High Risk PCI
Conditions
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age =18 years and =80 years 2.Subjects with at least 1 disease (both in situ and restenotic) in the coronary artery in situ or in the grafted bridge vessel undergoing PCI; 3.Subjects with one of the following disease conditions and assessed by the cardiac team as requiring haemodynamic support for high-risk PCI procedures; a.LVEF=35% b.Unprotected left main disease; c.Complex coronary artery triple vessel disease; d.The only remaining blood-supplying artery disease; e.Complex coronary artery surgery (e.g., coronary rotational milling, etc.) 4.Subjects who voluntarily participated and signed an informed consent form and were able to co-operate in completing the entire study.
Exclusion criteria
Exclusion criteria: 1.Acute ST-segment elevation myocardial infarction (STEMI) within 24 hours or CK-MB has not returned to the normal reference range after STEMI; 2.Subjects with cardiac arrest within 24 hours prior to surgery and requiring CPR; 3.Subjects with cardiogenic shock, Cardiogenic shock is defined as: Cardiac index (CI) 15 mmHg; or systemic hypotension (systolic BP 60 beats/min, or wet and cold extremities); 4.Thrombus in left ventricle; 5.Previous aortic valve replacement or Mechanical circulatory assist device implantees; 6.Subjects with mechanical complications of myocardial infarction; 7.Severe aortic stenosis; 8.Severe aortic valve insufficiency; 9.Subjects with severe peripheral vascular disease without appropriate surgical instrument placement pathway; 10.Aortic lesions that severely impede surgery include aortic aneurysms, aortic coarctation, and extreme tortuosity or calcification of the aorta; 11.Renal failure (serum creatinine = 4 mg/dL); 12.Hepatic insufficiency (transaminase and bilirubin = 3 times the upper limit of normal reference value (URL) or internationalization ratio (INR) =2); 13.Uncorrected coagulopathy (platelet count = 50?109/L or INR = 2 or fibrinogen = 1. 5g/L); 14.Historian of stroke or TIA within 1 month; 15.Severe right ventricular insufficiency; 16.Patients with known allergy or intolerance to iodine contrast, heparin, aspirin, ADP receptor inhibitors; 17.Previous history of heparin-induced thrombocytosis (HIT); 18.Pregnant or lactating women; 19.Subjects who are currently participating in other clinical studies or have participated in other clinical studies in the last 1 month; 20.Subjects considered unsuitable for this clinical study by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful haemodynamic support;Major device-related adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success;Procedure success;Incidence of major device-related adverse events at 30 days postoperatively;Composite incidence of major device-related adverse events at 30 days postoperatively; | — |
Countries
China
Contacts
Public ContactJunbo Ge
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed