| CTRI Number |
CTRI/2025/12/098464 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Prospective Clinical evaluation of Drug Eluting Coronary Stents |
|
Scientific Title of Study
|
A Prospective, Single Centre, Observational, 12-months follow-up, clinical evaluation study to investigate the safety and performance of the M’Sure-S, Sirolimus Eluting Coronary Stent System in coronary artery lesion. |
| Trial Acronym |
PRISM-1 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahesh Nalin Kumar |
| Designation |
HOD Senior Consultant Cardiology |
| Affiliation |
St Gregorios Medical Mission Multi-Specialty Hospital |
| Address |
Room No. 405
Department of Cardiology
St Gregorios Medical Mission Multi-Specialty Hospital
Parumala Kerala
Pathanamthitta
KERALA
689626
India |
| Phone |
7042279191 |
| Fax |
|
| Email |
drnkmahesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Nalin Kumar |
| Designation |
HOD Senior Consultant Cardiology |
| Affiliation |
St Gregorios Medical Mission Multi-Specialty Hospital |
| Address |
Room No. 405
Department of Cardiology
St Gregorios Medical Mission Multi-Specialty Hospital
Parumala Kerala
Pathanamthitta
KERALA
689626
India |
| Phone |
7042279191 |
| Fax |
|
| Email |
drnkmahesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Nalin Kumar |
| Designation |
HOD Senior Consultant Cardiology |
| Affiliation |
St Gregorios Medical Mission Multi-Specialty Hospital |
| Address |
Room No. 405
Department of Cardiology
St Gregorios Medical Mission Multi-Specialty Hospital
Parumala Kerala
Pathanamthitta
KERALA
689626
India |
| Phone |
7042279191 |
| Fax |
|
| Email |
drnkmahesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Multimedics LLP
Plot No. -28,Extn ( Phase-3) HPSIDC Industrial AreaBaddi, Solan-BBN, Himachal Pradesh (India) - 173205 |
|
|
Primary Sponsor
|
| Name |
Multimedics LLP |
| Address |
Plot No. -28,Extn ( Phase-3) HPSIDC Industrial AreaBaddi, Solan-BBN, Himachal Pradesh, India |
| Type of Sponsor |
Other [Medical Device Manufacturer] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mahesh Nalin Kumar |
St. Gregorios Medical Mission Hospital |
Room No. 405
Department of Cardiology
Church Post Office Road near Parumala, Thiruvalla, Kerala 689626
Pathanamthitta
KERALA |
07042279191
drnkmahesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC St. Gregorios Medical Mission Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I20||Angina pectoris, (2) ICD-10 Condition: I219||Acute myocardial infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient with an age greater than 18 years |
|
| ExclusionCriteria |
| Details |
5. The subject is participating in another device or drug study.
6. Female patients with a known pregnancy or who are lactating.
7. Current medical condition with a life expectancy of less than 12months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To prospectively analyze the safety profile of the M’Sure-S, Sirolimus Eluting Coronary Stent in patients who underwent percutaneous coronary intervention (PCI) for coronary artery lesions. |
6 month, 9 month and 12 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To prospectively evaluate the performance of the M’Sure-S, Sirolimus Eluting Coronary Stent in terms of major adverse cardiovascular events (MACE), target lesion revascularization (TLR), target vessel revascularization (TVR), and clinical outcomes at 12-months follow-up. |
6 month, 9 month and 12 month |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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 Objectives-1.
To
prospectively analyse the safety profile
of the M’SURE-S, Sirolimus
Eluting Coronary Stent in patients who underwent percutaneous coronary
intervention (PCI) for coronary artery lesions. To prospectively evaluate the performance of the M’SURE-S,
Sirolimus Eluting Coronary Stent in terms of major adverse
cardiovascular events (MACE), target lesion revascularization (TLR), target
vessel revascularization (TVR), and clinical outcomes at 12-month follow-up. Primary endpoint- Major
Adverse Cardiac Events (MACE), defined as composite endpoint of cardiac death,
Myocardial infarction (MI) and Target Lesion Revascularization (TLR) at 12
months. Secondary endpoints- 1. Clinical device and procedural success.
·
Device Success is defined
as the achievement of a final residual in-stent diameter stenosis of
< 30% (visual estimate).
·
Procedure success is defined as the
achievement of a final in-stent diameter stenosis of < 30% (by visual
estimate) without the occurrence of MACE during the hospital stay (up to 7 days
if the subject still in the hospital).
2. Telephonic follow
up for all study patients
at 12-months post-procedure.
3.
Composite rate of any death (cardiac
death, vascular death,
or non-cardiac death) at 12-months post-procedure.
4. Composite rate of cardiac death, any target vessel MI (QMI or NQMI),
and TLR (PCI
or CABG, CI vs. non-CI) at 12-months post-procedure.
5. Device malfunctions at 12-months post-procedure. 6. Serious adverse
events at 12-months
post-procedure. |