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CTRI Number  CTRI/2025/08/093024 [Registered on: 13/08/2025] Trial Registered Prospectively
Last Modified On: 04/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Study to check the safety and performance of the Newtech balloon used to open blocked heart arteries 
Scientific Title of Study   A Prospective, Interventional, Single-Center, Single-Arm Clinical Investigation to Evaluate the Safety and Effectiveness of the Newtech Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA) in Patients with Coronary Artery Stenosis. 
Trial Acronym  NIL 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
NMDPT/BDC-01/CI-P/079 1.1 dated 16 Oct 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vikas Gupta 
Designation  Cardiologist Surgeon  
Affiliation  Heart and General Hospital Jaipur 
Address  Heart and General Hospital Cardiology department, Cardiology Division, First floor,7 Vivekanand Marg Panch Batti C Scheme Ashok Nagar Jaipur Rajasthan 302001

Jaipur
RAJASTHAN
30001
India 
Phone  9540364009  
Fax    
Email  vikasgupta9317@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Praveen Shukla  
Designation  Regulatory Head 
Affiliation  Newtech Medical Devices PVT LTD 
Address  Newtech Medical Devices Pvt Ltd 14/5 NH-19 Pocket B Sector 27 Faridabad, Haryana 121003

Faridabad
HARYANA
121003
India 
Phone  9717990905  
Fax    
Email  praveenshukla@ntmdevices.in  
 
Details of Contact Person
Public Query  
Name  Mr Praveen Shukla  
Designation  Regulatory Head 
Affiliation  Newtech Medical Devices PVT LTD 
Address  Newtech Medical Devices Pvt Ltd 14/5 NH-19 Pocket B Sector 27 Faridabad, Haryana 121003

Faridabad
HARYANA
121003
India 
Phone  9717990905  
Fax    
Email  praveenshukla@ntmdevices.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Newtech Medical Devices Pvt. Ltd. 
Address  Newtech Medical Devices Pvt. Ltd. 14/5 NH-19 Pocket B Sector 27 Faridabad Haryana 121003  
Type of Sponsor  Other [(Medical device Manufacturer)] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vikas Gupta  Heart and General Hospital, Jaipur  Cardiology department, Cardiology Division, First floor,7 Vivekanand Marg Panch Batti C Scheme Ashok Nagar Jaipur Rajasthan 302001
Jaipur
RAJASTHAN 		 9540364009

vikasgupta9317@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Heart and General Hospital EthicsCommittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Balloon Dilatation Catheter  The balloon dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery of bypass graft stenosis for the purpose of improving myocardial perfusion. The balloon dilatation catheter (balloon models 2.25 mm -4.0 mm) is also indicated for post-delivery expansion of balloon expandable stents. 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Adults aged 18 years or older male and female
Diagnosis of coronary artery disease requiring elective percutaneous transluminal coronary angioplasty PTCA in a native coronary artery or coronary artery bypass graft.
Presence of a significant stenotic lesion of 70 percent or more in one or more coronary vessels suitable for balloon angioplasty using the investigational device.
Target lesion is angiographically accessible and crossable with a balloon catheter.
Reference vessel diameter and lesion characteristics are within the available balloon size range eg 2.25 mm to 4.0 mm specified in the device IFU.
Subject is eligible to undergo angiography and interventional procedures under local anesthesia.
Subject or legally authorized representative has provided written informed consent prior to enrollment.
Willing and able to comply with the protocol-required follow-up schedule.
 
 
ExclusionCriteria 
Details  Unprotected left main coronary artery disease as noted in the IFU under contraindications.
Presence of coronary artery spasm in the absence of significant stenosis, per IFU contraindications.
Acute ST-elevation myocardial infarction STEMI requiring emergency intervention.
Presence of chronic total occlusion or heavily calcified lesions not suitable for balloon angioplasty alone.
Known bleeding disorders or abnormal blood clotting profiles, such as an INR greater than 1.5 or a platelet count less than 100,000 per cubic millimeter.
Severe left ventricular dysfunction with an ejection fraction less than 30 percent or hemodynamic instability.
History of hypersensitivity or contraindication to contrast media, heparin, or balloon materials.
Participation in another investigational device or drug study within the last 30 days.
Pregnant or breastfeeding women, or women of childbearing potential not using acceptable contraception.
Life expectancy of less than 90 days due to non-cardiac health conditions, such as advanced cancer.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome
Modification(s)  
Outcome  TimePoints 
To evaluate the safety and performance of the Newtech Balloon Dilatation Catheter in achieving successful dilatation of stenotic lesions in coronary arteries or bypass grafts in patients with myocardial ischemia.
To assess the procedural success rate, defined as successful delivery, inflation, and withdrawal of the catheter without device-related complications.
 		 Pre-operative, Operative Day, Day2, Day7 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
To evaluate the incidence of device-related adverse events during immediately after the procedure eg vessel dissection perforation acute occlusion or spasm
To assess angiographic improvement post-procedure such as restoration of target vessel patency improved coronary blood flow.
To evaluate the ease of device use including aspects such as catheter deliverability balloon inflation deflation performance overall procedural compatibility.
To monitor post-procedural clinical outcomes including any cardiovascular symptoms adverse events, or need for additional interventions during the follow-up period.
 		 Pre-operative, Operative Day, Day2, Day7 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/08/2025 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

This is a prospective, interventional, multi-center, single-arm, open-label clinical investigation designed to evaluate the clinical safety and performance of the Newtech Balloon Dilatation Catheter in patients undergoing percutaneous transluminal coronary angioplasty (PTCA) for the treatment of coronary artery disease. The study population will include patients aged 18 years and above, diagnosed with significant stenosis in native coronary arteries or coronary artery bypass grafts, who are scheduled for elective PTCA and meet all inclusion and exclusion criteria. 

 
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