Coronary Artery Disease Clinical Trial
— ANTARESOfficial title:
distAl vs. coNventional Transradial Access for coRonary procEdures Study (ANTARES)
Verified date | August 2023 |
Source | Indywidualna Praktyka Lekarska Lekarz Lukasz Kozinski |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The distal transradial approach (dTRA) via the anatomical snuffbox is hypothesized to be more beneficial than the conventional transradial access (cTRA) in patients undergoing coronary procedures. This prospective single-center randomized trial was designed to investigate the safety, efficacy, and various ultrasound parameters of dTRA.
Status | Completed |
Enrollment | 400 |
Est. completion date | May 31, 2023 |
Est. primary completion date | February 28, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - patients referred for CAG and/or PCI Exclusion Criteria: - ST-elevation myocardial infarction - sudden cardiac arrest - hemody-namic instability - chronic kidney disease (stages 4-5) - forearm artery occlusion - previous unsuccessful ipsilateral TRA - unfavorable RA diameter - ultrasound unavailability |
Country | Name | City | State |
---|---|---|---|
Poland | Szpital Specjalistyczny | Chojnice | Pomeranian |
Lead Sponsor | Collaborator |
---|---|
Lukasz Kozinski |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Access-time | counted from local anesthesia to successful insertion of the sheath | during procedure | |
Other | radial artery size | parameter measured by Doppler Ultrasound at the access point | before the procedure, 24 hours and 60 days after the procedure | |
Other | radial artery velocity | parameter measured by Doppler Ultrasound at the access point | before the procedure, 24 hours and 60 days after the procedure | |
Primary | The primary composite endpoint consisted of rate of access crossover, rate of major adverse cardiovascular events (MACE) and rate of access-related vascular complications. | Access crossover from unsuccessful random arterial access (if the initial access point fails) to another one.
Access-related complications after the procedure measured with Doppler Ultrasound (included radial artery occlusion, significant hematoma (EASY classification grade III-V), arteriovenous fistula, pseudoaneurysm, perforation and spasm). MACE definied as myocardial infarction, stroke, urgent revascularization, all-cause death. |
up to 24 hours | |
Secondary | efficacy endpoint: rate of access crossover | Access crossover from unsuccessful random arterial access (if the initial access point fails) to another one. | during the procedure index | |
Secondary | safety endpoint: patients' discomfort evaluated during access performance | physical discomfort at the time of vascular access performance was assessed using a numerical scale (0/1/2/3 - respectively no/mild/moderate/severe discomfort) | during the procedure | |
Secondary | efficacy endpoint: duration of access performance | (measured from the time of skin puncture with local anesthetic to the successful sheath insertion confirmed by an outflow of arterial blood) | during the procedure index | |
Secondary | safety endpoint: access-site vascular complications | it is composed by the rate of radial artery occlusion, significant hematoma (EASY classification grade III-V), arteriovenous fistula, pseudoaneurysm, perforation and spasm; measured with Doppler Ultrasound | after 24 hours post procedure |
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