| CTRI Number |
CTRI/2018/01/011230 [Registered on: 10/01/2018] 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 the BioMimeâ„¢ Morph Sirolimus-Eluting Coronary Stent Systems in the treatment of patients with coronary artery blockage. |
Scientific Title of Study
Modification(s)
|
A multicenter, observational, real-world, safety and performance evaluation of BioMimeâ„¢ Morph Sirolimus-Eluting Coronary Stent System for coronary artery lesions. |
| Trial Acronym |
BioMimeâ„¢ Morph |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MLS/MOR-KIMS Version 1.0.0 dated 15 June 2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P Rajendra Kumar Jain |
| Designation |
Principal Investigator |
| Affiliation |
Krishna Institute of Medical Sciences (KIMS Hospital) |
| Address |
Department of Cardiology, Krishna Institute of Medical Sciences (KIMS Hospital), Minister Road, Krishna Nagar Colony, Begumpet, Secundrabad-500003, Hyderabad, India.
Hyderabad
ANDHRA PRADESH
500003
India |
| Phone |
9848029443 |
| Fax |
|
| Email |
kumarpre@hotmail.com |
|
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 396191, Vapi, Gujarat, India
Valsad
GUJARAT
396191
India |
| Phone |
9879443584 |
| Fax |
09879443584 |
| 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 396191, Vapi, Gujarat, India
Valsad
GUJARAT
396191
India |
| Phone |
9879443584 |
| Fax |
09879443584 |
| 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 [Other [Medical Device Company] ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Satish Suryavanshi |
Fortis Escorts Heart Centre |
Department of Cardiology, Pandit JNM Medical College, Jail Road, Beind Mekahara Hospital, Raipur HO, Raipur, Chhattisgarh - 492001, India
Raipur
CHHATTISGARH |
9826334404
drsatish_suryavanshi@yahoo.co.in |
| Dr P Rajendra Kumar Jain |
Krishna Institute of Medical Sciences (KIMS Hospital) |
Department of Cardiology, Minister Road, Krishna Nagar Colony, Begumpet, Secundrabad-500003, Hyderabad, Andhra Pradesh, India.
Hyderabad
ANDHRA PRADESH |
9848029443
kumarpre@hotmail.com |
| Dr Raghu T R |
Sri Jayadeva Institute of Cardiovascular Sciences and Research |
Department of Cardiology, GIMS Campus, Sedam Road
Kalaburagi, Karnataka, India
Bangalore
KARNATAKA |
8022977286
drtrraghu@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, KIMS Hospitals, Secundrabad |
Approved |
| Sangini Hospital Ethics Committee, Ahmedabad |
Approved |
| Sri Jayadeva Institute Ethics Committee, Bangalore |
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 |
| Intervention |
BioMimeâ„¢ Morph |
BioMimeâ„¢ Morph Sirolimus Eluting Coronary Stent System |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who have been treated with BioMimeâ„¢ Morph.
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) |
2 years follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Target vessel failure (TVF), Stent Thrombosis, Procedure Success, Device Success |
2 years follow up |
|
Target Sample Size
Modification(s)
|
Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "362"
Final Enrollment numbers achieved (India)="362" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
13/10/2014 |
| Date of Study Completion (India) |
10/11/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Patted SV, Jain RK, Jiwani PA, Suryavanshi S, Raghu TR, Raveesh H, Rajalakshmi S, Thakkar AS, Turiya PK, Desai PJ, Patted AS. Clinical Outcomes of Novel Long-Tapered Sirolimus-Eluting Coronary Stent System in Real-World Patients With Long Diffused De Novo Coronary Lesions. Cardiology Research. 2018 Dec 7;9(6):350-7. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a retrospective, multicenter, observational,
real-world, study to evaluate safety and performance of BioMimeâ„¢ Morph
Sirolimus Eluting Coronary Stent Systems in the treatment of
approximately 400 patients with coronary artery lesions at approximately
5-10 centers.
The objective of the study is to evaluate safety and performance
of BioMime in the real world settings at specific time point [Time frame: 2
years follow up].
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 that have been treated with Sirolimus Eluting Coronary
Stent Systems will be selected for the study.
As this is a retrospective study, the patients will be followed up for
only observation and the data will be collected.
|