| CTRI Number |
CTRI/2023/08/056881 [Registered on: 24/08/2023] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Different Approach To PCI] |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Different Approach for performing Percutaneous Coronary Revascularization |
|
Scientific Title of Study
|
Comparison of Distal with Proximal Radial Access for Patients undergoing Percutaneous Coronary Revascularization via trans-radial approach. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
H S ISSER |
| Designation |
PROFFESSOR |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Room no 723 7th floor, Department of Cardiology, Super Speciality Block, VMMC and SJH, Ansari Nagar East, New Delhi
New Delhi
DELHI
110016
India |
| Phone |
9899128399 |
| Fax |
|
| Email |
drhsisser@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
H S ISSER |
| Designation |
PROFFESSOR |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Room No 723 7th floor, Department of Cardiology, Super Speciality Block, VMMC and SJH, Ansari Nagar East, New Delhi
New Delhi
DELHI
110016
India |
| Phone |
9899128399 |
| Fax |
|
| Email |
drhsisser@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anbhigya Kumar Arya |
| Designation |
Senior Resident |
| Affiliation |
VMMC AND SJH |
| Address |
Room No 724 7th floor, Department of Cardiology, Super Speciality Block, VMMC and SJH, Ansari Nagar East, New Delhi
New Delhi
DELHI
110016
India |
| Phone |
7376081644 |
| Fax |
|
| Email |
dr.akarya95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No 723, 7th floor, Department of Cardiology, Super Speciality Block, VMMC and SJH, Ansari Nagar East, New Delhi |
|
|
Primary Sponsor
|
| Name |
Safdarjung Hospital |
| Address |
Room No 723, 7th floor, Department of Cardiology, Super Speciality Block, VMMC and SJH, Ansari Nagar East, New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| H S ISSER |
Safdarjung Hospital |
Room no 723, 7th floor, Department of Cardiology, Super Speciality Block, VMMC and SJH, Ansari Nagar East, New Delhi
New Delhi
DELHI |
9899128399
drhsisser@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Vardhman Mahavir Medical College and Safdarjung Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Distal Radial |
Distal radial access for Percutaneous Coronary Revascularization |
| Comparator Agent |
Proximal Radial |
Proximal Radial Access For Percutaneous Coronary Revascularization |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All Patients above the age of 18 years undergoing coronary artery revascularization via Trans-Radial Approach |
|
| ExclusionCriteria |
| Details |
Recent Radial Intervention
No Radial Pulse on both Radial access sites
Peripheral artery disease
Complex PCI requiring more than 7 french sheath
Hemodynamically Unstable
Patients having radial AV fistula for hemodialysis
Previous CABG using radial artery or IMA |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Distal radial access is comparable to proximal radial access for patients undergoing percutaneous coronary revascularization via trans radial approach |
18 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Distal radial access is comparable & superior to proximal radial access for patients undergoing percutaneous coronary revascularization via trans radial approach in terms of access site complications & radial artery occlusion |
18 months |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/10/2023 |
| Date of Study Completion (India) |
31/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/01/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
|
The purpose of this study is to compare distal with proximal radial access for patients undergoing percutaneous coronary revascularization via trans radial approach and whether distal radial access can be used as an alternative to proximal radial access for percutaneous coronary interventions via trans radial approach. |