Transradial Approach,NCT02034084
A Comparison of Left and Right Radial Approach for Percutaneous Coronary Procedures
A study testing left radial approach and Right radial approach in people with Transradial Approach, and Coronary Angiography,, run by Capital Medical University at 1 site in China.
Trial summary
Previous studies have shown that the transradial cardiac catheterization has decreased not only bleeding complications related to the access site and procedural discomfort but also morbidity and hospitalization as compared to transfemoral approach. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Transradial Approach,, Coronary Angiography,, Percutaneous Coronary
- What is being tested?
- left radial approach and Right radial approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 1 siteChina
- Study dates
- Mar 2011to Jun 2014
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All consecutive patients who undergo to diagnostic coronary procedures
Who cannot join
- Acute ST-elevation myocardial infarction
- Previous coronary artery bypass graft surgery
- Hemodynamic instability
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100050
About this study
Previous studies have shown that the transradial cardiac catheterization has decreased not only bleeding complications related to the access site and procedural discomfort but also morbidity and hospitalization as compared to transfemoral approach. At present, the right radial approach (RRA) is the first choice routinely for coronary angiography and interventions in daily clinical practice despite more marked subclavian artery tortuosity than left radial approach (LRA). Although LRA has been thought to be more direct access to the ascending aorta similar to transfemoral approach and may reduce fluoroscopy time and cerebrovascular complications compared with RRA, the application of LRA for coronary intervention is still low. Moreover, several studies have also obtained conflicting results showing no difference in procedural success rate compared LRA and RRA using Judkins catheters. To date, it remains unclear whether LRA is superior to RRA in term of safety and feasibility for coronary angiography and interventions in real world practice and few data of randomized control trial are available.
The aim of this study was to randomly investigate and compare the safety and feasibility of LRA compared with RRA for coronary diagnostic angiography in Chinese subjects.
Read more
The investigators will enroll consecutively for 2 years all patients undergoing coronary diagnostic procedures through trans radial approach.
The primary outcome was total procedural duration. Secondary outcomes included fluoroscopy time, dose of radiation including cumulative air kerma and dose area product, contrast volume and the incidence of vascular complications.
- Being tested
- left radial approach, Right radial approach
- Keywords
- Transradial approach,, Coronary angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
left radial approachProcedure or surgery
Coronary diagnostic procedures performed through left radial approach
Right radial approachProcedure or surgery
coronary diagnostic procedures performed through right radial approach
| Study group | Role | What they receive |
|---|---|---|
| Right radial approach | Experimental | Coronary diagnostic procedures performed through right radial approach Receives: Procedure: Right radial approach |
| Left radial approach | Experimental | Coronary diagnostic procedures performed through left radial approach Receives: Procedure: left radial approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total procedural duration
Measured: 1 day
Secondary outcomes (3)
Fluoroscopy time
Measured: 7 days
Dose of radiation
Dose of radiation include cumulative air kerma (CAK) and CAK dose area product (CAK DAP)
Measured: 7 days
Contrast volume
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startMar 2011
- Primary completionMar 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transradial Approach,Studies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buxing Chen, Capital Medical University
- Investigators
- Buxing Chen, Dr, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034084
- Sponsor's protocol ID
- COLAR
- Status last verified
- Jan 2014
- First submitted
- 9 Jan 2014
- Last updated
- 23 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Left and Right Radial Approach for Percutaneous Coronary Procedures
- ClinicalTrials.gov ID
- NCT02034084
- Acronym / sponsor ID
- COLAR
- Keywords
- Transradial approach,, Coronary angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,400 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 13 Jan 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.
Previous studies have shown that the transradial cardiac catheterization has decreased not only bleeding complications related to the access site and procedural discomfort but also morbidity and hospitalization as compared to transfemoral approach. At present, the right radial approach (RRA) is the first choice routinely for coronary angiography and interventions in daily clinical practice despite more marked subclavian artery tortuosity than left radial approach (LRA). Although LRA has been thought to be more direct access to the ascending aorta similar to transfemoral approach and may reduce fluoroscopy time and cerebrovascular complications compared with RRA, the application of LRA for coronary intervention is still low. Moreover, several studies have also obtained conflicting results showing no difference in procedural success rate compared LRA and RRA using Judkins catheters. To date, it remains unclear whether LRA is superior to RRA in term of safety and feasibility for coronary angiography and interventions in real world practice and few data of randomized control trial are available.
The aim of this study was to randomly investigate and compare the safety and feasibility of LRA compared with RRA for coronary diagnostic angiography in Chinese subjects.
The investigators will enroll consecutively for 2 years all patients undergoing coronary diagnostic procedures through trans radial approach.
The primary outcome was total procedural duration. Secondary outcomes included fluoroscopy time, dose of radiation including cumulative air kerma and dose area product, contrast volume and the incidence of vascular complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right radial approach | Experimental | Procedure: Right radial approachCoronary diagnostic procedures performed through right radial approach |
| Left radial approach | Experimental | Procedure: left radial approachCoronary diagnostic procedures performed through left radial approach |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All consecutive patients who undergo to diagnostic coronary procedures
Key exclusion criteria (3 listed)
- Acute ST-elevation myocardial infarction
- Previous coronary artery bypass graft surgery
- Hemodynamic instability
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 |
|---|---|---|
| left radial approachCoronary diagnostic procedures performed through left radial approach | Procedure or surgery | Left radial approach |
| Right radial approachcoronary diagnostic procedures performed through right radial approach | Procedure or surgery | Right radial approach |
Primary outcome
Total procedural duration
Time frame: 1 day
3 secondary outcomes
Fluoroscopy time
Time frame: 7 days
Dose of radiation
Time frame: 7 days
Contrast volume
Time frame: 7 days
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 23 Apr 2015.
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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.
Buxing Chen, Dr principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing left radial approach and Right radial approach in people with Transradial Approach, and Coronary Angiography,, run by Capital Medical University 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 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: finished, as of the sponsor's last update on 23 Apr 2015. 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?
Total procedural duration (time frame: 1 day). 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 23 Apr 2015.