Clinical Evidence

Transradial Intervention

Key clinical program
  • DISCO RADIAL
  • The COLOR(Complex Large-Bore Radial Percutaneous Coronary Intervention) trial
  • Reduction of door to balloon time
DISCO RADIAL

Feature

The trial compares the novel distal radial access with conventional radial access approach,in terms of radial occlusion rates (RAO) at discharge.
DISCO RADIAL is the first large international randomized study designed to investigate the benefits of distal radial access over conventional radial access approach.
Study TypeRandomized Clinical Trial
Estimated Enrollment1300 participants
AllocationRandomized
Intervention ModelParallel Assignment
Intervention Model DescriptionRandomization to distal transradial access or conventional transradial access. Both techniques are standard of care.
MaskingNone (Open Label)
Primary PurposeSupportive Care
Actual Study Start DateDecember 10, 2019
Protocol of DISCO RADIAL (image)

Learn more >

DISCO RADIAL

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 TRA1 (7Fr) vs. TFA2 (7Fr) 
- Randomized 388 patients with complex PCI either to TRA1 (7Fr) or TFA2 (7Fr) PCI

1: TRA = Transradial access 
2: TFA = Transfemoral access
Study TypeRandomized controlled study
Actual Enrollment388 participants
AllocationRandomized
Intervention ModelParallel Assignment
Official TitleComplex 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 DateApril, 2020
Actual Study Completion DateMay, 2020
(*3) PCI:percutaneous coronary intervention

Learn more >

COLOR Trial

Reduction of door to balloon time

Feature

The objectives of this study is to confirm reduction of door-to-balloon (D2B) time with single-catheter percutaneous coronary intervention (SC-PCI) method.

Ikari left curve was reported as a universal guiding catheter for left and right coronary arteries. Several procedure steps can be skipped by SC-PCI method as the advantage of a universal catheter.

Enrollment1,316 consecutive STEMI patients
Number of facility14 hospitals
Interventional Model DescriptionPatients were divided into two groups, single-catheter percutaneous coronary intervention method (SC-PCI) and conventional PCI method.
Primary endpointDoor-to-balloon (D2B) time 
Radiation exposure dose
Term of studyJanuary 2014 to January 2018
Protocol of Door to Balloon time (image)

Learn more > 

Reduction of Door to balloon time