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NCT Number: NCT04125992

Distal vs. Forearm Radial Artery Access

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.

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Key information

Conditions

Coronary Artery Disease Acute Coronary Syndrome Angina Pectoris Angina, Stable Angina, Unstable Arterial Occlusive Diseases Arteriosclerosis Atheroscleroses, Coronary Atherosclerotic Heart Disease With Ischemic Chest Pain Cardiovascular Diseases Chest Pain Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Non ST Segment Elevation Myocardial Infarction Non STEMI Non-ST Elevated Myocardial Infarction Pain Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction ST-segment Elevation Myocardial Infarction (STEMI) Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

An-Najah National University Hospital

Nablus, Palestinian Territories

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Radial artery occlusion

    Time frame: Within 24 hours after the procedure.

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

Secondary outcomes

  1. Puncture Time

    Time frame: During the procedure

    Which is time from first attempt to puncture to the successful one in seconds

  2. Puncture Attempts

    Time frame: During the procedure

    Which is the number of puncture attempts from first one until the successful one (maximum 6)

  3. Procedure Duration

    Time frame: During the procedure

    In minutes from the insertion of the sheath to its exertion.

  4. Radiation Duration

    Time frame: During the procedure

    Which is measured by the radiological device in minutes.

  5. Radiology Dose

    Time frame: During the procedure

    Which is measured by the radiological device in mGy.

  6. Compression "hemostasis" time

    Time frame: 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.

  7. Arterial spasm

    Time frame: 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.

  8. Hematoma and bleeding complications

    Time frame: Within 24 hours after the procedure

    It is defined by EASY hematoma scale.

  9. Ischemic changes to the hand

    Time frame: Within 24 hours after the procedure

    It is noted by clinical features of pallor, absence of pulse, pain, cold, paresthesia or paralysis.

  10. Crossover (failure to puncture)

    Time frame: During the procedure

    It is transforming from the selected access to another after 6 failed attempts to puncture the first selected access

  11. Procedural pain

    Time frame: 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.

  12. Post-procedural pain

    Time frame: 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.

  13. Rare complications

    Time frame: 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.

  14. Radial Artery Occlusion on follow up

    Time frame: After 2 weeks of the procedure.

    Follow up Doppler Ultrasonography for patients with occluded radial artery within 24 hours.

Sponsors and collaborators

Lead sponsor

An-Najah National University

Other

Registry information

Official study title

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

Acronym: DRAvsFRA

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 14, 2019
Registry last updated
Jun 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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