Coronary DiseaseNCT04784078
Randomized Comparison of Distal Radial Versus Conventional Radial Access for Coronary Angiography and Intervention
A study testing Coronary Angiography and Intervention in people with Coronary Disease, run by Beijing Anzhen Hospital.
Trial summary
Distal radial access (dTRA) represents a novel site for radial artery access in interventional cardiology, there is little data compare dTRA with conventional radial access (cTRA) in a randomized manner. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Coronary Angiography and Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 938 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2021to 31 Jan 2022
- 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
- Patient is over 18 years of age.
- Patient is undergoing diagnostic coronary angiography and/or PCI for the first time.
- Patient has provided written informed consent.
- Patient is willing to comply with all protocol-required evaluations during the hospitalization.
Who cannot join
- No palpable radial artery or distal radial artery.
- Radial artery used as a bridging vessel.
- Severe heart failure (NYHA class IV).
- Severe renal insufficiency ( SCr>443umol/L).
- Height over 185 cm.
- A ≥7F catheter may be required for operation.
Trial locations and contacts
No sites are listed yet.
About this study
Distal radial access (dTRA) represents a novel site for radial artery access in interventional cardiology, there is little data compare dTRA with conventional radial access (cTRA) in a randomized manner.
It aims to randomly compare between the new distal radial access via the snuffbox and the conventional radial access for percutaneous coronary intervention (PCI) and angioplasty procedures. The objectives of comparing both procedures are to analyze the frequency of complications in terms of occlusion, arterial spasm, hematoma, and to weigh accesses effectiveness in terms of time and attempts to puncture, crossover rate, procedure duration, hemostasis time.
Candidates for coronary angiography are being randomized into the interventional group to undergo the angiography through the distal radial artery as the access site, or the control group accessing through the radial artery. Procedural and post procedural outcomes and complications are being reported while patients are in hospital. All patients undergo doppler ultrasonography within 24 hours before and after the procedure, 4 weeks after procedure.
- Conditions
- Coronary Disease
- Being tested
- Coronary Angiography and Intervention
- Keywords
- Distal radial artery, Radial access
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Angiography and InterventionProcedure or surgery
Transradial access puncture site
| Study group | Role | What they receive |
|---|---|---|
| dTRA group | Experimental | Not described Receives: Procedure: Coronary Angiography and Intervention |
| cTRA group | Active comparator | Not described Receives: Procedure: Coronary Angiography and Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radial artery occlusion
Doppler Ultrasonography of the radial artery for occlusions along its course, in both groups. Incidence of radial artery occlusion as confirmed by absense of antegrade flow in vascular doppler ultrasound.
Measured: Within 24 hours after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start10 Apr 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe 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
- 938 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yujie Zhou, Beijing Anzhen Hospital
- Investigators
- Yujie Zhou, Doctor, Study chair, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784078
- Sponsor's protocol ID
- DC radial
- Status last verified
- Apr 2021
- First submitted
- 3 Mar 2021
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nikolakopoulos I, Vemmou E, Brilakis ES. Distal radial access for cardiac catheterization: When and how. Hellenic J Cardiol. 2020 Mar-Apr;61(2):110-111. doi: 10.1016/j.hjc.2020.06.001. Epub 2020 Jun 14. No abstract available.
PubMed 32553614Liontou C, Kontopodis E, Oikonomidis N, Maniotis C, Tassopoulos A, Tsiafoutis I, Lazaris E, Koutouzis M. Distal Radial Access: A Review Article. Cardiovasc Revasc Med. 2020 Mar;21(3):412-416. doi: 10.1016/j.carrev.2019.06.003. Epub 2019 Jun 8.
PubMed 31227393Sgueglia GA, Di Giorgio A, Gaspardone A, Babunashvili A. Anatomic Basis and Physiological Rationale of Distal Radial Artery Access for Percutaneous Coronary and Endovascular Procedures. JACC Cardiovasc Interv. 2018 Oct 22;11(20):2113-2119. doi: 10.1016/j.jcin.2018.04.045.
PubMed 30336816Koutouzis M, Kontopodis E, Tassopoulos A, Tsiafoutis I, Katsanou K, Rigatou A, Didagelos M, Andreou K, Lazaris E, Oikonomidis N, Maniotis C, Ziakas A. Distal Versus Traditional Radial Approach for Coronary Angiography. Cardiovasc Revasc Med. 2019 Aug;20(8):678-680. doi: 10.1016/j.carrev.2018.09.018. Epub 2018 Oct 2.
PubMed 30314833Xenogiannis I, Brilakis ES. Distal radial access at the anatomic snuffbox: The new standard for left radial access? Catheter Cardiovasc Interv. 2019 Nov 1;94(5):658-659. doi: 10.1002/ccd.28551. No abstract available.
