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CTRI Number  CTRI/2025/08/093005 [Registered on: 13/08/2025] Trial Registered Prospectively
Last Modified On: 12/08/2025
Post Graduate Thesis   
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   A study to check if the Newtech heart stent is safe and works well in patients having angioplasty for heart disease. 
Scientific Title of Study   A Prospective, Interventional, Single-Center, Single-Arm Clinical Investigation to Assess the Safety and Performance of the Newtech Everolimus-Eluting Coronary Stent System in Patients with Symptomatic Ischemic Heart Disease Undergoing Percutaneous Transluminal Coronary Angioplasty (PTCA). 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NMDPT/DESE-07/CI-P/085 1.0 dated 04 Aug 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 & General Hospital 7 Vivekanand Marg Panch Batti C Scheme Ashok Nagar Jaipur Rajasthan 302001

Jaipur
RAJASTHAN
302001
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 India

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 India

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 India  
Type of Sponsor  Other [(Medical device Manufacturer)] 
 
Details of Secondary Sponsor  
Name  Address 
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  Heart and General Hospital Cardiology department, Cardiology Division, First floor,7 Vivekanand Marg Panch Batti C Scheme Ashok Nagar Jaipur Rajasthan 302001
Jaipur
RAJASTHAN 		 9540364009

heartghospital@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Heart and General Hospital EthicsCommittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
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  Everolimus-Eluting Coronary Stent Delivery System  The Everolimus eluting stent system is a combination product comprised of two regulated components: a device (a coronary stent system a drug product (aformulation of Evrolimus contained in a) and polymer coating) pre mounted on balloon catheter between two platinum iridium radio opaque marker bands. 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.Adults aged 18 years or older male or female.
2.Diagnosis of coronary artery disease CAD with de novo stenotic lesions in native coronary arteries requiring percutaneous coronary intervention PCI.
3.Target lesion is accessible and can be crossed with a guidewire and balloon catheter.
4.Subject is clinically stable and eligible to undergo angiography and PCI under local anaesthesia.
5.Subject or legally authorized representative has provided written informed consent prior to participation.
6.Subject is willing and able to comply with all protocol-required follow-up visits and assessments
 
 
ExclusionCriteria 
Details  1.Patients who are not candidates for coronary bypass surgery.
2.Patients with a target lesion involving a major side branch.
3.Patients with angiographic evidence of existing thrombus at the intended lesion site.
4.Patients with known hypersensitivity or allergy to cobalt-chromium L605 alloy.
5.Patients with a contraindication to antiplatelet or anticoagulant therapy including Recent major surgery Obstetric delivery Organ biopsy Active gastrointestinal bleeding History of cerebrovascular accident CVA Diabetic retinopathy any other condition associated with increased bleeding risk.
6.Pregnant women or women of childbearing potential.
7.Patients who have experienced a recent acute myocardial infarction within the past 7 days
8.Patients with diffuse coronary artery disease, defined as long segments of abnormal vessel without normal interposed segment.
9.Transplant patients

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1.To evaluate the safety and performance of the Newtech Everolimus-Eluting Coronary Stent in treating new coronary artery blockages during PCI, without major device-related complications during the procedure and follow-up.

2.To assess procedural success, defined as successful stent delivery, deployment, and removal without device-related complications.








 		 Procedure Day, Procedure(Day2), Day30, Day90, Day180 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor early device-related adverse events following implantation, including acute or subacute thrombosis, unstable angina, ventricular fibrillation, or access site complications such as hematoma, bleeding, or pseudoaneurysm.
To assess angiographic performance using quantitative coronary angiography (QCA) both during the procedure and throughout follow-up visits.
To assess the handling characteristics of the device during the procedure, including fluoroscopic visibility, ease of tracking and lesion crossing, inflation and deflation performance of the balloon, and overall compatibility with the guidewire and catheter system.
To ensure clinical adherence to the Instructions for Use by confirming appropriate patient selection, proper use of the stent within the indicated vessel diameter and lesion length, avoiding reuse of the device, and confirming compliance with storage and expiry conditions. 		 Procedure Day, Procedure(Day2), Day30, Day90, Day180 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   N/A 
Date of First Enrollment (India)   23/08/2025 
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="6"
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  

This is a prospective, interventional, Single-center, single-arm, open-label clinical investigation designed to evaluate the clinical safety and performance of the Newtech Everolimus-Eluting Coronary Stent System in patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). The study will include approximately 90 patients presenting with de novo atherosclerotic lesions in native coronary arteries who are eligible for stent placement in accordance with standard interventional cardiology practice. Subjects will be enrolled after providing written informed consent and undergoing screening as per the predefined inclusion and exclusion criteria.

 
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