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

NCT07146204 | Not Yet Recruiting DMC

• 1 other identifier: ROB-04
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

coronary artery disease; percutaneous coronary intervention; Robotic-assisted percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• Technical success

  The technical success is defined as the rate of the robotic-assisted PCI completed without total manual conversion due to irretrievable technical issue or platform limitation leading to the inability of the devices to navigate vessel anatomy.

  Periprocedural

Secondary Outcomes (9)

• Clinical success

  Within 48 hours of the procedure or prior to hospital discharge, whichever occurs first

• Absence of intra-procedural vascular complications

  Periprocedural

• Absence of target lesion failure (TLF)

  Hospital discharge visit 30-days follow up visit

• Absence of other device-related complications

  Hopistal discharge visit 30-days follow-up visit

• Total and robotic procedure duration

  Periprocedural

Study Arms (1)

Study participants

EXPERIMENTAL

Patients with confirmed CAD, with indication for elective PCI

Device: Robotic-assisted percutaneous coronary intervention

Interventions

Robotic-assisted percutaneous coronary intervention DEVICE

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

Study participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient ≥ 18 years old;
• Patient with confirmed CAD, with indication for elective PCI;
• Patient with CAD presenting the following specifications:
• de novo native coronary artery lesion (i.e. a coronary lesion not previously treated)
• Study reference vessel diameter is between 2.5 mm and 4.0 mm by visual estimate
• Study lesion diameter showing stenosis of at least 50% by visual estimate.
• Subject deemed appropriate for robotic-assisted PCI with R-Two system used per its intended use; based on the investigator's judgment;
• The patient provides written informed consent as approved by the applicable Ethics Committee and is willing to comply with all study requirements including 30 day follow-up;
• The patient is affiliated with a social security system.
• Female subjects must be of non-child bearing potential, or if able to bear children, have a negative urinary pregnancy test within 7 days prior to the intended index procedure.

You may not qualify if:

• Planned PCI or coronary artery bypass graft (CABG) within 30 days after the study procedure.
• Acute myocardial infarction within 72 hours before the study procedure.
• Left ventricular ejection fraction \< 30%.
• Recent PCI within 72 hours, or PCI within the past 30 days with a major adverse cardiac event.
• Known allergy or contraindication to study-related medications or materials (aspirin, heparin, P2Y12 inhibitors, stainless steel, cobalt chromium, contrast media) not manageable with premedication.
• Significant blood count abnormalities (platelets \< 100,000/mm³ or \> 700,000/mm³; WBC \< 3,000/mm³).
• Severe renal impairment (serum creatinine \> 2.0 mg/dL or eGFR \< 30 mL/min).
• Stroke within 30 days before the procedure.
• Hemodynamic instability or acute pulmonary edema.
• Significant active bleeding or high bleeding risk (recent GI bleeding, bleeding disorders, refusal of transfusion).
• Pregnancy, breastfeeding, or planning pregnancy before study completion.
• Current participation in another investigational study without completed follow-up.

Sponsors & Collaborators

• Robocath: lead
• Veranex Switzerland SA: collaborator

Study Sites (1)

Centre cardiologique du nord

Saint-Denis, 93200, France

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Hamouda Abassi, PhD

CONTACT

+33 7 62 06 04 10; hamouda.abassi@robocath.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 28, 2025
• Study Start: January 1, 2026
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)