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CTRI Number  CTRI/2023/07/055246 [Registered on: 14/07/2023] Trial Registered Prospectively
Last Modified On: 06/05/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to compare the outcomes of distal and proximal radial artery access used in coronary angioplasty  
Scientific Title of Study   Distal Versus Conventional Radial Access for Percutaneous Coronary Interventions (DICON-RADIAL Trial): A prospective randomized trial.  
Trial Acronym  DICON-RADIAL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ankush Gupta 
Designation  Professor of Medicine Interventional Cardiologist 
Affiliation  Army Institute of Cardio Thoracic Sciences 
Address  Department of Cardiology, Ground floor, Room No.5, Golibar Maidan

Pune
MAHARASHTRA
411040
India 
Phone  9592903488  
Fax    
Email  drankushgupta@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ankush Gupta 
Designation  Professor of Medicine Interventional Cardiologist 
Affiliation  Army Institute of Cardio Thoracic Sciences 
Address  Department of Cardiology, Ground Floor, Room No.5, Golibar Maidan

Pune
MAHARASHTRA
411040
India 
Phone  9592903488  
Fax    
Email  drankushgupta@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ankush Gupta 
Designation  Professor of Medicine Interventional Cardiologist 
Affiliation  Army Institute of Cardio Thoracic Sciences 
Address  Department of Cardiology, Ground Floor, Room No.5, Golibar Maidan

Pune
MAHARASHTRA
411040
India 
Phone  9592903488  
Fax    
Email  drankushgupta@gmail.com  
 
Source of Monetary or Material Support  
Army Institute of Cardio Thoracic Sciences (AICTS) Department of Cardiology Golibar Maidan Pune 411040 
 
Primary Sponsor  
Name  Principal Investigator 
Address  Army Institute of Cardio Thoracic Sciences (AICTS) Department of Cardiology Golibar Maidan Pune 411040 
Type of Sponsor  Other [Self funding] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prafull Sharma  Army Hospital Research And Referral  Department of Cardiology First floor,Near military hospital road,Subroto Park , New Delhi, Delhi-110010,
New Delhi
DELHI 
9971829207

drprafullsharma@gmail.com 
Dr Ankush Gupta  Army Institute of Cardio Thoracic Sciences  Department of Cardiology, Ground Floor, Room No. 5, Golibar Maidan
Pune
MAHARASHTRA 
9592903488

drankushgupta@gmail.com 
Dr Ankush Gupta  Command Hospital Airforce   Cambridge Rd,Jogupalya,Bengaluru, karnataka -560007,Department of cardiology 1st floor (CCL) ,OPD -room no 10 Grounf floor (ODP Building)
Bangalore
KARNATAKA 
9592903488

drankushgupta@gmail.com 
Dr Rajesh Vijayvergiya  Post Graduate Institute of Medical Education and Research  Department of Cardiology, Advanced cardiac center, PGIMER, 3rd Floor, C Block, Room No.3002
Chandigarh
CHANDIGARH 
9815221856

