Trials / Completed
CompletedNCT03870087
PRECISION GRX Post-Market Study - Japan
A Post-Market Study in Japan for the Evaluation of the CorPath® GRX System Effectiveness in Percutaneous Coronary Interventions
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 242 (actual)
- Sponsor
- Corindus Inc. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
To collect data on the routine patterns of use, safety and effectiveness, including the clinical and technical performance of the CorPath GRX System, in the delivery and manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide catheters during PCI procedures in the first 231 patients treated with the CorPath device in Japan.
Detailed description
This is a single-arm, open-label, multi-center patient registry in Japan of the CorPath GRX System to examine its performance during PCI procedures and patient outcomes through 72 hours post-procedure or hospital discharge, whichever occurs first.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Robotic-assisted PCI | The CorPath GRX is intended for use in the remote delivery and manipulation of guidewires and rapid exchange balloon/stent catheters, and remote manipulation of guide catheters during percutaneous coronary intervention (PCI) procedures. |
Timeline
- Start date
- 2019-04-12
- Primary completion
- 2020-10-09
- Completion
- 2020-10-09
- First posted
- 2019-03-11
- Last updated
- 2020-10-19
Locations
8 sites across 1 country: Japan
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03870087. Inclusion in this directory is not an endorsement.