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

Not Applicable

Completed

• Conditions: Distal Radial Artery; Radial Artery Occlusion; Coronary Artery Disease
• Interventions: Procedure: distal radial approach; Procedure: conventional radial access

• Registration Number: NCT05253820
• Lead Sponsor: Wujin People's Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-02-23
• Study First Posted: 2022-02-24
• Study Start: 2022-03-01
• Primary Completion: 2023-03-31
• Study Completion: 2023-08-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-08
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 801

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
distal radial approach group	distal radial approach	subjects randomized to experimental group were underwent coronary diagnosis and intervention via distal radial approach
conventional radial access group	conventional radial access	subjects randomized to active comparator group were underwent coronary diagnosis and intervention via conventional radial approach

Primary Outcome Measures

Name	Time	Method
long-term radial artery occlusion	3 months after procedure	Number of participants with the forearm radial artery occlusion is detected using high-frequent ultrasound at 3 months after procedure

Secondary Outcome Measures

Name	Time	Method
Radial artery trauma	at 24 hours and 3 months post procedure	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
radial artery occlusion	at 24 hours after procedure	Number of participants with the forearm radial artery occlusion is detected using high-frequent ultrasound at 24 hours after procedure
success rate of puncture	at 24 hours post procedure	Success of puncture is defined as the sheath inserted into the artery
time of puncture	at 24 hours post procedure	time of puncture is defined as the time from initial puncture to the sheath inserted into the artery

Trial Locations

Locations (1)

Changzhou Wujin People's Hospital; 🇨🇳 Changzhou, Jiangsu, China