Coronary Artery DiseaseDRAvsFRANCT04125992
Distal vs. Forearm Radial Artery Access
A study testing distal radial artery access in coronary angiography and angioplasty and Forearm radial artery access in coronary angiography and angioplasty in people with Coronary Artery Disease and Angina, Unstable, run by An-Najah National University at 1 site in Palestinian Territories.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Angina, Unstable, Angina, Stable
- What is being tested?
- distal radial artery access in coronary angiography and angioplasty and Forearm radial artery access in coronary angiography and angioplasty
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 1 Dec 2019to 21 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
An-Najah National University Hospital
Nablus
About this study
Official title: Distal Radial Artery Access in Comparison to Forearm Radial Artery Access for Cardiac Catheterization, a Randomized Controlled Trial
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
- Being tested
- distal radial artery access in coronary angiography and angioplasty, Forearm radial artery access in coronary angiography and angioplasty
- 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
- Medical subject headings
- Coronary Artery Disease, Angina, Unstable, Angina, Stable, Non-ST Elevated Myocardial Infarction, Acute Coronary Syndrome, Chest Pain, Myocardial Infarction, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
distal radial artery access in coronary angiography and angioplastyProcedure or surgery
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 angioplastyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Distal Radial | Experimental | Patients who undergo coronary catheterization by accessing the distal radial artery in the snuff-box of the hand. Receives: 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. Receives: Procedure: Forearm radial artery access in coronary angiography and angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radial artery occlusion
Doppler Ultrasonography of the radial artery for occlusions along its course, in both groups.
Measured: Within 24 hours after the procedure.
Secondary outcomes (14)
Puncture Time
Which is time from first attempt to puncture to the successful one in seconds
Measured: During the procedure
Puncture Attempts
Which is the number of puncture attempts from first one until the successful one (maximum 6)
Measured: During the procedure
Procedure Duration
In minutes from the insertion of the sheath to its exertion.
Measured: During the procedure
Radiation Duration
Which is measured by the radiological device in minutes.
Measured: During the procedure
Radiology Dose
Which is measured by the radiological device in mGy.
Measured: 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.
Measured: 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.
Measured: During the procedure
Hematoma and bleeding complications
It is defined by EASY hematoma scale.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After 2 weeks of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start1 Dec 2019
- Primary completion21 Dec 2020
- Study completion21 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- An-Najah National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunis Daralammouri, An-Najah National University
- Investigators
- Yunis Daralammouri, asst. prof., Principal investigator, An-Najah National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125992
- Sponsor's protocol ID
- DRAvsFRA
- Acronym
- DRAvsFRA
- Status last verified
- Jun 2023
- First submitted
- 29 Sep 2019
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distal Radial Artery Access in Comparison to Forearm Radial Artery Access for Cardiac Catheterization, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04125992
- Acronym / sponsor ID
- DRAvsFRA / DRAvsFRA
- Conditions
- Coronary Artery Disease, Angina, Unstable, Angina, Stable, Non STEMI, Non ST Segment Elevation Myocardial Infarction, Acute Coronary Syndrome
- Keywords
- cardiac catheterization, coronary angiography, coronary angioplasty, snuff-box, snuffbox, snuff box, radial fossa, distal radial artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- An-Najah National UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 21 Dec 2020 (actual)
- First posted
- 14 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Distal Radial | Experimental | Procedure: distal radial artery access in coronary angiography and angioplastyPatients who undergo coronary catheterization by accessing the distal radial artery in the snuff-box of the hand. |
| Forearm Radial | Active comparator | Procedure: Forearm radial artery access in coronary angiography and angioplastyPatients who undergo conventional coronary catheterization by accessing the forearm radial artery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| distal radial artery access in coronary angiography and angioplastyThe 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. | Procedure or surgery | Distal Radial |
| Forearm radial artery access in coronary angiography and angioplastyThe 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. | Procedure or surgery | Forearm Radial |
Primary outcome
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.
14 secondary outcomes
Puncture Time
Time frame: During the procedure
Puncture Attempts
Time frame: During the procedure
Procedure Duration
Time frame: During the procedure
Radiation Duration
Time frame: During the procedure
Radiology Dose
Time frame: During the procedure
Compression "hemostasis" time
Time frame: Up to 240 minutes after band placement
Arterial spasm
Time frame: During the procedure
Hematoma and bleeding complications
Time frame: Within 24 hours after the procedure
Ischemic changes to the hand
Time frame: Within 24 hours after the procedure
Crossover (failure to puncture)
Time frame: During the procedure
Procedural pain
Time frame: During the procedure
Post-procedural pain
Time frame: Within 24 hours after the procedure
Rare complications
Time frame: Within 24 hours after the procedure
Radial Artery Occlusion on follow up
Time frame: After 2 weeks of the procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yunis Daralammouri, asst. prof. principal investigator
An-Najah National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing distal radial artery access in coronary angiography and angioplasty and Forearm radial artery access in coronary angiography and angioplasty in people with Coronary Artery Disease and Angina, Unstable, run by An-Najah National University at 1 site in Palestinian Territories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radial artery occlusion (time frame: Within 24 hours after the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.