Distal vs. Forearm Radial Artery Access (DRAvsFRA)

An-Najah National University

Status: Completed

Conditions: Coronary Artery Disease; Acute Coronary Syndrome; Atherosclerotic Heart Disease With Ischemic Chest Pain; Chest Pain; Angina, Unstable; Myocardial Infarction; Non STEMI; Non ST Segment Elevation Myocardial Infarction; Myocardial Ischemia; Atheroscleroses, Coronary; Angina, Stable; ST-segment Elevation Myocardial Infarction (STEMI)

Treatments: Procedure: Forearm radial artery access in coronary angiography and angioplasty; Procedure: distal radial artery access in coronary angiography and angioplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT04125992

DRAvsFRA

Details and patient eligibility

About

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.

Enrollment: 212 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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212 participants in 2 patient groups

Distal Radial

Experimental group

Description:

Patients who undergo coronary catheterization by accessing the distal radial artery in the snuff-box of the hand.

Treatment:

Procedure: distal radial artery access in coronary angiography and angioplasty

Forearm Radial

Active Comparator group

Description:

Patients who undergo conventional coronary catheterization by accessing the forearm radial artery.

Treatment:

Procedure: Forearm radial artery access in coronary angiography and angioplasty