Arteriosclerosis, Cardiovascular Diseases, Coronary Artery Disease, Coronary Disease, Myocardial Ischemia
Conditions
Brief summary
The objective of this study is to examine the safety and effectiveness, from both clinical and technical perspectives, of utilizing the 5G-Robotic VRS100 system in percutaneous coronary intervention (PCI).
Interventions
DEVICE5G Tele-Robotic-Assisted PCI
The 5G Tele-Robotic-Assisted VRS100 system 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.
Sponsors
Shanghai Zhongshan Hospital
Kunming Chenggong District People's Hospital
Yan'an Affiliated Hospital of Kunming Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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. De-novo coronary artery 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. 6. Target lesion angiography meets the calculation criteria of Rui-Xin AngioQFA, and AngioQFA is ≤0.8.
Exclusion criteria
* Patients meeting any of the following criteria will be excluded: * General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success | 48 hours 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 |
|---|---|---|
| Fluoroscopy and/or X-Ray Time | During procedure | As recorded by an X-Ray System utilized during the procedure. |
| PCI Procedure Time | During procedure | Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter. |
| Contrast Fluid Volume | During procedure | The amount of contrast fluid used (mL) during the procedure. |
| Patient Radiation Exposure - Cumulative Dose | During procedure | Cumulative dose (mGy) as recored 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. |
Contacts
Primary ContactQiang Xue
Backup ContactLihui Li
Outcome results
None listed