The Prospective, Multi-center, Single-arm Clinical Evaluation Trial of the CorVad Percutaneous Ventricular Assist System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Shenzhen Core Medical Technology CO.,LTD.
- Enrollment
- 120
- Locations
- 12
- Primary Endpoint
- Combined incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days post-PCI.
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 years old≤ patient age ≤90 years old;
- •Patient willing and able to comply with protocol requirements and data collection procedures; able to understand study purpose and sign informed consent;
- •As assessed by the cardiac team the patient needs coronary revascularization, but CABG (Coronary Artery Bypass Grafting) is of high risk, or the patient refuses to undergo CABG. After comprehensive evaluation, the cardiac team believes that the patient can benefit from PCI (Percutaneous Coronary Intervention);
- •The patient is hemodynamically stable and meeting one of the following:
- •Left ventricular ejection fraction (LVEF) ≤30%, with multivessel disease, planning PCI to at least one complex lesion\* in a major epicardial vessel or branch;
- •LVEF ≤35% and either:
- •I. Unprotected left main intervention;
- •II. Or last patent coronary conduit;
- •LVEF ≤40%, planning PCI to at least one complex lesion\* in a major epicardial vessel or branch. The intervention team confirms there is a risk of cardiac arrest or circulatory collapse. This must be confirmed by at least two associate senior physicians or one chief senior physician.
- •Complex lesions include moderate-to-severe calcification, chronic total occlusions (CTO), diffuse disease, bifurcation lesions, severe tortuosity, etc.
Exclusion Criteria
- •ST-segment elevation myocardial infarction (STEMI) on ECG within 7 days;
- •Cardiac arrest requiring cardiopulmonary resuscitation within 24 hours pre-procedure;
- •Cardiogenic shock defined as meeting all of the following:
- •Systolic blood pressure \<90mmHg, or requiring vasopressors/inotropes to maintain blood pressure \>90mmHg;
- •Clinical evidence of end-organ hypoperfusion (cold extremities or urine output \<30ml/h), or use of IABP or other mechanical circulatory assist device;
- •Cardiac index (CI) \<2.2L/min/m\^2 and pulmonary capillary wedge pressure (PCWP) \>15mmHg;
- •Presence of left ventricular thrombus;
- •Presence of mechanical aortic valve or cardiac contractility device;
- •Presence of moderate-to-severe aortic valve stenosis;
- •Presence of moderate-to-severe aortic valve insufficiency;
Outcomes
Primary Outcomes
Combined incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days post-PCI.
Time Frame: 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%
Secondary Outcomes
- Change in creatinine clearance at 48 hours post-PCI(Pre-procedure and 48 hours post-PCI)
- Change in New York Heart Association (NYHA) functional classification(Pre-procedure and post-PCI)
- Combined incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 90 days post-PCI.(90 days post-PCI)
- Hemodynamic stability during PCI procedure(During PCI procedure)
- PCI procedural angiographic success rate(Post-PCI)
- Change of aortic valve regurgitation(Pre-procedure and pre-discharge)
- Change in left ventricular ejection fraction (LVEF) pre- and post-PCI(Pre-procedure, 48 hours post-PCI and pre-discharge)