Coronary Artery DiseaseCOMPARE-RadNCT03389503
Comparison of Left and Right Transradial Approach for CAG and PCI
A study testing Radial approach in people with Coronary Artery Disease and Stable Angina, run by Wonju Severance Christian Hospital at 1 site in South Korea.
Trial summary
This trial will compare the procedural success rate between right and left radial approach in patients undergoing coronary angiography and coronary intervention. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Coronary Artery Disease, Stable Angina, Unstable Angina
- What is being tested?
- Radial approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Mar 2017to 7 Sep 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects undergoing coronary angiography via radial approach
- Subjects undergoing coronary intervention via radial approach
- Subjects give written informed consent
Who cannot join
- Subjects undergoing procedure(s) other than coronary angiography or intervention
- Subjects with contraindication of radial approach (i.e, non-palpable radial pulsation, abnormal Allen's test, known radial artery tortuosity or occlusion, arteriovenous fistula for dialysis)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426
About this study
Official title: Comparison Between Left and Right Transradial Approach During Coronary Angiography and Percutaneous Coronary Intervention
This trial will compare the procedural success rate between right and left radial approach in patients undergoing coronary angiography and coronary intervention.
Read the detailed description
The three operators who are proficient in the left radial approach for coronary angiography and coronary intervention will be assigned to the right radial approach for 3 months (phase 1). After then, these three operators will switch approach site to the left radial for another 3 months (phase 2).
Procedural success, time of the procedure, use of contrast agent, and fluoroscopic data will be compared between right radial approach (phase 1) group and left radial approach (phase 2).
- Conditions
- Coronary Artery Disease, Stable Angina, Unstable Angina, Non-ST Elevation Myocardial Infarction, ST-segment Elevation Myocardial Infarction, Ischemic Heart Disease Without Angina
- Being tested
- Radial approach
- Keywords
- Access site, Transradial access, Coronary artery disease, Learning curve
- Medical subject headings
- Coronary Artery Disease, Angina, Stable, Angina, Unstable, Non-ST Elevated Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial approachProcedure or surgery
Approach site for coronary angiography and coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| Right radial approach | Active comparator | Right radial approach for coronary angiography and coronary intervention Receives: Procedure: Radial approach |
| Left radial approach | Active comparator | Left radial approach for coronary angiography and coronary intervention Receives: Procedure: Radial approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success
Finishing coronary angiography/intervention without changing approach site
Measured: At the end of procedure
Secondary outcomes (10)
Puncture time
Duration from the start of local anesthesia infiltration to the insertion of sheath
Measured: At the end of procedure
Coronary angiography time
Duration from the insertion of sheath to the end of coronary angiography
Measured: At the end of procedure
Puncture + Coronary angiography time
Sum of puncture time and coronary angiography time
Measured: At the end of procedure
Coronary intervention time
Duration from the end of coronary angiography to the end of coronary intervention
Measured: At the end of procedure
Contrast amount during coronary angiography
Amount of contrast agent used during coronary angiography
Measured: At the end of procedure
Contrast amount during coronary intervention
Amount of contrast agent used during coronary intervention
Measured: At the end of procedure
Fluoroscopic dose, dose area product during coronary angiography
Dose area product during coronary angiography
Measured: At the end of procedure
Fluoroscopic dose, dose area product during coronary intervention
Dose area product during coronary intervention
Measured: At the end of procedure
Fluoroscopic time during coronary angiography
Fluoroscopic time during coronary angiography
Measured: At the end of procedure
Fluoroscopic time during coronary intervention
Fluoroscopic time during coronary intervention
Measured: At the end of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start8 Mar 2017
- Primary completion7 Sep 2017
- Study completion7 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 1\~3 months: Right radial approach 4\~6 months: Left radial approach
- Masking
- None (open label)
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wonju Severance Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Jin Youn, Wonju Severance Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389503
- Sponsor's protocol ID
- CR316096
- Acronym
- COMPARE-Rad
- Status last verified
- Dec 2017
- First submitted
- 27 Dec 2017
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Left and Right Transradial Approach During Coronary Angiography and Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT03389503
- Acronym / sponsor ID
- COMPARE-Rad / CR316096
- Conditions
- Coronary Artery Disease, Stable Angina, Unstable Angina, Non-ST Elevation Myocardial Infarction, ST-segment Elevation Myocardial Infarction, Ischemic Heart Disease Without Angina
- Keywords
- Access site, Transradial access, Coronary artery disease, Learning curve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Wonju Severance Christian HospitalUniversity, hospital or other
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 7 Sep 2017 (actual)
- Study completion
- 7 Sep 2017 (actual)
- First posted
- 3 Jan 2018 (actual)
- 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.
This trial will compare the procedural success rate between right and left radial approach in patients undergoing coronary angiography and coronary intervention.
Detailed description
The three operators who are proficient in the left radial approach for coronary angiography and coronary intervention will be assigned to the right radial approach for 3 months (phase 1). After then, these three operators will switch approach site to the left radial for another 3 months (phase 2).
Procedural success, time of the procedure, use of contrast agent, and fluoroscopic data will be compared between right radial approach (phase 1) group and left radial approach (phase 2).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1~3 months: Right radial approach 4~6 months: Left radial approach
| Arm | Type | Receives |
|---|---|---|
| Right radial approach | Active comparator | Procedure: Radial approachRight radial approach for coronary angiography and coronary intervention |
| Left radial approach | Active comparator | Procedure: Radial approachLeft radial approach for coronary angiography and coronary intervention |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects undergoing coronary angiography via radial approach
- Subjects undergoing coronary intervention via radial approach
- Subjects give written informed consent
Key exclusion criteria (2 listed)
- Subjects undergoing procedure(s) other than coronary angiography or intervention
- Subjects with contraindication of radial approach (i.e, non-palpable radial pulsation, abnormal Allen's test, known radial artery tortuosity or occlusion, arteriovenous fistula for dialysis)
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 |
|---|---|---|
| Radial approachApproach site for coronary angiography and coronary intervention | Procedure or surgery | Left radial approach, Right radial approach |
Primary outcome
Procedural success
Time frame: At the end of procedure
Finishing coronary angiography/intervention without changing approach site
10 secondary outcomes
Puncture time
Time frame: At the end of procedure
Coronary angiography time
Time frame: At the end of procedure
Puncture + Coronary angiography time
Time frame: At the end of procedure
Coronary intervention time
Time frame: At the end of procedure
Contrast amount during coronary angiography
Time frame: At the end of procedure
Contrast amount during coronary intervention
Time frame: At the end of procedure
Fluoroscopic dose, dose area product during coronary angiography
Time frame: At the end of procedure
Fluoroscopic dose, dose area product during coronary intervention
Time frame: At the end of procedure
Fluoroscopic time during coronary angiography
Time frame: At the end of procedure
Fluoroscopic time during coronary intervention
Time frame: At the end of procedure
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 3 Jan 2018.
- Individual participant dataSharing planned: No
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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 Radial approach in people with Coronary Artery Disease and Stable Angina, run by Wonju Severance Christian Hospital at 1 site in South Korea.
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 2 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 3 Jan 2018. 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 South Korea. 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?
Procedural success (time frame: At the end of procedure). 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 3 Jan 2018.