Distal vs. Forearm Radial Artery Access (DRAvsFRA)

Distal Radial Artery Access in Comparison to Forearm Radial Artery Access for Cardiac Catheterization, a Randomized Controlled Trial

The Distal Radial Access (DRA) to the coronaries has emerged recently. It's done via the distal radial artery in the radial fossa, which is known as the snuff-box. The rationale of conducting this research is to assess this new access advantages and disadvantages, in comparison with the standard conventional forearm radial access and examine if it's worthy to be a future alternative method for coronary angiography. It aims to randomly compare between the new distal radial access via the snuffbox and the conventional forearm radial access for percutaneous coronary angiography and angioplasty procedures. The objectives of comparing both procedures are to analyze the frequency of complications in terms of occlusion, arterial spasm, hematoma, and to weigh accesses effectiveness in terms of time and attempts to puncture, crossover rate, procedure duration, hemostasis time, and convenience of the patients and operators.

Candidates for coronary angiography are being randomized into the interventional group to undergo the angiography through the distal radial artery as the access site, or the control group accessing through the radial artery in the forearm. Procedural and post procedural outcomes and complications are being reported while patients are in hospital. All patients undergo doppler ultrasonography within 24 hours after the procedure.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Myocardial Ischemia; Coronary Artery Disease; Chest Pain; Angina, Stable; Acute Coronary Syndrome; Angina, Unstable; Non ST Segment Elevation Myocardial Infarction; ST-segment Elevation Myocardial Infarction (STEMI); Non STEMI; Atheroscleroses, Coronary; Atherosclerotic Heart Disease With Ischemic Chest Pain
• Intervention / Treatment: Procedure: distal radial artery access in coronary angiography and angioplasty; Procedure: Forearm radial artery access in coronary angiography and angioplasty

• Study Type: Interventional
• Enrollment (Actual): 212
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Palestinian Territory, occupied
  • Nablus, Palestinian Territory, occupied
    • An-Najah National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who agree to participate in the study and sign the consent form.
• Patients with an indication for coronary catheterization
• Clinically stable patients
• Patients with palpable pulses on both access sites of the radial artery.

Exclusion Criteria:

• Patients with STEMI
• Patients with radial AV shunt for hemodialysis
• Patients with previous CABG using radial artery
• Patients with previous CABG using LIMA, RIMA or both.
• Patients with Renaud phenomenon or lymphedema

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Distal Radial; Patients who undergo coronary catheterization by accessing the distal radial artery in the snuff-box of the hand.	Procedure: distal radial artery access in coronary angiography and angioplasty; The patient grasps his thumb towards the palm to bring the radial artery up to the surface. The left hand is set on the right side of the groin toward the operator, who stands on the right side, with the dorsal surface of hand upwards. Afterward, the access site is disinfected, lidocaine HCL is SC injected for local anesthesia. Subsequently, the distal radial artery is palpated to find the point of the strongest pulse. Later, at a 45-degree angle, the artery is punctured with a 21-gauge needle and a 0.018 soft, flexible, metallic wire is then inserted in the needle. Through the sheath, 200 micrograms of Nitroglycerin is given. A 5000 unit of unfractionated heparin is administered through the IV line. A weight-adjusted dose of heparin is further added if PCI is needed. Then, a 0.035 wire is introduced in the sheath with other required instruments such as the intracoronary device and the catheters. After pulling out the sheath, a compression device, Safe Guard, is used for hemostasis.
Active Comparator: Forearm Radial; Patients who undergo conventional coronary catheterization by accessing the forearm radial artery.	Procedure: Forearm radial artery access in coronary angiography and angioplasty; The right hand is set in the anatomical position, with the anterior surface of arm face upwards. Afterward, the access site is disinfected, lidocaine HCL is SC injected for local anesthesia. Subsequently, the forearm radial artery is palpated to find the point of the strongest pulse. Later, at a 45-degree angle, the artery is punctured with a 21-gauge needle and a 0.018 soft, flexible, metallic wire is then inserted in the needle. Through the sheath, 200 micrograms of Nitroglycerin is given. A 5000 unit of unfractionated heparin is administered through the IV line. A weight-adjusted dose of heparin is further added if PCI is needed. Then, a 0.035 wire is introduced in the sheath with other required instruments such as the intracoronary device and the catheters. After pulling out the sheath, a compression device, TR band, is used for hemostasis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radial artery occlusion	Doppler Ultrasonography of the radial artery for occlusions along its course, in both groups.	Within 24 hours after the procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ischemic changes to the hand	It is noted by clinical features of pallor, absence of pulse, pain, cold, paresthesia or paralysis.	Within 24 hours after the procedure
Post-procedural pain	Assessed by numerical rating scale (NRS) for pain, which is an 11 point subjective scale (0-10) where 0 refers for no pain, 1-3 for mild pain, 4-6 for moderate pain and 7-10 for severe pain.	Within 24 hours after the procedure
Puncture Time	Which is time from first attempt to puncture to the successful one in seconds	During the procedure
Puncture Attempts	Which is the number of puncture attempts from first one until the successful one (maximum 6)	During the procedure
Procedure Duration	In minutes from the insertion of the sheath to its exertion.	During the procedure
Radiation Duration	Which is measured by the radiological device in minutes.	During the procedure
Radiology Dose	Which is measured by the radiological device in mGy.	During the procedure
Compression "hemostasis" time	The time from the placement of the compression band until its removal (when there's no blood oozing after deflation), measured by minutes.	Up to 240 minutes after band placement
Arterial spasm	Which is assessed by the operator if present or absent in terms of the difficulty in inserting the wire at the time of the procedures. of the procedure.	During the procedure
Hematoma and bleeding complications	It is defined by EASY hematoma scale.	Within 24 hours after the procedure
Crossover (failure to puncture)	It is transforming from the selected access to another after 6 failed attempts to puncture the first selected access	During the procedure
Rare complications	Pseudo-aneurysm, AV fistula formation, radial artery dissection, which are assessed by Doppler US. In addition to radial artery eversion or perforation.	Within 24 hours after the procedure
Radial Artery Occlusion on follow up	Follow up Doppler Ultrasonography for patients with occluded radial artery within 24 hours.	After 2 weeks of the procedure.
Procedural pain	Assessed by numerical rating scale (NRS) for pain, which is an 10 point subjective scale (0-10) where 0 refers for no pain, 1-3 for mild pain, 4-6 for moderate pain and 7-10 for severe pain.	During the procedure

Collaborators and Investigators

• Sponsor: An-Najah National University
• Investigators: Principal Investigator: Yunis Daralammouri, asst. prof., An-Najah National University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): December 21, 2020
• Study Completion (Actual): December 21, 2020

Study Registration Dates

• First Submitted: September 29, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (Actual): October 14, 2019

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 4, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: randomized controlled trial; Percutaneous Coronary Intervention; coronary artery disease; angiography; angioplasty; cardiac catheterization; radial; coronary angiography; coronary angioplasty; radial artery occlusion; coronary catheterization; distal radial artery; radial artery; catheterization; safeguard; radial access; distal radial access; snuff-box; snuffbox; snuff box; radial fossa; distal radial angiography; distal radial; coronary arteries; left distal radial artery; forearm radial access; forearm radial artery; left distal radial; radial vs distal
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Myocardial Infarction; Infarction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; ST Elevation Myocardial Infarction; Chest Pain; Atherosclerosis; Acute Coronary Syndrome; Angina Pectoris; Angina, Stable; Angina, Unstable
• Other Study ID Numbers: DRAvsFRA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No