Trials / Completed
CompletedNCT03278301
PRECISION GRX Registry
A Multicenter Post-Market Registry for the Evaluation of the CorPath® GRX System Effectiveness in Percutaneous Coronary Interventions
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 952 (actual)
- Sponsor
- Corindus Inc. · Industry
- Sex
- All
- Age
- 18 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.
Detailed description
This is a single-arm, open-label, multi-center patient registry 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
- 2017-08-27
- Primary completion
- 2020-02-06
- Completion
- 2020-02-06
- First posted
- 2017-09-11
- Last updated
- 2020-10-19
Locations
20 sites across 4 countries: United States, Brazil, India, Singapore
Source: ClinicalTrials.gov record NCT03278301. Inclusion in this directory is not an endorsement.