Coronary Artery Disease, Distal Radial Artery, Radial Artery Occlusion
Conditions
Keywords
coronary artery disease, distal radial artery, conventional radial artery, radial artery occlusion
Brief summary
Randomized-controlled trial to comparison of the long-term radial artery occlusion in coronary diagnosis and intervention via distal vs conventional radial approach
Detailed description
Coronary diagnosis and intervention via distal radial artery is prevalent worldwide. This study aims to explore the long-term radial artery occlusion after coronary diagnosis and intervention via distal radial artery at 3 months after procedure using portable high-frequent ultrasound. The secondary endpoints include the success rate of puncture, time of puncture, duration of hemostasis, radial artery trauma, etc.
Interventions
PROCEDUREdistal radial approach
coronary diagnosis and intervention via distal vs conventional radial approach
PROCEDUREconventional radial access
conventional radial access
Sponsors
Wujin People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Single-center parallel randomized controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years; * Palpable unilateral distal radial and radial artery
Exclusion criteria
* Age ≥ 90years; * Height≥ 185cm; * Cardiogenic shock; * Contraindications to puncture at the puncture site; * Inability to obtain written informed consent * Previous right radial or distal artery intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| long-term radial artery occlusion | 3 months after procedure | Number of participants with the forearm radial artery occlusion is detected using high-frequent ultrasound at 3 months after procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| radial artery occlusion | at 24 hours after procedure | Number of participants with the forearm radial artery occlusion is detected using high-frequent ultrasound at 24 hours after procedure |
| success rate of puncture | at 24 hours post procedure | Success of puncture is defined as the sheath inserted into the artery |
| time of puncture | at 24 hours post procedure | time of puncture is defined as the time from initial puncture to the sheath inserted into the artery |
| Radial artery trauma | at 24 hours and 3 months post procedure | Number of participants with radial artery trauma in the radial and distal radial artery, such as the intimal tears, dissections, thrombosis, and pseudoaneurysms in the radial and distal radial artery, which is detected by ultrasound |
Countries
China
Outcome results
None listed