| CTRI Number |
CTRI/2025/08/093386 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
The purpose of this clinical investigation is to assess the safety and performance of the diagnostic catheter when used in angiographic procedures. This study aims to generate clinical evidence supporting the safe and effective use of the device in real-world settings. |
|
Scientific Title of Study
|
A prospective study to evaluate the safety and
performance of a Angiographic catheter Diagnostic catheter in Angiographic procedures |
| 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 N Rajasekar |
| Designation |
Consultant & Interventional Cardiologist |
| Affiliation |
Sudha Hospitals |
| Address |
Sudha Hospitals,Ground floor Room No 1
162, SIMS (SUDHA) hospital, 181, Perundurai Rd,
Edayankattuvalasu, Erode, Tamil Nadu
Erode
TAMIL NADU
638011
India |
| Phone |
919894634040 |
| Fax |
|
| Email |
sekarjumbo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Rajasekar |
| Designation |
Consultant & Interventional Cardiologist |
| Affiliation |
Sudha Hospitals |
| Address |
Sudha Hospitals,Ground floor Room No 1
162, SIMS (SUDHA) hospital, 181, Perundurai Rd,
Edayankattuvalasu, Erode, Tamil Nadu
Erode
TAMIL NADU
638011
India |
| Phone |
919894634040 |
| Fax |
|
| Email |
sekarjumbo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Rajasekar |
| Designation |
Consultant & Interventional Cardiologist |
| Affiliation |
Sudha Hospitals |
| Address |
Sudha Hospitals,Ground floor Room No 1
162, SIMS (SUDHA) hospital, 181, Perundurai Rd,
Edayankattuvalasu, Erode, Tamil Nadu
Erode
TAMIL NADU
638011
India |
| Phone |
919894634040 |
| Fax |
|
| Email |
sekarjumbo@gmail.com |
|
|
Source of Monetary or Material Support
|
| POLY MEDICURE LIMITED
Plot No.: 33 -34, Sector 68, IMT,
Faridabad- 121004, Haryana, India
|
|
|
Primary Sponsor
|
| Name |
POLY MEDICURE LIMITED |
| Address |
Plot No.: 33 -34, Sector 68, IMT,
Faridabad- 121004, Haryana, 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 N Rajasekar |
Sudha Hospitals |
Ground floor Room No.1 162,SIMS (SUDHA) hospital, 181,Perundurai Rd,
Edayankattuvalasu, Erode, Tamil Nadu 638011
Erode
TAMIL NADU |
919894634040
sekarjumbo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sudha Hospitals Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I30-I52||Other forms of heart disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diagnostic Catheter |
Diagnostic catheters are specialized diagnostic intravascular catheters used for the coronary diagnostic angiography performed as part of diagnostic cardiac catheterization. The basic design of diagnostic catheter comprises of a catheter tube having a proximal end and a distal end. A Nylon lumen extends from the proximal end of the diagnostic catheter to the distal end of the catheter and is configured to serve as a conduit for contrast media delivery, catheter flushing and pressure measurement during cardiac catheterization procedure. The lumen of the catheter is also designed to house a guidewire. The diagnostic catheter are designed to allow access into the arterial vasculature from access sites such as femoral, radial, and brachial arteries. Diagnostic catheter manufactured with different material (Polycarbonate, Pebax, Polyurethane, Polyamide, Stainless Steel, Nylon. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or female subjects aged 18 years and above.
2.Subjects undergoing angiography requiring a diagnostic catheter for
contrast injection.
3.Subjects with suitable vascular anatomy for catheter placement.
4.Ability to provide written informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Subjects with severe vascular calcification or tortuosity that may impede
catheter advancement.
2.Presence of active infection at the catheter insertion site.
3.Subjects with coagulopathy or on anticoagulant therapy, increasing the
risk of bleeding.
4.History of vascular dissection or aneurysm at the planned access site.
5.Pregnant or lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the study is the performance of the diagnostic catheter during angiographic procedures. This includes catheter should facilitate smooth and successful navigation through the blood vessels, ensuring stable positioning for angiographic imaging Additionally, it should enable effective contrast injection, providing clear imaging for accurate diagnosis of vascular lesions and determining the need for PTCA. |
In this clinical study, follow-ups will be conducted on the 7th day and 30th day. Data collected at each follow-up will be assessed, recorded, and analyzed to evaluate safety, performance, and any adverse events. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome of the study is the safety, the catheter is expected to have a low incidence of AEs and SAEs, including vessel perforation, thromboembolism, vasospasm, device-related infections, and complications at the insertion site. It should not cause significant trauma to vascular structures during insertion, navigation, or removal. |
In this clinical study, follow-ups will be conducted on the 7th day and 30th day. Data collected at each follow-up will be assessed, recorded, and analyzed to evaluate safety, performance, and any adverse events. |
|
|
Target Sample Size
|
Total Sample Size="73"
Sample Size from India="73"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
08/09/2025 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Product Name:Angiographic Catheter (Diagnostic Catheter) Study Design:This is a prospective, single-center, interventional clinical investigation designed to assess the safety and performance of the diagnostic catheter in angiography, enrolling 73 subjects. Eligible subjects will provide informed consent and baseline clinical data will be recorded. Pre-procedure assessments will include vital signs, a review of medical history and a vascular access evaluation. The catheter will be inserted in accordance with institutional guidelines, navigated to the target vessel, and used for contrast injection and angiographic imaging. Post-procedure, subject s will be monitored for AEs and SAEs. Follow-ups visits will be conducted on Day 7 and Day 30. Data from each visit will be collected and recorded in CRFs, and analyzed accordingly. Safety and performance endpoints will be evaluated using descriptive statistics. The investigator will assess and categorize adverse events based on their severity and relationship to the device.
Description of the investigational device- Diagnostic catheters are specialized diagnostic intravascular catheters used for the coronary diagnostic angiography performed as part of diagnostic cardiac catheterization. The basic design of diagnostic catheter comprises of a catheter tube having a proximal end and a distal end. A Nylon lumen extends from the proximal end of the diagnostic catheter to the distal end of the catheter and is configured to serve as a conduit for contrast media delivery, catheter flushing and pressure measurement during cardiac catheterization procedure. The lumen of the catheter is also designed to house a guidewire. The diagnostic catheter are designed to allow access into the arterial vasculature from access sites such as femoral, radial, and brachial arteries. Diagnostic catheter manufactured with different material (Polycarbonate, Pebax, Polyurethane, Polyamide, Stainless Steel, Nylon.
Primary Objective: To assess the safety of the diagnostic catheter in angiography procedures. Secondary Objective: To evaluate the performance of the diagnostic catheter in successfully facilitating contrast injection and imaging. |