Color Trial
Research type
Research Study
Full title
COLOR Trial - Complex Large-Bore Radial Percutaneous Coronary Intervention Trial Reducing access site complications with Slender technology for Complex PCI
IRAS ID
265511
Contact name
Sudhir Rathore
Contact email
Sponsor organisation
Isala, Maatschap cardiologie,
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 26 days
Research summary
The COLOR trial is a Multicentre Randomised trial. Patients are eligible for study participation when percutaneous cardiac intervention (PCI) is indicated for complex coronary lesions. If patients comply with inclusion and exclusion and provide written informed consent they will be randomised in a 1:1 ratio between the two study treatments. (7Fr. radial access with Glideslider sheath or 7Fr. femoral access with a standard femoral sheath).
During hospitalisation(before discharge) the access site(s) will be checked for bleeding and vascular complications. All access sites should be checked for absent pulsations and heamatomas and the size should be defined (length and width,cm) and accompanied complaints. Radial artery occlusion should be checked with the reverse Barbeau test. The femoral access site should be checked for murmers and absence of pulsations. Ultrasound or Dopplar of the access sites should be performed in those patients with suspected radial or femoral occlusion and the presence of other vascular complications, like)pseudo) aneurysms or arteriovenous(AV) fistular within 1 month. Patient-reported extremity dysfunction will be evaluated at baseline (before the procedure) and 1-month follow -up.REC name
London - Riverside Research Ethics Committee
REC reference
19/LO/1090
Date of REC Opinion
28 Aug 2019
REC opinion
Further Information Favourable Opinion