Pan-vascular Interventional Robotic System, Percutaneous Coronary Intervention
Conditions
Brief summary
The goal of this prospective, single-center, single-arm study is to explore the efficacy and safety of the pan-vascular interventional robotic system for percutaneous coronary intervention (PCI), researchers will assess the clinical success, technical success, and record the intraoperative data (PCI time, guidewire operation time, dose of contrast medium, radiation exposure doses, etc). All subjects will be followed up on the day of surgery, before discharge (or 48 hours after surgery) and 1 month after surgery to observe the safety indicators.
Interventions
Pan-vascular interventional robotic system assited PCI for delivery and manipulation of guidewires, catheters, and quick exchange balloon dilatation catheters/stents.
Sponsors
Shenzhen Institute of Advanced Biomedical Robot Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1\. General Inclusion criteria: 1. 18 years old ≤ age ≤80 years old; 2. have a clinical indication for PCI (clinical evidence of ischemic heart disease or a positive functional study); 3. Subjects or their legal representative has been informed of the nature of the study, signed informed consent and were willing to cooperate in the follow-up. 2\. Angiographic inclusion criteria: 1. study lesion is a single de novo native coronary artery lesion (previously untreated coronary artery disease); 2. target vessel diameter between 2.5 mm and 4.0 mm; 3. single lesion length ≤38 mm, with at least 2.0 mm normal segments on the proximal and distal edges of the lesion; 4. stenosis ≥50% and \< 100%.
Exclusion criteria
1\. General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success | Discharge or 48 hours post intervention, whichever comes first | Less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the Pan-vascular interventional robotic system, without in-hospital major adverse coronary events (MACE). |
| Technical Success | Procedure | Defined as successful completion of the robotic-assisted PCI absent unplanned conversion to manual for guidewire or balloon/stent catheter inability to navigate vessel anatomy or poor guide catheter support. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fluoroscopy Time | Procedure | Total Fluoroscopy Time during procedure will be captured |
| Procedure Time | Procedure | Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter. |
| Contrast agent dosage | Procedure | The total amount of contrast agent used during the whole procedure. |
| Radiation Exposure | Procedure | Patient and Main operator radiation exposure dose recorded by portable radiation monitor during the procedure, respectively. |
| PCI time | Procedure | Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter. |
Countries
China
Contacts
Primary ContactQingxing Chen, MD
Outcome results
None listed