Arteriosclerosis, Cardiovascular Diseases, Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Vascular Disease Occlusive
Conditions
Brief summary
The objective of this study is to evaluate the safety and effectiveness of the clinical and technical performance of the VRS100 system with disposable surgical kit in the delivery and manipulation of coronary guidewires and stent/balloon systems for use in percutaneous coronary interventions (PCI).
Interventions
PROCEDUREVRS100 robotic-assisted PCI
The VRS100 is intended for use in the remote delivery and manipulation of guidewires and rapid exchange balloon/stent catheters, and remote manipulation of guide catheters during percutaneous coronary intervention (PCI) procedures.
PROCEDUREManual PCI
Use the traditional technique of manually advancing intracoronary guidewires, balloons, and stents at the patient's tableside.
Sponsors
Shanghai Zhongshan Hospital
West China Hospital
Shenzhen People's Hospital
Shenzhen Raysight Intelligent Medical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* General Inclusion Criteria: 1. Age ≥18 years. 2. Patients with coronary artery disease undergoing Percutaneous Coronary Intervention (PCI). 3. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. * Angiographic Inclusion Criteria: 1. In situ primary coronary vascular disease. 2. Reference vessel diameter is 2.5-4.0mm by visual estimate. 3. Target lesion length is ≤30.0mm. 4. Target lesion is a single de novo native coronary artery lesion. This lesion may consist of multiple lesions (with ≤10mm between diseased segments) and must be completely covered by a single stent with ≥5.0mm of normal segments on proximal and distal edges of the lesion. 5. Target lesion diameter showing stenosis ≥70% by visual estimate, or ≥50% with myocardial ischemia.
Exclusion criteria
Patients meeting any of the following criteria will be excluded: * General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success | 48-hrs or hospital discharge, whichever occurs first | Defined as angiographic success (residual stenosis after stenting of \<30% with final TIMI \[Thrombolysis In Myocardial Infarction\] flow grade 3) without an in-hospital major adverse cardiovascular event (MACE) (cardiovascular death, MI, clinically driven target vessel revascularization). |
| Technical Success | 1 day | Defined as the successful advancement and retraction of PCI devices using the VRS100 System and without conversion to manual operation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance of the Experimental Device | During procedure | The frequency of failures and performance evaluation |
| PCI Procedure Time | During procedure | Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter. |
| Patient Radiation Exposure - Cumulative Dose | During procedure | Cumulative dose (mGy) as recored during the procedure. |
| Fluoroscopy and/or X-Ray Time | During procedure | As recorded by an X-Ray System utilized during the procedure. |
| Overall Procedure Time | During procedure | Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter. |
| Contrast Fluid Volume | During procedure | The amount of contrast fluid used (mL) during the procedure. |
Countries
China
Contacts
Primary ContactLihui Li
Outcome results
None listed