Status:
NOT_YET_RECRUITING
First in Human Trial of R-Star: A Novel Robotic System for Minimally Invasive Coronary Artery Procedures.
Lead Sponsor:
Robocath
Collaborating Sponsors:
Veranex Switzerland SA
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 w...
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 evaluat...
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07146204
Start Date
January 1 2026
End Date
February 1 2026
Last Update
August 28 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre cardiologique du nord
Saint-Denis, France, 93200