| CTRI Number |
CTRI/2026/03/105735 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
11/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To assess the safety and performance of Mural Non-Complaint Balloon |
|
Scientific Title of Study
|
A Prospective, Multi Center, Single Arm, Open Label, Observational, Real World, Post Market Clinical Follow up Study to Evaluate the Safety & Performance of Mural NC Non Compliance Rx PTCA Balloon Dilatation Catheter |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr KiranKumar Shetty |
| Designation |
Assistant General Manager-Product Performance & 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 |
Assistant General Manager-Product Performance & 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 |
Assistant General Manager-Product Performance & 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 no 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 = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrJaspal Arneja |
Arneja Heart and Multispeciality Hospital |
Cardiology Department,Plot No 123, behind Somalwar High School,
Rajmachi, Raamdaspeth, Nagpur, Maharashtra 440010
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 |
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= 5 |
| 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 |
| 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. Participants aged 18 and above, irrespective of gender.
2. Participants with cardiovascular stenosis who are undergoing endovascular procedure requiring vessel dilatation and treated with Mural™ NC Non-compliant Rx PTCA Balloon Dilatation Catheter.
3. Participants with percutaneous transluminal coronary angioplasty.
4. Participants with to treat obstructive lesions of a native coronary artery or aortocoronary bypass, or need post-dilatation of a coronary stent.
5. Mural™ NC Non-compliant Rx PTCA Balloon Dilatation Catheter used in the primary lesion treated during the procedure by the decision physician.
6. Participant who has been provided written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Participants with unprotected left main coronary artery lesions.
2. Participants having coronary artery spasm in the absence of a significant stenosis.
3. Pregnant or lactating women.
4. Participants with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, or materials such as pebax, nylon, stainless steel, polytetrafluoroethylene, sodium hyaluronate, or
any contrast media.
5. Participating in another medical device or pharmaceutical clinical trial.
6. 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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Procedure Success
2. Major Adverse Cardiac events
3. Angiographic Success |
1. Intra-operative
2. Through discharge, 7 days ± 2 days, 30 days ± 7 days, 3 months ± 15 days, 6 months ± 30 days, 1 year ± 30 days.
3.Intraoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Freedom from Balloon Rupture
2. Freedom from Coronary Perforation
3. Procedure Time
4. Stent Thrombosis Changes
5. Lesion cross and inflation - deflation cycles
6. Adverse Events
7. Target Lesion Failure
8. Short Form 36
9. Ease of Use |
1. Inra Operative
2. Intra Operative
3. Intra Operative
4. Intra Operative
5. Intra - Operative
6. Through discharge, 7 days, 30 days, 3 months, 6 months, 1 year
7.6 Months, 1 year
8. Pre opeartive , Discharge , 7 days , 30 days , 3 months, 6 months , 1 year
9. Intra Operative |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
09/03/2026 |
| 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
|
Title : 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 Design : A prospective, multi-center, open-label, single-arm, observational, real-world, post-market clinical follow-up study
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. |