Clinical trial NCT04125992: Distal vs. Forearm Radial Artery Access
Official title: Distal Radial Artery Access in Comparison to Forearm Radial Artery Access for Cardiac Catheterization, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: An-Najah National University
Sponsor class: OTHER
First posted: 2019-10-14
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Radial artery occlusion
timeFrame: Within 24 hours after the procedure.
Secondary outcomes:
measure: Puncture Time
timeFrame: During the procedure
measure: Puncture Attempts
timeFrame: During the procedure
measure: Procedure Duration
timeFrame: During the procedure
measure: Radiation Duration
timeFrame: During the procedure
measure: Radiology Dose
timeFrame: During the procedure
measure: Compression "hemostasis" time
timeFrame: Up to 240 minutes after band placement
measure: Arterial spasm
timeFrame: During the procedure
measure: Hematoma and bleeding complications
timeFrame: Within 24 hours after the procedure
measure: Ischemic changes to the hand
timeFrame: Within 24 hours after the procedure
measure: Crossover (failure to puncture)
timeFrame: During the procedure
measure: Procedural pain
timeFrame: During the procedure
measure: Post-procedural pain
timeFrame: Within 24 hours after the procedure
measure: Rare complications
timeFrame: Within 24 hours after the procedure
measure: Radial Artery Occlusion on follow up
timeFrame: After 2 weeks of the procedure.
Other outcomes:
Locations:
city: Nablus
country: Palestinian Territory, occupied
facility: An-Najah National University Hospital
Study officials:
affiliation: An-Najah National University
name: Yunis Daralammouri, asst. prof.
role: PRINCIPAL_INVESTIGATOR
References: