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

Wujin People's Hospital801 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

801

Conditions

Coronary Artery Disease Distal Radial Artery Radial Artery Occlusion

Interventions

distal radial approachPROCEDURE

coronary diagnosis and intervention via distal vs conventional radial approach

conventional radial accessPROCEDURE

conventional radial access

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Changzhou Wujin People's Hospital

Changzhou, Jiangsu, China

Outcomes

Primary Outcomes

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

Time frame: 3 months after procedure

Secondary Outcomes

radial artery occlusion

Number of participants with the forearm radial artery occlusion is detected using high-frequent ultrasound at 24 hours after procedure

Time frame: at 24 hours after procedure

success rate of puncture

Success of puncture is defined as the sheath inserted into the artery

Time frame: 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

Time frame: 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

Time frame: at 24 hours and 3 months post procedure

Data from ClinicalTrials.gov

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