A Prospective, Multicenter, Randomized Controlled, Non-inferiority Clinical Trial to Assess the Efficacy and Safety of the OmniHeart 4.0 Percutaneous Ventricular Assist Device for Hemodynamic Support in Patients Undergoing High-risk Percutaneous Coronary Intervention (PCI).
A Prospective, Multicenter, Randomized Controlled, Non-inferiority Clinical Trial to Assess the Efficacy and Safety of the OmniHeart 4.0 Percutaneous Ventricular Assist Device for Hemodynamic Support in Patients Undergoing High-risk Percutaneous Coronary Intervention (PCI).
The objective of this clinical trial is to understand the effectiveness and safety of the OmniHeart 4.0 percutaneous ventricular assist device produced by ShanghaiDynaheart Medical Technology Co., Ltd. in providing hemodynamic support for high-risk PCI patients. The main questions it aims to answer are:
During the treatment of high-risk PCI, will the application of the OmniHeart 4.0 percutaneous ventricular assist device achieve hemodynamic support that is not inferior to that of ECMO? What medical problems will occur during or after the treatment for participants who receive the OmniHeart 4.0 percutaneous ventricular assist device during high-risk PCI treatment? The researchers will compare the OmniHeart 4.0 percutaneous ventricular assist device with ECMO (a mechanical circulatory support device) using ECMO as the control group to compare the efficacy differences between the two and thereby evaluate the effectiveness and safety of the OmniHeart 4.0 percutaneous ventricular assist device in high-risk PCI treatment.
Participants will:
Be randomly assigned in a 1:1 ratio according to need during high-risk PCI treatment to either the experimental group or the control group. The experimental group will receive the OmniHeart 4.0 percutaneous ventricular assist device for assistance, while the control group will receive the veno-arterial extracorporeal membrane oxygenation (VA-ECMO) device for assistance.
Check-ups and follow-ups will be conducted during the device usage period, at the time of weaning from the device, before discharge, 30 days after surgery, and 90 days after surgery.
The effectiveness endpoint will be evaluated by recording indicators such as the incidence of major adverse cardiovascular and cerebrovascular events (MACCE) free of death within 30 days after surgery.
This clinical trial adopts a prospective, multicenter, randomized controlled, non-inferiority design, with a planned enrollment of 254 subjects. It comprehensively evaluates the safety and effectiveness of the investigational device in human subjects, so as to provide sufficient evidence for the marketing approval and registration of the product in China. The rationale for the trial design is specified as follows:
Prospective design: A prospective study can establish clear causal relationships, with unified diagnostic, testing and evaluation criteria for collected data, thus enabling controllable data processing.
Multicenter design: A multicenter trial can accrue a larger number of cases within the same time frame, thereby shortening the duration of the clinical trial; since a multicenter trial is conducted by multiple clinical investigators across different regions and trial sites, its conclusions generally have broad representativeness.
Randomized controlled trial：
1) Randomization: In this trial, random grouping was conducted using a central randomization system. The Interactive Web Response System (IWRS) automatically assigned groups according to the sequence of enrollment, thereby reducing the bias in the trial caused by sampling errors. A random table was generated by statisticians or designated personnel. The random table was generated by the SAS software based on the preset seed number and block number. A stratified block randomization design by center was adopted, with a ratio of 1:1 between the treatment group and the control group. After verifying the inclusion and exclusion criteria, the researchers entered the subject information into the central randomization system. The researchers clicked the "Randomization" button in the IWRS system, and the system would automatically generate the random grouping of the subjects and provide the feedback through the network to the researchers indicating whether the subject was assigned to the treatment group or the control group. After receiving the randomization results, the researchers provided corresponding treatment to the subjects according to the respective groups. Throughout the entire trial process, the researchers would not be able to modify the group to which the subjects were assigned. For any subjects who completed randomization but withdrew from the clinical trial before starting treatment, their random number (the random number assigned to the subject) would be retained (the random number assigned to the subject would not be reused). Additionally, for those subjects who prematurely withdrew from the clinical trial, no substitution would be provided.
