| CTRI Number |
CTRI/2025/08/093146 [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 safety, performance, and procedural efficiency of a PTCA Balloon Dilatation Catheter, including both semi-compliant and non-compliant balloon types, in subjects undergoing coronary angioplasty. |
|
Scientific Title of Study
|
A Prospective Clinical Study to Evaluate the Safety and Performance of PTCA Balloon Dilatation Catheters in Patients Undergoing Coronary Angioplasty. |
| 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 |
Sudha Hospitals,
Dept Interventional Cardiologist,Ground Floor Room no 1
162, SIMS (SUDHA) hospital, 181, Perundurai Rd,
Edayankattuvalasu, Erode, Tamil Nadu
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
PTCA Balloon Dilatation Catheter |
PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion in the coronary artery or bypass graft stenosis for the purpose of myocardial perfusion. This product is also indicated for the post-delivery expansion of balloon expandable stents. |
|
|
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 diagnosed with coronary artery disease requiring percutaneous coronary intervention (PCI).
3.No prior stenting at the target lesion within the last 6 months.
4.Subjects with suitable vascular anatomy for catheter placement.
5.Ability to provide written informed consent. |
|
| ExclusionCriteria |
| Details |
1.Known allergy to contrast media or balloon catheter materials.
2.Subjects with an unprotected left main coronary artery.
3.Subjects with coronary artery spasm in the absence of a significant stenosis.
4.Bleeding diathesis or contraindication to anticoagulation.
5.Pregnant or lactating women or women of childbearing potential not using adequate contraception. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| evaluation on safety of the PTCA Balloon Dilatation Catheter in achieving successful balloon dilatation of hemodynamically significant coronary artery or bypass graft stenosis. |
Follow-ups will be conducted on Day 7 and Day 30, data collected at each follow-up will be assessed, recorded, and analysed to evaluate safety and performance. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the device performance characteristics including balloon deliverability, trackability, crossing profile, inflation/deflation times, balloon integrity, & compatibility with guidewires & stents during the procedure. |
Follow-ups will be conducted on Day 7 & Day 30, data collected at each follow-up will be assessed, recorded, & analysed to evaluate safety & performance. |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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, non-randomized and open label study.
Description of the investigational device- The Rapid Exchange Balloon Dilatation Catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange system. The distal section of this catheter consists of a balloon and dual lumen shafts (co-axial). The outer lumen is used for inflation and deflation of the balloon with contrast medium diluted with saline solution. The inner lumen (the guidewire lumen; from the distal tip to the guidewire port) is for inserting a compatible guidewire to facilitate advancing the catheter through the stenotic lesion or stent to be dilated. The proximal section is a single lumen shaft with a single luer port hub for connecting an inflation/deflation device. Inside the balloon, two radiopaque markers which indicate the working length of the balloon, are placed to guide the physician for positioning the balloon properly in the targeted lesion under fluoroscopy. POLYMED PTCA Balloon Dilatation Catheter is available in various balloon sizes by its diameter and length at recommended inflation pressures (Nominal pressure). Upon inflation, the balloon diameter varies according to the inflating pressure. The balloon compliance chart for PTCA Balloon Dilatation Catheter is provided at the end of this Instructions for Use. In the sterilization package, the device is equipped with protective materials: a balloon protective tube and a stylet, which are to be removed before use. The catheter’s distal tip is tapered to facilitate advancing into the stenotic lesion or stent. The catheter’s outer surface is partially coated with hydrophilic polymer to generate lubricity when wet.
Study Design:This is a prospective, single-center, interventional clinical investigation designed to assess the safety and performance of the PTCA Balloon Dilatation Catheter in angioplasty, enrolling 74 subjects. Eligible subjects will provide informed consent, and baseline clinical data will be recorded. Pre-procedure assessments will include vital signs, medical history, and vascular access evaluation. Eligible subjects will then proceed to angioplasty using the investigational PTCA Balloon Dilatation Catheter. Under fluoroscopic guidance, a compatible guidewire will be introduced across the lesion, followed by advancement of the balloon catheter to the target site. The balloon will be inflated to the appropriate nominal or rated burst pressure as per the lesion characteristics and deflated after sufficient expansion. In some cases, the catheter may also be used for post-dilatation following stent placement, if deemed necessary by the treating physician. Operator feedback on device performance, such as trackability, crossing success, and inflation/deflation behaviour, will be recorded in real time. Follow-up visits will be conducted on Day 7 and Day 30. Data from each visit will be collected and recorded in CRFs and analysed accordingly. Safety and performance endpoints will be evaluated using descriptive statistics. The investigator will assess and categorize all adverse events based on their severity and relationship to the device.
|