| CTRI Number |
CTRI/2022/12/048054 [Registered on: 13/12/2022] Trial Registered Prospectively |
| Last Modified On: |
31/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to check the safety and performance of stent in all comer patients with de novo coronary artery disease . |
|
Scientific Title of Study
|
A retrospective, single-arm, multi-center, observational, post-market clinical follow-up study to evaluate the safety and performance of FlexyRap Cobalt Chromium Rapamycin Eluting Coronary
Stent System in patients with de novo coronary artery disease under real-world settings. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nitish Garg |
| Designation |
Director, Chief Consultant and Interventional Cardiologist |
| Affiliation |
Cardinova Institute of Medical Science |
| Address |
Department of Cardiology, Ground Floor Room Number-1.
292, Near, Guru Nanak Mission Chowk, Lajpat Nagar, Jalandhar, Punjab 144001.
Jalandhar
PUNJAB
144001
India |
| Phone |
9736088888 |
| Fax |
|
| Email |
nitishgarg@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitish Garg |
| Designation |
Director, Chief Consultant and Interventional Cardiologist |
| Affiliation |
Cardinova Institute of Medical Science |
| Address |
Department of Cardiology, Ground Floor Room Number-1.
292, Near, Guru Nanak Mission Chowk, Lajpat Nagar, Jalandhar, Punjab 144001.
Jalandhar
PUNJAB
144001
India |
| Phone |
9736088888 |
| Fax |
|
| Email |
nitishgarg@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Preeti Vani |
| Designation |
Head - Medical Division |
| Affiliation |
Sahajanand Laser Technology Ltd. |
| Address |
A-8, Electronics Estate, G.I.D.C., Sector-25, GANDHINAGAR
382016.Gujarat, INDIA.
Gandhinagar
GUJARAT
382016.
Gandhinagar
GUJARAT
382016.
India |
| Phone |
9909033527 |
| Fax |
|
| Email |
preeti.vani@sltl.com |
|
|
Source of Monetary or Material Support
|
| Sahajanand Laser Technology Ltd A-8, Electronics Estate, G.I.D.C.,
Sector-25, GANDHINAGAR 382025.Gujarat, INDIA.
|
|
|
Primary Sponsor
|
| Name |
Sahajanand Laser Technology Ltd |
| Address |
Sahajanand Laser Technology Ltd A-8, Electronics Estate, G.I.D.C.,Sector-25, GANDHINAGAR 382025.Gujarat, INDIA.
|
| Type of Sponsor |
Other [Medical Device ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nitish Garg |
Cardinova Institute of Medical Science |
Department of Cardiology, Ground Floor Room Number-1. 292, Near, Guru Nanak Mission Chowk, Lajpat Nagar, Jalandhar, Punjab 144001.
Jalandhar
PUNJAB |
9736088888
nitishgarg@yahoo.com |
| Dr Raman Chawla |
CAREMAX Hospital |
Department of Cardiology Ground Floor OPD Room Number 3 333, Near Guru Nanak Mission Chowk, Shastri Nagar, Lajpat Nagar, Jalandhar, Punjab 144001
Jalandhar
PUNJAB |
9876060217
Chawlaheartcarecentre@gmail.com |
| Dr Vivek Tandon |
EMC Super Speciality Hospital |
Department of Cardiology Ground Floor OPD Room Number 5 Backside Income Tax office, Green Avenue, Amritsar, Punjab 143001
Amritsar
PUNJAB |
9873317600
vivtan69@hotmail.com |
| Dr Deepak Garg |
Moga Medicity Hospital |
Department of Cardiology First Floor Opd Room Number-201 Near Radha Vallabh Mandir Wali Gali, Dutt Rd, Civil Lines, Shanti Nagar, Moga, Punjab 142001
Moga
PUNJAB |
7034650420
deepaksir1985@yahoo.in |
| Dr Nilesh Parshottam |
Sunshine Global Hospital |
Department of Cardiology, Opd Room Number 105 Dumas Rd, beside Big Bazar, Piplod, Surat, Gujarat 395007
Surat
GUJARAT |
8866709233
drnileshparshottam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Om Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients implanted with FlexyRap Cobalt Chromium
Rapamycin Eluting Coronary Stent System |
|
| ExclusionCriteria |
| Details |
Patients who are not implanted with FlexyRap Cobalt Chromium Rapamycin Eluting Coronary Stent System |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Target Lesion Failure which is defined as a composite of cardiovascular death, target vessel myocardial
infarction (TV-MI) and clinically driven target lesion revascularization |
12 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cardiovascular Death
Target Vessel Myocardial Infarction
Clinically-Driven TLR
Stent Thrombosis
Target vessel failure
Target vessel revascularization |
5 years |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "500"
Final Enrollment numbers achieved (India)="500" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/12/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A retrospective, single-arm, multi-center, observational, post-market clinical follow-up study to evaluate the safety and performance of FlexyRap Cobalt Chromium Rapamycin Eluting Coronary Stent System in patients with de novo coronary artery disease under real-world settings. The clinical endpoints are target lesion failure, cardiovascular death, target vessel myocardial infarction, clinically-driven target lesion revascularisation (CD-TLR), stent thrombosis (ST), target vessel failure (TVF), target vessel revascularization at 12 months, 3 years, 5 years follow-up. Total Number of 500 patients will be enrolled who have been implanted with FlexyRap Cobalt Chromium Rapamycin Eluting Coronary Stent . |