Decrease Artery Occlusion by Distal Radial Arterial Cannulation in ACS Patients

Not Applicable

• Conditions: Procedural Complication; Acute Coronary Syndrome
• Interventions: Procedure: distal TRA group; Procedure: conventional TRA group

• Registration Number: NCT05255939
• Lead Sponsor: Shenzhen People's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-17
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-24
• Last Update Submitted: 2022-02-24
• Study First Posted: 2022-02-25
• Last Update Posted: 2022-02-25
• Study Start: 2022-03-01
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dTRA group	distal TRA group	Investigators perform percutaneous coronary intervention by dTRA
TRA group	conventional TRA group	Investigators perform percutaneous coronary intervention by conventional TRA

Primary Outcome Measures

Name	Time	Method
Forearm radical occlusion	during procedure	Doppler ultrasound to determine whether patients suffer forearm radial occlusion
MACEs	during procedure	Major Adverse Cardiovascular Events, including cardiovascular death, myocardial infarction and heart failure.

Secondary Outcome Measures

Name	Time	Method
The total cost in hospitalization	up to 2 years	Healthcare cost .
Procedure time	during procedure	Procedure time of 2 kinds of procedure
Contrast dose	during procedure	Contrast dose of 2 kinds of procedure
Rate of One attempt success	during procedure	Rate of One attempt success of 2 kinds of procedure
Access time	during procedure	Access time of 2 kinds of procedure
Fluoroscopy dose	during procedure	Fluoroscopy dose of 2 kinds of procedure
hand hematoma	during procedure	hand hematoma rate of 2 kinds of procedure
Crossover rate	during procedure	Crossover rate of 2 kinds of procedure

Trial Locations

Locations (1)

Shenzhen People's hospital; 🇨🇳 Shenzhen, Guangdong, China