number |
CTRI/2017/11/010531 [Registered on: 16/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
24/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate safety and performance of Drug Eluting Stent and Bare Metal Stent in the treatment of patients with coronary artery blockage. |
|
Scientific Title of Study
|
A retrospective, observational, real-world, safety and performance evaluation of DES and BMS for coronary artery lesions. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MLS/ BHI Version 1.0.0 Dated 16-Nov-16 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahesh Basarge |
| Designation |
Principal Investigator |
| Affiliation |
Baroda Heart Institute and Research Centre |
| Address |
Department of Cardiology, Baroda Heart Institute and Research Centre, 44, Haribhakti Colony, Old Padra Road, Vadodara-390007, Gujarat, India
Vadodara
GUJARAT
390007
India |
| Phone |
9825026760 |
| Fax |
|
| Email |
mahesh_basarge@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Thakkar |
| Designation |
Head of Clinical Research |
| Affiliation |
Meril Life Sciences Pvt Ltd |
| Address |
Department of Clinical Resaerch, Meril Life Sciences Pvt Ltd, Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala, Vapi
Valsad
GUJARAT
396191
India |
| Phone |
9879443584 |
| Fax |
|
| Email |
ashok.thakkar@merillife.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Thakkar |
| Designation |
Head of Clinical Research |
| Affiliation |
Meril Life Sciences Pvt Ltd |
| Address |
Department of Clinical Resaerch, Meril Life Sciences Pvt Ltd, Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala, Vapi
GUJARAT
396191
India |
| Phone |
9879443584 |
| Fax |
|
| Email |
ashok.thakkar@merillife.com |
|
|
Source of Monetary or Material Support
|
| Meril Life Sciences Pvt Ltd, Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala, Vapi-396191, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Meril Life Sciences Pvt Ltd |
| Address |
Meril Life Sciences Pvt Ltd, Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala, Vapi-396191, Gujarat, India |
| Type of Sponsor |
Other [Medical Device Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mahesh Basarge |
Baroda Heart Institute and Research Centre |
Department of Cardiology, Baroda Heart Institute and Research Centre, 44, Haribhakti Colony, Old Padra Road, Vadodara-390007, Gujarat, India
Vadodara
GUJARAT |
9825026760
mahesh_basarge@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Baroda Heart Institute Ethics Committee, Gujarat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
OSUMâ„¢ and Metaforâ„¢ |
OSUMâ„¢ -Cobalt Chromium Coronary Stent System
Metaforâ„¢ Sirolimus-Eluting Coronary Stent System
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who have been treated with OSUMâ„¢ and/or Metaforâ„¢.
2. Patients who are contactable, willing to participate will be taken into the study by signing voluntary informed consent form.
|
|
| ExclusionCriteria |
| Details |
1. There are no exclusion criteria for this study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Major Adverse Cardiac Events (MACE) |
In-Hospital, 1 month, 6 months, 12 months and 24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Target vessel failure (TVF)
2. Stent Thrombosis (Definite, possible, and Probable) Rate as Defined by Academic Research Consortium (ARC) |
1. 1 month, 6 months, 12 months and 24 months
2. In-Hospital, 1 month, 6 months, 12 months and 24 months |
|
|
Target Sample Size
|
Total Sample Size="2000"
Sample Size from India="2000"
Final Enrollment numbers achieved (Total)= "750"
Final Enrollment numbers achieved (India)="750" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
17/01/2012 |
| Date of Study Completion (India) |
08/10/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a
retrospective, observational, real-world study to evaluate safety and performance of Drug Eluting Stent and Bare
Metal Stent in the treatment of approximately
2000 patients with coronary artery lesions will be enrolled
from Baroda
Heart Institute (BHI) in India.
The objective of the
study is to evaluate safety and performance of OSUMâ„¢ and Metaforâ„¢ in
the real world at
different time points [Time Frame: In-Hospital, 1 month, 6
months, 12 months and 24 months].
All Subjects will be approached to sign ICF
approved by respective Ethics Committee before starting the study related
process. A list of all the potential
patients meeting inclusion criteria will be selected for the study.
Subject’s clinical/telephonic follow-up
will be taken at 1 month ± 07 days, 6 months ± 14 days, 12
months ± 14 days and 24 months ± 28 days. |