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

Not Applicable

• Conditions: Coronary Disease
• Interventions: Procedure: Coronary Angiography and Intervention

• Registration Number: NCT04784078
• Lead Sponsor: Beijing Anzhen Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-03
• Study First Posted: 2021-03-05
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-08
• Study Start: 2021-04-10
• Last Update Posted: 2021-04-13
• Primary Completion: 2021-12-31
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 938

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dTRA group	Coronary Angiography and Intervention	-
cTRA group	Coronary Angiography and Intervention	-

Primary Outcome Measures

Name	Time	Method
Radial artery occlusion	Within 24 hours after the procedure.	Doppler Ultrasonography of the radial artery for occlusions along its course, in both groups. Incidence of radial artery occlusion as confirmed by absense of antegrade flow in vascular doppler ultrasound.