Hand Dysfunction in Coronary Diagnosis and Intervention Via Distal Radial Access (CONFINE)

Wujin People's Hospital

Status: Not yet enrolling

Conditions: Coronary Arterial Disease (CAD); Hand Functions; Distal Raidal Artery

Treatments: Procedure: Distal radial artery access; Procedure: Conventional radial artery access

Study type: Interventional

Funder types: Other

Identifiers

NCT06986889

20250501

Details and patient eligibility

About

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

Full 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.

Enrollment: 640 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Indications for coronary diagnosis and intervention
• Distal and conventional radial artery pulsation are palpable
• Patient should be able to comply with the protocol

Exclusion Criteria

• Age < 18 years or ≥ 90 years
• Height ≥ 185 cm
• Acute STEMI
• Haemodynamic instability
• Contraindications to puncture at the puncture site (such as infection, scarring or indwelling needles)
• Enrollment in another study that competes or interferes with this study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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640 participants in 2 patient groups

Distal radial artery access group

Experimental group

Description:

Subjects randomized to experimental group were underwent coronary diagnosis and intervention via distal radial artery access.

Treatment:

Procedure: Distal radial artery access

Conventional radial artery access group

Active Comparator group

Description:

Subjects randomized to active comparator group were underwent coronary diagnosis and intervention via conventional radial artery access.

Treatment:

Procedure: Conventional radial artery access