Acute Coronary Syndrome, Procedural Complication
Conditions
Keywords
Distal Radial Access, Radial Artery Occlusion, Major Adverse Cardiovascular Events
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.
Interventions
PROCEDUREdistal TRA group
dTRA for PCI procedure to ACS patients.
PROCEDUREconventional TRA group
Conventional TRA for PCI procedure to ACS patients
Sponsors
Shenzhen People's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Forearm radical occlusion | during procedure | Doppler ultrasound to determine whether patients suffer forearm radial occlusion |
| MACEs | during procedure | Major Adverse Cardiovascular Events, including cardiovascular death, myocardial infarction and heart failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure time | during procedure | Procedure time of 2 kinds of procedure |
| Crossover rate | during procedure | Crossover rate of 2 kinds of procedure |
| Contrast dose | during procedure | Contrast dose of 2 kinds of procedure |
| Rate of One attempt success | during procedure | Rate of One attempt success of 2 kinds of procedure |
| hand hematoma | during procedure | hand hematoma rate of 2 kinds of procedure |
| The total cost in hospitalization | up to 2 years | Healthcare cost . |
| Fluoroscopy dose | during procedure | Fluoroscopy dose of 2 kinds of procedure |
| Access time | during procedure | Access time of 2 kinds of procedure |
Countries
China
Outcome results
None listed