| CTRI Number |
CTRI/2023/10/058946 [Registered on: 20/10/2023] Trial Registered Prospectively |
| Last Modified On: |
19/10/2023 |
| 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 Vector® NC PTCA Balloon Catheter |
|
Scientific Title of Study
|
A retrospective, single-arm, multi-center, observational, post-market clinical follow-up study to
evaluate the safety and performance of Vector® NC PTCA Balloon Catheter in 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 Kumar Abishek |
| Designation |
Consultant Cardiologist |
| Affiliation |
Maharaja Agrasen Hospital |
| Address |
Maharaja Agrasen Hospital Fulbari Truck Terminus, Dist, Siliguri, West Bengal 734015
Department of Cardiology 3 floor Room Number 303
Jalpaiguri
WEST BENGAL
734015
India |
| Phone |
9800449121 |
| Fax |
|
| Email |
drkumarabhishek39@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kumar Abishek |
| Designation |
Consultant Cardiologist |
| Affiliation |
Maharaja Agrasen Hospital |
| Address |
Maharaja Agrasen Hospital Fulbari Truck Terminus, Dist, Siliguri, West Bengal 734015
Department of Cardiology 3 floor Room Number 303
Jalpaiguri
WEST BENGAL
734015
India |
| Phone |
9800449121 |
| Fax |
|
| Email |
drkumarabhishek39@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Preeti Vani |
| Designation |
Head- Medical Division |
| Affiliation |
Sahajanand Laser Technology Ltd. |
| Address |
A-8, Electronic Estate, G.I.D.C., Sector-25, Gandhinagar
Plant Head Cabin
Medical Division
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 |
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 = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kumar Abishek |
Maharaja Agrasen Hospital |
Fulbari Truck Terminus, Dist, Siliguri, West Bengal 734015
Jalpaiguri
WEST BENGAL |
9800449121
drkumarabhishek39@gmail.com |
| Dr Kailash Goyal |
North Bengal Neuro Centre Multispecialty Hospital |
Meghnad Saha Sarani , Ward 2 , Pradhan Nagar , Silluguri , West Bengal 734003
Jalpaiguri
WEST BENGAL |
7034670531
drKailashdrgoyal1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OM Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I21A||Other type of myocardial infarction, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients who had been treated with Vector NC PTCA
Balloon Catheter. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Procedure Success |
Peri-Procedural |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Target lesion revascularization
Myocardial Infraction
Death |
12 Months |
|
|
Target Sample Size
|
Total Sample Size="125"
Sample Size from India="125"
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)
|
28/10/2023 |
| 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
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A
retrospective, single-arm, multi-center, observational,
post-market clinical follow-up study to evaluate
the safety and performance of Vector NC PTCA Balloon Catheter
The Vector NC PTCA Balloon Catheter is also indicated for post-delivery
expansion of balloon expandable stents. All consecutive patients who had been
treated with Vector NC PTCA Balloon Catheter for balloon dilatation of stenotic
portion of coronary artery or by pass graft stenosis for improving myocardial
perfusion and/or post-delivery expansion of balloon expandable stents. The
study Population is about 125 patients and The objective of this study is to
evaluate the safety and performance of Vector NC PTCA Balloon Catheter in
real-world settings. |