NCT06986889

Hand Dysfunction in Coronary Diagnosis and Intervention Via Distal Radial Access

COmparison of the HaNd DysFunction in Coronary Diagnosis and INtervention Via Distal vs Conventional Radial AccEss: Randomized Controlled Trial (CONFINE)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 640 (estimated)
• Sponsor: Wujin People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Randomized controlled trial for comparison of the hand dysfunction in coronary diagnosis and intervention via distal vs conventional radial access

Detailed description

Coronary diagnosis and intervention via distal radial access has gradually become an alternative access to the conventional radial access because of its advantages of reducing radial artery occlusion (RAO), shortening compression time, and decreasing patient discomfort. However, as awareness of distal radial access has increased, some patients have been found to have symptoms such as abnormal hand sensation and inflexibility after the procedure. The primary objective is to assess hand function after coronary diagnosis and intervention via distal vs conventional radial access at 24 hours and 1 month. Hand sensory and motor dysfunction will be assessed by: * Consultation and physical examination * Hand grip test * Hand pinch test (lateral pinch) * Monofilament sensory test * Quick DASH questionnaire * High-frequent ultrasound The other endpoints include the success rate of puncture, the success rate of single-attempt puncture, time of puncture, procedural duration, duration of hemostasis, vascular complication, etc.

Conditions

• Coronary Arterial Disease (CAD)
• Distal Raidal Artery
• Hand Functions

Interventions

Type	Name	Description
PROCEDURE	Conventional radial artery access	Half of the patients enrolled in the study undergoing coronary diagnosis and intervention will be randomized conventional radial access for cardiac catheterization.
PROCEDURE	Distal radial artery access	Half of the patients enrolled in the study undergoing coronary diagnosis and intervention will be randomized distal radial access for cardiac catheterization.

Timeline

• Start date: 2025-05-20
• Primary completion: 2026-03-20
• Completion: 2026-05-20
• First posted: 2025-05-23
• Last updated: 2025-05-23