Coronary DiseaseNCT04232488
Distal vs Proximal Radial Approach for Coronary Interventions
A study testing coronary angiography using distal radial artery and coronary angiography using proximal radial artery in people with Coronary Disease and Vascular Diseases, run by University Hospital Sestre Milosrdnice.
Trial summary
The distal radial approach ('snuff box' / fossa radialis) has become as valuable as the 'classical' radial approach for coronary angiography and interventions. Up to now, the success of the procedures has been described in several papers, with no difference in the complication rate and characteristics of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease, Vascular Diseases
- What is being tested?
- coronary angiography using distal radial artery and coronary angiography using proximal radial artery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2020to 1 Feb 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- signed a performed consent, older than 18 YO, clear indication for coronary angiography, palpable radial pulse
Who cannot join
- hemodynamic instability, critically ill patient, usual coronary angiography contraindication
Trial locations and contacts
No sites are listed yet.
Nikola Pavlović, MD, PhD contact
About this study
Official title: Comparison of the Distal Radial Approach Using a "Snuff Box" and the Proximal Radial Approach in Coronary Angiography and PCI
The distal radial approach ('snuff box' / fossa radialis) has become as valuable as the 'classical' radial approach for coronary angiography and interventions. Up to now, the success of the procedures has been described in several papers, with no difference in the complication rate and characteristics of the coronarography compared to the radial approach. It was observed that patients using distal radial access had fewer postoperative radial artery occlusions. This study will compare the characteristics of coronary angiography / percutaneous coronary intervention (duration of procedure, time to obtain the vascular arterial access, amount of contrast used, time and amount of radiation, success of procedure) and patency of radial arteries 3 months after the intervention using the distal ('snuff box') and proximal ('classic') radial approach
Read the detailed description
Introduction: The distal radial approach ('snuff box' / fossa radialis) has become as valuable as the 'classical' radial approach for coronary angiography and interventions. Up to now, the success of the procedures has been described in several papers, with no difference in the complication rate and characteristics of the coronarography compared to the radial approach. It was observed that patients using distal radial access had fewer postoperative radial artery occlusions, which is particularly suitable for patients with renal disease (for preservation of the radial artery due to the potential formation of AV fistula for dialysis) and progressive coronary disease in order to preserve the radial artery for aortocoronary bypass formation. It is also potentially less likely to develop compartment syndrome and is suitable for patients with reduced forearm mobility. Since wrist immobilization during hemostatic compression is not required, the use of a distal radial approach allows for early mobilization of patients and a shorter duration of compression itself.
Aim of the study: To compare the characteristics of coronary angiography / percutaneous coronary intervention (duration of procedure, time to obtain the vascular arterial access, amount of contrast used, time and amount of radiation, success of procedure) and patency of radial arteries 3 months after the intervention using the distal ('snuff box') and proximal ('classic') radial approach Purpose of the study: to confirm the efficacy of the distal radial approach as equally effective with a lower degree of radial artery occlusion during the follow-up period Research Hypothesis: Patients using a coronary angiography / percutaneous intervention using a distal radial approach had less occlusion of the radial arteries at long-term follow-up, with no significant difference in the features of the angiography / intervention itself (duration of procedure, time to obtain the vascular access, amount of contrast used , time and amount of radiation, procedure success).
Study participants: patients undergoing coronary intervention at the Catheterization Laboratory of the Clinic for Cardiovascular Diseases at the Clinical Hospital Center "Sestre milosrdnice", Zagreb Research Methodology and Material: Standard materials and standard methods will be used to perform coronary angiography and percutaneous coronary intervention Research Plan: After signing the informed consent, the study will include 250 patients in the distal transradial approach group, and 500 patients in the proximal radial approach group (control group). The materials, as well as the procedure technique, are standardized; the characteristics of the procedure (duration of the procedure, time of obtaining the arterial access, amount of contrast used, time and amount of radiation, success of the procedure) will be observed and Doppler of the radial artery will be performed on the first following operator-specified control (usually after 3 months of the procedure) to determine the patency of the artery.
- Conditions
- Coronary Disease, Vascular Diseases
- Being tested
- coronary angiography using distal radial artery, coronary angiography using proximal radial artery
- Keywords
- coronary disease, snuff box, radial access
- Medical subject headings
- Coronary Disease, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary angiography using distal radial arteryProcedure or surgery
Patients undergoing coronary angiography with or without percutaneous coronary intervention will be catheterised using distal radial artery ('snuff box'); color doppler will be performed after 3 months to estimate eventual occlusion of the radial artery
coronary angiography using proximal radial arteryProcedure or surgery
Patients undergoing coronary angiography with or without percutaneous coronary intervention will be catheterised using proximal radial artery; color doppler will be performed after 3 months to estimate eventual occlusion of the radial artery
| Study group | Role | What they receive |
|---|---|---|
| Angiography performed using distal radial artery | Experimental | Patients undergoing coronary angiography with or without intervention using distal radial artery ('snuff box') as a vascular access Receives: Procedure: coronary angiography using distal radial artery |
| Angiography performed using proximal radial artery | Active comparator | Patients undergoing coronary angiography with or without intervention using proximal radial artery as a vascular access Receives: Procedure: coronary angiography using proximal radial artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occlusion of the radial artery
Occlusion of the radial artery used for coronary intervention diagnosed using Color Doppler
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Feb 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion1 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Sestre Milosrdnice
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikola Kos, University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232488
- Sponsor's protocol ID
- Nikola1
- Status last verified
- Jan 2020
- First submitted
- 14 Jan 2020
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Distal Radial Approach Using a "Snuff Box" and the Proximal Radial Approach in Coronary Angiography and PCI
- ClinicalTrials.gov ID
- NCT04232488
- Acronym / sponsor ID
- Nikola1
- Conditions
- Coronary Disease, Vascular Diseases
- Keywords
- coronary disease, snuff box, radial access
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- University Hospital Sestre MilosrdniceUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 18 Jan 2020 (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.
