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The COLOR(Complex Large-Bore Radial Percutaneous Coronary Intervention) trial
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The COLOR(Complex Large-Bore Radial Percutaneous Coronary Intervention) trial

Feature

Randomized Comparison Between Radial and Femoral Large-Bore Access for Complex Percutaneous Coronary Intervention (Complex Large Bore Radial PCI)
The COLOR trial is
- A multicenter prospective randomized trial comparing TRA*1 (7Fr) vs. TFA*2 (7Fr)
- Randomized 388 patients with complex PCI* either to TRA*1 (7Fr) or TFA*2 (7Fr) PCI

(*1) TRA: Transradial access
(*2) TFA: Transfemoral access

Study Design

Study Type Randomized controlled study
Actual Enrollment 388 participants
Allocation Randomized
Intervention Model Parallel Assignment
Official Title Complex Large-bore Radial PCI Trial Randomized Trial Reducing Access Site Complications With Slender Technology for Complex PCI*3
Actual Study Start Date: March, 2019
Actual Primary Completion Date April, 2020
Actual Study Completion Date May, 2020

(*3) PCI:percutaneous coronary intervention

The primary end-point

access site–related clinically significant bleeding or vascular complications requiring intervention at discharge

One of the secondary end-points

- procedural success

Result

The enhanced safety and comparable efficacy of 7Fr GSS TRA over 7Fr TFA

Significant reduction of BARC 2, 3, or 5 Bleeding or Vascular Complication Requiring Intervention of the Randomized Access Site ---- 7Fr GSS TRA (3.6%) vs. 7Fr TFA (19.1%)
Comparable procedural success regardless of the selection of access site ---- 7Fr GSS TRA (86%) vs. 7Fr TFA (89%)
No significant difference in procedure time, contrast use, and radiation between 7Fr GSS TRA and 7Fr TFA

The 7Fr Glidesheath slender TRA is as efficacious as 7Fr TFA in successfully performing complex PCI, while enhancing its procedural safety with significant reduction of clinically relevant access-site related bleeding or vascular complications.

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