| CTRI Number |
CTRI/2025/12/099358 [Registered on: 17/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/04/2026 |
| 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 |
| Type of Sponsor |
Other [Medical Device Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jaspal Arneja |
Arneja Heart and Multispeciality Hospital |
Cardiology Department,Plot No 123, behind Somalwar High School, Rajmachi, Raamdaspeth, Nagpur, Maharashtra 440010
Nagpur
MAHARASHTRA
Nagpur
MAHARASHTRA |
7122448721
jaspalarneja_200@yahoo.com |
| Dr Hemant Khemani |
Lotus Superspeciality Hospital |
Cardiology Department,Sai Krupa Society, Chs Ltd, ONE Borivali, Ram Mandir Rd, Babhai Naka, Borivali West, Mumbai, Maharashtra 400091
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
9820456683
hemant_lk1@yahoo.com |
| Dr Sanjay Sharma |
Mata Chanan Devi Hospital |
Cardiology department,Block C1, Janakpuri, New Delhi, Delhi, 110058
New Delhi
DELHI |
9810704174
sanjayupmanyu.sharma@gmail.com |
| Dr Pramod Mundra |
Platina Heart Hospital |
Cardiology Department Sitabuldi Commercial Complex, Platina Heart Hospital, 2nd & 3rd Floor, Dhanashree, Humpyard Rd, near Hardeo Hotel, Sitabuldi, Nagpur, Maharashtra 440012
Nagpur
MAHARASHTRA
Nagpur
MAHARASHTRA |
9823026651
platinahearthospitalnagpur@gmail.com |
| Dr Ashar Khan |
Synergy Multispeciality Hospital |
Cardiology department,Plot No. 42 & 43, Near Palloti School Gorewada, Mankapur, Mankapur Ring Rd, Nagpur, Maharashtra 440013
Nagpur
MAHARASHTRA
Nagpur
MAHARASHTRA |
9920571334
drasharhusain@gmail.com |
| Dr Gautam Swaroop |
Tender Palm Super Speciality Hospital |
Ground Floor, Dept of Cardiology,Amar Shaheed Path, near Ekana International Cricket Stadium Road, Sector-7, Gomti Nagar, Lucknow, Ahmamau, Uttar Pradesh 226002
Lucknow
UTTAR PRADESH |
9307852939
drgautam.swaroop@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Adroit Ethics Committee |
Approved |
| ARNEJA’S INSTITUTIONAL ETHICS COMMITTEE |
Approved |
| Atharva Institutional Ethics Committee |
Approved |
| Gillurkar Hospital Ethics Committee |
Approved |
| Good Society for Ethical Research |
Approved |
| Platina Heart Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Target Lesion Failure
2. Major Adverse Cardiac Events
3. Device Success |
1. 1 week , 1 month, 3 months, 6 months , 1 year
2. Through Discharge, 7 days , 30 days , 3 months , 6 months , 1 Year
3. Intra operative
3. Device Success |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Target Vessel Revascularization
2. Stent Thrombosis
3. Procedural Success
4.Adverse Events
5. Lenght of Hospital Stay
6. Target Vessel Failure
7. Enzyme Measurements |
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) |
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 - 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. |