Peripheral Artery OcclusionNCT02583854
Comparison Study of Compression Devices Used in Transradial Coronary Angiography
A study testing RY-STOP hemostasis device and TR-Band, Terumo in people with Peripheral Artery Occlusion and Hemostasis, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The transradial route is used in 90% of the coronary angiograms performed at Oslo University Hospital (OUS), Ullevål. A compression device needs to be applied after the procedure to achieve hemostasis. Patients and staff will benefit from using a device that yields safe and painless hemostasis. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Peripheral Artery Occlusion, Hemostasis, Injury of Radial Artery
- What is being tested?
- RY-STOP hemostasis device and TR-Band, Terumo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 499 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2015to 1 Nov 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing coronary angiograms via the transradial route
Who cannot join
- Patients who have a long way to travel for the follow up, ultrasound scan
- Patients that do not understand Norwegian
- Patients presenting with acute ST segment elevation myocardial infarction (STEMI)
Trial locations and contacts
1 site in 1 country.
About this study
The transradial route is used in 90% of the coronary angiograms performed at Oslo University Hospital (OUS), Ullevål. A compression device needs to be applied after the procedure to achieve hemostasis. Patients and staff will benefit from using a device that yields safe and painless hemostasis.
Patients will be randomly assigned to receive either the standard compression device (control group, A) or a recently developed compression device (experimental group, B). The study will be designed as a non-inferiority, prospective randomized controlled trial, with outcome measures being patient comfort during compression time and complication rates. Complications that will be measured are radial artery occlusion (RAO) measured using ultrasound at a follow up visit. Hematomas or bleeds from the puncture site after application of the compression device will also be classified as complications.
The aim of the study is to investigate whether the new device, RY-STOP is non-inferior compared to the standard device, when considering the outcome measures.
- Being tested
- RY-STOP hemostasis device, TR-Band, Terumo
- Keywords
- Coronary angiography, Transradial, Patient experience, VAS, Compression device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RY-STOP hemostasis deviceDevice
TR-Band, TerumoDevice
| Study group | Role | What they receive |
|---|---|---|
| Hemostasis achieved by TR Band | Active comparator | After the transradial procedure and randomization TR Band will be applied to achieve hemostasis. Patient experience and complications after the application will be measured. Receives: Device: TR-Band, Terumo |
| Hemostasis achieved by RY Stop | Experimental | After the transradial procedure and randomization, RY Stop will be applied to achieve hemostasis. Patient experience and complications after the application will be measured. Receives: Device: RY-STOP hemostasis device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radial artery occlusion
Subjects wil have an ultrasound scan of their radial artery preformed after their transradial coronary angiogram to see the rate of occluded arteries.
Measured: 90-120 days
Secondary outcomes (2)
Patient experience
Patients will be asked to rate their comfort level associated with the hemostasis device they have been assigned
Measured: 1-4 hours
Device complications
Staff responsible for the application of the hemostasis devices will be asked to observe and record bleeds and hematomas that occur.
Measured: 1-4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startSep 2015
- Primary completion15 May 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery OcclusionStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 499 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Sor-Ost
- Responsible party
- Principal investigator, Anders Opdahl, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583854
- Sponsor's protocol ID
- 573099
- Status last verified
- Apr 2018
- First submitted
- 21 Oct 2015
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Due-Tonnessen N, Egeland CH, Meyerdierks OJ, Opdahl A. Is radial artery occlusion and local vascular complications following transradial coronary procedures affected by the type of haemostasis device used? A non-inferiority Randomized Controlled Trial (RadCom trial). Eur J Cardiovasc Nurs. 2021 Aug 20;20(6):580-587. doi: 10.1093/eurjcn/zvab004.
PubMed 33615328
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Study of Compression Devices Used in Transradial Coronary Angiography
- ClinicalTrials.gov ID
- NCT02583854
- Acronym / sponsor ID
- 573099
- Keywords
- Coronary angiography, Transradial, Patient experience, VAS, Compression device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 499 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Helse Sor-Ost
- Study start
- Sep 2015 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 22 Oct 2015 (estimated)
- 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 transradial route is used in 90% of the coronary angiograms performed at Oslo University Hospital (OUS), Ullevål. A compression device needs to be applied after the procedure to achieve hemostasis. Patients and staff will benefit from using a device that yields safe and painless hemostasis.
Patients will be randomly assigned to receive either the standard compression device (control group, A) or a recently developed compression device (experimental group, B). The study will be designed as a non-inferiority, prospective randomized controlled trial, with outcome measures being patient comfort during compression time and complication rates. Complications that will be measured are radial artery occlusion (RAO) measured using ultrasound at a follow up visit. Hematomas or bleeds from the puncture site after application of the compression device will also be classified as complications.
The aim of the study is to investigate whether the new device, RY-STOP is non-inferior compared to the standard device, when considering the outcome measures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemostasis achieved by TR Band | Active comparator | Device: TR-Band, TerumoAfter the transradial procedure and randomization TR Band will be applied to achieve hemostasis. Patient experience and complications after the application will be measured. |
| Hemostasis achieved by RY Stop | Experimental | Device: RY-STOP hemostasis deviceAfter the transradial procedure and randomization, RY Stop will be applied to achieve hemostasis. Patient experience and complications after the application will be measured. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing coronary angiograms via the transradial route
Key exclusion criteria (3 listed)
- Patients who have a long way to travel for the follow up, ultrasound scan
- Patients that do not understand Norwegian
- Patients presenting with acute ST segment elevation myocardial infarction (STEMI)
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 |
|---|---|---|
| RY-STOP hemostasis device | Device | Hemostasis achieved by RY Stop |
| TR-Band, Terumo | Device | Hemostasis achieved by TR Band |
Primary outcome
Radial artery occlusion
Time frame: 90-120 days
Subjects wil have an ultrasound scan of their radial artery preformed after their transradial coronary angiogram to see the rate of occluded arteries.
2 secondary outcomes
Patient experience
Time frame: 1-4 hours
Device complications
Time frame: 1-4 hours
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 10 Apr 2018.
- Derived from this study: PubMed 33615328Due-Tonnessen N, Egeland CH, Meyerdierks OJ, Opdahl A. Is radial artery occlusion and local vascular complications following transradial coronary procedures affected by the type of haemostasis device used? A non-inferiority Randomized Controlled Trial (RadCom trial). Eur J Cardiovasc Nurs. 2021 Aug 20;20(6):580-587. doi: 10.1093/eurjcn/zvab004.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RY-STOP hemostasis device and TR-Band, Terumo in people with Peripheral Artery Occlusion and Hemostasis, run by Oslo University Hospital at 1 site in Norway.
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 3 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 10 Apr 2018. 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 Norway. 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: 90-120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02583854, which also lists 1 linked publication.
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 10 Apr 2018.