Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2026-01-02 @ 3:47 AM
Study NCT ID:
NCT04163393
Status:
COMPLETED
Last Update Posted:
2022-02-08
First Post:
2019-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
R-One Efficiency For PCI Evolution With Robotic Assistance
Sponsor:
Robocath
Organization:
Study Overview
Official Title:
R-One Efficiency For PCI Evolution With Robotic Assistance
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
R-EVOLUTION
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: