Randomized Comparison of Distal Radial Versus Conventional Radial Access for Coronary Angiography and Intervention

Capital Medical University

Status: Unknown

Conditions: Coronary Disease

Treatments: Procedure: Coronary Angiography and Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04784078

DC radial

Details and patient eligibility

About

Distal radial access (dTRA) represents a novel site for radial artery access in interventional cardiology, there is little data compare dTRA with conventional radial access (cTRA) in a randomized manner.

It aims to randomly compare between the new distal radial access via the snuffbox and the conventional radial access for percutaneous coronary intervention (PCI) and angioplasty procedures. The objectives of comparing both procedures are to analyze the frequency of complications in terms of occlusion, arterial spasm, hematoma, and to weigh accesses effectiveness in terms of time and attempts to puncture, crossover rate, procedure duration, hemostasis time.

Candidates for coronary angiography are being randomized into the interventional group to undergo the angiography through the distal radial artery as the access site, or the control group accessing through the radial artery. Procedural and post procedural outcomes and complications are being reported while patients are in hospital. All patients undergo doppler ultrasonography within 24 hours before and after the procedure, 4 weeks after procedure.

Enrollment: 938 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is over 18 years of age.
• Patient is undergoing diagnostic coronary angiography and/or PCI for the first time.
• Patient has provided written informed consent.
• Patient is willing to comply with all protocol-required evaluations during the hospitalization.

Exclusion criteria

• No palpable radial artery or distal radial artery.
• Radial artery used as a bridging vessel.
• Severe heart failure (NYHA class IV).
• Severe renal insufficiency ( SCr>443umol/L).
• Height over 185 cm.
• A ≥7F catheter may be required for operation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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938 participants in 2 patient groups

dTRA group

Experimental group

Treatment:

Procedure: Coronary Angiography and Intervention

cTRA group

Active Comparator group

Treatment:

Procedure: Coronary Angiography and Intervention