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CTRI Number  CTRI/2025/08/092735 [Registered on: 11/08/2025] Trial Registered Prospectively
Last Modified On: 08/08/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Study to Evaluate the Performance of MeRes100™ BioResorbable Scaffold in Heart Patients Using CT Angiogram in a single centre 
Scientific Title of Study   A single-arm, single-centre, observational study to assess the efficacy of MeRes100™ Sirolimus Eluting BioResorbable Vascular Scaffold System by CT angiogram in patients with coronary artery 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 Girish Navasundi 
Designation  Senior Consultant 
Affiliation  Apollo Hospitals 
Address  Room No.54, Level-1,Cardiology Division,Apollo Hospitals,154/11, Bannerghatta Main Rd, opposite Krishnaraju Layout, Krishnaraju Layout, Amalodbhavi Naga, Panduranga Nagar, Bengaluru

Bangalore
KARNATAKA
560076
India 
Phone  9475414086  
Fax    
Email  drgirishnavasundi.ct@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Girish Navasundi 
Designation  Senior Consultant 
Affiliation  Apollo Hospitals 
Address  Room No.54, Level-1,Cardiology Division,Apollo Hospitals, 154/11, Bannerghatta Main Rd, opposite Krishnaraju Layout, Krishnaraju Layout, Amalodbhavi Naga, Panduranga Nagar, Bengaluru

Bangalore
KARNATAKA
560076
India 
Phone  9475414086  
Fax    
Email  drgirishnavasundi.ct@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Girish Navasundi 
Designation  Senior Consultant 
Affiliation  Apollo Hospitals 
Address  Room No.54, Level-1,Cardiology Division,Apollo Hospitals,154/11, Bannerghatta Main Rd, opposite Krishnaraju Layout, Krishnaraju Layout, Amalodbhavi Naga, Panduranga Nagar, Bengaluru

Bangalore
KARNATAKA
560076
India 
Phone  9475414086  
Fax    
Email  drgirishnavasundi.ct@gmail.com  
 
Source of Monetary or Material Support  
Meril Life Sciences Pvt. Ltd., Bilakhia House, Survey no. 135/139, Muktananda Marg, Chala, Vapi-396191, Gujarat, India 
 
Primary Sponsor  
Name  Apollo Hospitals 
Address  IIM, 154/11, Bannerghatta Main Rd, opposite Krishnaraju Layout, Krishnaraju Layout, Amalodbhavi Naga, Panduranga Nagar, Bengaluru, Karnataka 560076 
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 Girish Navasundi  Apollo Hospitals  IIM, 154/11, Bannerghatta Main Rd, opposite Krishnaraju Layout, Krishnaraju Layout, Amalodbhavi Naga, Panduranga Nagar, Bengaluru
Bangalore
KARNATAKA 		 9475414086

drgirishnavasundi.ct@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-Clinical Studies, Apollo Hospitals, Bengaluru  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I702||Atherosclerosis of native arteriesof the extremities,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Patient who has been implanted with MeRes100 BRS.
2. Patient has given written informed consent for participation prior to
enrolment.
3. Patient is willing to undergo all study procedures and follow-up
requirements 
 
ExclusionCriteria 
Details  1. Any condition, which in the Investigator’s opinion would preclude safe
participation of patient in the study.
2. Patient participating in another clinical investigation 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Area stenosis
Area stenosis is calculated as the reference minus the minimal lumen area
as a percentage of the reference lumen area. The reference vessel lumen
area is calculated as the average of the mean proximal and mean distal vessel
areas  		 12 month 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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)   21/08/2025 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drgirishnavasundi.ct@gmail.com].

  6. For how long will this data be available start date provided 07-04-2028 and end date provided 07-07-2031?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This is a prospective, single-arm, single-centre study to evaluate the CT angiographic outcomes after implantation of MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System in patients with coronary artery disease. The objective of this study is to assess vessel patency, luminal dimensions, and presence of in-scaffold obstruction using CT angiography after MeRes100 BRS implantation. The safety and efficacy of MeRes100 BRS has been previously established in the MeRes-1 and MeRes-1 Extend trials, which reported sustained safety and clinical performance up to three years. Two-year outcomes showed favourable angiographic results with a low rate of target lesion failure and no definite or probable scaffold thrombosis. CT angiography has demonstrated good diagnostic accuracy in detecting in-scaffold luminal obstruction and measuring luminal dimensions post implantation. Studies suggest that CT angiography and conventional coronary angiography offer similar diagnostic accuracy in identifying obstructive coronary artery disease. Therefore, this study aims to further evaluate CT angiographic outcomes in patients treated with MeRes100 BRS. 
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