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Distal vs. Forearm Radial Artery Access (DRAvsFRA)

Primary Purpose

Coronary Artery Disease, Angina, Unstable, Angina, Stable

Status
Completed
Phase
Not Applicable
Locations
Palestinian Territory, occupied
Study Type
Interventional
Intervention
distal radial artery access in coronary angiography and angioplasty
Forearm radial artery access in coronary angiography and angioplasty
Sponsored by
An-Najah National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • An-Najah National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Distal Radial

Forearm Radial

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Puncture Time
Which is time from first attempt to puncture to the successful one in seconds
Puncture Attempts
Which is the number of puncture attempts from first one until the successful one (maximum 6)
Procedure Duration
In minutes from the insertion of the sheath to its exertion.
Radiation Duration
Which is measured by the radiological device in minutes.
Radiology Dose
Which is measured by the radiological device in mGy.
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.
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.
Hematoma and bleeding complications
It is defined by EASY hematoma scale.
Ischemic changes to the hand
It is noted by clinical features of pallor, absence of pulse, pain, cold, paresthesia or paralysis.
Crossover (failure to puncture)
It is transforming from the selected access to another after 6 failed attempts to puncture the first selected access
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.
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.
Rare complications
Pseudo-aneurysm, AV fistula formation, radial artery dissection, which are assessed by Doppler US. In addition to radial artery eversion or perforation.
Radial Artery Occlusion on follow up
Follow up Doppler Ultrasonography for patients with occluded radial artery within 24 hours.

Full Information

First Posted
September 29, 2019
Last Updated
June 4, 2023
Sponsor
An-Najah National University
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1. Study Identification

Unique Protocol Identification Number
NCT04125992
Brief Title
Distal vs. Forearm Radial Artery Access
Acronym
DRAvsFRA
Official Title
Distal Radial Artery Access in Comparison to Forearm Radial Artery Access for Cardiac Catheterization, a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
December 21, 2020 (Actual)
Study Completion Date
December 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
An-Najah National University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Distal Radial
Arm Type
Experimental
Arm Description
Patients who undergo coronary catheterization by accessing the distal radial artery in the snuff-box of the hand.
Arm Title
Forearm Radial
Arm Type
Active Comparator
Arm Description
Patients who undergo conventional coronary catheterization by accessing the forearm radial artery.
Intervention Type
Procedure
Intervention Name(s)
distal radial artery access in coronary angiography and angioplasty
Intervention Description
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
Intervention Name(s)
Forearm radial artery access in coronary angiography and angioplasty
Intervention Description
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 Outcome Measure Information:
Title
Radial artery occlusion
Description
Doppler Ultrasonography of the radial artery for occlusions along its course, in both groups.
Time Frame
Within 24 hours after the procedure.
Secondary Outcome Measure Information:
Title
Puncture Time
Description
Which is time from first attempt to puncture to the successful one in seconds
Time Frame
During the procedure
Title
Puncture Attempts
Description
Which is the number of puncture attempts from first one until the successful one (maximum 6)
Time Frame
During the procedure
Title
Procedure Duration
Description
In minutes from the insertion of the sheath to its exertion.
Time Frame
During the procedure
Title
Radiation Duration
Description
Which is measured by the radiological device in minutes.
Time Frame
During the procedure
Title
Radiology Dose
Description
Which is measured by the radiological device in mGy.
Time Frame
During the procedure
Title
Compression "hemostasis" time
Description
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
Title
Arterial spasm
Description
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
Title
Hematoma and bleeding complications
Description
It is defined by EASY hematoma scale.
Time Frame
Within 24 hours after the procedure
Title
Ischemic changes to the hand
Description
It is noted by clinical features of pallor, absence of pulse, pain, cold, paresthesia or paralysis.
Time Frame
Within 24 hours after the procedure
Title
Crossover (failure to puncture)
Description
It is transforming from the selected access to another after 6 failed attempts to puncture the first selected access
Time Frame
During the procedure
Title
Procedural pain
Description
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
Title
Post-procedural pain
Description
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
Title
Rare complications
Description
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
Title
Radial Artery Occlusion on follow up
Description
Follow up Doppler Ultrasonography for patients with occluded radial artery within 24 hours.
Time Frame
After 2 weeks of the procedure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunis Daralammouri, asst. prof.
Organizational Affiliation
An-Najah National University
Official's Role
Principal Investigator
Facility Information:
Facility Name
An-Najah National University Hospital
City
Nablus
Country
Palestinian Territory, occupied

12. IPD Sharing Statement

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Distal vs. Forearm Radial Artery Access

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