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CTRI Number  CTRI/2024/06/069583 [Registered on: 26/06/2024] Trial Registered Prospectively
Last Modified On: 04/05/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective 
Study Design  Other 
Public Title of Study   Assessment of Stent in Symptomatic Ischemic Heart Disease: A Retrospective Analysis 
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 symptomatic ischemic heart disease. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Satish Suryavanshi 
Designation  Senior Consultant Cardiologist 
Affiliation  SMC Heart Institute and IVF Research Centre 
Address  SMC Heart Institute and IVF Research Centre Infront of BSNL Office Vidhan Sabha Road Khamardih Raipur Chhattisgarh 492007

Raipur
CHHATTISGARH
492007
India 
Phone  9826334404  
Fax    
Email  drsatish_suryavanshi@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Satish Suryavanshi 
Designation  Senior Consultant Cardiologist 
Affiliation  SMC Heart Institute and IVF Research Centre 
Address  SMC Heart Institute and IVF Research Centre Infront of BSNL Office Vidhan Sabha Road Khamardih Raipur Chhattisgarh 492007

Raipur
CHHATTISGARH
492007
India 
Phone  9826334404  
Fax    
Email  drsatish_suryavanshi@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Satish Suryavanshi 
Designation  Senior Consultant Cardiologist 
Affiliation  SMC Heart Institute and IVF Research Centre 
Address  SMC Heart Institute and IVF Research Centre Infront of BSNL Office Vidhan Sabha Road Khamardih Raipur Chhattisgarh 492007

Raipur
CHHATTISGARH
492007
India 
Phone  9826334404  
Fax    
Email  drsatish_suryavanshi@yahoo.co.in  
 
Source of Monetary or Material Support  
SMC Heart Institute and IVF Research Centre In front of BSNL Office Vidhan Sabha Road Khamardih Raipur Chhattisgarh 492007 
 
Primary Sponsor  
Name  SMC Heart Institute and IVF Research Centre 
Address  SMC Heart Institute and IVF Research Centre In front of BSNL Office Vidhan Sabha Road Khamardih Raipur Chhattisgarh 492007 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Satish Suryavanshi  SMC Heart Institute and IVF Research Centre  Room No. 01, Basement beside MRD, Clinical Research department, SMC Heart Institute and IVF Research Centre In front of BSNL Office Vidhan Sabha Road Khamardih Raipur Chhattisgarh 492007
Raipur
CHHATTISGARH 		 9826334404

drsatish_suryavanshi@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMC Heart Institute Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I248||Other forms of acute ischemic heart disease,  
 
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 symptomatic ischemic heart disease who were implanted with
BioMimeâ„¢ Morph SES System between 1st January 2021 and 31st December
2022. 
 
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)  1 Year 
 
Secondary Outcome  
Outcome  TimePoints 
1. Cardiovascular death [Time Frame: Through 1 year]
2. Target Vessel Myocardial Infarction (TV-MI) [Time Frame: Through 1 year]
3. Target Lesion Revascularization (TLR) [Time Frame: Through 1 year]
4. Target Vessel Failure (TVF) [Time Frame: Through 1 year]
5. Target Vessel Revascularization (TVR) [Time Frame: Through 1 year]
6. Stent Thrombosis [Time Frame: Through 1 year]
7. Stroke [Time Frame: Through 1 year]
8. Procedure success [Time Frame: At Discharge]
9. Device success [Time Frame: During procedure]
10. Length of Hospital Stay [Time Frame: At Discharge] 		 1 Year 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   08/07/2024 
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="3"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Applicable 
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
Modification(s)  

Data to be collected between 1st January 2021 and 30th April 2026.

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 BioMimeâ„¢ 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 BioMimeâ„¢ Morph Sirolimus Eluting Coronary Stent System.

 
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