| CTRI Number |
CTRI/2024/09/073861 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Post-Market Clinical Follow-up to evaluate Clinical Outcomes after Implantation f Polymer based Sirolimus Eluting Coronary
Stent System. |
|
Scientific Title of Study
|
Post Market clinical Follow up to evaluate clinical outcome after Implantation of Biodegradable Polymer based Sirolimus Eluting Coronary Stent System |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| Clinexel-PMP-001, Version 2.0, Date 02 Apr 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jay Shah |
| Designation |
Associate Professor |
| Affiliation |
Star Hospital |
| Address |
1st floor, Star Hospital, Lal Bahadur Shastri Rd, near Indica Laboratories, Vadilal Park, Bapunagar, Ahmedabad, Gujarat.
Ahmadabad
GUJARAT
380024
India |
| Phone |
9898209755 |
| Fax |
|
| Email |
drjayshah1975@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa Arora |
| Designation |
Chief Executive Officer |
| Affiliation |
Clinexel Life Sciences Pvt. Ltd. |
| Address |
Department Clinical Research, Room number 1401, Clinexel Life Sciences Pvt. Ltd., The Affaires, Sector 17, Sanpada, Navi Mumbai
Thane
MAHARASHTRA
400705
India |
| Phone |
9820648395 |
| Fax |
|
| Email |
deepaarora@clinexel.com |
|
Details of Contact Person
Public Query
|
| Name |
Pratyesh Somani |
| Designation |
Quality Assurance Regulatory Affairs |
| Affiliation |
Purple MicroPort Cardiovascular Private Limited |
| Address |
136-B, Surat Special Economic Zone, Diamond Park, G.I.D.C. Sachin, Surat, Gujarat, India - 394 230
Surat
GUJARAT
394 230
India |
| Phone |
8849739261 |
| Fax |
|
| Email |
pratyeshsomani@purplemicroport.com |
|
|
Source of Monetary or Material Support
|
| Purple MicroPort Cardiovascular Private Limited,
136-B, Surat Special Economic Zone, Diamond Park, G.I.D.C. Sachin, Surat, Gujarat, India - 394 230 |
|
|
Primary Sponsor
|
| Name |
Purple MicroPort Cardiovascular Private Limited |
| Address |
136-B, Surat Special Economic Zone, Diamond Park, G.I.D.C. Sachin, Surat, Gujarat, India - 394 230 |
| Type of Sponsor |
Other [Medical Device] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tarun Madan |
Ananta Hospital |
1st Floor, Ananta Hospital,New India Colony, Near Shaheed Major Rushikesh Ramani Garden, Nikol, Ahmedabad, Gujarat 382350
Ahmadabad
GUJARAT |
9824743624
9824743624
drtarunmadan@yahoo.co.in |
| Dr Sachin Patil |
Sachin Multispeciality Hospita |
The Icon Building, Consultant room no 02, 2nd floor, Cardiology Department,
near Shriram high school, Rajarampuri 6th lane, Shahu Mill Side Kolhapur, 416008.
Kolhapur
MAHARASHTRA |
9225068519
9225068519
drsachinpatil78@gmail.com |
| Dr Jay Shah |
Star Hospital |
1st floor, Lal Bahadur Shastri Road, near Indica Laboratories, Vadilal Park, Bapunagar, Ahmedabad, Gujarat.
Ahmadabad
GUJARAT |
9898209755
drjayshah1975@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Sangini Hospital Ethics Committee |
Approved |
| Sangini Hospital Ethics Committe |
Approved |
| Sangini Hospital Ethics Committee |
Approved |
| Sunrise Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I249||Acute ischemic heart disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not applicable. Study is observational. |
Not applicable. Study is observational. |
| Comparator Agent |
Not Applicable. Study is observational. |
Not Applicable. Study is observational. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with minimum age of 18 years.
Patients implanted with study device and the hospital stay to a maximum of first seven days post index procedure.
