Decrease Artery Occlusion by Distal Radial Arterial Cannulation in ACS Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 1,500
- Locations
- 1
- Primary Endpoint
- Forearm radical occlusion
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
dTRA group
Investigators perform percutaneous coronary intervention by dTRA
Intervention: distal TRA group (Procedure)
TRA group
Investigators perform percutaneous coronary intervention by conventional TRA
Intervention: conventional TRA group (Procedure)
Outcomes
Primary Outcomes
Forearm radical occlusion
Time Frame: during procedure
Doppler ultrasound to determine whether patients suffer forearm radial occlusion
MACEs
Time Frame: during procedure
Major Adverse Cardiovascular Events, including cardiovascular death, myocardial infarction and heart failure.
Secondary Outcomes
- The total cost in hospitalization(up to 2 years)
- Procedure time(during procedure)
- Contrast dose(during procedure)
- Rate of One attempt success(during procedure)
- Access time(during procedure)
- Fluoroscopy dose(during procedure)
- hand hematoma(during procedure)
- Crossover rate(during procedure)