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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05230719
Other study ID # DONATION-OB
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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
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