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CTRI Number  CTRI/2025/08/092775 [Registered on: 11/08/2025] 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 Guiding Catheter in patients with heart and blood vessel problems 
Scientific Title of Study   A prospective, interventional, Single-centre, single-arm, clinical investigation to assess the safety and performance of the Newtech Guiding Catheter during diagnostic and interventional use in patients with Coronary and Peripheral Vascular Disease. 
Trial Acronym  NIL 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
NMDPT/GC-02/CI-P/080 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
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  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 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Guiding Catheter  Guiding Catheter Used to record intra cardiac pressures, to sample blood, and to introduce substances into the heart and vessels. 
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 and female
Subjects scheduled for diagnostic or interventional cardiovascular procedures eg angiography, PCI where the use of a guiding catheter is clinically indicated.
2.Subjects able to provide written informed consent before any study specific procedures.
3.Subjects who are hemodynamically stable and suitable for catheter-based vascular access.
4.Target vessel anatomy is appropriate for catheter navigation and guide placement based on pre-procedural imaging.
Willing and able to comply with protocol requirements, including a 7day follow-up.
 
 
ExclusionCriteria 
Details  1.Known allergy or hypersensitivity to materials used in the guiding catheter eg polymer coating, EO sterilization residuals.
2.Severe peripheral vascular disease, tortuous anatomy, or calcified vessels that may compromise safe catheter introduction or tracking.
3.Participation in another investigational study within the last 30 days that may interfere with this investigation.
4.Active systemic infection or localized infection at the planned vascular access site.
5.Pregnant or breastfeeding women, unless the procedure is clinically necessary and ethically justified.
6.Subjects with known coagulation disorders or on anticoagulant therapy that poses increased procedural risk.
7.Significant anatomical abnormalities eg aneurysm, severe aortic arch angulation that may preclude safe catheter navigation.
8.Life expectancy less than 30 days due to underlying non-cardiac illnesses.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Procedural Success Rate: Successful vascular access, device delivery, and contrast injection without catheter-related failure.
Device-Related Adverse Events (within 7 days): No major complications such as dissection, perforation, vasospasm, embolism, hematoma, or catheter malfunction.
 		 Pre-operative, Operative, Day2, Day7 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
1.Usability Investigator feedback on insertion, navigation, torque control, kink resistance, visibility.
2.Technical Issues Any problems like flushing difficulty, incompatibility, or need for catheter replacement.
3.Fluoroscopy Compatibility: Adequate visibility compatibility with common devices stents, balloons, wires.
Workflow Impact Any delays or procedural issues due to catheter performance.
 		 Pre-operative, Operative, Day2, Day 7 
 
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)   19/08/2025 
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, Single-center, single-arm, open-label clinical investigation designed to evaluate the clinical performance, safety, and usability of the Newtech Guiding Catheter during real-world diagnostic and interventional cardiovascular procedures involving the coronary and peripheral vasculature. The study population will include patients who are scheduled to undergo elective or indicated percutaneous coronary or peripheral interventions and meet all study eligibility criteria. Subjects will be enrolled only after providing written informed consent, and the investigational guiding catheter will be used in accordance with the manufacturer’s Instructions for Use (IFU) and routine interventional protocols.

 
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