Coronary Artery Disease
Conditions
Interventions
Experimental group:Using the PCI assisted operating system produced by Shanghai Shenji Medical Technology Co., Ltd.
Sponsors
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. General selection criteria: (1) 18 years old = 70% by visual inspection (or >= 50%, accompanied by clinical evidence of myocardial ischemia within this range); (2) 2.5 mm <= visual reference vessel diameter <= 4.0 mm; (3) The length of the target lesion is less than or equal to 30 mm according to visual inspection (if it consists of multiple small lesions, the distance between the small lesions does not exceed 10 mm), and can be completely covered by a single stent, and there is at least 2 mm of normal margin at the proximal and distal edges of the lesion Segmental blood vessel; (4) There are <= 2 target vessels to be treated, and one target lesion is allowed to be treated with one stent for each target vessel, and the target lesion cannot be treated in stages; (5) TIMI blood flow grade 3 in the target lesion.
Exclusion criteria
Exclusion criteria: 1. General exclusion criteria: (1) The subject has received other PCI within 72 hours before the PCI operation; (2) The subject has received PCI within 30 days before the PCI operation, and has experienced MACE or other serious adverse events; (3) Acute MI occurred within one week before the scheduled PCI operation; (4) Severe heart failure (NYHA IV grade); (5) Cardiogenic shock occurred within 48 hours before PCI operation; (6) Pregnant and lactating women, or women who plan to become pregnant during clinical trials; (7) Those who are allergic to aspirin, heparin, clopidogrel, contrast media, metal materials and rapamycin; (8) Patients with acute or chronic kidney disease (such as serum creatinine > 2.5 mg/dL or > 221 umol/L) or dialysis; (9) The subject suffered from stroke within 30 days before the planned PCI operation; (10) Subjects suffered from active peptic ulcer or upper gastrointestinal bleeding within 6 months before PCI surgery; (11) The subject has a history of massive bleeding or coagulation disorders within the past 6 months, or refuses blood transfusion; (12) The subject is currently participating in another clinical study that has not completed the entire follow-up period; (13) The investigator believes that the patient is not suitable for robot-assisted PCI; 2. Exclusion criteria for angiography: (1) In-stent restenosis, or the target vessel has been placed with a stent before and the location is close to the target lesion; (2) In addition to balloon angioplasty and stent angioplasty, other treatment methods (such as rotational atherectomy or laser therapy) are required; (3) There are two or more lesions in a single blood vessel that need to be treated at the same time; (4) Bifurcation lesions requiring intervention; (5) Visible thrombus appears; (6) The target lesion is located in the left main coronary artery; (7) The target lesion is within 5mm from the opening of LAD (left anterior descending artery), LCX (left circumflex artery), and RCA (right coronary artery); (8) Severely distorted lesions, and the investigator believes that the coronary anatomy is not suitable for robot-assisted PCI; (9) Severe calcified lesions whose coronary artery anatomy is considered unsuitable for robot-assisted PCI by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical success rate;Technical success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of surgery;Duration of PCI assisted therapy;Radiation exposure dose for the patient;Radiation exposure dose for the operator;Contrast agent dosage (ml);Cardiovascular disease-related deaths; | — |
Countries
China
Contacts
Public ContactGuosheng Fu
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Outcome results
None listed