Coronary Artery DiseaseANGIENCT03986151
Anatomical sNuffbox for Coronary anGiography and IntervEntions
A study testing Coronary angiography +/- percutaneous coronary intervention in people with Coronary Artery Disease and Vascular Access Complication, run by University Hospital of Patras at 1 site in Greece.
Trial summary
This randomized, single-center, prospective study seeks to compare the conventional radial approach with the recently described distal radial approach (anatomical snuffbox) concerning the patency of the radial artery in patients subjected to coronary angiography or percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Vascular Access Complication
- What is being tested?
- Coronary angiography +/- percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,042 participants
- Where
- 1 siteGreece
- Study dates
- 11 Jun 2019to 20 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
- Indication for coronary angiography
- Informed consent
Who cannot join
- Non palpable right radial artery
- Prior complicated right transradial intervention (radial artery dissection, perforation, occlusion)
- Prior CABG
- STEMI
- Hemodynamic instability
- Anatomical restrictions (fistula, etc)
Trial locations and contacts
1 site in 1 country.
About this study
This randomized, single-center, prospective study seeks to compare the conventional radial approach with the recently described distal radial approach (anatomical snuffbox) concerning the patency of the radial artery in patients subjected to coronary angiography or percutaneous coronary intervention.
Read the detailed description
Transradial approach has become the standard approach for coronary angiography (CAG) and percutaneous coronary intervention (PCI). The current ESC/EACTS guidelines of myocardial revascularization support using radial approach (RA) rather than femoral approach (FA) if the operators are experts for RA. Recently, an alternative transradial access has been suggested at the anatomical snuffbox, with potential additional benefits including a reduction in radial artery occlusion rate (which allows reintervention through the same access site and potential use as a graft), a decrease in other local vascular complications, shorter hemostasis duration, patients' intra and post procedural comfort and shorter recovery time. However, the feasibility of PCI via snuffbox approach is still concerned due to the lack of data. Therefore, the aim of the study is to compare the two approaches concerning the patency of the radial artery ≥30 days after the intervention with Doppler in a randomized way. Due to the anastomosis of the distal radial artery with the superficial palmar arch, even in case of total radial artery occlusion within the anatomical snuffbox, the antegrade blood flow may be preserved and, therefore, decreased incidents of radial artery occlusion are expected in the right distal radial artery approach group. The mean diameter of radial artery at the anatomical snuffbox is 2.4 mm, whereas the mean diameter of the radial artery at the forearm is 2.7 mm, and this could potentially contribute to shorter hemostasis duration.
- Being tested
- Coronary angiography +/- percutaneous coronary intervention
- Keywords
- coronary angiography, radial access, distal radial access, anatomical snuffbox, radial artery occlusion
- Medical subject headings
- Coronary Artery Disease, Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary angiography +/- percutaneous coronary interventionProcedure or surgery
Comparison of the conventional radial approach with the distal radial approach (anatomical snuffbox)
| Study group | Role | What they receive |
|---|---|---|
| Conventional radial access | Active comparator | Not described Receives: Procedure: Coronary angiography +/- percutaneous coronary intervention |
| Distal radial access | Experimental | Not described Receives: Procedure: Coronary angiography +/- percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of right radial artery occlusion
Measured: ≥30 days after CAG or PCI
Secondary outcomes (12)
Rate of successful insertion of the sheath
Measured: Immediately post-procedurally
Duration of sheath insertion procedure
Measured: Immediately post-procedurally
Rate of successful completion of coronary angiography
Measured: Immediately post-procedurally
Rate of successful completion of percutaneous coronary intervention
Measured: Immediately post-procedurally
Total Contrast volume
Measured: Immediately post-procedurally
Total Fluoroscopy time
Measured: Immediately post-procedurally
Total Radiation Dose
Measured: Immediately post-procedurally
Total Procedure Time
Measured: Immediately post-procedurally
Time required for hemostasis
Measured: 1-6 hours
Postprocedural Hematoma (modified EASY class)
Measured: 3 hours
Rate of distal radial artery occlusion
Measured: ≥30 days after CAG or PCI
Pain associated with the procedure: Pain scale 0-10
Pain scale 0-10. A visual anlog pain scale 0-10 will be shown to the patient post-precedurally. 0=no pain, 10=worst pain. Patient will be asked to report the severity of the pain associated with the procedure.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start11 Jun 2019
- Primary completion20 Feb 2021
- Study completion20 Feb 2021
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,042 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grigorios Tsigkas, University Hospital of Patras
- Investigators
- Grigorios Tsigkas, MD, Phd, Principal investigator, University Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986151
- Sponsor's protocol ID
- 11994/6-5-2019
- Acronym
- ANGIE
- Status last verified
- Mar 2021
- First submitted
- 11 Jun 2019
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical sNuffbox for Coronary anGiography and IntervEntions
- ClinicalTrials.gov ID
- NCT03986151
- Acronym / sponsor ID
- ANGIE / 11994/6-5-2019
- Keywords
- coronary angiography, radial access, distal radial access, anatomical snuffbox, radial artery occlusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,042 participants (actual)
- Lead sponsor
- University Hospital of PatrasUniversity, hospital or other
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 20 Feb 2021 (actual)
- Study completion
- 20 Feb 2021 (actual)
- First posted
- 14 Jun 2019 (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 randomized, single-center, prospective study seeks to compare the conventional radial approach with the recently described distal radial approach (anatomical snuffbox) concerning the patency of the radial artery in patients subjected to coronary angiography or percutaneous coronary intervention.
