Percutaneous Coronary InterventionRAPandBEATNCT02269449
Radial Artery Patency and Bleeding, Efficacy, Adverse evenT Trial
A study testing 6Fr Glidesheath Slender sheath, 5Fr sheath and Hemostasis with TR band in people with Percutaneous Coronary Intervention, run by NPO International TRI Network.
Trial summary
The objectives of this study are to demonstrate the safety and efficacy of the new 6Fr sheath (Glidesheath slender; Terumo, Tokyo,Japan ; GSS) compared with the contemporary 5Fr sheath (Hydrophilic coating sheath from Terumo; Tokyo, Japan (standard of care ; SOC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Coronary Intervention
- What is being tested?
- 6Fr Glidesheath Slender sheath, 5Fr sheath and Hemostasis with TR band
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,900 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Apr 2015
- 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
- Patient is able to verbally acknowledge an understanding of the associated risks, benefits and treatment alternatives and he or his legally authorized representative provides written informed consent prior to the randomization, as approved by the appropriate IRB.
- Patient who is expected to diagnose by coronary artery angiography or followed by PCI.
- Patient must agree to undergo all protocol-required follow-up examinations.
- Patient who can accept radial access.
Who cannot join
- Patient has other medical illness (e.g., cancer or congestive heart failure) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
- Hemodialysis patient
- STEMI
About this study
Official title: RAP and BEAT Clinical Trial (Radial Artery Patency and Bleeding, Effectiveness, Adverse evenT Trial)
The objectives of this study are to demonstrate the safety and efficacy of the new 6Fr sheath (Glidesheath slender; Terumo, Tokyo,Japan ; GSS) compared with the contemporary 5Fr sheath (Hydrophilic coating sheath from Terumo; Tokyo, Japan (standard of care ; SOC).
- Conditions
- Percutaneous Coronary Intervention
- Being tested
- 6Fr Glidesheath Slender sheath, 5Fr sheath, Hemostasis with TR band, Any hemostasis procedure
- Keywords
- transradial intervention, radial artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6Fr Glidesheath Slender sheathDevice
6Fr sheath (Glidesheath slender: GSS), which is characterized with the same inner lumen diameter with contemporary 6Fr sheath as well as the sheath outer diameter similar with contemporary 5Fr sheath.
5Fr sheathDevice
5Fr Hydrophilic coating sheath from Terumo.
Hemostasis with TR bandProcedure or surgery
Hemostasis is achieved using TR band (TERUMO) Patent hemostasis.
Any hemostasis procedureProcedure or surgery
Hemostasis is achieved by any hemostasis of each hospital's routine procedure.
| Study group | Role | What they receive |
|---|---|---|
| 6Fr Glidesheath Slender sheath | Experimental | TRI will be performed using a new 6Fr sheath (Glidesheath slender: GSS). Receives: Device: 6Fr Glidesheath Slender sheath |
| 5Fr contemporary sheath | Active comparator | TRI will be performed using a contemporary safety of 5Fr sheath. Receives: Device: 5Fr sheath |
| Hemostasis with TR band | Experimental | Hemostasis is achieved by randomization of using TR band (TERUMO) Patent hemostasis. Receives: Procedure: Hemostasis with TR band |
| Any hemostasis procedure | Active comparator | Hemostasis is achieved by randomization of any hemostasis of each hospital's routine procedure. Receives: Procedure: Any hemostasis procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radial artery occlusion
Measured: Day 1
Local bleeding from puncture site
Measured: Day 1
Secondary outcomes (8)
Procedure success rate
Measured: Day 1
Vascular access site complication
Measured: Day 1
Radial spasm during the index procedure
Measured: Day 1
Total Procedure Time
Measured: Day 1
Total Amount of Contrast Dye
Measured: Day 1
Total Radiation Doses
Measured: Day 1
Device failure for the assigned sheath introducer
Measured: Day 1
Pain score
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary InterventionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NPO International TRI Network
- Sponsor type
- Research network
- Collaborators
- European Cardiovascular Research Center, Duke Clinical Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269449