Comparison: In the routine clinical treatment, ECMO is of certain representativeness. Therefore, this product was selected as the control device for this clinical trial. Using the ECMO product as the control, the efficacy differences between the experimental group and the control group were compared to evaluate the effectiveness and safety of the experimental product.
Non-inferiority: To evaluate the experimental device when used in high-risk PCI treatment, the rate of avoiding major adverse cardiovascular and cerebrovascular events (MACCE) within 30 days after surgery was non-inferior to that of the control device.
Inclusion Criteria:
- 1. The patient's age is between 18 and 90 years old (inclusive). 2. There is at least one lesion (including primary lesions and restenosis lesions) in the native coronary artery or grafted bypass vessel, and percutaneous coronary intervention (PCI) needs to be performed under hemodynamic support.
3. The patient meets one of the following conditions:
Among them, a three-vessel coronary artery lesion is defined as follows: there is at least one significant stenosis in each of the three main epicardial coronary arteries (the left anterior descending branch and/or its branches, the left circumflex branch and/or its branches, the right coronary artery and/or its branches). A significant stenosis is defined as a luminal stenosis >= 50% (by visual inspection) or complete occlusion, and at least two vessels have a luminal stenosis >= 70%. For left-dominant coronary arteries, the presence of >= 50% stenosis in both the left anterior descending branch and the proximal left circumflex branch is also regarded as a three-vessel coronary artery lesion.
4. The subject or his/her legal guardian is able to understand the purpose of the trial, voluntarily participates in the trial and signs the informed consent form, and is willing to complete the follow-up as required by the trial.
Exclusion Criteria:
1. Acute ST-segment elevation myocardial infarction within 24 hours before enrollment.
2. Cardiac arrest occurred within 24 hours before enrollment and cardiopulmonary resuscitation was required.
3. Emergency thrombolysis was performed before enrollment. 4. Cardiogenic shock exists, and cardiogenic shock is defined as follows: (1) Cardiac index (CI) < 2.2 L/min/m² and pulmonary capillary wedge pressure (PCWP) > 15 mmHg; (2) Hypotensive state (systolic blood pressure < 90 mmHg for more than 30 minutes, or systolic blood pressure maintained >= 90 mmHg with the support of vasoactive drugs and/or circulatory assist devices), accompanied by end-organ hypoperfusion (urine output < 30 ml/hour and heart rate > 60 beats/minute, or cold and clammy extremities).
5. Left ventricular mural thrombus exists. 6. After aortic valve replacement (including mechanical valves, biological valves), implantation of mechanical circulatory assist devices or cardiac contractile devices.
7. Moderate or severe aortic stenosis, moderate or severe aortic insufficiency. 8. Severe peripheral arterial stenosis or occlusion lesions that interfere with the implantation of the test device or the control device.
9. Aortic lesions (including aortic aneurysms, aortic dissections, extreme tortuosity or calcification) that interfere with the operation.
10. Chronic renal insufficiency (serum creatinine >= 4 mg/dl), or dialysis treatment is required.
11. Liver insufficiency (liver transaminase and bilirubin levels are more than 3 times the upper limit of the normal range).
12. Uncorrected abnormal coagulation function (platelet count <= 75,000/mm³ or INR >= 2.0 or fibrinogen <= 1.5 g/L).
13. A history of stroke or transient ischemic attack (TIA) within 1 month before enrollment.
14. Allergic or intolerant to iodine contrast agents, heparin, aspirin, ADP receptor inhibitors, and with a history of heparin-induced thrombocytopenia (HIT) in the past.
15. Infectious endocarditis exists or is suspected to exist, or there is a systemic active infection.
16. Currently participating in other drug/device clinical trials and the primary endpoint has not been reached.
17. Pregnant or lactating women, those with a fertility plan within 1 year or those who are unwilling to take effective contraceptive measures.
18. Other situations judged by the investigator as not suitable for enrollment that are unforeseen.