PubMed 31675155
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Distal Radial Versus Conventional Radial Access for Coronary Angiography and Intervention
- ClinicalTrials.gov ID
- NCT04784078
- Acronym / sponsor ID
- DC radial
- Conditions
- Coronary Disease
- Keywords
- Distal radial artery, Radial access
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 938 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 10 Apr 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 5 Mar 2021 (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.
Distal radial access (dTRA) represents a novel site for radial artery access in interventional cardiology, there is little data compare dTRA with conventional radial access (cTRA) in a randomized manner.
It aims to randomly compare between the new distal radial access via the snuffbox and the conventional radial access for percutaneous coronary intervention (PCI) and angioplasty procedures. The objectives of comparing both procedures are to analyze the frequency of complications in terms of occlusion, arterial spasm, hematoma, and to weigh accesses effectiveness in terms of time and attempts to puncture, crossover rate, procedure duration, hemostasis time.
Candidates for coronary angiography are being randomized into the interventional group to undergo the angiography through the distal radial artery as the access site, or the control group accessing through the radial artery. Procedural and post procedural outcomes and complications are being reported while patients are in hospital. All patients undergo doppler ultrasonography within 24 hours before and after the procedure, 4 weeks after procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dTRA group | Experimental | Procedure: Coronary Angiography and Intervention |
| cTRA group | Active comparator | Procedure: Coronary Angiography and Intervention |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is over 18 years of age.
- Patient is undergoing diagnostic coronary angiography and/or PCI for the first time.
- Patient has provided written informed consent.
- Patient is willing to comply with all protocol-required evaluations during the hospitalization.
Key exclusion criteria (6 listed)
- No palpable radial artery or distal radial artery.
- Radial artery used as a bridging vessel.
- Severe heart failure (NYHA class IV).
- Severe renal insufficiency ( SCr>443umol/L).
- Height over 185 cm.
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 |
|---|---|---|
| Coronary Angiography and InterventionTransradial access puncture site | Procedure or surgery | cTRA group, dTRA group |
Primary outcome
Radial artery occlusion
Time frame: Within 24 hours after the procedure.
Doppler Ultrasonography of the radial artery for occlusions along its course, in both groups. Incidence of radial artery occlusion as confirmed by absense of antegrade flow in vascular doppler ultrasound.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Background: PubMed 32553614Nikolakopoulos I, Vemmou E, Brilakis ES. Distal radial access for cardiac catheterization: When and how. Hellenic J Cardiol. 2020 Mar-Apr;61(2):110-111. doi: 10.1016/j.hjc.2020.06.001. Epub 2020 Jun 14. No abstract available.
- Results publication: PubMed 31227393Liontou C, Kontopodis E, Oikonomidis N, Maniotis C, Tassopoulos A, Tsiafoutis I, Lazaris E, Koutouzis M. Distal Radial Access: A Review Article. Cardiovasc Revasc Med. 2020 Mar;21(3):412-416. doi: 10.1016/j.carrev.2019.06.003. Epub 2019 Jun 8.
- Results publication: PubMed 30336816Sgueglia GA, Di Giorgio A, Gaspardone A, Babunashvili A. Anatomic Basis and Physiological Rationale of Distal Radial Artery Access for Percutaneous Coronary and Endovascular Procedures. JACC Cardiovasc Interv. 2018 Oct 22;11(20):2113-2119. doi: 10.1016/j.jcin.2018.04.045.
- Results publication: PubMed 30314833Koutouzis M, Kontopodis E, Tassopoulos A, Tsiafoutis I, Katsanou K, Rigatou A, Didagelos M, Andreou K, Lazaris E, Oikonomidis N, Maniotis C, Ziakas A. Distal Versus Traditional Radial Approach for Coronary Angiography. Cardiovasc Revasc Med. 2019 Aug;20(8):678-680. doi: 10.1016/j.carrev.2018.09.018. Epub 2018 Oct 2.
- Results publication: PubMed 31675155Xenogiannis I, Brilakis ES. Distal radial access at the anatomic snuffbox: The new standard for left radial access? Catheter Cardiovasc Interv. 2019 Nov 1;94(5):658-659. doi: 10.1002/ccd.28551. No abstract available.
- 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.
Yujie Zhou, Doctor study chair
Beijing Anzhen Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Coronary Angiography and Intervention in people with Coronary Disease, run by Beijing Anzhen Hospital.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lixia Yang, Doctor (13661339066, ylx966@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radial artery occlusion (time frame: Within 24 hours after the procedure.). 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 NCT04784078, which also lists 5 linked publications.
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 13 Apr 2021.