Distal vs. Forearm Radial Artery Access

Not Applicable

Completed

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

• Registration Number: NCT04125992
• Lead Sponsor: An-Najah National University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-29
• Study First Submitted QC: 2019-10-11
• Study First Posted: 2019-10-14
• Study Start: 2019-12-01
• Primary Completion: 2020-12-21
• Study Completion: 2020-12-21
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-04
• Last Update Posted: 2023-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 212

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Distal Radial	distal radial artery access in coronary angiography and angioplasty	Patients who undergo coronary catheterization by accessing the distal radial artery in the snuff-box of the hand.
Forearm Radial	Forearm radial artery access in coronary angiography and angioplasty	Patients who undergo conventional coronary catheterization by accessing the forearm radial artery.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Compression "hemostasis" time	Up to 240 minutes after band placement	The time from the placement of the compression band until its removal (when there's no blood oozing after deflation), measured by minutes.
Puncture Time	During the procedure	Which is time from first attempt to puncture to the successful one in seconds
Puncture Attempts	During the procedure	Which is the number of puncture attempts from first one until the successful one (maximum 6)
Procedure Duration	During the procedure	In minutes from the insertion of the sheath to its exertion.
Radiation Duration	During the procedure	Which is measured by the radiological device in minutes.
Radiology Dose	During the procedure	Which is measured by the radiological device in mGy.
Arterial spasm	During the procedure	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.
Hematoma and bleeding complications	Within 24 hours after the procedure	It is defined by EASY hematoma scale.
Crossover (failure to puncture)	During the procedure	It is transforming from the selected access to another after 6 failed attempts to puncture the first selected access
Procedural pain	During the procedure	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.
Radial Artery Occlusion on follow up	After 2 weeks of the procedure.	Follow up Doppler Ultrasonography for patients with occluded radial artery within 24 hours.
Ischemic changes to the hand	Within 24 hours after the procedure	It is noted by clinical features of pallor, absence of pulse, pain, cold, paresthesia or paralysis.
Post-procedural pain	Within 24 hours after the procedure	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.
Rare complications	Within 24 hours after the procedure	Pseudo-aneurysm, AV fistula formation, radial artery dissection, which are assessed by Doppler US. In addition to radial artery eversion or perforation.

Trial Locations

Locations (1)

An-Najah National University Hospital; 🇵🇸 Nablus, Palestinian Territory, occupied