Coronary Artery DiseaseR-STAR-FIHNCT07146204
First in Human Trial of R-Star: A Novel Robotic System for Minimally Invasive Coronary Artery Procedures.
A study testing Robotic-assisted percutaneous coronary intervention in people with Coronary Artery Disease, run by Robocath at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Robotic-assisted percutaneous coronary intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2026to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects eligible for inclusion in this study must meet all of the following inclusion criteria:
- 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
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- 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.
Who cannot join
- 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).
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- 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.
- Angiographic exclusions: total occlusion, intraluminal thrombus, need for atherectomy or other non-balloon devices before stenting, unprotected left main stenosis > 50%, or certain bypass graft lesions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre cardiologique du nord
Saint-Denis, 93200
Mohammed Nejjari, Dr, 0033 1 49 33 41 13
About this study
Official title: First in Human Evaluation of the R-Star, a Novel Robotic-assisted Percutaneous Coronary Intervention System
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:
Read more
- 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Robotic-assisted percutaneous coronary intervention
- Keywords
- coronary artery disease, percutaneous coronary intervention, Robotic-assisted percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted percutaneous coronary interventionDevice
Patients with coronary artery disease will be treated usiing the R-Star robotic system for a robotic-assisted percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| Study participants | Experimental | Patients with confirmed CAD, with indication for elective PCI Receives: Device: Robotic-assisted percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Periprocedural
Secondary outcomes (9)
Clinical success
Less than 30% of residual stenosis post PCI in the lesions treated using the robotic system without target lesion failure (TLF) either within 48 hours of the procedure or prior to hospital discharge, whichever occurs first.
Measured: Within 48 hours of the procedure or prior to hospital discharge, whichever occurs first
Absence of intra-procedural vascular complications
Measured: Periprocedural
Absence of target lesion failure (TLF)
Measured: Hospital discharge visit 30-days follow up visit
Absence of other device-related complications
Measured: Hopistal discharge visit 30-days follow-up visit
Total and robotic procedure duration
Measured: Periprocedural
Fluoroscpoy time
Measured: Periprocedural
Radiation exposure for the patient and the primary operator
Dose of radiation exposure for the patient and the primary operator
Measured: Periprocedural
Score of operator ergonomic assessment scale
This questionnaire is designed to assess your perceived ergonomic experience when using a robotic system compared to performing the same procedure manually. It covers several dimensions including physical, cognitive, organizational, environmental, and functional ergonomics.
Measured: Periprocedural
Robotic precision as assessed by the rate of the longitudinal geographical miss
The longitudinal geographical miss is determined by a core lab using a quantitative coronary angiography (QCA). Longitudinal geographic miss is defined as cases where the entire length of the injured or stenotic segment was not fully covered by the total length of the stent.
Measured: Procedure visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study startJan 2026 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robocath
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Veranex Switzerland SA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146204
- Sponsor's protocol ID
- ROB-04
- Acronym
- R-STAR-FIH
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First in Human Evaluation of the R-Star, a Novel Robotic-assisted Percutaneous Coronary Intervention System
- ClinicalTrials.gov ID
- NCT07146204
- Acronym / sponsor ID
- R-STAR-FIH / ROB-04
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, percutaneous coronary intervention, Robotic-assisted percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- RobocathIndustry (pharma, biotech, devices)
- Collaborators
- Veranex Switzerland SA
- Study start
- Jan 2026 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study participants | Experimental | Device: Robotic-assisted percutaneous coronary interventionPatients with confirmed CAD, with indication for elective PCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects eligible for inclusion in this study must meet all of the following inclusion criteria:
- Patient ≥ 18 years old;
- Patient with confirmed CAD, with indication for elective PCI;
- Patient with CAD presenting the following specifications:
- Subject deemed appropriate for robotic-assisted PCI with R-Two system used per its intended use; based on the investigator's judgment;
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic-assisted percutaneous coronary interventionPatients with coronary artery disease will be treated usiing the R-Star robotic system for a robotic-assisted percutaneous coronary intervention | Device | Study participants |
Primary outcome
Technical success
Time frame: Periprocedural
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.
9 secondary outcomes
Clinical success
Time frame: Within 48 hours of the procedure or prior to hospital discharge, whichever occurs first
Absence of intra-procedural vascular complications
Time frame: Periprocedural
Absence of target lesion failure (TLF)
Time frame: Hospital discharge visit 30-days follow up visit
Absence of other device-related complications
Time frame: Hopistal discharge visit 30-days follow-up visit
Total and robotic procedure duration
Time frame: Periprocedural
Fluoroscpoy time
Time frame: Periprocedural
Radiation exposure for the patient and the primary operator
Time frame: Periprocedural
Score of operator ergonomic assessment scale
Time frame: Periprocedural
Robotic precision as assessed by the rate of the longitudinal geographical miss
Time frame: Procedure visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-assisted percutaneous coronary intervention in people with Coronary Artery Disease, run by Robocath at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hamouda Abassi, PhD (+33 7 62 06 04 10, hamouda.abassi@robocath.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success (time frame: Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.