Embolism and Thrombosis of the Radial ArteryCAPITAL-PRONCT02324764
Use of Glidesheath Slender to Reduce Radial Artery Occlusion and Vascular Access Site Complications Following Transradial Coronary Angiography
A study testing Glidesheath Slender and standard 6- French radial sheath in people with Embolism and Thrombosis of the Radial Artery and Coronary Heart Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
The objective of this study is to determine the rate of radial artery occlusion and vascular access site complications following transradial angiogram using a new Terumo (Tokyo, Japan) Glidesheath Slender, in comparison with the currently used 6 French (6 Fr.) radial sheath. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Embolism and Thrombosis of the Radial Artery, Coronary Heart Disease
- What is being tested?
- Glidesheath Slender and standard 6- French radial sheath
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2014to 21 Mar 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing coronary angiography and/or PCI via transradial approach
- Informed consent
- Documented normal Allen's test
Who cannot join
- Patient who had a previous angiogram using the same radial artery
- Abnormal Allen's test
- Previous failed radial access.
- Known bleeding disorder or hypercoagulable condition
- Cardiogenic shock
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to determine the rate of radial artery occlusion and vascular access site complications following transradial angiogram using a new Terumo (Tokyo, Japan) Glidesheath Slender, in comparison with the currently used 6 French (6 Fr.) radial sheath.
Read the detailed description
Based on previously reported studies the rates of radial artery occlusion using a standard 6 Fr. sheath is around 5-10%, compared to the single feasibility study of the Glidesheath Slender by Aminian et al (see reference in the citations), the rate of radial artery occlusion was reported 0.88%.
This study will be a prospective randomized, single-blinded (patient-blinded) study, comparing the rate of radial artery occlusion and vascular access site complications between the Glidesheath Slender (Terumo, Tokyo, Japan) and the standard 6 Fr. radial sheath in patients undergoing transradial coronary catheterization.
- The study will enroll patients who will undergo elective or emergency coronary angiography and/or percutaneous coronary intervention (PCI) via transradial approach at the University of Ottawa Heart Institute.
- A baseline clinical vascular \& ultrasound assessment will be performed prior to the procedure to document patency of the radial artery.
- Patients will be randomized in 1:1 fashion to either receive the Terumo Glidesheath Slender versus the currently used 6 Fr. sheath.
- The standard angiogram/ PCI will be performed as per usual practice.
- Following the angiogram, clinical vascular assessment as well as an ultrasound will be performed prior to discharge.
- At 30 days follow up the patient will come back for clinical and ultrasound assessment of radial artery patency and access site vascular complications.
- Being tested
- Glidesheath Slender, standard 6- French radial sheath
- Keywords
- transradial coronary angiography, radial artery occlusion, coronary heart disease, Glidesheath Slender
- Medical subject headings
- Embolism, Coronary Disease, Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glidesheath SlenderDevice
Also called Glidesheath Slender, Terumo, Tokyo, Japan
testing the efficacy and safety of the new transradial sheath in comparison to the standard 6 french sheath.
standard 6- French radial sheathDevice
| Study group | Role | What they receive |
|---|---|---|
| Glidesheath Slender | Experimental | The transradial procedure will be performed using the glidesheath slender (studied sheath) Receives: Device: Glidesheath Slender |
| Standard sheath | Active comparator | The transradial procedure will be performed using the standard 6- French radial sheath (comparator sheath) Receives: Device: standard 6- French radial sheath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radial artery occlusion
Evaluated clinically and by ultrasound
Measured: 30 days
Secondary outcomes (5)
Vascular access site complications
Includes: Radial artery occlusion, bleeding or hematoma, pseudoaneurysm, artery dissection, compartment syndrome of the forearm
Measured: up to 30 days
Radial artery spasm
Measured: participants will be followed for the duration of hospital stay, an expected average of 1 day
Procedure success
Defined as ability to finish the angiogram/PCI via the intended access site, without the need to change access site.
Measured: participants will be followed for the duration of hospital stay, an expected average of 1 day
Sheath kinking
Major requiring sheath exchange or minor
Measured: participants will be followed for the duration of hospital stay, an expected average of 1 day
Painful sheath removal
Scored on a scale of 1-10 scoring system
Measured: participants will be followed for the duration of hospital stay, an expected average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2019
- Study completion21 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Embolism and Thrombosis of the Radial ArteryStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aun Yeong Chong, Ottawa Heart Institute Research Corporation
- Investigators
- Aun-Yeong Chong, MRCP, MD, Principal investigator, University of Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324764
- Sponsor's protocol ID
- 20140262
- Acronym
- CAPITAL-PRO
- Status last verified
- Jan 2022
- First submitted
- 8 Dec 2014
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kotowycz MA, Johnston KW, Ivanov J, Asif N, Almoghairi AM, Choudhury A, Nagy CD, Sibbald M, Chan W, Seidelin PH, Barolet AW, Overgaard CB, Dzavik V. Predictors of radial artery size in patients undergoing cardiac catheterization: insights from the Good Radial Artery Size Prediction (GRASP) study. Can J Cardiol. 2014 Feb;30(2):211-6. doi: 10.1016/j.cjca.2013.11.021. Epub 2013 Nov 23.
PubMed 24461923Aminian A, Dolatabadi D, Lefebvre P, Zimmerman R, Brunner P, Michalakis G, Lalmand J. Initial experience with the Glidesheath Slender for transradial coronary angiography and intervention: a feasibility study with prospective radial ultrasound follow-up. Catheter Cardiovasc Interv. 2014 Sep 1;84(3):436-42. doi: 10.1002/ccd.25232. Epub 2013 Nov 6.
