Distal vs. Forearm Radial Artery Access

NCT ID: NCT04125992

Last Updated: 2023-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2020-12-21

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Distal Radial

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

Group Type: EXPERIMENTAL

distal radial artery access in coronary angiography and angioplasty

Intervention Type: PROCEDURE

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.

Forearm Radial

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

Group Type: ACTIVE_COMPARATOR

Forearm radial artery access in coronary angiography and angioplasty

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

An-Najah National University

OTHER

Sponsor Role: lead

Responsible Party

Yunis Daralammouri

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yunis Daralammouri, asst. prof.

Role: PRINCIPAL_INVESTIGATOR

An-Najah National University

Locations

An-Najah National University Hospital

Nablus, , Palestinian Territories

Countries

Palestinian Territories

Other Identifiers

DRAvsFRA

Identifier Type: -

Identifier Source: org_study_id