Coronary Angiography and InterventionRAONCT06688747
The Primary Endpoint is to Compare the Incidence of Forearm RAO Between Distal and Traditional Radial Access Assessed by Vascular Ultrasound At Discharge
An observational study of Coronary Angiography and Intervention, run by Assiut University.
Trial summary
The primary endpoint is to compare the incidence of forearm RAO between distal and traditional radial access for coronary angiography and intervention Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Angiography and Intervention
- How many people
- 230 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will include patients will undergo coronary angiography and\or PCI in Assiut university heart hospital
Who may be able to join
- Aged ≥18 y
- Signed informed consent form
- Indication to diagnostic coronary angiography or PCI
- Patient's suitability for both DRA and conventional TRA using 6 Fr Sheath
Who cannot join
- Chronic hemodialysis
- Treatment of a coronary chronic total occlusion (CTO) lesion
- Patients who underwent CA or PCI with radial access before
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Distal Versus Traditional Radial Access for Coronary Angiography and Intervention
The primary endpoint is to compare the incidence of forearm RAO between distal and traditional radial access for coronary angiography and intervention
Read the detailed description
Trans radial access (TRA) has become the standard vascular access for coronary angiography and percutaneous coronary intervention (PCI) and is currently endorsed with a class IA recommendation in the latest European Society of Cardiology/European Association for Cardiothoracic Surgery (ESC/EACTS) Guidelines on myocardial revascularization, irrespective of clinical presentation Several clinical and procedural characteristics have been linked to the occurrence of RAO, and best practices recommendations for the prevention of RAO include reduction of the sheath/catheter size, adequate procedural anticoagulation, non-occlusive hemostasis (4) and a minimal pressure strategy with short (≤ 120 min) hemostasis time. The use of the distal radial artery with arterial access in the anatomical snuffbox or on the dorsum of the hand, has recently emerged as a promising alternative access route to further reduce the risk of RAO (5) The distal radial artery may be punctured proximally to the tendon of the extensor pollicis longus muscle in the anatomical snuffbox or distally to it in the dorsum of the hand.(6) the distal radial artery lies in the subcutaneous space superficial to the fascial compartments of the hand, thus favoring a faster, and safer hemostasis as compared to conventional TRA(7) The study will enroll 228 patients who will undergo a diagnostic coronary angiography and/or a PCI using a 6 Fr Sheath as the standard access sheath will be divided into two groups DRA versus TRA (114 cases in each group) The primary endpoint is the incidence of forearm RAO between the two groups at hospitalization discharge assessed by duplex ultrasound with independent investigator, who was not involved in the procedure. The presence or absence of a duplex ultrasound anterograde flow signal distal to the radial artery access site is checked between 8 to 48 hours post-procedure The secondary endpoints as successful sheath insertion, access site cross-over, total procedure time, sheath insertion time, puncture site bleeding overall bleeding, vascular access-site complication and radial artery spasm.
- Conditions
- Coronary Angiography and Intervention
- Keywords
- RAO, DISTAL, Traditional radial
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Distal access | Distal radial access for coronary angiography and intervention | |
| Traditional access | Distal radial access for coronary angiography and intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the incidence of forearm RAO between distal and traditional radial access assessed by vascular ultrasound at discharge
The primary endpoint is the incidence of forearm RAO between the two groups at hospitalization discharge assessed by duplex ultrasound with independent investigator, who was not involved in the procedure. The presence or absence of a duplex ultrasound anterograde flow signal distal to the radial artery access site is checked between 8 to 48 hours post-procedure and follow up after 3 months
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
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 Angiography and InterventionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Talaat Bakr, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688747
- Sponsor's protocol ID
- AssiutU/Mostafa Talaat
- Acronym
- RAO
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sgueglia GA, Santoliquido A, Gaspardone A, Di Giorgio A. First Results of the Distal Radial Access Doppler Study. JACC Cardiovasc Imaging. 2021 Jun;14(6):1281-1283. doi: 10.1016/j.jcmg.2020.11.023. Epub 2021 Jan 13. No abstract available.
