Randomized Comparison of Distal Radial Versus Conventional Radial Access for Coronary Angiography and Intervention

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Comparison of Distal Radial Versus Conventional Radial Access for Coronary Angiography and Intervention

Conditions
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Coronary Disease

Intervention / Treatment
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* Procedure: Coronary Angiography and Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dTRA group<br> | Procedure: Coronary Angiography and Intervention<br>* Transradial access puncture site<br>|
| Active Comparator: cTRA group<br> | Procedure: Coronary Angiography and Intervention<br>* Transradial access puncture site<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within 24 hours after the procedure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Distal radial artery, Radial access