Anatomical sNuffbox for Coronary anGiography and IntervEntions

Study Overview
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Brief Summary
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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
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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.

Official Title
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Anatomical sNuffbox for Coronary anGiography and IntervEntions

Conditions
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Coronary Artery Disease, Vascular Access Complication

Intervention / Treatment
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* Procedure: Coronary angiography +/- percutaneous coronary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication for coronary angiography Informed consent Exclusion Criteria: Non palpable right radial artery Prior complicated right transradial intervention (radial artery dissection, perforation, occlusion) Prior CABG STEMI Hemodynamic instability Anatomical restrictions (fistula, etc)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional radial access<br> | Procedure: Coronary angiography +/- percutaneous coronary intervention<br>* Comparison of the conventional radial approach with the distal radial approach (anatomical snuffbox)<br>|
| Experimental: Distal radial access<br> | Procedure: Coronary angiography +/- percutaneous coronary intervention<br>* Comparison of the conventional radial approach with the distal radial approach (anatomical snuffbox)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of right radial artery occlusion |  | ≥30 days after CAG or PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful insertion of the sheath |  | Immediately post-procedurally | 
| Duration of sheath insertion procedure |  | Immediately post-procedurally | 
| Rate of successful completion of coronary angiography |  | Immediately post-procedurally | 
| Rate of successful completion of percutaneous coronary intervention |  | Immediately post-procedurally | 
| Total Contrast volume |  | Immediately post-procedurally | 
| Total Fluoroscopy time |  | Immediately post-procedurally | 
| Total Radiation Dose |  | Immediately post-procedurally | 
| Total Procedure Time |  | Immediately post-procedurally | 
| Time required for hemostasis |  | 1-6 hours | 
| Postprocedural Hematoma (modified EASY class) |  | 3 hours | 
| Rate of distal radial artery occlusion |  | ≥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. | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary angiography, radial access, distal radial access, anatomical snuffbox, radial artery occlusion