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First in Human Trial of R-Star: A Novel Robotic System for Minimally Invasive Coronary Artery Procedures.

NCT07146204 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-08-28

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Robotic-assisted percutaneous coronary intervention

Patients with coronary artery disease will be treated usiing the R-Star robotic system for a robotic-assisted percutaneous coronary intervention

Sponsors & Collaborators

  • Veranex Switzerland SA

    collaborator INDUSTRY

  • Robocath

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2026-02-28
Completion
2026-02-28

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07146204 on ClinicalTrials.gov