An interventional study of distal radial artery access in coronary angiography and angioplasty and Forearm radial artery access in coronary angiography and angioplasty in Coronary Artery Disease, Angina, Unstable and Angina, Stable, sponsored by An-Najah National University. Completed at 1 site in Palestinian Territory, occupied. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-06.
Sponsored by An-Najah National University · Not applicable, Interventional, and Treatment
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 212 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
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Exclusion Criteria:
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
Patients who undergo conventional coronary catheterization by accessing the forearm radial artery.
Procedure: Forearm 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.
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.
Radial artery occlusion
Doppler Ultrasonography of the radial artery for occlusions along its course, in both groups.
Time frame: Within 24 hours after the procedure.
Puncture Time
Which is time from first attempt to puncture to the successful one in seconds
Time frame: During the procedure
Puncture Attempts
Which is the number of puncture attempts from first one until the successful one (maximum 6)
Time frame: During the procedure
Procedure Duration
In minutes from the insertion of the sheath to its exertion.
Time frame: During the procedure
Radiation Duration
Which is measured by the radiological device in minutes.
Time frame: During the procedure
Radiology Dose
Which is measured by the radiological device in mGy.
Time frame: During the procedure
Compression "hemostasis" time
The time from the placement of the compression band until its removal (when there's no blood oozing after deflation), measured by minutes.
Time frame: Up to 240 minutes after band placement
Arterial spasm
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.
Time frame: During the procedure
Hematoma and bleeding complications
It is defined by EASY hematoma scale.
Time frame: Within 24 hours after the procedure
Ischemic changes to the hand
It is noted by clinical features of pallor, absence of pulse, pain, cold, paresthesia or paralysis.
Time frame: Within 24 hours after the procedure
Crossover (failure to puncture)
It is transforming from the selected access to another after 6 failed attempts to puncture the first selected access
Time frame: During the procedure
Procedural pain
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.
Time frame: During the procedure
Post-procedural pain
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.
Time frame: Within 24 hours after the procedure
Rare complications
Pseudo-aneurysm, AV fistula formation, radial artery dissection, which are assessed by Doppler US. In addition to radial artery eversion or perforation.
Time frame: Within 24 hours after the procedure
Radial Artery Occlusion on follow up
Follow up Doppler Ultrasonography for patients with occluded radial artery within 24 hours.
Time frame: After 2 weeks of the procedure.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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