PubMed 24285594Kotowycz MA, Dzavik V. Radial artery patency after transradial catheterization. Circ Cardiovasc Interv. 2012 Feb 1;5(1):127-33. doi: 10.1161/CIRCINTERVENTIONS.111.965871. No abstract available.
PubMed 22338002
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Glidesheath Slender to Reduce Radial Artery Occlusion and Vascular Access Site Complications Following Transradial Coronary Angiography
- ClinicalTrials.gov ID
- NCT02324764
- Acronym / sponsor ID
- CAPITAL-PRO / 20140262
- Keywords
- transradial coronary angiography, radial artery occlusion, coronary heart disease, Glidesheath Slender
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Mar 2019 (actual)
- Study completion
- 21 Mar 2019 (actual)
- First posted
- 24 Dec 2014 (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 objective of this study is to determine the rate of radial artery occlusion and vascular access site complications following transradial angiogram using a new Terumo (Tokyo, Japan) Glidesheath Slender, in comparison with the currently used 6 French (6 Fr.) radial sheath.
Detailed description
Based on previously reported studies the rates of radial artery occlusion using a standard 6 Fr. sheath is around 5-10%, compared to the single feasibility study of the Glidesheath Slender by Aminian et al (see reference in the citations), the rate of radial artery occlusion was reported 0.88%.
This study will be a prospective randomized, single-blinded (patient-blinded) study, comparing the rate of radial artery occlusion and vascular access site complications between the Glidesheath Slender (Terumo, Tokyo, Japan) and the standard 6 Fr. radial sheath in patients undergoing transradial coronary catheterization.
- The study will enroll patients who will undergo elective or emergency coronary angiography and/or percutaneous coronary intervention (PCI) via transradial approach at the University of Ottawa Heart Institute.
- A baseline clinical vascular \& ultrasound assessment will be performed prior to the procedure to document patency of the radial artery.
- Patients will be randomized in 1:1 fashion to either receive the Terumo Glidesheath Slender versus the currently used 6 Fr. sheath.
- The standard angiogram/ PCI will be performed as per usual practice.
- Following the angiogram, clinical vascular assessment as well as an ultrasound will be performed prior to discharge.
- At 30 days follow up the patient will come back for clinical and ultrasound assessment of radial artery patency and access site vascular complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glidesheath Slender | Experimental | Device: Glidesheath SlenderThe transradial procedure will be performed using the glidesheath slender (studied sheath) |
| Standard sheath | Active comparator | Device: standard 6- French radial sheathThe transradial procedure will be performed using the standard 6- French radial sheath (comparator sheath) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing coronary angiography and/or PCI via transradial approach
- Informed consent
- Documented normal Allen's test
Key exclusion criteria (5 listed)
- Patient who had a previous angiogram using the same radial artery
- Abnormal Allen's test
- Previous failed radial access.
- Known bleeding disorder or hypercoagulable condition
- Cardiogenic shock
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 |
|---|---|---|
| Glidesheath SlenderAlso: Glidesheath Slender, Terumo, Tokyo, Japantesting the efficacy and safety of the new transradial sheath in comparison to the standard 6 french sheath. | Device | Glidesheath Slender |
| standard 6- French radial sheath | Device | Standard sheath |
Primary outcome
Radial artery occlusion
Time frame: 30 days
Evaluated clinically and by ultrasound
5 secondary outcomes
Vascular access site complications
Time frame: up to 30 days
Radial artery spasm
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 day
Procedure success
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 day
Sheath kinking
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 day
Painful sheath removal
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 day
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 28 Jan 2022.
- Background: PubMed 24461923Kotowycz MA, Johnston KW, Ivanov J, Asif N, Almoghairi AM, Choudhury A, Nagy CD, Sibbald M, Chan W, Seidelin PH, Barolet AW, Overgaard CB, Dzavik V. Predictors of radial artery size in patients undergoing cardiac catheterization: insights from the Good Radial Artery Size Prediction (GRASP) study. Can J Cardiol. 2014 Feb;30(2):211-6. doi: 10.1016/j.cjca.2013.11.021. Epub 2013 Nov 23.
- Background: PubMed 24285594Aminian A, Dolatabadi D, Lefebvre P, Zimmerman R, Brunner P, Michalakis G, Lalmand J. Initial experience with the Glidesheath Slender for transradial coronary angiography and intervention: a feasibility study with prospective radial ultrasound follow-up. Catheter Cardiovasc Interv. 2014 Sep 1;84(3):436-42. doi: 10.1002/ccd.25232. Epub 2013 Nov 6.
- Background: PubMed 22338002Kotowycz MA, Dzavik V. Radial artery patency after transradial catheterization. Circ Cardiovasc Interv. 2012 Feb 1;5(1):127-33. doi: 10.1161/CIRCINTERVENTIONS.111.965871. No abstract available.
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.
Aun-Yeong Chong, MRCP, MD principal investigator
University of Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glidesheath Slender and standard 6- French radial sheath in people with Embolism and Thrombosis of the Radial Artery and Coronary Heart Disease, run by Ottawa Heart Institute Research Corporation 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 3 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 28 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?
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: 30 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 NCT02324764, which also lists 3 linked publications.
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 28 Jan 2022.