Decrease Artery Occlusion by Distal Radial Arterial Cannulation in ACS Patients

Acute Coronary Syndrome Clinical Trial

— DONATION  

Official title:

Decrease Artery Occlusion by Distal Radial Arterial Cannulation in ACS Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05255939
• Other study ID #: DONATION
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: February 2022
• Source: Shenzhen People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Procedural Complication

Intervention

Procedure:
• distal TRA group
dTRA for PCI procedure to ACS patients.
• conventional TRA group
Conventional TRA for PCI procedure to ACS patients

Locations

Country	Name	City	State
China	Shenzhen People's hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forearm radical occlusion	Doppler ultrasound to determine whether patients suffer forearm radial occlusion	during procedure
Primary	MACEs	Major Adverse Cardiovascular Events, including cardiovascular death, myocardial infarction and heart failure.	during procedure
Secondary	Rate of One attempt success	Rate of One attempt success of 2 kinds of procedure	during procedure
Secondary	Access time	Access time of 2 kinds of procedure	during procedure
Secondary	Procedure time	Procedure time of 2 kinds of procedure	during procedure
Secondary	Crossover rate	Crossover rate of 2 kinds of procedure	during procedure
Secondary	Contrast dose	Contrast dose of 2 kinds of procedure	during procedure
Secondary	Fluoroscopy dose	Fluoroscopy dose of 2 kinds of procedure	during procedure
Secondary	hand hematoma	hand hematoma rate of 2 kinds of procedure	during procedure
Secondary	The total cost in hospitalization	Healthcare cost .	up to 2 years