Detailed description
Transradial approach has become the standard approach for coronary angiography (CAG) and percutaneous coronary intervention (PCI). The current ESC/EACTS guidelines of myocardial revascularization support using radial approach (RA) rather than femoral approach (FA) if the operators are experts for RA. Recently, an alternative transradial access has been suggested at the anatomical snuffbox, with potential additional benefits including a reduction in radial artery occlusion rate (which allows reintervention through the same access site and potential use as a graft), a decrease in other local vascular complications, shorter hemostasis duration, patients' intra and post procedural comfort and shorter recovery time. However, the feasibility of PCI via snuffbox approach is still concerned due to the lack of data. Therefore, the aim of the study is to compare the two approaches concerning the patency of the radial artery ≥30 days after the intervention with Doppler in a randomized way. Due to the anastomosis of the distal radial artery with the superficial palmar arch, even in case of total radial artery occlusion within the anatomical snuffbox, the antegrade blood flow may be preserved and, therefore, decreased incidents of radial artery occlusion are expected in the right distal radial artery approach group. The mean diameter of radial artery at the anatomical snuffbox is 2.4 mm, whereas the mean diameter of the radial artery at the forearm is 2.7 mm, and this could potentially contribute to shorter hemostasis duration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional radial access | Active comparator | Procedure: Coronary angiography +/- percutaneous coronary intervention |
| Distal radial access | Experimental | Procedure: Coronary angiography +/- percutaneous coronary intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Indication for coronary angiography
- Informed consent
Key exclusion criteria (6 listed)
- Non palpable right radial artery
- Prior complicated right transradial intervention (radial artery dissection, perforation, occlusion)
- Prior CABG
- STEMI
- 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 |
|---|---|---|
| Coronary angiography +/- percutaneous coronary interventionComparison of the conventional radial approach with the distal radial approach (anatomical snuffbox) | Procedure or surgery | Conventional radial access, Distal radial access |
Primary outcome
Rate of right radial artery occlusion
Time frame: ≥30 days after CAG or PCI
12 secondary outcomes
Rate of successful insertion of the sheath
Time frame: Immediately post-procedurally
Duration of sheath insertion procedure
Time frame: Immediately post-procedurally
Rate of successful completion of coronary angiography
Time frame: Immediately post-procedurally
Rate of successful completion of percutaneous coronary intervention
Time frame: Immediately post-procedurally
Total Contrast volume
Time frame: Immediately post-procedurally
Total Fluoroscopy time
Time frame: Immediately post-procedurally
Total Radiation Dose
Time frame: Immediately post-procedurally
Total Procedure Time
Time frame: Immediately post-procedurally
Time required for hemostasis
Time frame: 1-6 hours
Postprocedural Hematoma (modified EASY class)
Time frame: 3 hours
Rate of distal radial artery occlusion
Time frame: ≥30 days after CAG or PCI
Pain associated with the procedure: Pain scale 0-10
Time frame: 1 hour
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 12 Mar 2021.
- Individual participant dataSharing planned: Yes
Related trials for Coronary Artery Disease
Not yet recruiting
GOT VOICE Feasibility With In-Person Group Singing
Elderly, Coronary Arterial Disease (CAD)
RecruitingObservational study
Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry
Cardiovascular Diseases
Recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruiting
Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses
Coronary Artery Disease, Coronary Artery Stenoses
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.
Grigorios Tsigkas, MD, Phd principal investigator
University Hospital of Patras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary angiography +/- percutaneous coronary intervention in people with Coronary Artery Disease and Vascular Access Complication, run by University Hospital of Patras at 1 site in Greece.
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 2 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: finished, as of the sponsor's last update on 12 Mar 2021. 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 Greece. 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?
Rate of right radial artery occlusion (time frame: ≥30 days after CAG or PCI). 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 12 Mar 2021.