radial artery occlusion occlusie van de a. radialis
Conditions
Interventions
receive GSS 6Fr sheath (950 patients) or SOC 5Fr
sheath (950 patients).
Sponsors
NPO International TRI Network, Research Center, Cardiovascular Dept., Shonan Kamakura General hospital
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 5.4 General Inclusion Criteria 1. Patient must be at least 18 years of age. 2. Patient is able to verbally acknowledge an understanding of the associated risks, benefits and treatment alternatives 3. Patient who is expected to diagnose by coronary artery angiography or followed by PCI. 4. Patient must agree to undergo all protocol-required follow-up examinations. 5. Patient who can accept radial access.
Exclusion criteria
Exclusion criteria: 1. Patient has other medical illness (e.g., cancer or congestive heart failure) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year). 2. Hemodialysis patient 3. STEMI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is composite of the freedom from radial artery occlusion (RAO) and local bleeding from the puncture site at the time of discharge or the next day, the earlier of the two. | — |
Secondary
| Measure | Time frame |
|---|---|
| Procedure success rate at the index procedure. * Vascular access site complication * Radial spasm during the index procedure. * Total Procedure Time * Total Amount of Contrast Dye * Fluoroscope time * Procedure failure due to the assigned sheath. * Pain score | — |
Countries
Netherlands
Outcome results
None listed