The distal radial approach ('snuff box' / fossa radialis) has become as valuable as the 'classical' radial approach for coronary angiography and interventions. Up to now, the success of the procedures has been described in several papers, with no difference in the complication rate and characteristics of the coronarography compared to the radial approach. It was observed that patients using distal radial access had fewer postoperative radial artery occlusions. This study will compare the characteristics of coronary angiography / percutaneous coronary intervention (duration of procedure, time to obtain the vascular arterial access, amount of contrast used, time and amount of radiation, success of procedure) and patency of radial arteries 3 months after the intervention using the distal ('snuff box') and proximal ('classic') radial approach
Detailed description
Introduction: The distal radial approach ('snuff box' / fossa radialis) has become as valuable as the 'classical' radial approach for coronary angiography and interventions. Up to now, the success of the procedures has been described in several papers, with no difference in the complication rate and characteristics of the coronarography compared to the radial approach. It was observed that patients using distal radial access had fewer postoperative radial artery occlusions, which is particularly suitable for patients with renal disease (for preservation of the radial artery due to the potential formation of AV fistula for dialysis) and progressive coronary disease in order to preserve the radial artery for aortocoronary bypass formation. It is also potentially less likely to develop compartment syndrome and is suitable for patients with reduced forearm mobility. Since wrist immobilization during hemostatic compression is not required, the use of a distal radial approach allows for early mobilization of patients and a shorter duration of compression itself.
Aim of the study: To compare the characteristics of coronary angiography / percutaneous coronary intervention (duration of procedure, time to obtain the vascular arterial access, amount of contrast used, time and amount of radiation, success of procedure) and patency of radial arteries 3 months after the intervention using the distal ('snuff box') and proximal ('classic') radial approach Purpose of the study: to confirm the efficacy of the distal radial approach as equally effective with a lower degree of radial artery occlusion during the follow-up period Research Hypothesis: Patients using a coronary angiography / percutaneous intervention using a distal radial approach had less occlusion of the radial arteries at long-term follow-up, with no significant difference in the features of the angiography / intervention itself (duration of procedure, time to obtain the vascular access, amount of contrast used , time and amount of radiation, procedure success).
Study participants: patients undergoing coronary intervention at the Catheterization Laboratory of the Clinic for Cardiovascular Diseases at the Clinical Hospital Center "Sestre milosrdnice", Zagreb Research Methodology and Material: Standard materials and standard methods will be used to perform coronary angiography and percutaneous coronary intervention Research Plan: After signing the informed consent, the study will include 250 patients in the distal transradial approach group, and 500 patients in the proximal radial approach group (control group). The materials, as well as the procedure technique, are standardized; the characteristics of the procedure (duration of the procedure, time of obtaining the arterial access, amount of contrast used, time and amount of radiation, success of the procedure) will be observed and Doppler of the radial artery will be performed on the first following operator-specified control (usually after 3 months of the procedure) to determine the patency of the artery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Angiography performed using distal radial artery | Experimental | Procedure: coronary angiography using distal radial arteryPatients undergoing coronary angiography with or without intervention using distal radial artery ('snuff box') as a vascular access |
| Angiography performed using proximal radial artery | Active comparator | Procedure: coronary angiography using proximal radial arteryPatients undergoing coronary angiography with or without intervention using proximal radial artery as a vascular access |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- signed a performed consent, older than 18 YO, clear indication for coronary angiography, palpable radial pulse
Key exclusion criteria (1 listed)
- hemodynamic instability, critically ill patient, usual coronary angiography contraindication
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 using distal radial arteryPatients undergoing coronary angiography with or without percutaneous coronary intervention will be catheterised using distal radial artery ('snuff box'); color doppler will be performed after 3 months to estimate eventual occlusion of the radial artery | Procedure or surgery | Angiography performed using distal radial artery |
| coronary angiography using proximal radial arteryPatients undergoing coronary angiography with or without percutaneous coronary intervention will be catheterised using proximal radial artery; color doppler will be performed after 3 months to estimate eventual occlusion of the radial artery | Procedure or surgery | Angiography performed using proximal radial artery |
Primary outcome
Occlusion of the radial artery
Time frame: 3 months
Occlusion of the radial artery used for coronary intervention diagnosed using Color Doppler
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
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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.
Nikola Pavlović, MD, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing coronary angiography using distal radial artery and coronary angiography using proximal radial artery in people with Coronary Disease and Vascular Diseases, run by University Hospital Sestre Milosrdnice.
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: status not confirmed, as of the sponsor's last update on 18 Jan 2020. 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 Nikola Kos, MD (+385989638946, nikolakos89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occlusion of the radial artery (time frame: 3 months). 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 18 Jan 2020.