Coronary Artery DiseasePhase 3PRACTICALNCT02269722
Postcath Radial Arterial Clamp Time In the CAth Lab
A Phase 3 study testing Vascular compression device- RADAR TM-Short clamp time and Vascular compression device RADAR TM-Long clamp time in people with Coronary Artery Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
The investigators will assess the effect of different times of radial clamp post procedure on radial artery occlusion and bleeding. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Vascular compression device- RADAR TM-Short clamp time and Vascular compression device RADAR TM-Long clamp time
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 564 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2014to Jul 2016
- Phase
- Phase 3
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients who require cardiac catheterization via the radial approach for the investigation and treatment of coronary artery disease.
- Patients must have evidence of pre-procedural radial artery patency using Barbeau test.
- Patients must be able to give informed consent
Who cannot join
- Evidence of pre-procedural radial artery thrombosis
- Inability to give informed consent
- Patient desire not to participate in the study
- Emergent procedures when the delay associated for obtaining informed consent may affect patient outcome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Radial Artery Clamp Times in Patients Undergoing Cardiac Catheterization Via a Percutaneous Transradial Approach
The investigators will assess the effect of different times of radial clamp post procedure on radial artery occlusion and bleeding.
Read the detailed description
The purpose of this study is to determine the safety of shorter radial artery clamp time post cardiac catheterization with respect to achieving hemostasis and the incidence of radial artery occlusion. The investigators hypothesize that shorter radial artery clamp times following cardiac catheterization will achieve similar hemostasis to longer clamp times with a decrease in the incidence of radial artery occlusion.
- Conditions
- Coronary Artery Disease
- Being tested
- Vascular compression device- RADAR TM-Short clamp time, Vascular compression device RADAR TM-Long clamp time
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular compression device- RADAR TM-Short clamp timeDevice
A clamp is placed on the radial artery following cardiac catheterization for 20 minutes
Vascular compression device RADAR TM-Long clamp timeDevice
A clamp is placed on the radial artery following cardiac catheterization for 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| Short Clamp time | Experimental | Radial clamp applied at full pressure for 20 minutes. At the end of 20 minutes, the clamp will be loosened ¼ turn every 5 minutes over 20 minutes and then removed. Receives: Device: Vascular compression device- RADAR TM-Short clamp time |
| Long Clamp Time | Experimental | Radial clamp applied at full pressure for 60 minutes. At the end of 60 minutes, the clamp is to be loosened and removed under the same instruction as those patients in arm one. Receives: Device: Vascular compression device RADAR TM-Long clamp time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of radial artery occlusion
Flow assessed by pulse oximeter
Measured: 24 hours
Secondary outcomes (1)
Bleeding
Need to retighten clamp, ooze, hematoma
Measured: 24 hours
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 startJul 2014
- Primary completionJul 2016
- Study completionJul 2016
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 Coronary Artery DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 564 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahar Lavi, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Shahar Lavi, MD, Principal investigator, LHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269722
- Sponsor's protocol ID
- 10796
- Acronym
- PRACTICAL
- Status last verified
- Oct 2016
- First submitted
- 28 Sep 2014
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lavi S, Cheema A, Yadegari A, Israeli Z, Levi Y, Wall S, Alemayehu M, Parviz Y, Murariu BD, McPherson T, Syed J, Bagur R. Randomized Trial of Compression Duration After Transradial Cardiac Catheterization and Intervention. J Am Heart Assoc. 2017 Feb 3;6(2):e005029. doi: 10.1161/JAHA.116.005029.
PubMed 28159821
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Radial Artery Clamp Times in Patients Undergoing Cardiac Catheterization Via a Percutaneous Transradial Approach
- ClinicalTrials.gov ID
- NCT02269722
- Acronym / sponsor ID
- PRACTICAL / 10796
- Conditions
- Coronary Artery Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 564 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- 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 investigators will assess the effect of different times of radial clamp post procedure on radial artery occlusion and bleeding.
Detailed description
The purpose of this study is to determine the safety of shorter radial artery clamp time post cardiac catheterization with respect to achieving hemostasis and the incidence of radial artery occlusion. The investigators hypothesize that shorter radial artery clamp times following cardiac catheterization will achieve similar hemostasis to longer clamp times with a decrease in the incidence of radial artery occlusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short Clamp time | Experimental | Device: Vascular compression device- RADAR TM-Short clamp timeRadial clamp applied at full pressure for 20 minutes. At the end of 20 minutes, the clamp will be loosened ¼ turn every 5 minutes over 20 minutes and then removed. |
| Long Clamp Time | Experimental | Device: Vascular compression device RADAR TM-Long clamp timeRadial clamp applied at full pressure for 60 minutes. At the end of 60 minutes, the clamp is to be loosened and removed under the same instruction as those patients in arm one. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- All patients who require cardiac catheterization via the radial approach for the investigation and treatment of coronary artery disease.
- Patients must have evidence of pre-procedural radial artery patency using Barbeau test.
- Patients must be able to give informed consent
Key exclusion criteria (4 listed)
- Evidence of pre-procedural radial artery thrombosis
- Inability to give informed consent
- Patient desire not to participate in the study
- Emergent procedures when the delay associated for obtaining informed consent may affect patient outcome
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 |
|---|---|---|
| Vascular compression device- RADAR TM-Short clamp timeA clamp is placed on the radial artery following cardiac catheterization for 20 minutes | Device | Short Clamp time |
| Vascular compression device RADAR TM-Long clamp timeA clamp is placed on the radial artery following cardiac catheterization for 20 minutes | Device | Long Clamp Time |
Primary outcome
Incidence of radial artery occlusion
Time frame: 24 hours
Flow assessed by pulse oximeter
1 secondary outcome
Bleeding
Time frame: 24 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 5 Oct 2016.
- Derived from this study: PubMed 28159821Lavi S, Cheema A, Yadegari A, Israeli Z, Levi Y, Wall S, Alemayehu M, Parviz Y, Murariu BD, McPherson T, Syed J, Bagur R. Randomized Trial of Compression Duration After Transradial Cardiac Catheterization and Intervention. J Am Heart Assoc. 2017 Feb 3;6(2):e005029. doi: 10.1161/JAHA.116.005029.
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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.
Shahar Lavi, MD principal investigator
LHSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vascular compression device- RADAR TM-Short clamp time and Vascular compression device RADAR TM-Long clamp time in people with Coronary Artery Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 4 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 5 Oct 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 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of radial artery occlusion (time frame: 24 hours). 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 NCT02269722, 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 5 Oct 2016; AzTrials last refreshed its copy on 31 Oct 2026.