Patients or Legally Acceptable Representative (LAR)/Impartial Witness understand study requirements and willing to provide written informed consent and willing to comply to study requirements.
|
|
| ExclusionCriteria |
| Details |
Patient with known hypersensitivity or idiosyncratic reaction to
a) Sirolimus or its derivatives.
b) Antiplatelet/anticoagulant drugs.
c) L605 CrCo alloy.
d) Biodegradable polymers Poly(L-Lactide), 50:50 Poly (D,L-lactide-coglycolide).
Patient with terminal illness with life expectancy less than 1 year.
Patient with history of Cardiovascular Accident (CVA) within last 3 months.
Patient with history of diabetic haemorrhagenic retinopathy.
Patients with coronary stents implanted less than one calendar year ago.
Patients with previous coronary stents implanted in the targeted lesion(s).
Patient Implanted with other then the study devices DES or BMS.
Patients who are not willing to visit the same study site for 5-years of the follow-up period as per the study requirements.
Women of childbearing potential.
Any significant medical condition which in the Investigator’s opinion may interfere with the patient’s optimal participation in the study such as an active infection or peptic ulcer or upper GI bleeding.
Currently participating in another investigational drug or another device study, or subject to inclusion in another investigational drug or another device study during follow up.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of Major Adverse
Cardiac Events (MACE) as
composite of cardiac-death,
myocardial infarction (MI),
target lesion revascularization
(TLR) and target vessel
revascularization (TVR), in the
1-, 6- and 12-month clinical
follow-up of post implantation
index procedure
• Patient Oriented Composite
Endpoint (PoCE) (primary) -
defined as the composite of allcause death, any MI (Nontarget vessel), any stroke, Stent
Thrombosis (ST), Stent
Restenosis, Non-TLR, Non TVR, Target Lesion Failure
(TLF) at 1-, 6- and 12-months
clinical follow-up of post
implantation index procedure |
1, 6, 12 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of Major Adverse
Cardiac Events (MACE) as
composite of cardiac-death,
Myocardial Infarction (MI),
Target Lesion
Revascularization (TLR) and
Target Vessel
Revascularization (TVR), at
intervals of 24, 36, 48 and 60-
months of post implantation
index procedure
• PoCE (secondary) - defined
as the composite of all-cause
death, any MI (Non-target
vessel), any stroke, Stent
Thrombosis (ST), Stent
Restenosis, Non-TLR, NonTVR, Target Lesion Failure
(TLF) at intervals of 24, 36, 48
and 60-months of post
implantation index procedure |
24, 36, 48 and 60 months. |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="1500"
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)
|
30/09/2024 |
| 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="8"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This PMCF plan is developed to conduct a prospective multicentre registry study to
evaluate the long-term safety of the Biodegradable Polymer based Sirolimus Eluting
Coronary Stent System Post Marketing Surveillance (PMS) for Long Term Follow-up
(5 Years), in patients of coronary artery disease (CAD) that qualify for percutaneous
coronary intervention with Sirolimus drug eluting coronary stent (DES). The most known and the most frequent heart diseases are caused by atherosclerosis, a
process of vessel wall degradation and calcification, leading to narrowing and/or
occlusion of the blood vessels. This is one of the major causes of deaths in countries
of developed world. Lifestyle modifications of healthy eating and healthy habits (quit
smoking, regular exercise) are largely advised at the onset of atherosclerosis.
However, in severe conditions it is imperative to perform Percutaneous Coronary
Intervention.
This study seeks to evaluate the clinical outcomes of BPSS for Long Term PostMarket Clinical Follow-up for Long Term Follow-up (5 Years), in various clinical
sites/hospitals of India.
Based on the review of clinical studies published between 2001 to 2018, it is assumed
that as the outcome of this Post-Market Clinical Follow-up (PMCF) study of
Biodegradable Polymer based Sirolimus Eluting Coronary Stent Systems in patients of CAD amenable to percutaneous coronary intervention (PCI) should be similar in
India and Europe.
|