Safety and Feasibility of Transulnar Artery Approach for Coronary Angiography or Angioplasty

Study Overview
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Brief Summary
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The transradial approach for coronary angiography and angioplasty is now widely used in catheterization laboratories worldwide, which had been shown as advantages over the conventional femoral and brachial approaches due to the lower incidence of bleeding and other cardiovascular complications. However, the transradial approach does not seem suitable for 5-15% of patients undergoing coronary angiography and angioplasty. The ulnar artery which is one of the two terminal branches of the brachial artery is usually larger than radial artery and it may be as a potential approach for cardiac catheterization. Recently, some reports have demonstrated that the transulnar approach may be both feasible and safe for coronary angiography and angioplasty in selective patients.we performed this study to evaluate the safety and feasibility of transulnar approach coronary catheterization in real world non-selective patients.

Official Title
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Safety and Feasibility of Transulnar Artery Approach for Coronary Angiography or Angioplasty

Conditions
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Intervention, Transulnar, Transradial

Intervention / Treatment
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* Procedure: transulnar approach interventional procedure
* Procedure: transradial approach interventional procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of coronary artery disease Needed to perform coronary angiography or angioplasty Exclusion Criteria: Arterial circulatory disease in an upper limb History of deformity Forearm trauma Forearm amputated Hemodialysis Symptomatic peripheral artery disease Raynaud's syndrome Hemorrhagic disease Cardiogenic shock Others who were unwilling to participate the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transulnar approach group<br>Patients in transulnar group received interventional procedure through ulnar artery | Procedure: transulnar approach interventional procedure<br> <br> |
| Other: transradial approach group<br>patients in transradial group received interventional procedure through radial artery | Procedure: transradial approach interventional procedure<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary artery cannulation | vascular events including arterial occlusion through ulnar/radial artery approach | 1-12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interventional procedure characteristic | The secondary end points included the crossover rate, spasm, total time for the procedure | during procedure | 
| The access-site related complications | The access-site related complications were defined as the occurrence of hematoma, artery stenosis, arteriovenous fistula, pseudoaneurysm, and nerve injury | 1-12 month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transulnar approach, transradial approach, angiography, angioplasty