| 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
|
|
|
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
|
|
|
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. |