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 Type | Randomized Clinical Trial |
| Estimated Enrollment | 1300 participants |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Intervention Model Description | Randomization to distal transradial access or conventional transradial access. Both techniques are standard of care. |
| Masking | None (Open Label) |
| Primary Purpose | Supportive Care |
| Actual Study Start Date | December 10, 2019 |
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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 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
2: TFA = Transfemoral access
| 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
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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.
| Enrollment | 1,316 consecutive STEMI patients |
| Number of facility | 14 hospitals |
| Interventional Model Description | Patients were divided into two groups, single-catheter percutaneous coronary intervention method (SC-PCI) and conventional PCI method. |
| Primary endpoint | Door-to-balloon (D2B) time Radiation exposure dose |
| Term of study | January 2014 to January 2018 |
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