Radial AngiographyACCESS-INCT02637843
Randomized Comparison of Sheaths for Radial Access
A study testing Slender Sheath in people with Radial Angiography, run by Aarhus University Hospital Skejby at 1 site in Denmark.
Trial summary
Coronary angiography (CAG) and possible angioplasty (Percutaneous Coronary Intervention = PCI) can be performed by access from the groin (a. femoralis), the wrist (a. radialis) or the elbow (a. brachialis). It is well established that there is less risk of bleeding complications when using a radial access. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Radial Angiography
- What is being tested?
- Slender Sheath
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2015to Jul 2016
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients scheduled for radial angiography or angioplasty
- Able to give written informed consent
Who cannot join
- Negative Barbaue test or Allens test
- Use of 8F catheters
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of cardiology, Aarhus University Hospital in Skejby
Aarhus, 8200
About this study
Official title: Randomized Comparison of Coated Slender Versus Un-coated Traditional Sheath
Coronary angiography (CAG) and possible angioplasty (Percutaneous Coronary Intervention = PCI) can be performed by access from the groin (a. femoralis), the wrist (a. radialis) or the elbow (a. brachialis). It is well established that there is less risk of bleeding complications when using a radial access. The smaller diameters of the vessels in the forearm, however, may result in increased risk of pain during CAG/PCI via a. radialis. This is associated with vascular spasm (spasm tendency). Ultimately this means that one may have to convert to access via a. femoralis.
To perform a CAG/PCI, a tube (a so-called sheath) has to be inserted in a. radialis. It is unclear whether the design of the sheaths can reduce the spasm tendency, thus reducing pain. Terumo has recently introduced a new kind of sheath, so-called Terumo Glide Slender Heath Coated (hereafter referred to as "Slender sheath"). This sheath is partly coated, partly made of a thinner material. "Slender sheath" thus has an outer diameter smaller than that of the sheath from traditional use (Terumo Radio Focus sheath, hereafter referred to as "Standard sheath"), although the inner diameter (lumen) is the same in the two sheaths. In turn, the "Slender sheath" is more fragile and far more expensive.
The purpose of the present study is to evaluate whether use of slender sheath compared with standard sheath is Associated with less pain and fewer complications following CAG/PCI.
Read the detailed description
Study design: Randomized study
Purposes: to investigate whether the use of "Slender sheath" is associated with less pain compared to use of "Standard Sheath" and less complications corresponding at the access site. Specific hypotheses:
- Use of "Slender sheath" results in less pain related to CAG/PCI compared to use of "Standard sheath".
- Use of "Slender sheath" is associated with fewer conversions to femoral access compared to use of "Standard sheath".
- Use of "Slender sheath" is associated with less use of analgesic during the procedure compared to use of "Standard sheath".
- Use of "Slender sheath" is associated with fewer cases of occlusion of a. radialis at discharge and post-examination compared to use of "Standard sheath".
Time Schedule The trial will run from December 2015 until a total number of 1000 patients are included. It is expected that the data collection and publication of the results will be completed within a year.
Endpoints
- Pain related to the application of the sheath (Visual Analog Scale = VAS)
- Maximal pain during CAG/PCI (VAS)
- Frequency of conversions to femoral access
- Use of analgesics (cumulative amount of mg Fentanyl given)
- Use of sedatives (cumulative amount of mg Midazolam given)
- Use of Verapamil (cumulative amount of mg given, used to reduce spasms)
- Number of catheters used
- Number of sheaths used (femoral and radial)
- Occlusion of a. radialis at the time of discharge estimated by ultrasound of the artery
- Occlusion of a. radialis after a month (Assumes that all patients with open vessels at discharge also have open vessels after a month. Only patients with occluded vessels at discharge will be offered a new ultrasound scan)
- Conditions
- Radial Angiography
- Being tested
- Slender Sheath
- Keywords
- radial, angiography, angioplasty, randomized, sheath, slender
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slender SheathDevice
Comparing outcomes for two different sheaths used during radial CAG/PCI
| Study group | Role | What they receive |
|---|---|---|
| Slender arm | Active comparator | Uses the terumo slender sheath for radial angiography or angioplasty Receives: Device: Slender Sheath |
| Standard arm | No intervention | Uses the terumo standard sheath (Routine) for radial angiography or angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during sheath insertion
Maximal pain (Visual analogue scale) during sheath insertion
Measured: 1-2 minutes during sheath insertion
Pain during the procedure
Maximal pain (Visual analogue scale) during CAG/PCI
Measured: 10 minutes to 2 hours (during CAG/PCI)
Proportion converted to femoral access
Proportion of patients where the operator has to change to femoral access to complete the CAG/PCI
Measured: 10 minutes to 2 hours (during CAG/PCI)
Use of analgesics, sedatives and verapamil during the procedure
cumulative amount of analgesics, sedatives and verapamil during the procedure
Measured: 10 minutes to 2 hours (during CAG/PCI)
Patency of a.radialis
Ultrasound and reverse Barbaeu test is performed to test patency of a.radialis following CAG/PCI. If patency not documented at time of discharge the tests are repeated at one month. The artery is patent if normal Barbaue test and ultrasound without occlusion.
