InterventionNCT02831322
A Study of Structure and Function of Radial Artery After Transradial Coronary Intervention
A study testing Percutaneous coronary intervention in people with Intervention and Transradial, run by The First Hospital of Qinhuangdao at 1 site in China.
Trial summary
Several approaches have been proposed to reduce the risk of RAO, including anticoagulation, immediate postprocedural sheath removal, and a small sheath/radial artery ratio. Doppler ultrasound examination showed that interrupted blood flow in RA tend to occur in the proximal end rather than distal part of the… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Intervention, Transradial
- What is being tested?
- Percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2016to 1 Oct 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- admitted for transradial catheterization.
Who cannot join
- femoral access, arterial circulatory disease, pathological Allen tests, decompensated heart failure, chronic renal failure
Trial locations and contacts
1 site in 1 country.
About this study
Several approaches have been proposed to reduce the risk of RAO, including anticoagulation, immediate postprocedural sheath removal, and a small sheath/radial artery ratio. Doppler ultrasound examination showed that interrupted blood flow in RA tend to occur in the proximal end rather than distal part of the artery,which was ignored by a majority of interventional cardiologists. Different insights into occlusion location may lead to different options of sheath materials, models, catheters and puncture access. Thus, the investigators designed this present study to explore the reason of radial artery endothelial dysfuction and damage and occlusion location by flow-mediated dilation (FMD) to determine the suitable method to reduce occlusion risk during TRI.
- Conditions
- Intervention, Transradial
- Being tested
- Percutaneous coronary intervention
- Keywords
- Transradial, flow-mediated vasodilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionProcedure or surgery
Percutaneous coronary intervention was a nonsurgical technique for treating obstructive coronary artery disease
| Study group | Role | What they receive |
|---|---|---|
| radial artery occlusion | Experimental | Radial artery occlusion was the absence of a flow signal by Doppler ultrasound examination. Receives: Procedure: Percutaneous coronary intervention |
| radial artery normal | Other | Radial artery normal was blood flow signal by Doppler ultrasound Receives: Procedure: Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
radial artery occlusion
radial artery occlusion was the absence of a flow signal by Doppler ultrasound examination
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study start10 Jul 2016
- Primary completion5 Sep 2016
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Qinhuangdao
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831322
- Sponsor's protocol ID
- 21735
- Status last verified
- Feb 2023
- First submitted
- 4 Jul 2016
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Structure and Function of Radial Artery After Transradial Coronary Intervention
- ClinicalTrials.gov ID
- NCT02831322
- Acronym / sponsor ID
- 21735
- Conditions
- Intervention, Transradial
- Keywords
- Transradial, flow-mediated vasodilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- The First Hospital of QinhuangdaoOther government
- Study start
- 10 Jul 2016 (actual)
- Primary completion
- 5 Sep 2016 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 13 Jul 2016 (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.
Several approaches have been proposed to reduce the risk of RAO, including anticoagulation, immediate postprocedural sheath removal, and a small sheath/radial artery ratio. Doppler ultrasound examination showed that interrupted blood flow in RA tend to occur in the proximal end rather than distal part of the artery,which was ignored by a majority of interventional cardiologists. Different insights into occlusion location may lead to different options of sheath materials, models, catheters and puncture access. Thus, the investigators designed this present study to explore the reason of radial artery endothelial dysfuction and damage and occlusion location by flow-mediated dilation (FMD) to determine the suitable method to reduce occlusion risk during TRI.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radial artery occlusion | Experimental | Procedure: Percutaneous coronary interventionRadial artery occlusion was the absence of a flow signal by Doppler ultrasound examination. |
| radial artery normal | Other | Procedure: Percutaneous coronary interventionRadial artery normal was blood flow signal by Doppler ultrasound |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- admitted for transradial catheterization.
Key exclusion criteria (1 listed)
- femoral access, arterial circulatory disease, pathological Allen tests, decompensated heart failure, chronic renal failure
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 |
|---|---|---|
| Percutaneous coronary interventionPercutaneous coronary intervention was a nonsurgical technique for treating obstructive coronary artery disease | Procedure or surgery | radial artery normal, radial artery occlusion |
Primary outcome
radial artery occlusion
Time frame: 6 month
radial artery occlusion was the absence of a flow signal by Doppler ultrasound examination
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 15 Feb 2023.
- Individual participant dataSharing planned: Yes
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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 Percutaneous coronary intervention in people with Intervention and Transradial, run by The First Hospital of Qinhuangdao at 1 site in China.
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 1 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 15 Feb 2023. 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 China. 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: 6 month). 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 15 Feb 2023.