- Sponsor's protocol ID
- TRI20140920
- Acronym
- RAPandBEAT
- Status last verified
- Oct 2014
- First submitted
- 7 Oct 2014
- Last updated
- 21 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAP and BEAT Clinical Trial (Radial Artery Patency and Bleeding, Effectiveness, Adverse evenT Trial)
- ClinicalTrials.gov ID
- NCT02269449
- Acronym / sponsor ID
- RAPandBEAT / TRI20140920
- Conditions
- Percutaneous Coronary Intervention
- Keywords
- transradial intervention, radial artery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,900 participants (estimated)
- Lead sponsor
- NPO International TRI NetworkResearch network
- Collaborators
- European Cardiovascular Research Center, Duke Clinical Research Institute
- Study start
- Oct 2014
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 21 Oct 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 objectives of this study are to demonstrate the safety and efficacy of the new 6Fr sheath (Glidesheath slender; Terumo, Tokyo,Japan ; GSS) compared with the contemporary 5Fr sheath (Hydrophilic coating sheath from Terumo; Tokyo, Japan (standard of care ; SOC).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 6Fr Glidesheath Slender sheath | Experimental | Device: 6Fr Glidesheath Slender sheathTRI will be performed using a new 6Fr sheath (Glidesheath slender: GSS). |
| 5Fr contemporary sheath | Active comparator | Device: 5Fr sheathTRI will be performed using a contemporary safety of 5Fr sheath. |
| Hemostasis with TR band | Experimental | Procedure: Hemostasis with TR bandHemostasis is achieved by randomization of using TR band (TERUMO) Patent hemostasis. |
| Any hemostasis procedure | Active comparator | Procedure: Any hemostasis procedureHemostasis is achieved by randomization of any hemostasis of each hospital's routine procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is able to verbally acknowledge an understanding of the associated risks, benefits and treatment alternatives and he or his legally authorized representative provides written informed consent prior to the randomization, as approved by the appropriate IRB.
- Patient who is expected to diagnose by coronary artery angiography or followed by PCI.
- Patient must agree to undergo all protocol-required follow-up examinations.
- Patient who can accept radial access.
Key exclusion criteria (3 listed)
- Patient has other medical illness (e.g., cancer or congestive heart failure) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
- Hemodialysis patient
- 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 |
|---|---|---|
| 6Fr Glidesheath Slender sheath6Fr sheath (Glidesheath slender: GSS), which is characterized with the same inner lumen diameter with contemporary 6Fr sheath as well as the sheath outer diameter similar with contemporary 5Fr sheath. | Device | 6Fr Glidesheath Slender sheath |
| 5Fr sheath5Fr Hydrophilic coating sheath from Terumo. | Device | 5Fr contemporary sheath |
| Hemostasis with TR bandHemostasis is achieved using TR band (TERUMO) Patent hemostasis. | Procedure or surgery | Hemostasis with TR band |
| Any hemostasis procedureHemostasis is achieved by any hemostasis of each hospital's routine procedure. | Procedure or surgery | Any hemostasis procedure |
Primary outcome
Radial artery occlusion
Time frame: Day 1
Local bleeding from puncture site
Time frame: Day 1
8 secondary outcomes
Procedure success rate
Time frame: Day 1
Vascular access site complication
Time frame: Day 1
Radial spasm during the index procedure
Time frame: Day 1
Total Procedure Time
Time frame: Day 1
Total Amount of Contrast Dye
Time frame: Day 1
Total Radiation Doses
Time frame: Day 1
Device failure for the assigned sheath introducer
Time frame: Day 1
Pain score
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing 6Fr Glidesheath Slender sheath, 5Fr sheath and Hemostasis with TR band in people with Percutaneous Coronary Intervention, run by NPO International TRI Network.
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 4 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: status not confirmed, as of the sponsor's last update on 21 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
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: Day 1). The study lists 2 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 21 Oct 2014.