rajeshvijay999@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institutional Ethics Committee Armed Forces Medical College  Approved 
Institutional Ethics Committee Army Hospital (R & R), Delhi Cantt  Approved 
Institutional Ethics Committee Command Hospital Air Force Bangalore  Approved 
Postgraduate Institute of Medical Education and Research, Chandigarh Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: I20||Angina pectoris, (2) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, (3) ICD-10 Condition: I214||Non-ST elevation (NSTEMI) myocardial infarction, (4) ICD-10 Condition: I200||Unstable angina,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Trans radial access (TRA)  Conventional Trans radial access (TRA) group will receive standard of care for TRA access. Local anesthesia will be administered with a subcutaneous injection of 1% lidocaine after skin preparation. Radial artery access is obtained using either anterior or counter-puncture technique based on the operator’s preference, using a 21 gauge bare needle or 20/22 gauge sheath-covered needle, after which a 6 Fr hydrophilic sheath will be inserted over a guidewire. 
Intervention  Distal Trans radial access (dTRA)  For, Distal Trans radial access dTRA , the wrist rests on a comfortable arm support which brings the wrist in passive ulnar flexion. The patient is asked to bring the thumb under the other four fingers. This brings the distal radial artery more superficial at snuffbox and allows easier puncture. The artery is identified and local anesthesia is applied by subcutaneous injection of lidocaine in the anatomical snuffbox above the artery. Arterial puncture is performed at the point of maximal pulsation. The arterial puncture is done with the traditional radial access needle using the modified Seldinger technique. After successful anterior wall puncture, a radial sheath wire is advanced carefully. Proper position is verified by fluoroscopy if resistance is encountered to ensure the wire didnt traverse the palmar arch. This is followed by introduction of a hydrophilic radial sheath. A vasodilator cocktail containing 200–400 micrograms of nitroglycerin and 2.5–5 mg of diltiazem is administered through the radial sheath. Once the sheath is inserted, dTRA is successfully achieved at this point for PCI. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All patients are at least 18 years of age with palpable proximal and distal radial artery who are planned for percutaneous coronary intervention using 6F radial sheath and guiding catheter. 
 
ExclusionCriteria 
Details  1.Patients having clinical instability with compromised hemodynamics.
2.ST segment elevation myocardial infarction undergoing primary PCI.
3.History of previous coronary angiography or PCI through trans-radial access.
4.Chronic kidney disease on maintenance hemodialysis.
5.Patient or family refusal 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
The primary end point will be incidence of Radial Artery Occlusion at hospital discharge & at 60 days  At hospital discharge & at 60 days 
 
Secondary Outcome  
Outcome  TimePoints 
the secondary endpoints will include successful sheath insertion, access-site crossover, access site hematoma, access site bleeding, radial artery pseudoaneurysm, radial artery spasm during procedure, access site related pain according to visual analog scale.  At hospital discharge & at 60 days 
 
Target Sample Size   Total Sample Size="874"
Sample Size from India="874" 
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)   14/07/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  

Trans-radial access (TRA) has been established as a safer and superior to femoral artery access for percutaneous coronary procedures(1–3). This is due to its lower risk of bleeding and vascular complications, as well as faster post procedure recovery. TRA is associated with better quality of life and allows safe performance of same-day discharge for diagnostic and interventional procedures in stable patients, contributing to overall cost-effectiveness(4,5).

Radial artery occlusion (RAO) is by far the most frequent complication of TRA, with highest incidence in the first 24 hours and spontaneous recanalization at 30 days in only about one-half of the patients. Its incidence varies from 0.8 to 10% at 24 hrs and up to 5.5% at 30 days of follow-up(6–10). An occluded radial artery as such is unsuitable for a future percutaneous coronary or noncoronary procedures. In light of the increasing use of TRA in numerous interventional procedures, prevention of RAO is becoming a central consideration for achieving a successful radial program.

There is a growing interest in the distal trans radial artery access (dTRA) as an alternative to conventional TRA, with multiple studies reporting feasibility since its first public introduction in 2017(11). dTRA in the anatomical snuff box or the dorsum of the hand has emerged as a promising alternative access to reduce the risk for RAO because of the puncture site being beyond the hand anastomotic network, which most likely ensures persistent blood flow in the radial artery. It has also been shown to be associated with less pain and lower incidence of compartment syndrome as compare to TRA and has shown to improve both patient and operator comfort, especially when using the left radial, as there is no disagreeable forearm supination.  Recently published randomized control trials (RCT) have shown striking reductions of RAO after dTRA compared with conventional TRA(10,12,13), whereas, the multi-centered DISCO RADIAL study did not show a significant difference in RAO, but did demonstrate a significantly shorter hemostasis time with dTRA(7). There is no evidence for or against the use of dTRA during PCI from Indian subcontinent.

To further unravel the role of dTRA in current interventional practice in India, a prospective, multicenter randomized control trial is planned to compare the outcomes of dTRA and conventional TRA used for percutaneous coronary intervention.

 
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