PubMed 33454250
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distal Versus Traditional Radial Access for Coronary Angiography and Intervention
- ClinicalTrials.gov ID
- NCT06688747
- Acronym / sponsor ID
- RAO / AssiutU/Mostafa Talaat
- Conditions
- Coronary Angiography and Intervention
- Keywords
- RAO, DISTAL, Traditional radial
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 14 Nov 2024 (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 primary endpoint is to compare the incidence of forearm RAO between distal and traditional radial access for coronary angiography and intervention
Detailed description
Trans radial access (TRA) has become the standard vascular access for coronary angiography and percutaneous coronary intervention (PCI) and is currently endorsed with a class IA recommendation in the latest European Society of Cardiology/European Association for Cardiothoracic Surgery (ESC/EACTS) Guidelines on myocardial revascularization, irrespective of clinical presentation Several clinical and procedural characteristics have been linked to the occurrence of RAO, and best practices recommendations for the prevention of RAO include reduction of the sheath/catheter size, adequate procedural anticoagulation, non-occlusive hemostasis (4) and a minimal pressure strategy with short (≤ 120 min) hemostasis time. The use of the distal radial artery with arterial access in the anatomical snuffbox or on the dorsum of the hand, has recently emerged as a promising alternative access route to further reduce the risk of RAO (5) The distal radial artery may be punctured proximally to the tendon of the extensor pollicis longus muscle in the anatomical snuffbox or distally to it in the dorsum of the hand.(6) the distal radial artery lies in the subcutaneous space superficial to the fascial compartments of the hand, thus favoring a faster, and safer hemostasis as compared to conventional TRA(7) The study will enroll 228 patients who will undergo a diagnostic coronary angiography and/or a PCI using a 6 Fr Sheath as the standard access sheath will be divided into two groups DRA versus TRA (114 cases in each group) The primary endpoint is the incidence of forearm RAO between the two groups at hospitalization discharge assessed by duplex ultrasound with independent investigator, who was not involved in the procedure. The presence or absence of a duplex ultrasound anterograde flow signal distal to the radial artery access site is checked between 8 to 48 hours post-procedure The secondary endpoints as successful sheath insertion, access site cross-over, total procedure time, sheath insertion time, puncture site bleeding overall bleeding, vascular access-site complication and radial artery spasm.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Distal access | – | –Distal radial access for coronary angiography and intervention |
| Traditional access | – | –Distal radial access for coronary angiography and intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will include patients will undergo coronary angiography and\or PCI in Assiut university heart hospital
Key inclusion criteria (4 listed)
- Aged ≥18 y
- Signed informed consent form
- Indication to diagnostic coronary angiography or PCI
- Patient's suitability for both DRA and conventional TRA using 6 Fr Sheath
Key exclusion criteria (3 listed)
- Chronic hemodialysis
- Treatment of a coronary chronic total occlusion (CTO) lesion
- Patients who underwent CA or PCI with radial access before
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To compare the incidence of forearm RAO between distal and traditional radial access assessed by vascular ultrasound at discharge
Time frame: One year
The primary endpoint is the incidence of forearm RAO between the two groups at hospitalization discharge assessed by duplex ultrasound with independent investigator, who was not involved in the procedure. The presence or absence of a duplex ultrasound anterograde flow signal distal to the radial artery access site is checked between 8 to 48 hours post-procedure and follow up after 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Background: PubMed 33454250Sgueglia GA, Santoliquido A, Gaspardone A, Di Giorgio A. First Results of the Distal Radial Access Doppler Study. JACC Cardiovasc Imaging. 2021 Jun;14(6):1281-1283. doi: 10.1016/j.jcmg.2020.11.023. Epub 2021 Jan 13. No abstract available.
- Individual participant dataSharing planned: Undecided
Related trials for Coronary Angiography and Intervention
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
PREventive Invasive Strategy for Obstructive Coronary Artery Disease With Vulnerable Plaque Evaluated by CoroNary Computed Tomography Angiography-2
Coronary Artery Disease
Recruiting
Effect of Stress Ball Application During Coronary Angiography on Anxiety, Procedure-related Fear, Physiological Parameters, and Comfort
Stress Ball
Active, not recruiting
Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease
Acute Myocardial Infarction, Coronary Artery Disease
Not yet recruitingObservational study
The PICCOLETO XIII REVEAL-DCB Cohort A Study
Coronary Artery Disease, Coronary Stenosis
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Angiography and Intervention, run by Assiut University.
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 3 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: opening soon, as of the sponsor's last update on 14 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mostafa Talaat Bakr Mostafa Mostafa Talaat, MD (0201007952006, Mostafatalaat554@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the incidence of forearm RAO between distal and traditional radial access assessed by vascular ultrasound at discharge (time frame: One year). 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 NCT06688747, 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 14 Nov 2024.