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COmparison of the HaNd DysFunction in Coronary Diagnosis and INtervention Via Distal vs Conventional Radial AccEss: Randomized Controlled Trial (CONFINE)
Randomized controlled trial for comparison of the hand dysfunction in coronary diagnosis and intervention via distal vs conventional radial access
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.
Age
18 - 90 years
Sex
ALL
Healthy Volunteers
No
Start Date
May 20, 2025
Primary Completion Date
March 20, 2026
Completion Date
May 20, 2026
Last Updated
May 23, 2025
640
ESTIMATED participants
Conventional radial artery access
PROCEDURE
Distal radial artery access
PROCEDURE
Lead Sponsor
Wujin People's Hospital
NCT06916520
NCT07444957
Data Source & Attribution
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