Randomised Comparison Of Introducer Sheaths And Compression Devices In Patients Undergoing Transradial Coronary Procedures

Completed

• Conditions: Surgery: Thoracic; Surgery; Thoracic

• Registration Number: ISRCTN68853500
• Lead Sponsor: Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-28
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 800

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified