Percutaneous Coronary Intervention
Conditions
Brief summary
The purpose of this prospective, randomized, open, parallel controlled, multicenter trial is to investigate the efficacy and safety of the pan-vascular interventional robotic system for percutaneous coronary intervention (PCI). Investigators will evaluate clinical success, technical success, and record intraoperative data (PCI time, total operating time, contrast agent dose, radiation exposure dose, etc.). All subjects were followed up on the day of surgery, before discharge 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.
PROCEDURETraditional artificial percutaneous coronary intervention
Doctors perform traditional percutaneous coronary intervention
Sponsors
Shenzhen Institute of Advanced Biomedical Robot Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1\. General Inclusion criteria: 1. 18 years old ≤ age ≤85 years old; 2. have a clinical indication for PCI (clinical evidence of ischemic heart disease or a positive functional study); 3. Subject or guardian can understand the purpose of the experiment and sign informed consent voluntarily Book and willing to cooperate to complete the follow-up. 2\. Angiographic inclusion criteria: 1. The stenosis degree of visual target lesion ≥50%; 2. 2.5mm≤ Visual target vessel diameter ≤4.0mm; 3. Visual target lesions ≤38mm in length, or successive small lesions that can be completely covered by a single stent; 4. Target lesions to be treated intraoperatively cannot be treated in stages.
Exclusion criteria
1. General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success | Immediate postoperative angiography | Immediate postoperative angiography showed residual stenosis \< 30% and TIMI blood flow fraction Level 3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiation Exposure | Procedure | Patient and Main operator radiation exposure dose recorded by portable radiation |
| Fluoroscopy Time | Procedure | Total Fluoroscopy Time during procedure will be captured. |
| Contrast agent dosage | Procedure | The total amount of contrast agent used during the whole procedure. |
| Technical success rate | Procedure | 1. PCI was assisted by the Pan-vascular Interventional Robotic System. 2. No unplanned complete conversion to artificial surgery occurred due to the inability to complete the delivery of the guide wire or balloon/stent catheter through the vessel with the test instrument as intended, or due to insufficient guide catheter support. |
| PCI time | Procedure | Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter. |
| the Pan-vascular Interventional Robotic Systemt performance evaluation | After the operation | The performance of the product was subjectively evaluated by the surgeon. |
| Procedure Time | Procedure | Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter. |
Countries
China
Contacts
Primary ContactJunbo Ge
Outcome results
None listed