Status:
COMPLETED
R-ONE® Robotically-Enhanced PCI Intervention Study
Lead Sponsor:
Cathbot (Shanghai) Robot Co., Ltd
Collaborating Sponsors:
Chinese PLA General Hospital
People's Hospital of Xinjiang Uygur Autonomous Region
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The aim of this study was to evaluate the safety as well as the clinical and technical effectiveness of robotic assisted percutaneous coronary intervention. This was a prospective, single-arm, multice...
Detailed Description
Purpose To evaluate the effectiveness of the R-OneTM vascular interventional navigation control system for percutaneous coronary interventions. To evaluate the safety of the R-OneTM vascular interven...
Eligibility Criteria
Inclusion
- General Inclusion Criteria
- Subjects must meet all of the following inclusion criteria:
- 18 years of age ≤ age ≤ 80 years of age.
- Have clinical indication(s) for PCI and need to be treated with a PCI procedure.
- Subjects voluntarily signed an informed consent form and were willing to complete follow-up visits.
- Angiography Inclusion Criteria
- Visual description of target lesion diameter stenosis ≥70% (or ≥50% accompanied with clinical evidence of myocardial ischemia within that range;
- 2.5 mm ≤reference vessel diameter by visual description ≤ 4.0 mm.
- 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.
- ≤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
- General Exclusion Criteria
- Subjects cannot meet any of the following exclusion criteria:
- Subjects have undergone other PCI within 72 hours prior to the R-One PCI procedure;
- Subjects have undergone PCI within 30 days prior to the R-One PCI procedure and have experienced a MACE or other serious adverse event;
- Acute myocardial infarction (MI) within one week prior to scheduled R-One PCI procedure;
- Severe heart failure (NYHA ≥ Class III);
- Cardiogenic shock within 48 hours prior to the PCI procedure;
- Pregnant and lactating women, or women with plans to become pregnant during the clinical trial;
- Subjects with allergies to aspirin, heparin, clopidogrel, contrast media, metallic materials and rapamycin;
- 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);
- Subjects with creatinine levels ≥ 177 umol/L;
- Subjects had a stroke within 30 days prior to the planned R-One PCI procedure.
- Subjects with an active peptic ulcer or upper gastrointestinal hemorrhage within 6 months prior to the PCI procedure.
- Subjects with a history of massive haemorrhage or coagulation disorder, or refusal of blood transfusion within the previous 6 months.
- Subjects are currently enrolled in another clinical study that has not yet completed the entire follow-up period.
- The investigators determined that the patient was not applicable for robot-assisted PCI.
- Angiography Exclusion Criteria
- TIMI blood flow grade of \<3 for the target lesion.
- In-stent restenosis, or the target vessel has implanted a stent previous which in close proximity to the target lesion.
- Need other treatments (e.g., atherectomy or laser treatment) in addition to balloon angioplasty and stentoplasty.
- 2 or more lesions in a single vessel that need treatment concurrently;
- Bifurcation lesions requiring protection;
- Visible thrombosis;
- Target lesion located in the left coronary artery trunk;
- Target lesion within 5 mm of left anterior descending (LAD), left circumflex (LCX) or right coronary artery (RCA) opening;
- Severe distorted and/or calcified lesions, and its coronary anatomy is not applicable for robot-assisted PCI according to the the investigator.
Key Trial Info
Start Date :
November 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2022
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT07135557
Start Date
November 23 2021
End Date
June 20 2022
Last Update
August 22 2025
Active Locations (4)
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1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
2
Meizhou People's Hospital
Meizhou, Guangdong, China, 514031
3
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, China, 030024
4
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, China, 830001