Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-01-01 @ 1:36 PM
Study NCT ID:
NCT07146204
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-28
First Post:
2025-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First in Human Trial of R-Star: A Novel Robotic System for Minimally Invasive Coronary Artery Procedures.
Sponsor:
Robocath
Organization:
Study Overview
Official Title:
First in Human Evaluation of the R-Star, a Novel Robotic-assisted Percutaneous Coronary Intervention System
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
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-STAR-FIH
Brief Summary:
The goal of this clinical trial is to learn if the R-Star robotic system can be used safely and effectively to perform percutaneous coronary intervention (PCI) in adults with coronary artery disease who are scheduled for an elective PCI.
The main questions it aims to answer are:
* Can PCI be completed with the robotic system without needing to switch fully to manual operation because of a technical issue or system limitation?
* Is the treated artery adequately opened without complications during the procedure?
Participants will:
* Have selection tests, including a medical exam, lab tests, ECG, and a review of their medical history.
* Undergo PCI using the R-Star robotic system, with angiography before and after the procedure.
* Have checkups before leaving the hospital and about 30 days later to monitor recovery and collect study data.
The main questions it aims to answer are:
* Can PCI be completed with the robotic system without needing to switch fully to manual operation because of a technical issue or system limitation?
* Is the treated artery adequately opened without complications during the procedure?
Participants will:
* Have selection tests, including a medical exam, lab tests, ECG, and a review of their medical history.
* Undergo PCI using the R-Star robotic system, with angiography before and after the procedure.
* Have checkups before leaving the hospital and about 30 days later to monitor recovery and collect study data.
Detailed Description:
the R-STAR PCI FIH study is a prospective, interventional, first-in-human, exploratory, single-arm, open-label, pre-marketing pilot study conducted at a single site.
This study is designed to evaluate the safety and performance of the R-Two system, as well as the clinical feasibility of its use under normal conditions of use, in accordance with the General Safety and Performance Requirements pertaining to clinical evaluation of the device, as per Annex I of the Medical Device Regulation MDR 2017/745 (EU).
The study includes four visits. The baseline visit is performed prior to the index procedure and includes subject screening and eligibility verification as well as the informed consent process. The procedure visit (Day 0) corresponds to the index RA-PCI performed with the R-Two System and includes peri-procedural assessments. The post-procedure/hospital discharge visit (Day +1) allows for early follow-up and safety evaluation. Finally, the 30-day post-procedure visit (Day 30 ±7) is conducted to assess clinical status and collect follow-up information.
Based on preclinical findings and prior experience with robotic-assisted PCI, the R-Two platform is expected to demonstrate high levels of technical and clinical performance and safety in the intended population. The system is designed to reduce operator radiation exposure and to improve ergonomics by enabling remote operation from a control room, thereby limiting physical strain. Clinical outcomes are anticipated to be favorable, with low complication rates and improved operator working conditions. Secondary endpoints, such as procedure duration, fluoroscopy time, and contrast agent volume, are also expected to remain within clinically acceptable ranges.
This study is designed to evaluate the safety and performance of the R-Two system, as well as the clinical feasibility of its use under normal conditions of use, in accordance with the General Safety and Performance Requirements pertaining to clinical evaluation of the device, as per Annex I of the Medical Device Regulation MDR 2017/745 (EU).
The study includes four visits. The baseline visit is performed prior to the index procedure and includes subject screening and eligibility verification as well as the informed consent process. The procedure visit (Day 0) corresponds to the index RA-PCI performed with the R-Two System and includes peri-procedural assessments. The post-procedure/hospital discharge visit (Day +1) allows for early follow-up and safety evaluation. Finally, the 30-day post-procedure visit (Day 30 ±7) is conducted to assess clinical status and collect follow-up information.
Based on preclinical findings and prior experience with robotic-assisted PCI, the R-Two platform is expected to demonstrate high levels of technical and clinical performance and safety in the intended population. The system is designed to reduce operator radiation exposure and to improve ergonomics by enabling remote operation from a control room, thereby limiting physical strain. Clinical outcomes are anticipated to be favorable, with low complication rates and improved operator working conditions. Secondary endpoints, such as procedure duration, fluoroscopy time, and contrast agent volume, are also expected to remain within clinically acceptable ranges.
Study Oversight
Has Oversight DMC:
True
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?: