Coronary Artery DiseaseNCT03292367
The Procedural Success and Complication Rate of the Left Distal Radial Approach
An observational study of Coronary Artery Disease and Radial Artery Injury at Wrist and Hand Level, run by Wonju Severance Christian Hospital at 1 site in South Korea.
Trial summary
Left distal transradial approach (ldTRA) can be an attractive alternative route for left radial and right radial artery. Recently, Ferdinand Kiemeneij reported the feasibility and safety of the use of ldTRA. But, there is few studies focused on this issue. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Radial Artery Injury at Wrist and Hand Level
- What is being tested?
- ldTRA
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Oct 2017to 24 Feb 2018
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: During 1 year, more than 200 patients who are needed to perform coronary angiography or percutaneous coronary intervention will be prospectively enrolled.
Who may be able to join
- Patients over 20 years old requiring coronary angiography
- Patients who are palpable left distal radial artery
- Patients who agreed to participate in the study
Who cannot join
- Patients who are not palpable left distal radial artery
- Patients who are positive in Modified Allen's test (suspicious of occlusion of ulnar artery)
- Pregnant women
- Patients who are not appropriate for the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426
About this study
Official title: The Procedural Success and Complication Rate of the Left Distal Radial Approach for Coronary Angiography and Percutaneous Coronary Intervention. Prospective Observational Study
Left distal transradial approach (ldTRA) can be an attractive alternative route for left radial and right radial artery. Recently, Ferdinand Kiemeneij reported the feasibility and safety of the use of ldTRA. But, there is few studies focused on this issue. Therefore, the purpose of this prospective observational study is to assess the feasibility and safety of the ldTRA for CAG and PCI.
Read the detailed description
Femoral artery has been traditionally used as a standard route for coronary angiography (CAG) and percutaneous coronary intervention (PCI). Recently, the frequency of use of transradial approach (TRA) is increasing. TRA has several advantages in terms of more comfortable feeling, immediate ambulation, less bleeding complication and decreased mortality rate compared to transfemoral approach (TFA). 2015 ESC guidelines recommend to use of radial artery in order to reduce bleeding complication and mortality. But, most operators tend to prefer right radial approach (RRA) for the access route, because they are usually right-handed and feel more comfortable in the use of right radial artery. Particularly when the patient is obese or the operator's height is short or has a herniated disc on neck or waist, the discomfort may become greater.
In other hand, left radial approach (LRA) have several advantages. Left brachial artery or subclavian artery is less tortuous than right side. The manipulation of catheter is similar with femoral approach. Also, since most patients are right-handed, compression after LRA leads to greater comfort for the patient.
In comparison to the convenience of the patient and procedure, comparative studies on clinical outcomes showed similar results for both RRA and LRA. But LRA may be more at risk for radiation. This is because the operator has to lean more toward the patient for the procedure, which can result in increased radiation exposure.
Recently, the left distal radial artery approach (ldTRA) has been introduced as an alternative to feasibility and safety while satisfying both patient and operator convenience. The left palm is positioned facing the floor at the left groin. Left distal radial artery is punctured at the level of anatomical snuffbox. Ferdinand Kiemeneij reported that CAG and PCI were successfully performed in 70 patients.
There are no nerve and vein in the anatomical snuffbox. And distal radial artery is located at superficial area. So, there may be potential advantage to reduce bleeding complication and nerve injury. Moreover, ldTRA can be an alternative method for the patient requiring arteriovenous fistula and for the patient preparing coronary artery bypass graft because there is no injury of left radial artery.
The patients have potential bleeding risk because dual antiplatelet agents (aspirin 300mg and clopidogrel 300mg) and more than 3,000 units of unfractionated heparin should be loaded for CAG and PCI. The effective hemostasis method has not yet been established after ldTRA. Therefore, it is important to establish effective hemostasis method and timing. However, like TRA, ldTRA requires a learning curve to be mastered, and it cannot be performed if the pulse is not palpable. There are few studies related to ldTRA. The purpose of this prospective observational study is to assess the feasibility and safety of the ldTRA for CAG and PCI.
