| CTRI Number |
CTRI/2025/04/085082 [Registered on: 17/04/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Morph 60 Study |
|
Scientific Title of Study
|
A retrospective, single-center, observational study to assess the safety and performance of BioMime Morph Sirolimus Eluting Coronary Stent System in patients with Coronary Heart Diseases. |
| Trial Acronym |
IIT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BioMime Morph GHH-1 Version 1.0.0 21 Jan 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pushpraj Patel |
| Designation |
Director Golden Heart Hospital & Senior Interventional Cardiologist |
| Affiliation |
Golden Heart Hospital |
| Address |
Department of Cardiology, Golden Heart Hospital
1179/1, Plot No. 109 & 112, Ward No.32, Shubhadra Kumari Chouhan Ward Wright Town Extension, Jabalpur (M.P.)
Jabalpur
MADHYA PRADESH
482002
India |
| Phone |
9584024074 |
| Fax |
|
| Email |
dr.pushprajpatel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pushpraj Patel |
| Designation |
Director Golden Heart Hospital & Senior Interventional Cardiologist |
| Affiliation |
Golden Heart Hospital |
| Address |
Department of Cardiology, Golden Heart Hospital
1179/1, Plot No. 109 & 112, Ward No.32, Shubhadra Kumari Chouhan Ward Wright Town Extension, Jabalpur (M.P.)
MADHYA PRADESH
482002
India |
| Phone |
9584024074 |
| Fax |
|
| Email |
dr.pushprajpatel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pushpraj Patel |
| Designation |
Director Golden Heart Hospital & Senior Interventional Cardiologist |
| Affiliation |
Golden Heart Hospital |
| Address |
Department of Cardiology, Golden Heart Hospital
1179/1, Plot No. 109 & 112, Ward No.32, Shubhadra Kumari Chouhan Ward Wright Town Extension, Jabalpur (M.P.)
MADHYA PRADESH
482002
India |
| Phone |
9584024074 |
| Fax |
|
| Email |
dr.pushprajpatel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Meril Life Sciences India Private Limited |
|
|
Primary Sponsor
|
| Name |
Meril Life Sciences Indian Private Limited |
| Address |
Survey No. 135,139 Bilakhia House, 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 Puspraj Patel |
Golden Heart Hospital |
Department of Cardiology, Golden Heart Hospital, S/O Shri B. N. Baderiya Hall No. 2 Kuchaini Parisar
Jabalpur
MADHYA PRADESH |
09584024074
dr.pushprajpatel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Ajay Bhandari Associates |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with coronary heart disease who were implanted with 60 mm of BioMime™ Morph SES System |
|
| ExclusionCriteria |
| Details |
As this is a retrospective study, there are no formal exclusion criteria for the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Target Lesion Failure (TLF)
- Defined as the composite of cardiovascular death, target vessel
myocardial infarction (TV-MI) and target lesion revascularization (TLR)
|
Through 1 Year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cardiovascular death |
Through 1 Year |
| Target Vessel Myocardial Infarction (TV-MI) |
Through 1 Year |
| Target Lesion Revascularization (TLR) |
Through 1 Year |
| Target Vessel Failure (TVF) |
Through 1 Year |
| Target Vessel Revascularization (TVR) |
Through 1 Year |
| Stent thrombosis |
Through 1 Year |
| Stroke |
Through 1 Year |
| Procedure success |
At Discharge |
| Device success |
During Procedure |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
27/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cardiovascular disease is a leading cause of global mortality, with
coronary heart disease posing a significant burden. While DES has
revolutionized interventional cardiology, concerns like late stent thrombosis
have driven ongoing DES advancements. A single long-tapered
BioMime Morph SES system is often
enough for treating long diffused lesion in tapered arteries, and therefore,
the local arterial walls can be saved from over-exposure to drug/metal and its
related adverse events such as delayed healing, peri-procedural MI, risk of
target lesion revascularization and very late ST, which are caused due to use
of multiple stents. The BioMime™ Morph Sirolimus Eluting
Coronary Stent System represents a new generation of DES, featuring
a unique stent morphology, advanced sirolimus-eluting technology, and
biocompatible polymer coatings. Therefore, this
study aims to assess the clinical safety and performance of the BioMime™ Morph
Sirolimus Eluting Coronary Stent System.
|