| CTRI Number |
CTRI/2025/12/099385 [Registered on: 18/12/2025] Trial Registered Prospectively |
| Last Modified On: |
07/09/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Mural Sirolimus Eluting Rx PTCA Balloon Dilatation Catheter] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Prospective Study to Evaluate the Safety and Performance of Mural Drug Eluting Balloon Dilatation Catheter in the real world setting |
|
Scientific Title of Study
|
A Prospective Single Arm Observational Post Market Clinical Follow Up Study to Evaluate the Safety and Performance of Mural Sirolimus - Eluting Rx PTCA Balloon Dilatation Catheter in the Real World Setting |
| Trial Acronym |
Mural SEB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MLS/Mural SEB V1.0.0 Dated 01-Sep-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kirankumar Shetty |
| Designation |
Additional General Manager Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Product Performance and Engineering Department Building Number 6 3rd Floor Near Bilakhia Stadium Survey no 135 139 Muktanand Marg Chala Vapi 396191 Gujarat India
Valsad
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrKiranKumar Shetty |
| Designation |
Additional General Manager Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Product Performance and Engineering Department Building Number 6 3rd Floor Near Bilakhia Stadium Survey no 135 139 Muktanand Marg Chala Vapi 396191 Gujarat India
Valsad
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
Details of Contact Person
Public Query
|
| Name |
DrKiranKumar Shetty |
| Designation |
Additional General Manager Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Product Performance and Engineering Department Building Number 6 3rd Floor Near Bilakhia Stadium Survey no 135 139 Muktanand Marg Chala Vapi 396191 Gujarat India
Valsad
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
|
Source of Monetary or Material Support
|
| Meril Life Sciences Pvt Ltd, Survey No. 135/139, Bilakhia House , Muktanand Marg,, Chala, Vapi, Valsad, Gujarat, 396191 |
|
|
Primary Sponsor
|
| Name |
Meril Life Sciences Pvt Ltd |
| Address |
Near Bilakhia Stadium Survey No 135/139 Muktanand Marg Chala Vapi 396191 Gujarat India |
| Type of Sponsor |
Other [Medical Device] |
|
|
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 |
Multispeciality Hospital Cardiology Department,Plot No 123, behind Somalwar High School, Rajmachi, Raamdaspeth, Nagpur, Maharashtra 440010
Nagpur
MAHARASHTRA |
7122448721
jaspalarneja_200@yahoo.com |
| Dr Sarang Kotrange |
Hrudayaa Cardiac and Vascular Care Center Nagpur |
Hingna Road, Digdoh hills, Police Nagar, Digdoh, Maharastra 440019
Nagpur
MAHARASHTRA |
9619394268
sarangkotrange@gmail.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 |
9820456683
hemant_lk1@yahoo.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 |
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 |
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 |
| Institutional Ethics Committee NKP Salve Institute of Medical Sciences |
Approved |
| Platina Heart Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I222||Subsequent non-ST elevation (NSTEMI) myocardial infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants aged Above or older to 18 years irrespective of gender with cardiovascular stenosis who will undergo an endovascular procedure require vessel dilatation.
2. Participants who require dilatation of stenotic portions also including total occlusionsand AMI participants.
3.The participants who require dilatation of native coronary arteries for plaque modification.
4. The Participant is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent Form in the presence of an impartial witness.
5. Participant is willing and able to comply with post-operative scheduled clinical evaluations |
|
| ExclusionCriteria |
| Details |
1.Participants with hypersensitivity or allergies to aspirin heparin clopidogrel ticlopidine bivalidurin prasugrel ticagrelor and drug such as Sirolimus (Rapamycin) or similar drugs or any analogue or derivative, hydrogenated castor oil polyvinyl pyrollidone vitamin E TPGS , Pluronic F 68 or any contrast media.
2. Participants in whom anti-platelet and or anti-coagulant therapy are contraindicated.
3. Pregnant or lactating females.
4. Participants judged to have a lesion that prevents complete inflation of an angioplasty balloon.
5.Transplant Participants.
6. Participants with calcified lesions requiring another type of treatment, such as Rotational Atherectomy.
7. Participants with unprotected left main coronary artery lesions.
8. The Participants with Coronary artery spasm in the absence of a significant stenosis.
9. Participants whose diseased segment cannot be pre-dilated or prepared before drug-coated balloon treatment.
10. Participants with unresolved vessel thrombus at the lesion site.
11.Participants with unprotected lesions located in the left main coronary artery.
12. Participants under high risk of primary Percutaneous Coronary Intervention (PCI) for acute myocardial infarction characterized by presence of cardiogenic shock or evidence of massive thrombus in the infarct-related artery.
13.The participant who is unwilling or unable to sign the Informed Consent Document. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Procedure Success
2.Major Adverse Cardiac Events |
1. Intraoperative
2.Through discharge, 1 week ± 2 days, 1 month ± 7 days, 3 months ± 15 days, 6 months ± 30 days, 1 year ± 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Device Success
2. Change in Late Lumne Loss
3. Target Vessel Revascularization
4. Product Performance
5. Adverse Events
6. Laboratory Measurements & Non-Invasive Tests |
Baseline , Through Discharge , 1 week , 1 month, 6 months, 1 year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/11/2026 |
| 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="0"
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
|
Mural SEB : A prospective, single-arm, multi-centre, observational, post-market clinical follow-up study to evaluate the safety and performance of Mural Sirolimus-Eluting Rx PTCA Balloon Dilatation Catheter in the real-world setting
Device Used : Mural Sirolimus-Eluting Rx PTCA Balloon Dilatation Catheter
Objectives : The objective of this study is to assess the safety and performance of the Mural™ Sirolimus Eluting Rx PTCA Balloon Dilatation Catheter in the real-world setting
Study Population : Mural™ Sirolimus-Eluting Rx PTCA Balloon Dilatation Catheter is indicated for the coronary native arteries. It is indicated for the dilatation of stenotic portions also including total occlusions, AMI participants and it can also be used for the post-dilatation of balloon expandable stents. |