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 @ 6:56 PM
Ignite Modification Date:
2025-12-24 @ 6:56 PM
NCT ID:
NCT07135557
Eligibility Criteria:
Inclusion Criteria:
General Inclusion Criteria
Subjects must meet all of the following inclusion criteria:
1. 18 years of age ≤ age ≤ 80 years of age.
2. Have clinical indication(s) for PCI and need to be treated with a PCI procedure.
3. Subjects voluntarily signed an informed consent form and were willing to complete follow-up visits.
Angiography Inclusion Criteria
1. Visual description of target lesion diameter stenosis ≥70% (or ≥50% accompanied with clinical evidence of myocardial ischemia within that range;
2. 2.5 mm ≤reference vessel diameter by visual description ≤ 4.0 mm.
3. Target lesion length ≤34.0 mm by visual description (If it is made up of multiple small lesions, the distance of which should not exceed 10 mm) and can be fully covered by a single stent. There are no less than 2.0 mm normal segmental vessels at the proximal and distal margins of the diseased region.
4. ≤2 target vessels to be treated, one single stent for each target lesion per target vessel, and target lesions can not be treated through stages.
Exclusion Criteria:
General Exclusion Criteria
Subjects cannot meet any of the following exclusion criteria:
1. Subjects have undergone other PCI within 72 hours prior to the R-One PCI procedure;
2. Subjects have undergone PCI within 30 days prior to the R-One PCI procedure and have experienced a MACE or other serious adverse event;
3. Acute myocardial infarction (MI) within one week prior to scheduled R-One PCI procedure;
4. Severe heart failure (NYHA ≥ Class III);
5. Cardiogenic shock within 48 hours prior to the PCI procedure;
6. Pregnant and lactating women, or women with plans to become pregnant during the clinical trial;
7. Subjects with allergies to aspirin, heparin, clopidogrel, contrast media, metallic materials and rapamycin;
8. Subjects with a platelet count \<100 x 109/L or \>700 x 109/L and a white blood cell (WBC) count \<3 x 109/L (e.g., thrombocytopenia, thrombocytosis, neutropenia or leukopenia);
9. Subjects with creatinine levels ≥ 177 umol/L;
10. Subjects had a stroke within 30 days prior to the planned R-One PCI procedure.
11. Subjects with an active peptic ulcer or upper gastrointestinal hemorrhage within 6 months prior to the PCI procedure.
12. Subjects with a history of massive haemorrhage or coagulation disorder, or refusal of blood transfusion within the previous 6 months.
13. Subjects are currently enrolled in another clinical study that has not yet completed the entire follow-up period.
14. The investigators determined that the patient was not applicable for robot-assisted PCI.
Angiography Exclusion Criteria
1. TIMI blood flow grade of \<3 for the target lesion.
2. In-stent restenosis, or the target vessel has implanted a stent previous which in close proximity to the target lesion.
3. Need other treatments (e.g., atherectomy or laser treatment) in addition to balloon angioplasty and stentoplasty.
4. 2 or more lesions in a single vessel that need treatment concurrently;
5. Bifurcation lesions requiring protection;
6. Visible thrombosis;
7. Target lesion located in the left coronary artery trunk;
8. Target lesion within 5 mm of left anterior descending (LAD), left circumflex (LCX) or right coronary artery (RCA) opening;
9. Severe distorted and/or calcified lesions, and its coronary anatomy is not applicable for robot-assisted PCI according to the the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07135557
Study Brief:
Protocol Section:
NCT07135557