- Being tested
- ldTRA
- 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.
ldTRAProcedure or surgery
After puncture of left distal radial artery, coronary angiography and percutaneous coronary intervention, if needed, will be performed.
| Study group | Role | What they receive |
|---|---|---|
| ldTRA | Patients who are planned to perform coronary angiography will be enrolled via left distal radial artery Receives: Procedure: ldTRA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of coronary angiography
The frequency of success rate of coronary angiography (%)
Measured: 1 year
Success rate of percutaneous coronary intervention
The frequency of success rate of percutaneous coronary intervention (%)
Measured: 1 year
Secondary outcomes (8)
Success rate of puncture of left distal radial artery
The frequency rate of successful puncture of left distal radial artery (%)
Measured: 1 year
Diameter of left distal radial artery
Measured by ultrasonography before procedure (mm)
Measured: 1 year
Hemostasis duration at the puncture site
Hemostasis duration after procedure (minute)
Measured: 1 year
Complications at the puncture site
The frequency rate of complications at the puncture site (%)
Measured: 1 year
Procedure time
Procedure time including coronary angiograph and percutaneous coronary intervention, if performed (minute)
Measured: 1 year
Exposure time of radiation
Total exposure time of radiation during procedure (minute)
Measured: 1 year
Dose of radiation
Dose of radiation during procedure (Gy-cm2)
Measured: 1 year
The degree of patient's satisfaction
Questionnaire using visual analogue scale for the pain and satisfaction of overall procedure especially focused on the left distal radial approach (Maximum 10 score, Minimum 0 score)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start11 Oct 2017
- Primary completion19 Feb 2018
- Study completion24 Feb 2018
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wonju Severance Christian Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Samjin Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Seung Hwan Lee, Wonju Severance Christian Hospital
- Investigators
- Seung-Hwan Lee, MD, PhD, Principal investigator, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292367
- Sponsor's protocol ID
- LeDRA
- Status last verified
- May 2018
- First submitted
- 17 Sep 2017
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kiemeneij F. Left distal transradial access in the anatomical snuffbox for coronary angiography (ldTRA) and interventions (ldTRI). EuroIntervention. 2017 Sep 20;13(7):851-857. doi: 10.4244/EIJ-D-17-00079.
PubMed 28506941
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Procedural Success and Complication Rate of the Left Distal Radial Approach for Coronary Angiography and Percutaneous Coronary Intervention. Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03292367
- Acronym / sponsor ID
- LeDRA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Wonju Severance Christian HospitalUniversity, hospital or other
- Collaborators
- Samjin Pharmaceutical Co., Ltd.
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 19 Feb 2018 (actual)
- Study completion
- 24 Feb 2018 (actual)
- First posted
- 25 Sep 2017 (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.
Left distal transradial approach (ldTRA) can be an attractive alternative route for left radial and right radial artery. Recently, Ferdinand Kiemeneij reported the feasibility and safety of the use of ldTRA. But, there is few studies focused on this issue. Therefore, the purpose of this prospective observational study is to assess the feasibility and safety of the ldTRA for CAG and PCI.
Detailed description
Femoral artery has been traditionally used as a standard route for coronary angiography (CAG) and percutaneous coronary intervention (PCI). Recently, the frequency of use of transradial approach (TRA) is increasing. TRA has several advantages in terms of more comfortable feeling, immediate ambulation, less bleeding complication and decreased mortality rate compared to transfemoral approach (TFA). 2015 ESC guidelines recommend to use of radial artery in order to reduce bleeding complication and mortality. But, most operators tend to prefer right radial approach (RRA) for the access route, because they are usually right-handed and feel more comfortable in the use of right radial artery. Particularly when the patient is obese or the operator's height is short or has a herniated disc on neck or waist, the discomfort may become greater.
