Radial Artery InjuryEASY-RAONCT04439513
Dual Artery Compression vs. Radial Artery-Only Hemostasis: Impact on Radial Artery Occlusion (EASY-RAO)
A study testing Hemostasis in people with Radial Artery Injury, run by Olivier F. Bertrand at 1 site in Canada.
Trial summary
This study aims to demonstrate the superiority in clinical performances of a dual artery compression device (Terry-2 band) compared to a standard radial artery-only hemostasis device (HemoSTOP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radial Artery Injury
- What is being tested?
- Hemostasis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 18 Jun 2020to Dec 2022
- 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
- any patients referred for diagnostic angiography and possible percutaneous coronary intervention (PCI)
Who cannot join
- Patient unable to understand study design or objectives
- Unable to sign informed consent
- Patient taking warfarin or other anticoagulant therapy
- Chronic RAO on both sides precluding TRA
- Previous ipsilateral transradial approach
- Inability to comply with the study follow-up
- Presence of plethysmographic waveform with radial and ulnar occlusive compression
- Pre-existing local complication (i.e. hematoma, pseudo-aneurysm, ...) precluding access-site evaluation.
Trial locations and contacts
1 site in 1 country.
Michèle Jadin contact
Canada1 site, 1 recruiting
- Recruiting
IUCPQ - Laval Hospital
Québec, G1V 4G5
Olivier F Bertrand, MD PhD, 418 656 8711, olivier.bertrand@crhl.ulaval.ca
Olivier F Bertrand, MD PhD
About this study
Official title: Randomized Comparison f Dual Artery Compression Versus Radial Artery-Only Hemostasis: Impact on Radial Artery Occlusion (EArly Discharge After Transradial Stenting of coronarY Arteries - EASY-RAO)
This study aims to demonstrate the superiority in clinical performances of a dual artery compression device (Terry-2 band) compared to a standard radial artery-only hemostasis device (HemoSTOP).
- Conditions
- Radial Artery Injury
- Being tested
- Hemostasis
- Keywords
- RAO, Hemostasis, TRA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemostasisDevice
Compression device to achieve hemostasis.
| Study group | Role | What they receive |
|---|---|---|
| Dual Artery Compression | Experimental | time to hemostasis and incidence of radial artery occlusion will be monitored while using a dual artery compression device (Terry-2-band) to achieve hemostasis. Receives: Device: Hemostasis |
| Radial Artery-Only | Active comparator | time to hemostasis and incidence of radial artery occlusion will be monitored while using the device currently approved by the institution (Hemo-Stop) and following institutional protocols for hemostasis. Receives: Device: Hemostasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of RAO after transradial approach (TRA) at hospital discharge
To determine whether the use of a dual artery compression decreases the rate of radial artery occlusion after transradial catheterization.
Measured: up to 24 hours
Secondary outcomes (4)
Percentage of radial artery patent-hemostasis during hemostasis
To determine the conservation of blood flow through the radial artery during compressive hemostasis
Measured: throughout intervention, up to 180 minutes
Patient comfort during hemostasis as assessed on a visual scale
To evaluate the level of patient comfort in relation to the device used
Measured: throughout intervention, up to 30 days
Rates of complications such as repeat bleeding and hematoma (EASY Scale)
To determine the incidence of complications in relation to the device used. Bleeding, spasm and presence of hematomas will be evaluated.
Measured: throughout intervention, up to 30 days
Nursing involvement in hemostasis management for sensitivity analysis on cost assessment
To determine the overall nursing involvement (time per nurse per patient) in hemostasis monitoring from end of procedure to patient discharge for a cost-benefit evaluation.
Measured: throughout intervention, up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start18 Jun 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radial Artery InjuryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olivier F. Bertrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Olivier F. Bertrand, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04439513
- Sponsor's protocol ID
- EASY-RAO
- Other IDs
- 2020-3400, 21885
- Acronym
- EASY-RAO
- Status last verified
- Jan 2022
- First submitted
- 15 Jun 2020
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison f Dual Artery Compression Versus Radial Artery-Only Hemostasis: Impact on Radial Artery Occlusion (EArly Discharge After Transradial Stenting of coronarY Arteries - EASY-RAO)
- ClinicalTrials.gov ID
- NCT04439513
- Acronym / sponsor ID
- EASY-RAO / EASY-RAO
- Conditions
- Radial Artery Injury
- Keywords
- RAO, Hemostasis, TRA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Olivier F. BertrandUniversity, hospital or other
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 19 Jun 2020 (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.
This study aims to demonstrate the superiority in clinical performances of a dual artery compression device (Terry-2 band) compared to a standard radial artery-only hemostasis device (HemoSTOP).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual Artery Compression | Experimental | Device: Hemostasistime to hemostasis and incidence of radial artery occlusion will be monitored while using a dual artery compression device (Terry-2-band) to achieve hemostasis. |
| Radial Artery-Only | Active comparator | Device: Hemostasistime to hemostasis and incidence of radial artery occlusion will be monitored while using the device currently approved by the institution (Hemo-Stop) and following institutional protocols for hemostasis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- any patients referred for diagnostic angiography and possible percutaneous coronary intervention (PCI)
Key exclusion criteria (8 listed)
- Patient unable to understand study design or objectives
- Unable to sign informed consent
- Patient taking warfarin or other anticoagulant therapy
- Chronic RAO on both sides precluding TRA
- Previous ipsilateral transradial approach
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 |
|---|---|---|
| HemostasisCompression device to achieve hemostasis. | Device | Dual Artery Compression, Radial Artery-Only |
Primary outcome
Rate of RAO after transradial approach (TRA) at hospital discharge
Time frame: up to 24 hours
To determine whether the use of a dual artery compression decreases the rate of radial artery occlusion after transradial catheterization.
4 secondary outcomes
Percentage of radial artery patent-hemostasis during hemostasis
Time frame: throughout intervention, up to 180 minutes
Patient comfort during hemostasis as assessed on a visual scale
Time frame: throughout intervention, up to 30 days
Rates of complications such as repeat bleeding and hematoma (EASY Scale)
Time frame: throughout intervention, up to 30 days
Nursing involvement in hemostasis management for sensitivity analysis on cost assessment
Time frame: throughout intervention, up to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Michèle Jadin contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemostasis in people with Radial Artery Injury, run by Olivier F. Bertrand at 1 site in Canada.
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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 31 Jan 2022. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier F Bertrand (4186568711, olivier.bertrand@crhl.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of RAO after transradial approach (TRA) at hospital discharge (time frame: up to 24 hours). 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 31 Jan 2022.