Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT07146204
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07146204
Study Brief:
Protocol Section:
NCT07146204