Trials / Unknown
UnknownNCT06032572
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
Evaluation of the Safety and Effectiveness of the VRS100 Robotic Console System in Percutaneous Coronary Interventions: A Multicenter, Randomised, Non-inferiority Trial (ESSENCE)
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 204 (estimated)
- Sponsor
- Shenzhen Raysight Intelligent Medical Technology Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate the safety and effectiveness of the clinical and technical performance of the VRS100 system with disposable surgical kit in the delivery and manipulation of coronary guidewires and stent/balloon systems for use in percutaneous coronary interventions (PCI).
Conditions
- Coronary Artery Disease
- Cardiovascular Diseases
- Coronary Disease
- Myocardial Ischemia
- Arteriosclerosis
- Vascular Disease Occlusive
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | VRS100 robotic-assisted PCI | The VRS100 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. |
| PROCEDURE | Manual PCI | Use the traditional technique of manually advancing intracoronary guidewires, balloons, and stents at the patient's tableside. |
Timeline
- Start date
- 2023-09-08
- Primary completion
- 2024-08-01
- Completion
- 2024-08-01
- First posted
- 2023-09-13
- Last updated
- 2023-09-13
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06032572. Inclusion in this directory is not an endorsement.