RadialACCESS-IINCT03060460
Ultrasound Guided Insertion of Sheath Before Angiography or Angioplasty
A study testing Ultrasound guided sheath insertion in people with Radial and Angioplasty, run by Christian Juhl Terkelsen at 1 site in Denmark.
Trial summary
The study evaluates whether routine use of ultrasound for sheath insertion during radial or femoral angiography or angioplasty has any impact on: number of punctures, patient discomfort, procedural length, successfull procedure or ideal vessel puncture. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Radial, Angioplasty, Angiography
- What is being tested?
- Ultrasound guided sheath insertion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Apr 2017to 31 Dec 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients scheduled for angiography or angioplasty in whom both radial and femoral access is possible
Who cannot join
- Abnormal pulse oxymetry test
- If severe lower-extremity calcification is known to exclude femoral access
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 Evaluation of Traditional Versus Ultrasound Guided Insertion of Sheath Before Angiography or Angioplasty
The study evaluates whether routine use of ultrasound for sheath insertion during radial or femoral angiography or angioplasty has any impact on: number of punctures, patient discomfort, procedural length, successfull procedure or ideal vessel puncture.
Read the detailed description
A randomised study with an historical control group.
Initially data on prespecified endpoints are collected for an historical control group of 200 patients (100 radial and 100 femoral procedures). Hereafter 400 patients are randomized to ultrasound guided or conventional sheath insertion (200 radial and 200 femoral procedures).
Only high-volume physicians who have passed a ultrasound course are allowed to include patients.
- Conditions
- Radial, Angioplasty, Angiography, Ultrasound, Randomized
- Being tested
- Ultrasound guided sheath insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided sheath insertionDiagnostic test
ultrasound is used routinely for sheath insertion
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound arm - Randomized group | Experimental | Ultrasound guided sheath insertion Receives: Diagnostic Test: Ultrasound guided sheath insertion |
| Conventional arm - Randomized group | No intervention | Conventional arm during randomized phase |
| Historical control group | No intervention | Conventional arm, non-randomization phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of puncture attempts
Number of attempts to puncture the vessel as evaluated by the physician and by go-pro camera recordings
Measured: during the procedure
time of procedure
time from administration of analgetics to removal of the sheath
Measured: during the procedure
Placement of sheath
Distance from proc.styloideus radius (radial procedure) or proximal part of caput femoris (femoral procedure) to vessel puncture site evaluated by angiography
Measured: during the procedure
Pain during sheath insertion and during the procedure
Pain according to numerical rating scale during sheath insertion and during the procedure
Measured: during the procedure
Successfull procedure
Proportion of patients where the procedure is completed according to prespecified access route (no conversion to femoral access if radial planned, and no conversion to radial access if femoral planned)
Measured: during the procedure
Secondary outcomes (4)
Use of analgetics
Cummulated dose of analgetics during the procedure
Measured: during the procedure
Use of sedatives
Cummulated dose of sedatives during the procedure
Measured: during the procedure
Use of calcium blocker
Cummulated dose of calcium blocker during the procedure
Measured: during the procedure
Radial artery patency
Patency according to reverse Barbeau test at time of sheath removal
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start26 Apr 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2018
Why it stopped: slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadialStudies 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
- Sequential
- Model description
- historical control cohort (Group A) and then a randomized prospective study (Group B and C).
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christian Juhl Terkelsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christian Juhl Terkelsen, Aarhus University Hospital Skejby
- Investigators
- erik sloth, professor, Study chair, Department of anaestesiology, Aarhus University Hospital, DK-8200 Aarhus N
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060460
- Sponsor's protocol ID
- ACCESS-II
- Acronym
- ACCESS-II
- Status last verified
- Apr 2019
- First submitted
- 18 Feb 2017
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymous data can be shared
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Evaluation of Traditional Versus Ultrasound Guided Insertion of Sheath Before Angiography or Angioplasty
- ClinicalTrials.gov ID
- NCT03060460
- Acronym / sponsor ID
- ACCESS-II / ACCESS-II
- Conditions
- Radial, Angioplasty, Angiography, Ultrasound, Randomized
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Christian Juhl TerkelsenUniversity, hospital or other
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 23 Feb 2017 (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 study evaluates whether routine use of ultrasound for sheath insertion during radial or femoral angiography or angioplasty has any impact on: number of punctures, patient discomfort, procedural length, successfull procedure or ideal vessel puncture.
Detailed description
A randomised study with an historical control group.
Initially data on prespecified endpoints are collected for an historical control group of 200 patients (100 radial and 100 femoral procedures). Hereafter 400 patients are randomized to ultrasound guided or conventional sheath insertion (200 radial and 200 femoral procedures).
Only high-volume physicians who have passed a ultrasound course are allowed to include patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- historical control cohort (Group A) and then a randomized prospective study (Group B and C).
| Arm | Type | Receives |
|---|---|---|
| Ultrasound arm - Randomized group | Experimental | Diagnostic Test: Ultrasound guided sheath insertionUltrasound guided sheath insertion |
| Conventional arm - Randomized group | No intervention | –Conventional arm during randomized phase |
| Historical control group | No intervention | –Conventional arm, non-randomization phase |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients scheduled for angiography or angioplasty in whom both radial and femoral access is possible
Key exclusion criteria (2 listed)
- Abnormal pulse oxymetry test
- If severe lower-extremity calcification is known to exclude femoral access
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 |
|---|---|---|
| Ultrasound guided sheath insertionultrasound is used routinely for sheath insertion | Diagnostic test | Ultrasound arm - Randomized group |
Primary outcome
number of puncture attempts
Time frame: during the procedure
Number of attempts to puncture the vessel as evaluated by the physician and by go-pro camera recordings
time of procedure
Time frame: during the procedure
time from administration of analgetics to removal of the sheath
Placement of sheath
Time frame: during the procedure
Distance from proc.styloideus radius (radial procedure) or proximal part of caput femoris (femoral procedure) to vessel puncture site evaluated by angiography
Pain during sheath insertion and during the procedure
Time frame: during the procedure
Pain according to numerical rating scale during sheath insertion and during the procedure
Successfull procedure
Time frame: during the procedure
Proportion of patients where the procedure is completed according to prespecified access route (no conversion to femoral access if radial planned, and no conversion to radial access if femoral planned)
4 secondary outcomes
Use of analgetics
Time frame: during the procedure
Use of sedatives
Time frame: during the procedure
Use of calcium blocker
Time frame: during the procedure
Radial artery patency
Time frame: during the procedure
Results and safety
The study was stopped early (reason given: slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Individual participant dataSharing planned: No. Anonymous data can be shared
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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.
erik sloth, professor study chair
Department of anaestesiology, Aarhus University Hospital, DK-8200 Aarhus N
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided sheath insertion in people with Radial and Angioplasty, run by Christian Juhl Terkelsen 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 1 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: stopped early, as of the sponsor's last update on 4 Apr 2019. 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 was stopped early (reason given: slow recruitment). Results are not available in the source record.
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?
number of puncture attempts (time frame: during the procedure). 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 4 Apr 2019.