Distal vs. Forearm Radial Artery Access

NCT04125992 | Completed DMC

• 1 other identifier: DRAvsFRA
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

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)

Keywords

cardiac catheterization; coronary angiography; coronary angioplasty; snuff-box; snuffbox; snuff box; radial fossa; distal radial artery; radial artery; safeguard; distal radial access; distal radial angiography; radial access; angiography; distal radial; radial; coronary arteries; randomized controlled trial; left distal radial artery; Percutaneous Coronary Intervention; radial artery occlusion; forearm radial access; forearm radial artery; coronary catheterization; catheterization; left distal radial; angioplasty; coronary artery disease; radial vs distal

Outcome Measures

Primary Outcomes (1)

• Radial artery occlusion

  Doppler Ultrasonography of the radial artery for occlusions along its course, in both groups.

  Within 24 hours after the procedure.

Secondary Outcomes (14)

• Puncture Time

  During the procedure

• Puncture Attempts

  During the procedure

• Procedure Duration

  During the procedure

• Radiation Duration

  During the procedure

• Radiology Dose

  During the procedure

Study Arms (2)

Distal Radial

EXPERIMENTAL

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

Forearm Radial

ACTIVE COMPARATOR

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

Procedure: Forearm radial artery access in coronary angiography and angioplasty

Interventions

distal radial artery access in coronary angiography and angioplasty 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.

Distal Radial

Forearm radial artery access in coronary angiography and angioplasty 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.

Forearm Radial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• An-Najah National University: lead

Study Sites (1)

An-Najah National University Hospital

Nablus, Palestinian Territories

Location

MeSH Terms

Conditions

Coronary Artery Disease; Angina, Unstable; Angina, Stable; Non-ST Elevated Myocardial Infarction; Acute Coronary Syndrome; Chest Pain; Myocardial Infarction; Myocardial Ischemia; ST Elevation Myocardial Infarction; Arterial Occlusive Diseases

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Vascular Diseases; Angina Pectoris; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Yunis Daralammouri, asst. prof.

  An-Najah National University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patients enrolled to the study were randomized into Forearm Radial or Distal Radial groups. Care providers operated on patients and investigators collected their data during and after the operation. The independent variable - Access site (Forearm Radial or Distal Radial) - was coded into X or Z groups, then data was sent to the outcomes assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 29, 2019
• First Posted: October 14, 2019
• Study Start: December 1, 2019
• Primary Completion: December 21, 2020
• Study Completion: December 21, 2020
• Last Updated: June 6, 2023

Record last verified: 2023-06

Locations

PA (1)