Long-term Radial Artery Occlusion in Coronary Diagnosis and Intervention Via Distal Radial Approach (CONDITION)

Study Overview
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Brief Summary
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Randomized-controlled trial to comparison of the long-term radial artery occlusion in coronary diagnosis and intervention via distal vs conventional radial approach

Detailed Description
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Coronary diagnosis and intervention via distal radial artery is prevalent worldwide. This study aims to explore the long-term radial artery occlusion after coronary diagnosis and intervention via distal radial artery at 3 months after procedure using portable high-frequent ultrasound. The secondary endpoints include the success rate of puncture, time of puncture, duration of hemostasis, radial artery trauma, etc.

Official Title
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Comparison of the Long-term Radial Artery Occlusion in Coronary Diagnosis and Intervention Via Distal vs Conventional Radial Approach: Randomized-controlled Trial(CONDITION)

Conditions
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Coronary Artery Disease, Distal Radial Artery, Radial Artery Occlusion

Intervention / Treatment
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* Procedure: distal radial approach
* Procedure: conventional radial access


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years; Palpable unilateral distal radial and radial artery Exclusion Criteria: Age ≥ 90years; Height≥ 185cm; Cardiogenic shock; Contraindications to puncture at the puncture site; Inability to obtain written informed consent Previous right radial or distal artery intervention

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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
Interventional Model Description: Single-center parallel randomized controlled study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: distal radial approach group<br>subjects randomized to experimental group were underwent coronary diagnosis and intervention via distal radial approach | Procedure: distal radial approach<br>* coronary diagnosis and intervention via distal vs conventional radial approach<br>|
| Active Comparator: conventional radial access group<br>subjects randomized to active comparator group were underwent coronary diagnosis and intervention via conventional radial approach | Procedure: conventional radial access<br>* conventional radial access<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| long-term radial artery occlusion | Number of participants with the forearm radial artery occlusion is detected using high-frequent ultrasound at 3 months after procedure | 3 months after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radial artery occlusion | Number of participants with the forearm radial artery occlusion is detected using high-frequent ultrasound at 24 hours after procedure | at 24 hours after procedure | 
| success rate of puncture | Success of puncture is defined as the sheath inserted into the artery | at 24 hours post procedure | 
| time of puncture | time of puncture is defined as the time from initial puncture to the sheath inserted into the artery | at 24 hours post procedure | 
| Radial artery trauma | Number of participants with radial artery trauma in the radial and distal radial artery, such as the intimal tears, dissections, thrombosis, and pseudoaneurysms in the radial and distal radial artery, which is detected by ultrasound | at 24 hours and 3 months post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, distal radial artery, conventional radial artery, radial artery occlusion