Decrease Artery Occlusion by Distal Radial Arterial Cannulation, Observational Study

Acute Coronary Syndrome Clinical Trial

— DONATION-OB  

Official title:

Decrease Artery Occlusion by Distal Radial Arterial Cannulation, Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05230719
• Other study ID #: DONATION-OB
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: January 1, 2024

Study information

• Verified date: January 2022
• Source: Shenzhen People's Hospital
• Contact: Tangzhiming Li, PhD.
• Phone: +86 18588269277
• Email: litangzhiming[@]126.com
• Is FDA regulated: No
• Study type: Observational

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. Investigators conduct this retrospected analysis to demonstrate the difference of the two procedure of Cannulation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• 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
• Outcome, Fatal
• Procedural Complication

Intervention

Procedure:
• Radial Artery Approach
dTRA or conventional TRA for radical artery approach

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	Doppler ultrasound to determine whether patients suffer forearm radial occlusion	2 years
Primary	MACEs	Major Adverse Cardiovascular Events, including cardiovascular death, myocardial infarction and heart failure.	2 years