CTRI/2025/12/099358 [Registered on: 17/12/2025] Trial Registered Prospectively
Last Modified On:
17/08/2026
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Medical Device
Study Design
Single Arm Study
Public Title of Study
To Evaluate the Safety and Performance of Mural Drug Eluting Stent .
Scientific Title of Study
A Prospective , Single arm , Multi center, Observational study to Evaluate the Safety and Performance of Mural DES Sirolimus Eluting Coronary Stent System in a real world setting
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
MLS/Mural-DES/SCSS/01/2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr KiranKumar Shetty
Designation
AGM Product Performance and Engineering Department
Affiliation
Meril Life Sciences Pvt. Ltd
Address
Meril Life Sciences Pvt. Ltd Building number 6, 3rd floor,Near Bilakhia Stadium, Survey no 135,139, Muktanand marg,Chala , Vapi-396191, Gujarat, India Valsad GUJARAT 396191 India
Phone
09743700109
Fax
Email
kirankumar.shetty@merillife.com
Details of Contact Person Scientific Query
Name
Dr KiranKumar Shetty
Designation
AGM Product Performance and Engineering Department
Affiliation
Meril Life Sciences Pvt. Ltd
Address
Meril Life Sciences Pvt. Ltd Building number 6, 3rd floor,Near Bilakhia Stadium, Survey no 135,139, Muktanand marg,Chala , Vapi-396191, Gujarat, India
GUJARAT 396191 India
Phone
09743700109
Fax
Email
kirankumar.shetty@merillife.com
Details of Contact Person Public Query
Name
Dr KiranKumar Shetty
Designation
AGM Product Performance and Engineering Department
Affiliation
Meril Life Sciences Pvt. Ltd
Address
Meril Life Sciences Pvt. Ltd Building number 6, 3rd floor,Near Bilakhia Stadium, Survey no 135,139, Muktanand marg,Chala , Vapi-396191, Gujarat, India
GUJARAT 396191 India
Phone
09743700109
Fax
Email
kirankumar.shetty@merillife.com
Source of Monetary or Material Support
Meril Life Sciences Pvt Ltd
Primary Sponsor
Name
Meril Life Sciences Pvt. Ltd
Address
Near Bilakhia Stadium, Survey 135/139 Muktanand Marg, Chala , Vapi 396191 Gujarat India
Institutional Ethics Committee NKP Salve Institute of Medical Sciences
Approved
Platina Heart Hospital Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: I748||Embolism and thrombosis of other arteries,
Intervention / Comparator Agent
Type
Name
Details
Intervention
NIL
NIL
Comparator Agent
NIL
NIL
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1.The participant must be aged 18 years or older, irrespective of gender.
2. Participant diagnosed with coronary artery disease (CAD)requiring revascularization, such as stable angina, unstable angina, acute myocardial infarction (STEMI or NSTEMI),silent ischemia with evidence of significant coronary artery disease.
3. Participants with single or multiple coronary artery lesions are eligible for stenting.
4. Participant with De novo coronary artery lesions.
5. The participant must be willing and able to provide written Informed Consentby signing and dating the IRB or ECapproved Informed Consent form.
6. The participant is willing and able to comply with postoperative scheduled clinical evaluations.
ExclusionCriteria
Details
1.Participants have any known hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, drug such as Sirolimus (Rapamycin) or similar drugs or any analogue or derivative, cobalt, chromium, nickel, molybdenum, tungsten
or any contrast media.
2.Life expectancy of less then 1 year will be excluded.
3. Pregnant women will be excluded.
Participants on anti-coagulant or anti-platelet therapy.
4.Participants known to have a lesion that prevents complete inflation of an angioplasty balloon.
5.Transplant participants.
6. Participant with active gastrointestinal bleeding or history of gastrointestinal bleeding within the past 6 months.
7. The participant is not willing and able to comply with postoperative scheduled clinical evaluations
1. 1 month, 3 months , 6 months , 1 year
2. 3 months , 6 months , 1 year
3. post operative , Discharge
4. Through Discharge, 1 week , 1 month, 3 months ,6 months , 1 year
5. admission to Discharge
6. 1 month, 3 months , 6 months , 1 year
7. 1 month , 3 months , 6 months , 1 year
Target Sample Size
Total Sample Size="136" Sample Size from India="136" 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)
15/01/2026
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)
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 - NO
Brief Summary
Study Name : A prospective, multi-center, open-label, single-arm, observational, real-world, post-market clinical follow-up study to evaluate the safety and performance of Mural NC Non-compliant Rx PTCA Balloon Dilatation Catheter
Study Objective : This study aims to evaluate the safety and performance of Mural™ NC Non-compliant Rx PTCA Balloon Dilatation Catheter in Participants with cardiovascular stenosis who will undergo an endovascular procedure requiring vessel dilatation
Study Design : A prospective, multi-center, single-arm, open-label, observational, real-world, post-market clinical follow-up study.