This study aims to evaluate the safety and effectiveness of the CorVad Percutaneous Ventricular Assist System for short-term ventricular support during high-risk percutaneous coronary intervention (HRPCI) in non-emergent, hemodynamically stable coronary artery disease patients via a prospective, multicenter, single-arm clinical trial.
This prospective, multicentre, single-arm clinical trial of the CorVad Percutaneous Ventricular Assist System is designed to measure the incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days after PCI and is planned to enrol 120 subjects. The target population of subjects are patients with coronary artery disease who need high-risk PCI treatment, and sign an informed consent form (ICF) approved by the Ethics Committee (EC). Subjects who meet the enrolment criteria as judged by the investigator will apply the trial product according to the requirements and will be followed up to 30 days after the procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
The CorVad Percutaneous Ventricular Assist System provides hemodynamics support for intraoperative protection during high-risk percutaneous coronary intervention.
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGFujian Medical University Union Hospital
Fuzhou, Fujian, China
Combined incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days post-PCI.
Major adverse events were defined as follows: death, new myocardial infarction, stroke, and target vessel revascularisation. Calculation formula: 30-day MACCE rate = Number of subjects experiencing any MACCE event within 30 days post-PCI ÷ Total number of subjects × 100%
Time frame: 30 days post-PCI
Hemodynamic stability during PCI procedure
Defined as mean arterial pressure (MAP) \<60mmHg for no more than 10 minutes during the PCI procedure, without needing additional pharmacological therapy.
Time frame: During PCI procedure
PCI procedural angiographic success rate
Angiographic success defined as: residual stenosis \<30% post stent implantation or residual stenosis \<50% post balloon angioplasty. Success rate calculated based on number of treated lesions.
Time frame: Post-PCI
Change of aortic valve regurgitation
Defined as changing from no or mild aortic regurgitation pre-procedure to moderate or severe regurgitation on pre-discharge echocardiography.
Time frame: Pre-procedure and pre-discharge
Change in creatinine clearance at 48 hours post-PCI
Assessed at 48 hours post-PCI and compared to baseline.
Time frame: Pre-procedure and 48 hours post-PCI
Change in left ventricular ejection fraction (LVEF) pre- and post-PCI
Assessed at 48 hours post-PCI and pre-discharge, and compared to baseline.
Time frame: Pre-procedure, 48 hours post-PCI and pre-discharge
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The First Hospital of Lanzhou University
Lanzhou, Gansu, China
RECRUITINGGuangdong Provincial People's Hospital
Guangzhou, Guangdong, China
RECRUITINGThe First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGThe 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGHunan Provincial People's Hospital
Changsha, Hunan, China
RECRUITINGChina-Japan Union Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGTangdu Hospital of Air Force Medical University
Xi'an, Shaanxi, China
NOT_YET_RECRUITINGShanghai East Hospital of Tongji University
Shanghai, Shanghai Municipality, China
RECRUITING...and 2 more locations
Change in New York Heart Association (NYHA) functional classification
Evaluated based on NYHA classification and compared to baseline.
Time frame: Pre-procedure and post-PCI
Combined incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 90 days post-PCI.
Major adverse events were defined as follows: death, new myocardial infarction, stroke, and target vessel revascularisation. Calculation formula: 90-day MACCE rate = Number of subjects experiencing any MACCE event within 90 days post-PCI ÷ Total number of subjects × 100%
Time frame: 90 days post-PCI