Trials / Completed
CompletedNCT04163393
R-One Efficiency For PCI Evolution With Robotic Assistance
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- Robocath · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is a Prospective, Multi-center, Single-arm clinical study, in patients with Coronary Artery Disease, including patients with silent ischemia (excluding STEMI), who qualify for elective Percutaneous Coronary Intervention (PCI), aimed to assess the Safety and Efficacy of the R-One device in elective PCI.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Percutaneous Coronary Intervention | PCI with robotic assistance |
| DEVICE | Percutaneous Coronary Intervention using R-One assistance | PCI with robotic assistance |
Timeline
- Start date
- 2019-09-17
- Primary completion
- 2021-11-08
- Completion
- 2021-12-15
- First posted
- 2019-11-14
- Last updated
- 2022-02-08
Locations
6 sites across 4 countries: Belgium, France, Luxembourg, Netherlands
Source: ClinicalTrials.gov record NCT04163393. Inclusion in this directory is not an endorsement.