Clinical trial NCT06198998: CorVad Percutaneous Ventricular Assist System Study
Official title: The Prospective, Multi-center, Single-arm Clinical Evaluation Trial of the CorVad Percutaneous Ventricular Assist System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Shenzhen Core Medical Technology CO.,LTD.
Sponsor class: INDUSTRY
First posted: 2024-01-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 1. 18 years old≤ patient age ≤90 years old;
* 2. Patient willing and able to comply with protocol requirements and data collection procedures; able to understand study purpose and sign informed consent;
* 3. 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);
* 4. The patient is hemodynamically stable and meeting one of the following:

  1. Left ventricular ejection fraction (LVEF) ≤30%, with multivessel disease, planning PCI to at least one complex lesion\* in a major epicardial vessel or branch;
  2. LVEF ≤35% and either:

     I. Unprotected left main intervention;

     II. Or last patent coronary conduit;
  3. 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:

* 1. ST-segment elevation myocardial infarction (STEMI) on ECG within 7 days;
* 2. Cardiac arrest requiring cardiopulmonary resuscitation within 24 hours pre-procedure;
* 3. Cardiogenic shock defined as meeting all of the following:

  1. Systolic blood pressure \<90mmHg, or requiring vasopressors/inotropes to maintain blood pressure \>90mmHg;
  2. Clinical evidence of end-organ hypoperfusion (cold extremities or urine output \<30ml/h), or use of IABP or other mechanical circulatory assist device;
  3. Cardiac index (CI) \<2.2L/min/m\^2 and pulmonary capillary wedge pressure (PCWP) \>15mmHg;
* 4. Presence of left ventricular thrombus;
* 5. Presence of mechanical aortic valve or cardiac contractility device;
* 6. Presence of moderate-to-severe aortic valve stenosis;
* 7. Presence of moderate-to-severe aortic valve insufficiency;
* 8. Deemed unable to tolerate percutaneous ventricular assist device based on clinical or imaging assessment, including iliac/femoral artery diameter \<6mm, severe tortuosity, severe bilateral iliofemoral/femoral artery disease, or other peripheral vascular disease;
* 9. Presence of aortic vascular disease or aortic dissection;
* 10. Presence of uncorrected, sustained ventricular arrhythmia causing inability to stable position percutaneous ventricular assist device;
* 11. History of stroke with permanent neurological deficit, intracerebral hemorrhage, subdural hematoma, or conditions predisposing to intracranial hemorrhage such as arteriovenous malformation or mass;
* 12. End-stage renal disease requiring dialysis or serum creatinine ≥4mg/dL;
* 13. Presence of potential bleeding diathesis or hypercoagulable state;
* 14. Pregnancy (for women of childbearing potential, pregnancy test required within 7 days prior to PCI procedure);
* 15. Presence of contraindication to anticoagulation;
* 16. History of liver failure, with ALT, AST, and bilirubin elevated to 3 times the upper limit of normal (ULN) or international normalized ratio (INR) ≥2;
* 17. Presence of uncorrected abnormal coagulation parameters (platelet count ≤75,000/mm\^3, INR≥2.0, or fibrinogen ≤1.50g/L);
* 18. Presence of uncontrolled active infection requiring antibiotic therapy;
* 19. Participation in any other clinical trial that may impact the results of this study;
* 20. Other circumstances that are unforeseen and determined by the investigator to be unsuitable for the study.

Primary outcomes:
measure: Combined incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days post-PCI.
timeFrame: 30 days post-PCI
Secondary outcomes:
measure: Hemodynamic stability during PCI procedure
timeFrame: During PCI procedure
measure: PCI procedural angiographic success rate
timeFrame: Post-PCI
measure: Change of aortic valve regurgitation
timeFrame: Pre-procedure and pre-discharge
measure: Change in creatinine clearance at 48 hours post-PCI
timeFrame: Pre-procedure and 48 hours post-PCI
measure: Change in left ventricular ejection fraction (LVEF) pre- and post-PCI
timeFrame: Pre-procedure, 48 hours post-PCI and pre-discharge
measure: Change in New York Heart Association (NYHA) functional classification
timeFrame: Pre-procedure and post-PCI
measure: Combined incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 90 days post-PCI.
timeFrame: 90 days post-PCI
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Harbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Harbin
country: China
facility: The 2nd Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Changsha
country: China
facility: Hunan Provincial People's Hospital
state: Hunan
city: Changchun
country: China
facility: China-Japan Union Hospital of Jilin University
state: Jilin
city: Xi'an
country: China
facility: Tangdu Hospital of Air Force Medical University
state: Shaanxi
city: Shanghai
country: China
facility: Shanghai East Hospital of Tongji University
state: Shanghai
city: Xi'an
country: China
facility: Xijing Hospital of Air Force Military Medical University
state: Shanxi
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Cardiometabolic Center, Fuwai Hospital, Chinese Academy of Medical Sciences
name: Ke Fei Dou
role: PRINCIPAL_INVESTIGATOR
References: