| CTRI Number |
CTRI/2025/08/093147 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
17/08/2025 |
| 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 study is to evaluate the efficacy and safety of PTFE guidewires when used in angioplasty and angiography procedures. |
|
Scientific Title of Study
|
A Prospective Clinical Investigation to Evaluate the Safety and Performance of a PTFE Guidewire in Angioplasty and Angiography |
| 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 |
09894634040 |
| 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
TAMIL NADU
638011
India |
| Phone |
09894634040 |
| 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
TAMIL NADU
638011
India |
| Phone |
09894634040 |
| 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 |
Interventional Cardiologist Dept,Ground floor Room No 1
162, SIMS (SUDHA) hospital, 181, Perundurai Rd,
Edayankattuvalasu, Erode, Tamil Nadu 638011
Erode
TAMIL NADU |
09894634040
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
PTFE Guidewire |
PTFE Guidewire for percutaneous entry and guidance of catheters, the Diagnostic Guidewire complements our diagnostic catheter and catheter sheath introducer lines. Performance, endurance, and safety are built into each Guidewire with solid tensile strength to minimize the likelihood of stretching or fracturing. |
|
|
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 or angiography or both requiring PTFE guide wire to support for the catheter, facilitating balloon inflation and stent placement.
3.Subjects with suitable vascular anatomy for PTFE guidewire navigation.
4.Ability to provide written informed consent. |
|
| ExclusionCriteria |
| Details |
1.Subjects with severe vascular calcification or tortuosity that may prevent PTFE guidewire advancement.
2.Presence of active infection at the device 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.
6.Subjects requiring guide wire use in the coronary arteries or neurovasculature. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the safety of the PTFE guidewire when used in angioplasty and angiography procedures.which focuses on the guidewire’s ability to minimize vessel trauma, enhance navigation particularly in complex anatomical regions and improve overall procedural outcomes. |
Follow-ups will be conducted on Days 7 and 30. Data collected at each follow-up will be assessed, recorded, and analyzed to evaluate safety and performance. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the performance of the PTFE guidewire in effectively supporting the catheter & assisting with image.The study claims that PTFE guidewires are expected to demonstrate a low incidence of adverse events (AEs) & serious adverse events (SAEs). Additionally, their use is associated with improved procedural efficiency, enhanced device navigation, reduced risk of complications, better patient outcomes, & quicker recovery times. |
Follow-ups will be conducted on Days 7 & 30. Data collected at each follow-up will be assessed, recorded, & analyzed to evaluate safety & performance. |
|
|
Target Sample Size
|
Total Sample Size="49"
Sample Size from India="49"
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
|
Type of Study:The study will be a prospective, interventional, single-centric and open label study.Description of the investigational device PTFE Guidewire for percutaneous entry and guidance of catheters, the Diagnostic Guidewire complements our diagnostic catheter and catheter sheath introducer lines. Performance, endurance, and safety are built into each Guidewire with solid tensile strength to minimize the likelihood of stretching or fracturing. PTFE Guidewire have a Nitinol shaft. The shaft is either, PTFE and Heparin coated, or uncoated. Guide wire length, diameter, core configuration, flexibility type, tip configuration are all indicated on the product label.
Study Design:This is a prospective, single-center, interventional clinical investigation designed to evaluate the safety and performance of a PTFE guidewire when used in angioplasty and angiography procedures. A total of 49 patients will be enrolled in the study. Following eligibility screening, informed consent will be obtained from all participants. Baseline clinical data, including vital signs, medical history, and vascular access status, will be collected during the pre-procedure assessments to establish each patient’s condition prior to device use. During the angioplasty procedures, the PTFE guidewire will be introduced as per standard procedural protocols. The guidewire is designed to enable smooth and controlled navigation through the vascular system, reaching the site of arterial blockage. Its role is to provide critical support for the catheter, thereby facilitating effective vessel dilation and enhancing blood flow. Similarly, in angiography procedures, the PTFE guidewire will be utilized in accordance with established clinical guidelines. It enables precise catheter placement at the target vascular location, assisting in the delivery of contrast media and contributing to the acquisition of accurate angiographic images. Post-procedure monitoring will include observation for any AEs or SAEs. Patients will be followed up on Day 7 and Day 30, during which clinical data will be collected and recorded in the CRFs. Safety and performance endpoints will be assessed using descriptive statistical methods. All adverse events will be evaluated and classified by the investigator based on severity and relationship to the investigational device.
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