Measured: Within one month of CAG/PCI
Secondary outcomes (2)
Number of catheters used
cumulative number of catheters used during the procedure
Measured: 10 minutes to 2 hours (during CAG/PCI)
Number of sheaths used
cumulative number of sheaths used during the procedure
Measured: 10 minutes to 2 hours (during CAG/PCI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radial AngiographyStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Juhl Terkelsen, Aarhus University Hospital Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637843
- Sponsor's protocol ID
- ACCESS-I
- Acronym
- ACCESS-I
- Status last verified
- Aug 2016
- First submitted
- 16 Dec 2015
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Coated Slender Versus Un-coated Traditional Sheath
- ClinicalTrials.gov ID
- NCT02637843
- Acronym / sponsor ID
- ACCESS-I / ACCESS-I
- Conditions
- Radial Angiography
- Keywords
- radial, angiography, angioplasty, randomized, sheath, slender
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 22 Dec 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.
Coronary angiography (CAG) and possible angioplasty (Percutaneous Coronary Intervention = PCI) can be performed by access from the groin (a. femoralis), the wrist (a. radialis) or the elbow (a. brachialis). It is well established that there is less risk of bleeding complications when using a radial access. The smaller diameters of the vessels in the forearm, however, may result in increased risk of pain during CAG/PCI via a. radialis. This is associated with vascular spasm (spasm tendency). Ultimately this means that one may have to convert to access via a. femoralis.
To perform a CAG/PCI, a tube (a so-called sheath) has to be inserted in a. radialis. It is unclear whether the design of the sheaths can reduce the spasm tendency, thus reducing pain. Terumo has recently introduced a new kind of sheath, so-called Terumo Glide Slender Heath Coated (hereafter referred to as "Slender sheath"). This sheath is partly coated, partly made of a thinner material. "Slender sheath" thus has an outer diameter smaller than that of the sheath from traditional use (Terumo Radio Focus sheath, hereafter referred to as "Standard sheath"), although the inner diameter (lumen) is the same in the two sheaths. In turn, the "Slender sheath" is more fragile and far more expensive.
The purpose of the present study is to evaluate whether use of slender sheath compared with standard sheath is Associated with less pain and fewer complications following CAG/PCI.
Detailed description
Study design: Randomized study
Purposes: to investigate whether the use of "Slender sheath" is associated with less pain compared to use of "Standard Sheath" and less complications corresponding at the access site. Specific hypotheses:
- Use of "Slender sheath" results in less pain related to CAG/PCI compared to use of "Standard sheath".
- Use of "Slender sheath" is associated with fewer conversions to femoral access compared to use of "Standard sheath".
- Use of "Slender sheath" is associated with less use of analgesic during the procedure compared to use of "Standard sheath".
- Use of "Slender sheath" is associated with fewer cases of occlusion of a. radialis at discharge and post-examination compared to use of "Standard sheath".
Time Schedule The trial will run from December 2015 until a total number of 1000 patients are included. It is expected that the data collection and publication of the results will be completed within a year.
Endpoints
- Pain related to the application of the sheath (Visual Analog Scale = VAS)
- Maximal pain during CAG/PCI (VAS)
- Frequency of conversions to femoral access
- Use of analgesics (cumulative amount of mg Fentanyl given)
- Use of sedatives (cumulative amount of mg Midazolam given)
- Use of Verapamil (cumulative amount of mg given, used to reduce spasms)
- Number of catheters used
- Number of sheaths used (femoral and radial)
- Occlusion of a. radialis at the time of discharge estimated by ultrasound of the artery
- Occlusion of a. radialis after a month (Assumes that all patients with open vessels at discharge also have open vessels after a month. Only patients with occluded vessels at discharge will be offered a new ultrasound scan)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Slender arm | Active comparator | Device: Slender SheathUses the terumo slender sheath for radial angiography or angioplasty |
| Standard arm | No intervention | –Uses the terumo standard sheath (Routine) for radial angiography or angioplasty |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients scheduled for radial angiography or angioplasty
- Able to give written informed consent
Key exclusion criteria (2 listed)
- Negative Barbaue test or Allens test
- Use of 8F catheters
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 |
|---|---|---|
| Slender SheathComparing outcomes for two different sheaths used during radial CAG/PCI | Device | Slender arm |
Primary outcome
Pain during sheath insertion
Time frame: 1-2 minutes during sheath insertion
Maximal pain (Visual analogue scale) during sheath insertion
Pain during the procedure
Time frame: 10 minutes to 2 hours (during CAG/PCI)
Maximal pain (Visual analogue scale) during CAG/PCI
Proportion converted to femoral access
Time frame: 10 minutes to 2 hours (during CAG/PCI)
Proportion of patients where the operator has to change to femoral access to complete the CAG/PCI
Use of analgesics, sedatives and verapamil during the procedure
Time frame: 10 minutes to 2 hours (during CAG/PCI)
cumulative amount of analgesics, sedatives and verapamil during the procedure
Patency of a.radialis
Time frame: Within one month of CAG/PCI
Ultrasound and reverse Barbaeu test is performed to test patency of a.radialis following CAG/PCI. If patency not documented at time of discharge the tests are repeated at one month. The artery is patent if normal Barbaue test and ultrasound without occlusion.
2 secondary outcomes
Number of catheters used
Time frame: 10 minutes to 2 hours (during CAG/PCI)
Number of sheaths used
Time frame: 10 minutes to 2 hours (during CAG/PCI)
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 16 Aug 2016.
- 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.
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 Slender Sheath in people with Radial Angiography, run by Aarhus University Hospital Skejby at 1 site in Denmark.
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 2 inclusion and 2 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 16 Aug 2016. 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 Denmark. 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?
Pain during sheath insertion (time frame: 1-2 minutes during sheath insertion). The study lists 5 primary outcomes in all. 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 16 Aug 2016.