Decrease Artery Occlusion by Distal Radial Arterial Cannulation in ACS Patients (DONATION)

Southern University of Science and Technology

Status: Unknown

Conditions: Procedural Complication; Acute Coronary Syndrome

Treatments: Procedure: conventional TRA group; Procedure: distal TRA group

Study type: Interventional

Funder types: Other

Identifiers

NCT05255939

DONATION

Details and patient eligibility

About

The site of arterial access for coronary angiography and intervention has been the focus of research for decades as it is the source of major complications. Transradial access (TRA) reduces complications among patients undergoing percutaneous coronary procedures but is reported with the complication of radial artery occlusion (RAO) that limits the radial artery for future needs.

Distal radial access (dTRA) has recently gained global popularity as an alternative access route for vascular procedures. Among the benefits of dTRA are the low risk of entry site bleeding complications, the low rate of radial artery occlusion, and improved patient and operator comfort.

This study aims to reveal the feasibility and safety of dTRA and routine TRA procedures in acute coronary syndrome patients. The primary endpoints are forearm radical occlusion rate and major adverse cardiovascular events (MACEs) in the two groups, respectively. Investigators will also focus on puncture success in diagnostic and interventional cases, rate of One attempt success, access time, procedure time, crossover rate, contrast dose of patients, fluoroscopy time and dose, and healthcare cost of each group.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• presence of a pulse in the snuffbox

Exclusion criteria

• Absence of pulse
• Ultrasound indication of arterial occlusion or severe calcification
• Severe forearm artery malformation
• Patients with severe liver and renal failure, or abnormal coagulation function
• Established cardiogenic shock
• History of previous coronary artery bypass grafting and radial artery use.
• Raynaud's disease in the medical history

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,500 participants in 2 patient groups

dTRA group

Experimental group

Description:

Investigators perform percutaneous coronary intervention by dTRA

Treatment:

Procedure: distal TRA group

TRA group

Other group

Description:

Investigators perform percutaneous coronary intervention by conventional TRA

Treatment:

Procedure: conventional TRA group