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Decrease Artery Occlusion by Distal Radial Arterial Cannulation, Observational Study (DONATION-OB)

S

Southern University of Science and Technology

Status

Unknown

Conditions

Procedural Complication
Acute Coronary Syndrome
Outcome, Fatal

Treatments

Procedure: Radial Artery Approach

Study type

Observational

Funder types

Other

Identifiers

NCT05230719
DONATION-OB

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

Enrollment

2,000 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

2,000 participants in 2 patient groups

dTRA group
Description:
Investigators perform percutaneous coronary intervention by dTRA for patients
Treatment:
Procedure: Radial Artery Approach
TRA group
Description:
Investigators perform percutaneous coronary intervention by conventional TRA for patients
Treatment:
Procedure: Radial Artery Approach

Trial contacts and locations

1

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Central trial contact

Tangzhiming Li, PhD.

Data sourced from clinicaltrials.gov

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