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CTRI Number  CTRI/2025/03/082122 [Registered on: 11/03/2025] Trial Registered Prospectively
Last Modified On: 10/03/2025
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Other 
Public Title of Study   Saviour PMS Registry Study  
Scientific Title of Study   A prospective post marketing clinical follow up study to evaluate the safety and performance of SAVIOUR-DES System in Real World Indian population 
Trial Acronym  PMCF 
Secondary IDs if Any  
Secondary ID  Identifier 
ACE/PMCF/DES/2023/01  Protocol Number 
VERSION 1.0 DATED 27 SEP 2023  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Yash Paul Sharma  
Designation  Professor and Head  
Affiliation  Postgraduate Institute Medical Education & Research 
Address  Room no 3012 Department of cardiology Postgraduate Institute Medical Education & Research
Sector-12 Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  9417167214  
Fax    
Email  ypspgi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Anoop Sharma  
Designation  Zonal Manager  
Affiliation  ACE Cardiopathy Solution Pvt Ltd  
Address  ACE Cardiopathy solution Private Limited 5th floor Krishna apra Business Square Neta Subhash Place Pritampura New Delhi

North West
DELHI
110034
India 
Phone  9871819777  
Fax    
Email  anoopsharma@acecardiopathy.com  
 
Details of Contact Person
Public Query  
Name  Mr Anoop Sharma  
Designation  Zonal Manager  
Affiliation  ACE Cardiopathy Solution Pvt Ltd  
Address  ACE Cardiopathy solution Private Limited 5th floor Krishna apra Business Square Neta Subhash Place Pritampura New Delhi

North West
DELHI
110034
India 
Phone  9871819777  
Fax    
Email  anoopsharma@acecardiopathy.com  
 
Source of Monetary or Material Support  
Ace Cardiopathy Solutions Pvt Ltd, 5th floor, Business Square, Krishna Apra Business Square, Netaji Subhash Plac, Pitampura, New Delhi, Delhi, India, 110034 
 
Primary Sponsor  
Name  Ace Cardiopathy Solutions Pvt Ltd 
Address  5th Floor Krishna Apra Business Square Netaji Subhash Place Pitampura New Delhi Delhi 110034 
Type of Sponsor  Other [Medical Devices ] 
 
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 Yash Paul Sharma  Postgraduate Institute Medical Education & Research  Room no 3012 Department of cardiology Postgraduate Institute Medical Education & Research
Chandigarh
CHANDIGARH 		 9417167214

ypspgi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee PGIMER   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I22||Subsequent ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction, (2) ICD-10 Condition: I22||Subsequent ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  SAVIOUR STENT   Brand Name: Saviour Classification of Device: Class III (As per EU MDR)6 and Class-D (As per Indian MDR-2017)7 Shelf Life: 24 months Intended User •The device should only be used at medical facilities by physicians who are adequately trained and experienced in performing vascular interventions (including cases of life-threatening complications).  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Patient who can provide informed consent form in writing to provide date for the study.

Patient that need a treatment with drug eluting stent. 
 
ExclusionCriteria 
Details  Prior stenting in target or non target vessel within 90 days before index procedure patient participating in other study.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Device Oriented Composite endpoints at 1 year post index procedure
1 Cardiac Death
2 Target Vessel related Myocardial Infarction (TV-MI) and
3 Clinically driven Target Lesion Revascularization (TLR)

 		 Clinical endpoints measured at 1 month 6 months and 1 year post index procedure

1 Patient Oriented Composite Endpoint (PoCE) defined as the composite of all-cause death, any MI, any stroke and any revascularization.
 
 
Secondary Outcome  
Outcome  TimePoints 
To determine any undesirable side effects under normal conditions of use and assess whether the risks constitute weighed against the intended performance of the Drug Eluting coronary Stent System.

To evaluate the performance of SAVIOUR- Drug Eluting Coronary Stent System.  		 One Year  
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   21/03/2025 
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="1"
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 - 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 -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

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

  6. For how long will this data be available start date provided 31-07-2025 and end date provided 12-12-2027?
    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   Drug-eluting stents (DES) are a significant advancement in percutaneous coronary interventions (PCI), reducing the need for repeat revascularization compared to bare metal stents. However, the potential for re-narrowing of the vessel and complications from permanent polymers in earlier DES models have limited their long-term success. Permanent polymers, while effective in prolonging drug release, have been associated with chronic inflammation and adverse clinical events. Biodegradable polymers offer a promising alternative, as they degrade into inert products after serving their function, potentially avoiding these issues. DES are made from cobalt chromium alloy, coated with a drug-polymer matrix, and delivered via a balloon catheter. The stents are available in various sizes and, once implanted, promote vessel healing through neointimal growth and reendothelialization. 
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