Surgery: Thoracic Surgery Thoracic
Conditions
Interventions
We will invite and screen all patients considered for coronary catheterisation and coronary intervention by the transradial approach.
Patients will be allocated in random fashion to different treatme
Sponsors
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Eligibility
Inclusion criteria
Inclusion criteria: Sample size - Clinical radial artery spasm rates are reported between 20-30% [as per literature] and to detect 50% reduction in incidence of radial artery spasm, we need to recruit 175 [200] patients in each arm. This is with significance level of 0.05 [alpha error], and power of 80% [beta error- .02]. In total we need 800 patients with 200 patients in each arm of different sheath type. There will therefore be 400 patients in each arm of compression device randomisation [TR band vs. Radistop]. Target population - All patients considered for coronary angiography and coronary intervention by the transradial approach. Inclusion Criteria: 1. Intended transradial coronary procedure 2. Patient > 18 years of age and able to give informed consent. All patients undergoing transradial procedure at the Cardiothoracic Centre, Liverpool under the care of JLM, RHS, RAP, NDP [after taking their permission] will be contacted about the study and procedures will be explained. Willing patients will then be assessed in detail and informed consent will be obtained.
Exclusion criteria
Exclusion criteria: 1. Unable or unwilling to give informed consent 2. Inability to demonstrate the presence of ulnar collateral circulation 3. Patients with A-V fistula or patients with chronic renal failure 4. Previous ipsilateral transradial procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end points: Incidence of clinical radial artery spasm. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of radial artery occlusion rates 2. Incidence of local vascular complications 3. Incidence of sterile inflammatory reaction 4. Incidence of spontaneous recanalisation of radial artery 5. Time to achieve haemostasis 6. Patient tolerance of haemostatic deviceThis study will help us in defining the problem of radial artery spasm, radial artery occlusion and local vascular complications. This study results will help us in deciding the best sheath and compression device from the variety of products available commercially for transradial coronary procedures. | — |
Countries
United Kingdom
Outcome results
None listed