Trials / Terminated
TerminatedNCT04883008
NAVIGATE GRX Study
A Multicenter Post-Market Study for the Evaluation of the CorPath® GRX technIQ Automated Movements in Percutaneous Coronary Interventions
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (actual)
- Sponsor
- Corindus Inc. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The objective of the present study is to detail the results of robotic-assisted PCI using technIQ automated movements in real-world clinical practice.
Detailed description
This multi-center, international, randomized, open-label, post-market study will enroll subjects to detail the results of robotic-assisted PCI using technIQ automated movements in real-world clinical practice by randomized comparison with a cohort of subjects undergoing robotic-assisted PCI with technIQ automated movements disabled. A secondary objective is to describe the learning curve associated with using technIQ.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CorPath GRX with technIQ automated movements enabled (technIQ ON) | The CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary and vascular procedures. TechnIQ automated movements are software-based automation of common maneuvers that interventionalists perform when manipulating catheters, guidewires, and devices by hand. In this group, automated movements will be enabled and used at the discretion of the interventionalist. |
| DEVICE | CorPath GRX with technIQ automated movements disabled (technIQ OFF). | The CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary and vascular procedures. TechnIQ automated movements are software-based automation of common maneuvers that interventionalists perform when manipulating catheters, guidewires, and devices by hand. In this group, automated movements will be disabled. |
Timeline
- Start date
- 2021-06-14
- Primary completion
- 2022-02-04
- Completion
- 2022-02-07
- First posted
- 2021-05-12
- Last updated
- 2023-12-20
Locations
1 site across 1 country: Poland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04883008. Inclusion in this directory is not an endorsement.