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CTRI Number  CTRI/2024/02/062921 [Registered on: 20/02/2024] Trial Registered Prospectively
Last Modified On: 29/11/2024
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Safety and Performance of the Relisys Pre-dilatation catheters in Coronary Angiography. 
Scientific Title of Study   QUIN-SC: A retrospective, open-label, non - randomized, post-market clinical follow up study to assess the safety and performance of the Relisys Pre-dilatation catheters in human subjects who underwent coronary angioplasty. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
QUIN-SC V1.1 dated 07 Sep 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjay R Tarlekar 
Designation  Principal Investigator 
Affiliation  Sushrusha Heart Care and Multispeciality Hospital 
Address  Plot No. 22/A, Phase III, Palm Beach Road, sector 6 Nerul West

Mumbai
MAHARASHTRA
400706
India 
Phone  9322297664  
Fax    
Email  srtarlekar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sneha Voruchu 
Designation  Clinical Research Associate 
Affiliation  Relisys Medical Devices Limited 
Address  Survey No. 312, Ibrahimpatnam Mandal, Mangalpally,

Hyderabad
TELANGANA
501510
India 
Phone  9618080999  
Fax    
Email  Snehav@relisys.in  
 
Details of Contact Person
Public Query  
Name  Dr Sneha Voruchu 
Designation  Clinical Research Associate 
Affiliation  Relisys Medical Devices Limited 
Address  Survey No. 312, Ibrahimpatnam Mandal, Mangalpally,

Hyderabad
TELANGANA
501510
India 
Phone  9618080999  
Fax    
Email  Snehav@relisys.in  
 
Source of Monetary or Material Support  
Relisys Medical Devices Limited Survey No.312, Pocharam Road, Mangalpally Village, Ibrahimpatnam Mandal, Ranga Reddy District, Telangana– 501510, India. 
 
Primary Sponsor  
Name  Relisys Medical Devices Limited 
Address  Survey No.312, Pocharam Road, Mangalpally Village, Ibrahimpatnam Mandal, Ranga Reddy District, Telangana– 501510, India. 
Type of Sponsor  Other [Medical Device company] 
 
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 Sanjay R Tarlekar  Shushrusha Heart Care Centre and Multispeciality Hospital  Cardiology department, 1st floor, Phase III, Palm Beach Road Sector 6 Nerul West Navi Mumbai
Mumbai
MAHARASHTRA 		 9102227700273

srtarlekar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Suraksha Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I708||Atherosclerosis of other arteries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Pre-dilatation Catheter  The Pre-dilatation balloon catheter is used for predilatation of the coronary arteries 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.The patient must be 18 years of age or older, irrespective of gender.
2.Subjects who underwent treatment with stenotic lesions in coronary arteries or bypass graft stenosis for percutaneous coronary intervention (PCI).
3. The patient had single or multiple vessel coronary artery disease and clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, and, or a positive functional study.
4. Underwent treatment with Relisys Pre-dilatation catheters during the period Jan 2019 to Dec 2023.
5. The subject must have denovo or restenotic lesions in native coronary arteries or bypass grafts that are suitable for percutaneous coronary intervention.
6. A maximum of three lesions, including must be in different coronary arteries or bypass grafts.
7. The target lesions must have a diameter stenosis greater than 70 percentage by visual estimation and be amenable to percutaneous intervention. 
 
ExclusionCriteria 
Details  1.Pregnant Female.
2.Presence of any known life-threatening noncardiac(major or progressive) disease that will limit the patients life expectancy.
3.Documented evidence of significant renal dysfunction(serum creatinine less than 3.0mg per dl) or on any form of dialysis.
4. Psychiatric or behavioral disease, including known alcohol or drug abuse ( continued use of alcohol, illegal drugs, or the misuse of prescription or the OTC drugs with negative physical or psychological consequences).
5. Subjects who have known hypersensitivity to device materials.
6. The patient has any other concurrent conditions that, in the opinion of the investigator, may compromise patient safety, privacy, and study objectives. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the safety of Relisys Pre-dilatation catheter in patients.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the performance of Relisys Pre-dilatation catheter in patients.  Baseline 
 
Target Sample Size   Total Sample Size="261"
Sample Size from India="261" 
Final Enrollment numbers achieved (Total)= "261"
Final Enrollment numbers achieved (India)="261" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   26/02/2024 
Date of Study Completion (India) 10/07/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   This study is a retrospective, non-randomized, open-label, single-arm post-marketing clinical follow-up study. The evaluation exhibits the safety and performance of the Relisys pre-dilatation catheters in human subjects who underwent coronary angioplasty. The study is designed to collect 5-year clinical data from patients from a single center where the device was consistently placed. The data from January 2019 to December 2023 on patients who underwent coronary angioplasty in the selected center and, during the procedure, Relisys pre-dilatation catheters of different brands like VEDA+R SC, JADE-SC, PEARL-SC, etc. that were used in patients will be collected. This retrospective data will be analyzed to assess the safety and performance of the device. 
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