An interventional study of distal TRA group and conventional TRA group in Acute Coronary Syndrome and Procedural Complication, sponsored by Shenzhen People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-02-25.
Sponsored by Shenzhen People's Hospital · Not applicable, Interventional, and Treatment
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.
1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →Shenzhen People's Hospital is the lead sponsor of 62 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Investigators perform percutaneous coronary intervention by dTRA
Procedure: distal TRA group
Investigators perform percutaneous coronary intervention by conventional TRA
Procedure: conventional TRA group
dTRA for PCI procedure to ACS patients.
Conventional TRA for PCI procedure to ACS patients
Forearm radical occlusion
Doppler ultrasound to determine whether patients suffer forearm radial occlusion
Time frame: during procedure
MACEs
Major Adverse Cardiovascular Events, including cardiovascular death, myocardial infarction and heart failure.
Time frame: during procedure
Rate of One attempt success
Rate of One attempt success of 2 kinds of procedure
Time frame: during procedure
Access time
Access time of 2 kinds of procedure
Time frame: during procedure
Procedure time
Procedure time of 2 kinds of procedure
Time frame: during procedure
Crossover rate
Crossover rate of 2 kinds of procedure
Time frame: during procedure
Contrast dose
Contrast dose of 2 kinds of procedure
Time frame: during procedure
Fluoroscopy dose
Fluoroscopy dose of 2 kinds of procedure
Time frame: during procedure
hand hematoma
hand hematoma rate of 2 kinds of procedure
Time frame: during procedure
The total cost in hospitalization
Healthcare cost .
Time frame: up to 2 years
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Shenzhen People's Hospital