| CTRI Number |
CTRI/2025/12/099451 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
07/09/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To check the Safety and Effectiveness of the Balloon Dilatation Catheter in Patients Undergoing Coronary Angioplasty |
|
Scientific Title of Study
|
A prospective, single-arm, open-label, multi-center, observational, real-world, post-market clinical follow-up study to evaluate the safety and performance of Mural SC Semi-Compliant 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 |
9743700109 |
| 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
Valsad
GUJARAT
396191
India |
| Phone |
9743700109 |
| 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
Valsad
GUJARAT
396191
India |
| Phone |
9743700109 |
| 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 |
Building number 6, 3rd floor, 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 = 7 |
| 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 |
7122448721
jaspalarneja_200@yahoo.com |
| Dr Ronak Shah |
Hridyam Heart Hospital |
Ground floor, Department of cardiologist,Polytechnic cross road, samlaji highway,
Motipura, Himatnagar, Gujarat 383001
Ahmadabad
GUJARAT |
9913701470
ronak.taj@gmail.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
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 |
| Atharva Institutional Ethics Committee |
Approved |
| Gillurkar Hospital Ethics Committee |
Approved |
| HET Pulmocare IEC |
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: I748||Embolism and thrombosis of other arteries, |
|
|
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 18 years, irrespective of gender.
2. Participants must be willing and able to provide written
Informed Consent by signing and dating the IRB or ECapproved Informed Consent Form.
3. The participants should be able to comply with protocol requirements and assessments.
4. Participants with cardiovascular stenosis who are undergoing an endovascular procedure requiring vessel dilatation and treated with Mural™ SC Semi-Compliant Rx PTCA Balloon Dilatation Catheter.
5. Participants with percutaneous transluminal coronary angioplasty.
6. Participants undergoing treatment for obstructive lesions in
a native coronary artery or bypass grafts, or need postdilatation of a coronary stent.
7. Target lesion amenable to treatment with the Mural™ SC Semi-Compliant Rx PTCA Balloon Dilatation Catheter .
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Major adverse cardiac events (MACE)
2. Device Success |
1. Post operative , 7 days , 1 month, 3 months, 6 months, 12 months
2. Intra Operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Procedural Success
2. Target Vessel Revascularization
3. Rate of Balloon Bursting
4. Change in Late Lumen Loss
5. Ease of Use
6. Product Performance
7. Adverse and Serious adverse events
|
1.Post operative
2.Post operative , 7 days , 1 month, 3 months , 6 months , 12 months
3. Intra Operative
4. Pre operative , Post Operative , 6 months
5. Intra Operative
6. Intra Operative
7. Post Operative , Discharge , 7 days , 1 month, 3 months,6 months , 1 year |
|
|
Target Sample Size
|
Total Sample Size="89"
Sample Size from India="89"
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)
|
31/12/2025 |
| 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
|
Mural SC Semi-Compliant Rx PTCA Balloon Dilation Catheter - A Prospective , Single-arm, Multi-center, Post- Market Surveillance Study to Evaluate the Safety and Performance of Mural SC Semi-Compliant Rx PTCA Balloon Dilatation Catheter. Study Device : Mural SC Semi-Compliant Rx PTCA Balloon Catheter
Indication : The Mural™ SC Semi-Compliant Rx PTCA Balloon Dilatation
Catheter is indicated for balloon dilatation of the stenotic portion of
a coronary artery or bypass graft stenosis for the purpose of
improving myocardial perfusion. The Mural™ SC Semi-compliant
Rx PTCA Balloon Dilatation Catheter is also indicated for post
delivery expansion of balloon expandable stents.
Objective : This study aims to evaluate the safety and performance of the
Mural™ SC Semi-Compliant Rx PTCA Balloon Dilation Catheter
|