In other hand, left radial approach (LRA) have several advantages. Left brachial artery or subclavian artery is less tortuous than right side. The manipulation of catheter is similar with femoral approach. Also, since most patients are right-handed, compression after LRA leads to greater comfort for the patient.
In comparison to the convenience of the patient and procedure, comparative studies on clinical outcomes showed similar results for both RRA and LRA. But LRA may be more at risk for radiation. This is because the operator has to lean more toward the patient for the procedure, which can result in increased radiation exposure.
Recently, the left distal radial artery approach (ldTRA) has been introduced as an alternative to feasibility and safety while satisfying both patient and operator convenience. The left palm is positioned facing the floor at the left groin. Left distal radial artery is punctured at the level of anatomical snuffbox. Ferdinand Kiemeneij reported that CAG and PCI were successfully performed in 70 patients.
There are no nerve and vein in the anatomical snuffbox. And distal radial artery is located at superficial area. So, there may be potential advantage to reduce bleeding complication and nerve injury. Moreover, ldTRA can be an alternative method for the patient requiring arteriovenous fistula and for the patient preparing coronary artery bypass graft because there is no injury of left radial artery.
The patients have potential bleeding risk because dual antiplatelet agents (aspirin 300mg and clopidogrel 300mg) and more than 3,000 units of unfractionated heparin should be loaded for CAG and PCI. The effective hemostasis method has not yet been established after ldTRA. Therefore, it is important to establish effective hemostasis method and timing. However, like TRA, ldTRA requires a learning curve to be mastered, and it cannot be performed if the pulse is not palpable. There are few studies related to ldTRA. The purpose of this prospective observational study is to assess the feasibility and safety of the ldTRA for CAG and PCI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ldTRA | – | Procedure: ldTRAPatients who are planned to perform coronary angiography will be enrolled via left distal radial artery |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- During 1 year, more than 200 patients who are needed to perform coronary angiography or percutaneous coronary intervention will be prospectively enrolled.
Key inclusion criteria (3 listed)
- Patients over 20 years old requiring coronary angiography
- Patients who are palpable left distal radial artery
- Patients who agreed to participate in the study
Key exclusion criteria (4 listed)
- Patients who are not palpable left distal radial artery
- Patients who are positive in Modified Allen's test (suspicious of occlusion of ulnar artery)
- Pregnant women
- Patients who are not appropriate for the study
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 |
|---|---|---|
| ldTRAAfter puncture of left distal radial artery, coronary angiography and percutaneous coronary intervention, if needed, will be performed. | Procedure or surgery | ldTRA |
Primary outcome
Success rate of coronary angiography
Time frame: 1 year
The frequency of success rate of coronary angiography (%)
Success rate of percutaneous coronary intervention
Time frame: 1 year
The frequency of success rate of percutaneous coronary intervention (%)
8 secondary outcomes
Success rate of puncture of left distal radial artery
Time frame: 1 year
Diameter of left distal radial artery
Time frame: 1 year
Hemostasis duration at the puncture site
Time frame: 1 year
Complications at the puncture site
Time frame: 1 year
Procedure time
Time frame: 1 year
Exposure time of radiation
Time frame: 1 year
Dose of radiation
Time frame: 1 year
The degree of patient's satisfaction
Time frame: 1 year
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 8 May 2018.
- Results publication: PubMed 28506941Kiemeneij F. Left distal transradial access in the anatomical snuffbox for coronary angiography (ldTRA) and interventions (ldTRI). EuroIntervention. 2017 Sep 20;13(7):851-857. doi: 10.4244/EIJ-D-17-00079.
- 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.
Seung-Hwan Lee, MD, PhD principal investigator
Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Radial Artery Injury at Wrist and Hand Level, 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 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 8 May 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?
Success rate of coronary angiography (time frame: 1 year). 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?
On the ClinicalTrials.gov record for NCT03292367, 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 8 May 2018.