Systematic Assessment of the Cook Radial shEath Device

Not Applicable

Completed

• Conditions: Cutaneous granuloma formation following the use of radial introducer sheaths used in coronary angiography and angioplasty procedures; Circulatory System

• Registration Number: ISRCTN51223303
• Lead Sponsor: iverpool Heart and Chest Hospital NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-17
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 415

Inclusion Criteria

1. Patients admitted for cardiac procedures with planned radial access
2. Patients under the care of a participating consultant

Exclusion Criteria

1. Patients under 18 years of age
2. Patients unable to give informed consent
3. Patients who feel unable or unwilling to return to the study centre for outcome measure assessment
4. Patients who have had previous procedures through the same radial access site
5. Emergency or high risk procedures with survival doubt
6. Where there is a known sensitivity to the study device

Study & Design

• Study Type: Observational
• Study Design: Not specified