Evaluating a new heart support system for patients undergoing high-risk heart procedures

The Prospective, Multi-center, Single-arm Clinical Evaluation Trial of the CorVad Percutaneous Ventricular Assist System

This study is testing a new heart support system to see if it can help people with coronary artery disease during risky heart procedures.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Shenzhen Core Medical Technology CO.,LTD. (Industry-sponsored)
• Locations: 12 sites (Beijing, Beijing and 11 other locations)
• Trial ID: NCT06198998 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of the CorVad Percutaneous Ventricular Assist System for providing short-term support during high-risk percutaneous coronary interventions (HRPCI) in patients with coronary artery disease. It is a prospective, multicenter, single-arm trial aiming to enroll 120 subjects who are hemodynamically stable and require PCI. The study will measure the incidence of major adverse cardiovascular and cerebrovascular events (MACCE) within 30 days post-procedure. Participants will be monitored closely to assess the system's performance and safety.

Who should consider this trial

Good fit: Ideal candidates are patients aged 18 to 90 with coronary artery disease who are hemodynamically stable and require PCI but are at high risk for CABG.

Not a fit: Patients who are not hemodynamically stable or those who do not require PCI may not benefit from this study.

Why it matters

Potential benefit: If successful, this could provide a new option for patients undergoing high-risk heart procedures, potentially improving outcomes and reducing complications.

How similar studies have performed: Other studies have shown promise with similar ventricular assist devices, indicating potential for success in this approach.

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.

Where this trial is running

Beijing, Beijing and 11 other locations

• Fuwai Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing, China (Recruiting)
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Not_yet_recruiting)
• The First Hospital of Lanzhou University — Lanzhou, Gansu, China (Recruiting)
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)
• The First Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (Not_yet_recruiting)
• The 2nd Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (Not_yet_recruiting)
• Hunan Provincial People's Hospital — Changsha, Hunan, China (Recruiting)
• China-Japan Union Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
• Tangdu Hospital of Air Force Medical University — Xi'an, Shaanxi, China (Not_yet_recruiting)
• Shanghai East Hospital of Tongji University — Shanghai, Shanghai, China (Recruiting)
• Xijing Hospital of Air Force Military Medical University — Xi'an, Shanxi, China (Not_yet_recruiting)
• The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Ke Fei Dou — Cardiometabolic Center, Fuwai Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Xiaoli Shi

Conditions Coronary Artery Disease